Sample records for research ethics review
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Is mandatory research ethics reviewing ethical?
Dyck, Murray; Allen, Gary
2013-08-01
Review boards responsible for vetting the ethical conduct of research have been criticised for their costliness, unreliability and inappropriate standards when evaluating some non-medical research, but the basic value of mandatory ethical review has not been questioned. When the standards that review boards use to evaluate research proposals are applied to review board practices, it is clear that review boards do not respect researchers or each other, lack merit and integrity, are not just and are not beneficent. The few benefits of mandatory ethical review come at a much greater, but mainly hidden, social cost. It is time that responsibility for the ethical conduct of research is clearly transferred to researchers, except possibly in that small proportion of cases where prospective research participants may be so intrinsically vulnerable that their well-being may need to be overseen.
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A 'good' ethical review: audit and professionalism in research ethics
DEFF Research Database (Denmark)
Douglas-Jones, Rachel
2015-01-01
How does one conduct, measure and record a ‘good’ ethical review of biomedical research? To what extent do ethics committees invoke professionalism in researchers and in themselves, and to what extent do they see competence as adherence to a set of standard operating procedures for ethical review......? Drawing on ethnographic fieldwork with the Forum of Ethics Review Committees of Asia and the Pacific (FERCAP), a capacity-building NGO that runs ethics committee trainings and reviews in the Asia Pacific region, I develop an analysis of ethical review and its effects. I focus on a ‘second-order audit’ run...... readings of ‘ethics’. I begin and end with a reflection on the ethical effects of a measurement practice that takes ethics itself as its object....
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Participatory action research: considerations for ethical review.
Khanlou, N; Peter, E
2005-05-01
This paper addresses the distinctive nature of participatory action research (PAR) in relation to ethical review requirements. As a framework for conducting research and reducing health disparities, PAR is gaining increased attention in community and public health research. As a result, PAR researchers and members of Research Ethics Boards could benefit from an increased understanding of the array of ethical concerns that can arise. We discuss these concerns in light of commonly held ethical requirements for clinical research (social or scientific value, scientific validity, fair subject/participant selection, favourable risk-benefit ratio, independent review, informed consent, and respect for potential and enrolled participants) and refer to guidelines specifically developed for participatory research in health promotion. We draw from our community-based experiences in mental health promotion research with immigrant and culturally diverse youth to illustrate the ethical advantages and challenges of applying a PAR approach. We conclude with process suggestions for Research Ethics Boards.
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Communicating Qualitative Research Study Designs to Research Ethics Review Boards
Ells, Carolyn
2011-01-01
Researchers using qualitative methodologies appear to be particularly prone to having their study designs called into question by research ethics or funding agency review committees. In this paper, the author considers the issue of communicating qualitative research study designs in the context of institutional research ethics review and offers…
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Getting the justification for research ethics review right.
Dunn, Michael
2013-08-01
Dyck and Allen claim that the current model for mandatory ethical review of research involving human participants is unethical once the harms that accrue from the review process are identified. However, the assumptions upon which the authors assert that this model of research ethics governance is justified are false. In this commentary, I aim to correct these assumptions, and provide the right justificatory account of the requirement for research ethics review. This account clarifies why the subsequent arguments that Dyck and Allen make in the paper lack force, and why the 'governance problem' in research ethics that they allude to ought to be explained differently.
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Research Ethics: Institutional Review Board Oversight of Art Therapy Research
Deaver, Sarah P.
2011-01-01
By having their research proposals reviewed and approved by Institutional Review Boards (IRBs), art therapists meet important ethical principles regarding responsibility to research participants. This article provides an overview of the history of human subjects protections in the United States; underlying ethical principles and their application…
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Ethical issues in trauma-related research: a review.
Newman, Elana; Risch, Elizabeth; Kassam-Adams, Nancy
2006-09-01
ETHICAL DECISION-MAKING ABOUT TRAUMA-RELATED STUDIES requires a flexible approach that counters assumptions and biases about victims, assures a favorable ethical cost-benefit ratio, and promotes advancement of knowledge that can benefit survivors of traumatic stress. This paper reviews several ethical issues in the field of traumatic stress: benefit and risks in trauma-related research, whether trauma-related research poses unique risks and if so what those might be, informed consent and mandatory reporting, and supervision of trauma-related research. For each topic, we review potential ethical issues, summarize the research conducted thus far to inform ethical practice, and recommend future practice, research questions and policies to advance the field so that research on trauma can continue to be a win-win situation for all stakeholders in the research enterprise.
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Nicholls, Stuart G; Hayes, Tavis P; Brehaut, Jamie C; McDonald, Michael; Weijer, Charles; Saginur, Raphael; Fergusson, Dean
2015-01-01
To date there is no established consensus of assessment criteria for evaluating research ethics review. We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction. Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial--randomised or otherwise--of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review. Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.
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Feasibility of rapid ethical assessment for the Ethiopian health research ethics review system.
Addissie, Adamu; Davey, Gail; Newport, Melanie; Farsides, Bobbie; Feleke, Yeweyenhareg
2015-01-01
One of the challenges in the process of ethical medical research in developing countries, including Ethiopia, is translating universal principles of medical ethics into appropriate informed consent documents and their implementation. Rapid Ethical Assessment (REA) has been suggested as a feasible approach to meet this application gap. In the past few years REA has been employed in few research project in Ethiopia and have been found to be a useful and practical approach. Feasibility assessment of REA for the Ethiopian research setting was conducted between 2012-2013 in order to inform the subsequent introduction of REA into research ethics review and governance system in the country. REA was found to be an appropriate, relevant and feasible venture. We argue that REA can be integrated as part of the ethics review and governance system in Ethiopia. REA tools and techniques are considered relevant and acceptable to the Ethiopian research community, with few practical challenges anticipated in their implementation. REA are considered feasible for integration in the Ethiopian ethics review system.
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Directory of Open Access Journals (Sweden)
Stuart G Nicholls
Full Text Available To date there is no established consensus of assessment criteria for evaluating research ethics review.We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction.Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial--randomised or otherwise--of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review.Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.
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Nicholls, Stuart G.; Hayes, Tavis P.; Brehaut, Jamie C.; McDonald, Michael; Weijer, Charles; Saginur, Raphael; Fergusson, Dean
2015-01-01
Background To date there is no established consensus of assessment criteria for evaluating research ethics review. Methods We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction. Results Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial - randomised or otherwise – of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review. Discussion Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review. PMID:26225553
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Ethical review from the inside: repertoires of evaluation in Research Ethics Committee meetings
de Jong, Jean Philippe; van Zwieten, Myra C. B.; Willems, Dick L.
2012-01-01
Evaluating the practice of ethical review by Research Ethics Committees (REC) could help protect the interests of human participants and promote scientific progress. To facilitate such evaluations, we conducted an ethnographic study of how an REC reviews research proposals during its meetings. We
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Human rights, politics, and reviews of research ethics.
Beyrer, Chris; Kass, Nancy E
2002-07-20
Although the human rights movement and the sphere of research ethics have overlapping principles and goals, there has been little attempt to incorporate external political and human rights contexts into research ethics codes or ethics reviews. Every element of a research ethics review--the balance of risks and benefits, the assurance of rights for individual participants, and the fair selection of research populations--can be affected by the political and human rights background in which a study is done. Research that at first seems to be low in risk may become high in risk if implemented in a country where the government might breach the confidentiality of study results or where results might be used to deport a refugee group. Researchers should determine whether research could or should be done by consulting human rights organisations and, when possible, a trusted colleague, to learn the background political context and human rights conditions of the settings in which they propose to do research.
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Measuring inconsistency in research ethics committee review.
Trace, Samantha; Kolstoe, Simon Erik
2017-11-28
The review of human participant research by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority (HRA) coordinates 67 committees, and has adopted a consistency improvement plan including a process called "Shared Ethical Debate" (ShED) where multiple committees review the same project. Committee reviews are compared for consistency by analysing the resulting minutes. We present a description of the ShED process. We report an analysis of minutes created by research ethics committees participating in two ShED exercises, and compare them to minutes produced in a published "mystery shopper" exercise. We propose a consistency score by defining top themes for each exercise, and calculating the ratio between top themes and total themes identified by each committee for each ShED exercise. Our analysis highlights qualitative differences between the ShED 19, ShED 20 and "mystery shopper" exercises. The quantitative measure of consistency showed only one committee across the three exercises with more than half its total themes as top themes (ratio of 0.6). The average consistency scores for the three exercises were 0.23 (ShED19), 0.35 (ShED20) and 0.32 (mystery shopper). There is a statistically significant difference between the ShED 19 exercise, and the ShED 20 and mystery shopper exercises. ShED exercises are effective in identifying inconsistency between ethics committees and we describe a scoring method that could be used to quantify this. However, whilst a level of inconsistency is probably inevitable in research ethics committee reviews, studies must move beyond the ShED methodology to understand why inconsistency occurs, and what an acceptable level of inconsistency might be.
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Research Ethics II: Mentoring, Collaboration, Peer Review, and Data Management and Ownership
Horner, Jennifer; Minifie, Fred D.
2011-01-01
Purpose: In this series of articles--"Research Ethics I", "Research Ethics II", and "Research Ethics III"--the authors provide a comprehensive review of the 9 core domains for the responsible conduct of research (RCR) as articulated by the Office of Research Integrity. In "Research Ethics II", the authors review the RCR domains of mentoring,…
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Directory of Open Access Journals (Sweden)
Bouësseau Marie-Charlotte
2008-03-01
Full Text Available Abstract Background Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants. Discussion Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices. The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals. Conclusion Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of
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ETHICAL REVIEW OF BIOMEDICAL RESEARCH IN BELARUS: CURRENT STATUS, PROBLEMS AND PERSPECTIVES.
Famenka, Andrei
2011-04-01
The paper provides description of the system of ethical review for biomedical research in Belarus, with special emphasis on its historical background, legal and regulatory framework, structure and functioning. It concludes that the situation with research ethics in Belarus corresponds to the tendency of bureaucratic approach to establishment of systems of ethical review for biomedical research, observed in a number of countries of Central and Eastern Europe. Different social, economical and political factors of transition have major impact on capacities of the Belarusian RECs to ensure adequate protection of human subjects. Among the main problems identified are non-equivalent stringency of ethical review for different types of biomedical research; lack of independence, multidisciplinarity, pluralism and lay representation experienced by RECs; low level of research ethics education and transparency of RECs activities. Recommendations are made to raise the issue of research ethics on the national agenda in order to develop and maintain the research ethics system capable to effectively protect research participants and promote ethical conduct in research.
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Directory of Open Access Journals (Sweden)
Matthew Hunt
Full Text Available Research conducted following natural disasters such as earthquakes, floods or hurricanes is crucial for improving relief interventions. Such research, however, poses ethical, methodological and logistical challenges for researchers. Oversight of disaster research also poses challenges for research ethics committees (RECs, in part due to the rapid turnaround needed to initiate research after a disaster. Currently, there is limited knowledge available about how RECs respond to and appraise disaster research. To address this knowledge gap, we investigated the experiences of REC members who had reviewed disaster research conducted in low- or middle-income countries.We used interpretive description methodology and conducted in-depth interviews with 15 respondents. Respondents were chairs, members, advisors, or coordinators from 13 RECs, including RECs affiliated with universities, governments, international organizations, a for-profit REC, and an ad hoc committee established during a disaster. Interviews were analyzed inductively using constant comparative techniques.Through this process, three elements were identified as characterizing effective and high-quality review: timeliness, responsiveness and rigorousness. To ensure timeliness, many RECs rely on adaptations of review procedures for urgent protocols. Respondents emphasized that responsive review requires awareness of and sensitivity to the particularities of disaster settings and disaster research. Rigorous review was linked with providing careful assessment of ethical considerations related to the research, as well as ensuring independence of the review process.Both the frequency of disasters and the conduct of disaster research are on the rise. Ensuring effective and high quality review of disaster research is crucial, yet challenges, including time pressures for urgent protocols, exist for achieving this goal. Adapting standard REC procedures may be necessary. However, steps should be
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Measuring inconsistency in research ethics committee review
Trace, Samantha; Kolstoe, Simon Erik
2017-01-01
Background The review of human participant research by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority (HRA) coordinates 67 committees, and has adopted a consistency improvement plan including a process called “Sha...
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Guta, Adrian; Nixon, Stephanie A; Wilson, Michael G
2013-12-01
In this paper we examine "ethics creep", a concept developed by Haggerty (2004) to account for the increasing bureaucratization of research ethics boards and institutional review boards (REB/IRBs) and the expanding reach of ethics review. We start with an overview of the recent surge of academic interest in ethics creep and similar arguments about the prohibitive effect of ethics review. We then introduce elements of Michel Foucault's theoretical framework which are used to inform our analysis of empirical data drawn from a multi-phase study exploring the accessibility of community-engaged research within existing ethics review structures in Canada. First, we present how ethics creep emerged both explicitly and implicitly in our data. We then present data that demonstrate how REB/IRBs are experiencing their own form of regulation. Finally, we present data that situate ethics review alongside other trends affecting the academy. Our results show that ethics review is growing in some ways while simultaneously being constrained in others. Drawing on Foucauldian theory we reframe ethics creep as a repressive hypothesis which belies the complexity of the phenomenon it purports to explain. Our discussion complicates ethics creep by proposing an understanding of REB/IRBs that locates them at the intersection of various neoliberal discourses about the role of science, ethics, and knowledge production. Copyright © 2012 Elsevier Ltd. All rights reserved.
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A Swedish perspective on research ethics review
Directory of Open Access Journals (Sweden)
Hans Thulesius, M.D., G.P., Ph.D.
2010-12-01
Full Text Available I have participated in writing ethical approval applications for research projects in Sweden a dozen times. I am also since some years a member of the local ethics advisory board in a mostly rural area serving 180.000 people. From that position I advise on what types of local project applications will have to be sent further to the regional ethics committee, REPN in Sweden. With that background I will try to give a brief Swedish perspective on research ethics reviews in general and regarding CGT (classic grounded theory studies using qualitative data in particular.The most famous Swedish example of unethical research is the 1947-1951 Vipeholm sugar trial (Krasse, 2001. Several hundred intellectually and mentally challenged persons at the Vipeholm institution were for years given an excess amount of sugar, mostly in the shape of candy. This resulted in caries that totally ruined the teeth of 50 persons. Of course participants did not give informed consent. Yet, at the time the research was not considered unethical. At least there was no debate about it.
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Research Ethics Review and Aboriginal Community Values: Can the Two be Reconciled?
Glass, Kathleen Cranley; Kaufert, Joseph
2007-06-01
CONTEMPORARY RESEARCH ETHICS REVIEW COMMITTEES (RECs) are heavily influenced by the established academic or health care institutional frameworks in which they operate, sharing a cultural, methodological and ethical perspective on the conduct of research involving humans. The principle of autonomous choice carries great weight in what is a highly individualistic decision-making process in medical practice and research. This assumes that the best protection lies in the ability of patients or research participants to make competent, voluntary, informed choices, evaluating the risks and benefits from a personal perspective. Over the past two decades, North American and international indigenous researchers, policy makers and communities have identified key issues of relevance to them, but ignored by most institutional or university-based RECs. They critique the current research review structure, and propose changes on a variety of levels in an attempt to develop more community sensitive research ethics review processes. In doing so, they have emphasized recognition of collective rights including community consent. Critics see alternative policy guidelines and community-based review bodies as challenging the current system of ethics review. Some view them as reflecting a fundamental difference in values. In this paper, we explore these developments in the context of the political, legal and ethical frameworks that have informed REC review. We examine the process and content of these frameworks and ask how this contrasts with emerging Aboriginal proposals for community-based research ethics review. We follow this with recommendations on how current REC review models might accommodate the requirements of both communities and RECs.
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Piasecki, Jan; Waligora, Marcin; Dranseika, Vilius
2017-06-01
Epidemiological research is subject to an ethics review. The aim of this qualitative review is to compare existing ethical guidelines in English for epidemiological research and public health practice in regard to the scope and matter of an ethics review. Authors systematically searched PubMed, Google Scholar and Google Search for ethical guidelines. Qualitative analysis (constant comparative method) was applied to categorize important aspects of the an ethics review process. Eight ethical guidelines in English for epidemiological research were retrieved. Five main categories that are relevant to the review of epidemiological research by Institutional Review Boards/Research Ethics Committees were distinguished. Within the scope of main categories, fifty-nine subcategories were analyzed. There are important differences between the guidelines in terms of the scope and matter of an ethics review. Not all guidelines encompass all identified ethically important issues, and some do not define precisely the scope and matter of an ethics review, leaving much to the ethics of the individual researchers and the discretion of IRBs/RECs.
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Contesting the science/ethics distinction in the review of clinical research
Dawson, Angus J; Yentis, Steve M
2007-01-01
Recent policy in relation to clinical research proposals in the UK has distinguished between two types of review: scientific and ethical. This distinction has been formally enshrined in the recent changes to research ethics committee (REC) structure and operating procedures, introduced as the UK response to the EU Directive on clinical trials. Recent reviews and recommendations have confirmed the place of the distinction and the separate review processes. However, serious reservations can be mounted about the science/ethics distinction and the policy of separate review that has been built upon it. We argue here that, first, the science/ethics distinction is incoherent, and, second, that RECs should not only be permitted to consider a study's science, but that they have anobligation do so. PMID:17329389
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Institutional ethical review and ethnographic research involving injection drug users: a case study.
Small, Will; Maher, Lisa; Kerr, Thomas
2014-03-01
Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators' responses to the committee's concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork, and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. Copyright © 2013 Elsevier Ltd. All rights reserved.
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Ethics review of health research on human participants in South Africa.
van Wyk, Christa
2010-06-01
In terms of South African legislation, all health research on human participants must be submitted to an accredited research ethics committee for independent ethics review. Health research covers a broad spectrum of research, including clinical trials. This article sets out the ethical-legal framework for the functioning and composition of such committees. It also deals with the newly created National Health Research Ethics Council, which registers and audits health research ethics committees. Special attention is given to the conduct of clinical trials. In conclusion, it is submitted that the National Health Act, the Draft Regulations Relating to Research on Human Subjects, and two sets of ethical guidelines adopted by the Department of Health provide a much needed and coherent ethical-legal framework for research in South Africa.
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Bevan, Joan C
2007-04-01
This review will examine research ethics in the context of globalization of clinical trials and recent rapid developments in bioscience. It will focus on international ethical guidelines and the functions of research ethics review boards in research governance. Consent issues in genetic research, which must comply with privacy laws by protecting confidentiality and privacy of personal health data, will be discussed. There has been a rapid expansion of genomic and proteonomic research and biotechnology in the last decade. International ethical guidelines have been updated and the bioscience industry has developed ethics policies. At the same time, problems in academic anesthesia in the US and UK have been identified, leading to recommendations to train physician-scientists in anesthesia to stimulate research activity in the future. Anesthesiologists are joining interdisciplinary research teams and the concept of evidence-based translational research is emerging. Anesthesiologists are moving towards participation in interdisciplinary research teams. They are well placed to speed the translation of research discovery into clinical practice and provide evidence-based perioperative care. This review provides the ethical framework that anesthesiologists will need to meet the challenges of this changing pattern of practice.
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2014-01-01
Background Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs’ perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently. Methods A web-based survey with closed- and open-ended questions was administered to research ethics chairs in Canada, the United States, and the United Kingdom. The survey presented three scenarios of CRTs involving cluster-level, professional-level, and individual-level interventions. For each scenario, a series of questions was posed with respect to the type of review required (full, expedited, or no review) and the identification of research subjects at cluster and individual levels. Results A total of 189 (35%) of 542 chairs responded. Overall, 144 (84%, 95% CI 79 to 90%) agreed or strongly agreed that there is a need for ethics guidelines for CRTs and 158 (92%, 95% CI 88 to 96%) agreed or strongly agreed that research ethics committees could be better informed about distinct ethical issues surrounding CRTs. There was considerable variability among research ethics chairs with respect to the type of review required, as well as the identification of research subjects. The cluster-cluster and professional-cluster scenarios produced the most disagreement. Conclusions Research ethics committees
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Ethics approval: responsibilities of journal editors, authors and research ethics committees.
Bain, Luchuo Engelbert
2017-01-01
Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research participants and uses tax payers' money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. Most researchers mistake scientific clearance or approval, for ethics approval. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks for the research participants.The researcher has the responsibility of systematically consulting the competent ethics committee for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to systematically evaluate the ethical soundness of manuscripts submitted for review. Capacity building in research ethics and institutional support for Research Ethics Committees to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from ethics committees functioning purely on altruistic grounds. Capacity building for researchers in research ethics, and institutional reforms and support for Research Ethics Committees appear not to have received the attention they truly deserve.
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Adams, Pornpimon; Prakobtham, Sukanya; Limphattharacharoen, Chanthima; Vutikes, Pitchapa; Khusmith, Srisin; Pengsaa, Krisana; Wilairatana, Polrat; Kaewkungwal, Jaranit
2015-09-14
Malaria research is typically conducted in developing countries in areas of endemic disease. This raises specific ethical issues, including those related to local cultural concepts of health and disease, the educational background of study subjects, and principles of justice at the community and country level. Research Ethics Committees (RECs) are responsible for regulating the ethical conduct of research, but questions have been raised whether RECs facilitate or impede research, and about the quality of REC review itself. This study examines the review process for malaria research proposals submitted to the Ethics Committee of the Faculty of Tropical Medicine at Mahidol University, Thailand. Proposals for all studies submitted for review from January 2010 to December 2014 were included. Individual REC members' reviewing forms were evaluated. Ethical issues (e.g., scientific merit, risk-benefit, sample size, or informed-consent) raised in the forms were counted and analysed according to characteristics, including study classification/design, use of specimens, study site, and study population. All 114 proposals submitted during the study period were analysed, comprising biomedical studies (17 %), drug trials (13 %), laboratory studies (24 %) and epidemiological studies (46 %). They included multi-site (13 %) and international studies (4 %), and those involving minority populations (28 %), children (17 %) and pregnant women (7 %). Drug trials had the highest proportion of questions raised for most ethical issues, while issues concerning privacy and confidentiality tended to be highest for laboratory and epidemiology studies. Clarifications on ethical issues were requested by the ethics committee more for proposals involving new specimen collection. Studies involving stored data and specimens tended to attract more issues around privacy and confidentiality. Proposals involving minority populations were more likely to raise issues than those that did not
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Wynn, L L
2016-04-01
In the human sciences, a student research-centered pedagogy is constrained by institutional ethics review, yet there is little research on the impact of ethics review on research-led teaching. This article documents a range of ways that Australian universities are responding to ethics review of undergraduate human research. Forty teachers and administrators were interviewed at 14 universities using purposive sampling to document the range of ways teachers are avoiding ethics review or incorporating it into their curriculum. Some reported halting undergraduate research or evading ethics review, regarding it as meaningless bureaucracy divorced from actual ethical thinking. Those who incorporated ethics review into student research did so by collaborating with administrators. Institutions can facilitate research-led teaching by designing dedicated forms and decentralized review procedures for student research. © The Author(s) 2016.
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Ethical Issues in Radiology Journalism, Peer Review, and Research.
Katz, Douglas S; Gardner, James B; Hoffmann, Jason C; Patlas, Michael N; Bhargava, Puneet; Moshiri, Mariam; Remer, Erick M; Gould, Elaine S; Smith, Stacy
2016-08-17
Although some research and publication practices are clearly unethical, including fraud and plagiarism, other areas of research and publication, such as informed consent and conflicts of interest, fall into grayer areas. The purposes of this article are, therefore, to review a variety of relevant ethical issues in radiology-related journalism, peer review, and research; to review the radiology literature to date that has addressed these issues; and to present position statements and potential solutions to these problems.
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Ethical considerations in sexual health research: A narrative review
Directory of Open Access Journals (Sweden)
Maryam Shirmohammadi
2018-01-01
Full Text Available Background: There is an assumption that sexual health research has great influence on the quality of human life through elevating sexual health standards, and their results will eliminate the burden of sexual health challenges on family relationships. The aim of this study was to review ethical considerations in sexual health research. Materials and Methods: This narrative review was conducted between January 1990 and December 2017 based on the five-step approach of York University. The keywords used to search for the studies included ethical issues, research, sexual health, reproductive health, and sensitive topics. The language of the literatures was English and the search process was performed on PubMed, Elsevier, Ovid, Springer, Google Scholar, ResearchGate, SAGE Publishing, ProQuest, WHO website, Kinsey Confidential, and Worldsexology. Results: After assessing the quality and eligibility of 94 articles, 13 were selected. The results of the present study showed that the most important ethical considerations were protecting the confidentiality and privacy of participants, obtaining informed consent, and paying attention to vulnerable people. Conclusions: The review of literature exhibited several considerations that sexual health researchers are faced with. In order to manage these considerations, the researcher should have sufficient understanding of them. The important matter is that strategies to manage these challenges should be completely rational and practical according to each context. These strategies can also be applied in other societies with great similarities in their context.
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Flicker, Sarah; Travers, Robb; Guta, Adrian; McDonald, Sean; Meagher, Aileen
2007-07-01
National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of "knowledge production" is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework more
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Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara
2018-01-01
Background Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of...
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Farajkhoda, Tahmineh
2017-01-01
Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs) research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies), appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights) in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening legislation systems
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Farajkhoda, Tahmineh
2017-02-01
Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs) research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies), appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights) in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening legislation systems
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Ethical review of research on human subjects at Unilever: reflections on governance.
Sheehan, Mark; Marti, Vernon; Roberts, Tony
2014-07-01
This article considers the process of ethical review of research on human subjects at a very large multinational consumer products company. The commercial context of this research throws up unique challenges and opportunities that make the ethics of the process of oversight distinct from mainstream medical research. Reflection on the justification of governance processes sheds important, contrasting light on the ethics of governance of other forms and context of research. © 2013 John Wiley & Sons Ltd.
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Research ethics for clinical researchers.
Harnett, John D; Neuman, Richard
2015-01-01
This chapter describes the history of the development of modern research ethics. The governance of research ethics is discussed and varies according to geographical location. However, the guidelines used for research ethics review are very similar across a wide variety of jurisdictions. The paramount importance of protecting the privacy and confidentiality of research participants is discussed at length. Particular emphasis is placed on the process of informed consent, and step-by-step practical guidelines are described. The issue of research in vulnerable populations is touched upon and guidelines are provided. Practical advice is provided for researchers to guide their interactions with research ethics boards. Issues related to scientific misconduct and research fraud are not dealt with in this paper.
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International Nuclear Information System (INIS)
Schreiner-Karoussou, A.
2008-01-01
A literature review was carried out in relation to general medical research and radiation protection research. A large number of documents were found concerning the subject of ethics in general medical research. For radiation protection research, the number of documents and the information available is very limited. A review of practices in 13 European countries concerning general medical research and radiation protection research was carried out by sending a questionnaire to each country. It was found that all countries reviewed were well regulated for general medical research. For research that involves ionising radiation, the UK and Ireland are by far the most regulated countries. For other countries, there does not seem to be much information available. From the literature review and the review of practices, a number of existing ethical issues were identified and exposed, and a number of conclusions were drawn. (authors)
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Dean, Peter J.
1993-01-01
Provides a review of the key ethical theories and relevant empirical research relating to the practice of human performance technology. Topics addressed include ethics, morals, business ethics, ethics officers, empiricism versus normative ethical theory, consequentialism, utilitarianism, nonconsequentialism, Kohlberg model of cognitive moral…
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Ethics, Ethical Human Research and Human Research Ethics Committees
Lindorff, Margaret
2010-01-01
Non-medical research involves the same issues of justice, beneficence, and respect for persons that apply to non-medical research. It also may involve risk of harm to participants, and conflicts of interest for researchers. It is therefore not possible to argue that such research should be exempt from ethical review. This paper argues that…
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Directory of Open Access Journals (Sweden)
Tahmineh Farajkhoda
2017-08-01
Full Text Available Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies, appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening
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Ethical considerations for field research on fishes
Directory of Open Access Journals (Sweden)
Rhett H. Bennett
2016-12-01
Full Text Available Collection of data from animals for research purposes can negatively impact target or by-catch species if suitable animal ethics practices are not followed. This study aimed to assess the ethical requirements of peer-reviewed scientific journals that publish primary literature on fishes, and review the ethical considerations and animal care guidelines of national and international documents on the ethical treatment of animals for research, to provide an overview of the general ethical considerations for field research on fishes. A review of 250 peer-reviewed, ISI-rated journals publishing primary research on fishes revealed that nearly half (46% had no mention of ethics, treatment of animals or ethical requirements for publication in their author guidelines or publication policies. However, 18% of the journals reviewed identify a specific set of ethical guidelines to be followed before publishing research involving animals. Ethical considerations for investigators undertaking field research on fishes, common to most animal care policies, legislation and guiding documents, include adhering to relevant legislation, minimising sample sizes, reducing or mitigating pain and distress, employing the most appropriate and least invasive techniques and accurately reporting methods and findings. This information will provide potential investigators with a useful starting point for designing and conducting ethical field research. Application of ethical best practices in field sampling studies will improve the welfare of study animals and the conservation of rare and endangered species. Conservation implications: This article provides a list of ethical considerations for designing and conducting field research on fishes. By reviewing sampling techniques and processes that are frequently used in field research on fishes and by highlighting the potential negative impacts of these sampling techniques, this article is intended to assist researchers in planning
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Travers, Robb; Guta, Adrian; McDonald, Sean; Meagher, Aileen
2007-01-01
National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of “knowledge production” is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework
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Research Ethics: Reforming Postgraduate Formation
Vallance, Roger J.
2005-01-01
Research ethics is not only a matter of doing no harm, or even abiding by the guidelines of the Ethics Review Board of the institution. While these matters are important and legal requirements, there is much more at stake in discussions of research ethics. Research ethics establish the foundation upon which research rests. Taking the social…
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Qualitative research ethics on the spot
DEFF Research Database (Denmark)
Sørensen, Nelli Øvre; Øye, Christine; Glasdam, Stinne
2015-01-01
Abstract Background: The increase in medical ethical regulations and bureaucracy handled by institutional review boards and healthcare institutions puts the researchers using qualitative methods in a challenging position. Method: Based on three different cases from three different research studies...... research ethical guidelines related to informed consent and doing no harm. Third, the article argues for the importance of having research ethical guidelines and review boards to question and discuss the possible ethical dilemmas that occur in qualitative research. Discussion and conclusion: Research...... ethics must be understood in qualitative research as relational, situational, and emerging. That is, that focus on ethical issues and dilemmas has to be paid attention on the spot and not only at the desktop....
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Luk, Hsiang-Ning; Ennever, John F; Day, Yuan-Ji; Wong, Chih-Shung; Sun, Wei-Zen
2015-03-01
For this guidance article, the Ethics Review Task Force (ERTF) of the Journal reviewed and discussed the ethics issues related to publication of human research in the field of anesthesia. ERTF first introduced international ethics principles and minimal requirements of reporting of ethics practices, followed by discussing the universal problems of publication ethics. ERTF then compared the accountability and methodology of several medical journals in assuring authors' ethics compliance. Using the Taiwan Institutional Review Board system as an example, ERTF expressed the importance of institutional review board registration and accreditation to assure human participant protection. ERTF presented four major human research misconducts in the field of anesthesia in recent years. ERTF finally proposed a flow-chart to guide journal peer reviewers and editors in ethics review during the editorial process in publishing. Examples of template languages applied in the Ethics statement section in the manuscript are expected to strengthen the ethics compliance of the authors and to set an ethical culture for all the stakeholders involved in human research. Copyright © 2015. Published by Elsevier B.V.
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Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara
2018-01-11
Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of clinical trials (chapters II and IV in 'Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants' in Lebanon?' This was a quantitative and descriptive questionnaire-based study conducted among RECs of university hospitals in Lebanon. The questionnaire had to be completed online and included general questions in addition to items reflecting the different aspects of a REC performance and effectiveness. All the questionnaire was assigned a total score of 175 points. General information and questions assigned point values/scores were analysed using descriptive statistics: frequency and percentage, mean score ± standard deviation. Ten RECs participated in the study (52 persons: four chairs, one vice-president, 47 ordinary members). Forty-seven (90.4%) had previous experience with clinical research and 30 (57.7%) had a diploma or had done a training in research ethics. Forty-one percent confirmed that they were required to have a training in research ethics. All RECs had a policy for disclosing and managing potential conflicts of interest for its members, but 71.8% of participants reported the existence of such a policy for researchers. Thirty-three point three percent reported that the RECs had an anti-bribery policy. The questionnaire mean score was 129.6 ± 22.3/175 points reflecting thus an excellent adherence to international standards. Inadequate training of REC members and the lack of anti-bribery policies should be resolved to
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Internet Research Ethics and the Policy Gap for Ethical Practice in Online Research Settings
Warrell, Jacqueline G.; Jacobsen, Michele
2014-01-01
A growing number of education and social science researchers design and conduct online research. In this review, the Internet Research Ethics (IRE) policy gap in Canada is identified along with the range of stakeholders and groups that either have a role or have attempted to play a role in forming better ethics policy. Ethical issues that current…
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Ethical Issues in Internet Research: International Good Practice and Irish Research Ethics Documents
Felzmann, Heike
2013-01-01
This chapter discusses the main research ethical concerns that arise in internet research and reviews existing research ethical guidance in the Irish context in relation to its application to internet research. The chapter begins with a brief outline of high profile cases in the early history of the internet that highlighted specific emerging…
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Artal, Raul; Rubenfeld, Sheldon
2017-08-01
Biomedical research is currently guided by ethical standards that have evolved over many centuries. Historical and political events, social and legal considerations, and continuous medical and technological advances have led to the prevailing research ethics and practice. Currently, patients and research subjects have complete autonomy while under medical care or when volunteering as research subjects. Enrolling volunteers in human subjects research includes a detailed and meaningful informed consent process that follows the cardinal principles of ethics: autonomy, beneficence, nonmaleficence, and justice. These principles were gradually adopted after World War II, primarily in response to the unethical behavior of German physicians and scientists during the Third Reich. This review emphasizes the importance of historical milestones and the essential role that ethics has in contemporary medical research. Research protocols should achieve maximum benefits for the society, have clinical and scientific value, be subject to independent review, respect human dignity, and follow the principles of informed consent, and most importantly, subjects should have complete autonomy. However, current principles and regulations cannot cover every conceivable situation, particularly in view of the new advances in science and technology. New and evolving medical technology, genetic research, therapeutic interventions, and innovations challenge society to maintain the highest moral and ethical principles. Copyright © 2017. Published by Elsevier Ltd.
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Kim, Jongyoung; Park, Kibeom
2013-06-01
The Hwang affair, a dramatic and far reaching instance of scientific fraud, shocked the world. This collective national failure prompted various organizations in Korea, including universities, regulatory agencies, and research associations, to engage in self-criticism and research ethics reforms. This paper aims, first, to document and review research misconduct perpetrated by Hwang and members of his research team, with particular attention to the agencies that failed to regulate and then supervise Hwang's research. The paper then examines the research ethics reforms introduced in the wake of this international scandal. After reviewing American and European research governance structures and policies, policy makers developed a mixed model mindful of its Korean context. The third part of the paper examines how research ethics reform is proactive (a response to shocking scientific misconduct and ensuing external criticism from the press and society) as well as reactive (identification of and adherence to national or international ethics standards). The last part deals with Korean society's response to the Hwang affair, which had the effect of a moral atomic bomb and has led to broad ethical reform in Korean society. We conceptualize this change as ethical modernization, through which the Korean public corrects the failures of a growth-oriented economic model for social progress, and attempts to create a more trustworthy and ethical society.
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Edwards, Hillary Anne; Hifnawy, Tamer; Silverman, Henry
2015-12-01
Recently, training programs in research ethics have been established to enhance individual and institutional capacity in research ethics in the developing world. However, commentators have expressed concern that the efforts of these training programs have placed 'too great an emphasis on guidelines and research ethics review', which will have limited effect on ensuring ethical conduct in research. What is needed instead is a culture of ethical conduct supported by national and institutional commitment to ethical practices that are reinforced by upstream enabling conditions (strong civil society, public accountability, and trust in basic transactional processes), which are in turn influenced by developmental conditions (basic freedoms of political freedoms, economic facilities, social opportunities, transparency guarantees, and protective security). Examining this more inclusive understanding of the determinants of ethical conduct enhances at once both an appreciation of the limitations of current efforts of training programs in research ethics and an understanding of what additional training elements are needed to enable trainees to facilitate national and institutional policy changes that enhance research practices. We apply this developmental model to a training program focused in Egypt to describe examples of such additional training activities. © 2014 John Wiley & Sons Ltd.
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Horner, Jennifer; Minifie, Fred D.
2011-01-01
Purpose: In this series of articles--"Research Ethics I", "Research Ethics II", and "Research Ethics III"--the authors provide a comprehensive review of the 9 core domains for the responsible conduct of research (RCR) as articulated by the Office of Research Integrity. Method: In "Research Ethics III", they review the RCR domains of publication…
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A Scoping Study on the Ethics of Health Systems Research.
Bachani, Abdulgafoor M; Rattani, Abbas; Hyder, Adnan A
2016-12-01
Currently, health systems research (HSR) is reviewed by the same ethical standards as clinical research, which has recently been argued in the literature to be an inappropriate standard of evaluation. The issues unique to HSR warrant a different review by research ethics committees (RECs), as it does not impose the same risks to study participants as other types of clinical or public health research. However, there are limited tools and supporting documents that clarify the ethical considerations. Therefore, there is a need for additional reflection around ethical review of HSR and their consideration by RECs. The purpose of this paper is to review, understand, and synthesize the current state of literature and practice to inform these deliberations and the larger discourse on ethics review guidelines for HSR. This paper presents a review of the literature on ethics of HSR in the biomedical, public health, and implementation research to identify ethical considerations specific to HSR; and to identify examples of commonly available guidance and/or tools for the ethical review of HSR studies. Fifteen articles were identified on HSR ethics issues, and forty-two international academic institutions were contacted (of the responses (n=29), no institution had special ethical guidelines for reviewing HSR) about their HSR ethics review guidelines. There appears to be a clear gap in the current health research ethics discourse around health systems research ethics. This review serves as a first step (to better understand the current status) towards a larger dialogue on the topic. © 2016 John Wiley & Sons Ltd.
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International Nuclear Information System (INIS)
Kwon, Hyuk; Min, Byung Joo
2007-01-01
After Dr. Hwang's Human embryonic stem cell scandal, research ethics stood out as the hot issue in both Korean scientific circles and general public. Science Publishing Group referred the limitation of peer review system and the absence of responsibility of author to one of the causes for the scandal. In order to prevent a similar fraud, Ministry of Science and Technology(MOST) established guidelines for research ethics and integrity in 2006. The guidelines included fabrication, falsification, and plagiarism(FFP) and unfair authorship. MOST committed the authority of administration and supervision to the society and the institutes of research to preserve the research integrity. The society and institute are charged with overseeing the implementation of enacted ethics guidelines. SCI(Scientific Citation Index) holds the guideline of research ethics and canon of the society which were crafted in order to guaranty the integrity and quality of the research. The publication policy pertains submission of articles, authorship and responsibilities of a reviewer. Societies pay attention to the peer review policy because the quality of articles is strongly dependent on the peer review. Nuclear Engineering and Technology (NET) is the journal of Korea Nuclear Society(KNS). NET is registered with SCIE(Science Citation Index Expanded), recently. In addition to the growth in external circulation, the improvement of quality requires the effort of the society to establish a strict peer review system and a fair authorship. The qualitative study on peer review and authorship of NET was put into force to improve the quality of NET. Based on studies and suggestions, the policy focuses on research ethics to improve the integrity of NET
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Energy Technology Data Exchange (ETDEWEB)
Kwon, Hyuk; Min, Byung Joo [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)
2007-10-15
After Dr. Hwang's Human embryonic stem cell scandal, research ethics stood out as the hot issue in both Korean scientific circles and general public. Science Publishing Group referred the limitation of peer review system and the absence of responsibility of author to one of the causes for the scandal. In order to prevent a similar fraud, Ministry of Science and Technology(MOST) established guidelines for research ethics and integrity in 2006. The guidelines included fabrication, falsification, and plagiarism(FFP) and unfair authorship. MOST committed the authority of administration and supervision to the society and the institutes of research to preserve the research integrity. The society and institute are charged with overseeing the implementation of enacted ethics guidelines. SCI(Scientific Citation Index) holds the guideline of research ethics and canon of the society which were crafted in order to guaranty the integrity and quality of the research. The publication policy pertains submission of articles, authorship and responsibilities of a reviewer. Societies pay attention to the peer review policy because the quality of articles is strongly dependent on the peer review. Nuclear Engineering and Technology (NET) is the journal of Korea Nuclear Society(KNS). NET is registered with SCIE(Science Citation Index Expanded), recently. In addition to the growth in external circulation, the improvement of quality requires the effort of the society to establish a strict peer review system and a fair authorship. The qualitative study on peer review and authorship of NET was put into force to improve the quality of NET. Based on studies and suggestions, the policy focuses on research ethics to improve the integrity of NET.
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Towards an ethics safe harbor for global biomedical research
Dove, Edward S.; Knoppers, Bartha M.; Zawati, Ma'n H.
2014-01-01
Although increasingly global, data-driven genomics and other ‘omics’-focused research hold great promise for health discoveries, current research ethics review systems around the world challenge potential improvements in human health from such research. To overcome this challenge, we propose a ‘Safe Harbor Framework for International Ethics Equivalency’ that facilitates the harmonization of ethics review of specific types of data-driven international research projects while respecting globally transposable research ethics norms and principles. The Safe Harbor would consist in part of an agency supporting an International Federation for Ethics Review (IFER), formed by a voluntary compact among countries, granting agencies, philanthropies, institutions, and healthcare, patient advocacy, and research organizations. IFER would be both a central ethics review body, and also a forum for review and follow-up of policies concerning ethics norms for international research projects. It would be built on five principle elements: (1) registration, (2) compliance review, (3) recognition, (4) monitoring and enforcement, and (5) public participation. The Safe Harbor would create many benefits for researchers, countries, and the general public, and may eventually have application beyond (gen)omics to other areas of biomedical research that increasingly engage in secondary use of data and present only negligible risks. PMID:27774154
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Hazy Boundaries: Virtual Communities and Research Ethics
Directory of Open Access Journals (Sweden)
Helena Kantanen
2016-10-01
Full Text Available This paper examines ethical issues specific to research into virtual communities. Drawing on an empirical case with online forums of education experts, we identify the following key issues: publicity versus privacy of the community; the definition of human subjects research; participant recruitment; informed consent; and ethical questions associated with observing virtual communities, and with reporting and disseminating research results. We maintain that different research cultures in different countries can present challenges when studying global forums. Acknowledging the ephemeral characteristics of Internet contexts, this paper argues that ethical considerations should be more case-based, instead of relying on one model for all solutions. We suggest that local ethics committees or institutional review boards could, with their expert knowledge of ethics, provide valuable support for researchers operating in the complex and dynamic terrain of Internet research, as well as in fields and research settings where an ethical review is not a standard part of the research process.
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A new prescription for empirical ethics research in pharmacy: a critical review of the literature
Cooper, R J; Bissell, P; Wingfield, J
2007-01-01
Empirical ethics research is increasingly valued in bioethics and healthcare more generally, but there remain as yet under-researched areas such as pharmacy, despite the increasingly visible attempts by the profession to embrace additional roles beyond the supply of medicines. A descriptive and critical review of the extant empirical pharmacy ethics literature is provided here. A chronological change from quantitative to qualitative approaches is highlighted in this review, as well as differi...
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Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E
2016-04-01
A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
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Ethics of health policy and systems research: a scoping review of the literature.
Pratt, Bridget; Paul, Amy; Hyder, Adnan A; Ali, Joseph
2017-07-01
Health policy and systems research (HPSR) is increasingly funded and undertaken as part of health system strengthening efforts worldwide. HPSR ethics is also a relatively new and emerging field, with numerous normative and descriptive questions that have largely not been considered. Normative questions include what ethical principles and values should guide HPSR. Descriptive questions include what ethical concerns arise when conducting HPSR. A small but growing body of scholarly work characterizes the various ethics issues inherent in HPSR. Towards informing the future development of ethics guidance for HPSR, a scoping review was undertaken to: (1) identify the range of ethics issues relevant to the conduct of HPSR-with a deliberate (though not exclusive) focus on low- and middle-income country settings and (2) describe existing guidance on key ethics issues relevant to HPSR. Using the Cochrane methods as a basis, the review identified formal and informal literature on HPSR ethics by searching the following databases: PubMed's Medline, Embase, Global Health, Scopus, WHO Global Health Regional Libraries, LILACs, OpenDOAR and Bielefeld Academic Search Engine. In total, 11 062 documents were identified from the formal (10 519) and informal (543) literature. One hundred and seven of these documents (formal 99 and informal 8) met at least one inclusion criterion and underwent thematic analysis. Ethical issues in four main categories were identified: upholding autonomy, identifying and balancing risks and benefits, justice and determination of ethical review requirements. The review indicated that the ethical values behind HPSR place an emphasis on its contributing to the reduction of health disparities. Unsurprisingly then, numerous ethical concerns relating to justice arise in HPSR. However, the majority of existing guidance focuses on obtaining or waiving informed consent and, thus, appears to be insufficient for HPSR. A list of priority ethics issues in HPSR in
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Ethics review in compassionate use.
Borysowski, Jan; Ehni, Hans-Jörg; Górski, Andrzej
2017-07-24
Compassionate use is the use of unapproved drugs outside of clinical trials. So far, compassionate use regulations have been introduced in the US, Canada, many European countries, Australia and Brazil, and treatment on a compassionate use basis may be performed in Japan and China. However, there are important differences between relevant regulations in individual countries, particularly that approval by a research ethics committee (institutional review board) is a requirement for compassionate use in some countries (e.g. the US, Spain, and Italy), but not in others (e.g. Canada, the UK, France, and Germany). The main objective of this article is to present aspects of compassionate use that are important for the discussion of the role of research ethics committees in the review of compassionate use. These aspects include the nature of compassionate use, potential risks to patients associated with the use of drugs with unproven safety and efficacy, informed consent, physicians' qualifications, and patient selection criteria. Our analysis indicates that the arguments for mandatory review substantially outweigh the arguments to the contrary. Approval by a research ethics committee should be obligatory for compassionate use. The principal argument against mandatory ethical review of compassionate use is that it is primarily a kind of treatment rather than biomedical research. Nonetheless, compassionate use is different from standard clinical care and should be subject to review by research ethics committees. First, in practice, compassionate use often involves significant research aspects. Second, it is based on unapproved drugs with unproven safety and efficacy. Obtaining informed consent from patients seeking access to unapproved drugs on a compassionate use basis may also be difficult. Other important problems include the qualifications of the physician who is to perform treatment, and patient selection criteria.
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Building Capacity in Ethical Review
DEFF Research Database (Denmark)
Douglas-Jones, Rachel
2017-01-01
review to ensure the protection of human subjects participating in research. Drawing on fieldwork with the Forum for Ethical Review Committees in the Asian and Western Pacific Region, I explore two distinct forms taken by capacity building within that organization to support and train members of ethics...... review committees. The first, with an emphasis on standards and measurability, takes as its priority international accountability for clinical trial research. e second explores how the organization goes about persuading trainees to see and do ‘ethics’ differently. is distinction between forms of capacity...
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Ethics in Higher Education Research
Parsell, Mitch; Ambler, Trudy; Jacenyik-Trawoger, Christa
2014-01-01
Many educational researchers have experienced challenges in obtaining ethics approval. This article explores some of the reasons why this is the case, looking specifically at the participatory action research methodology. The authors' experience of seeking ethics approval for a project intended to introduce peer review as an enhancement process is…
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Anthropological Research in Light of Research-Ethics Review: Canadian Master's Theses, 1995-2004.
van den Hoonaard, Will C; Connolly, Anita
2006-06-01
DESPITE CLAIMS THAT RESEARCH-ETHICS review is changing or discouraging social research, there are no studies that have tested this assumption. Examining Canadian Master's theses in anthropology between 1995 and 2004, this paper explores the extent to which the theses represent a change in number, topic, or methodology in relation to formal ethicsreview guidelines that came into force in Canada in 2001. ProQuest Digital Dissertations reveals that the number of theses has increased, and that there has not been a noticeable shift from research involving humans to research based on archival data, or theoretical or review theses. However, there has been a very significant increase in research that is called ethnography, but that relies exclusively on interviews. Possible reasons for the halving of percent of ethnographic or participantobservation research are explored.
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Internet research and ethics: transformative issues in nursing education research.
Mahon, Pamela Young
2014-01-01
As practice in the educational and clinical settings seeks to be evidence based, faculty are increasingly required to conduct research and publish the results to advance the science of our profession. The purpose of this article is to discuss transformative research ethics because Internet use is an increasing component of current research studies. How nurse educators can engage in research-utilizing methodologies inclusive of technology while adhering to ethical standards developed before the advance of the Internet is reviewed. Recommendations are cited to address the new questions that arise at institutional review board meetings resulting from potential ethical implications of using students or research participants in cyber space. © 2014.
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Innovations in research ethics governance in humanitarian settings.
Schopper, Doris; Dawson, Angus; Upshur, Ross; Ahmad, Aasim; Jesani, Amar; Ravinetto, Raffaella; Segelid, Michael J; Sheel, Sunita; Singh, Jerome
2015-02-26
Médecins Sans Frontières (MSF) is one of the world's leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board (ERB) in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper. We first update our previous work from 2009 describing ERB performance and then highlight five innovative practices: • A new framework to guide ethics review • The introduction of a policy exempting a posteriori analysis of routinely collected data • The preapproval of "emergency" protocols • General ethical approval of "routine surveys" • Evaluating the impact of approved studies. The new framework encourages a conversation about ethical issues, rather than imposing quasi-legalistic rules, is more engaged with the specific MSF research context and gives greater prominence to certain values and principles. Some of the innovations implemented by the ERB, such as review exemption or approval of generic protocols, may run counter to many standard operating procedures. We argue that much standard practice in research ethics review ought to be open to challenge and revision. Continued interaction between MSF researchers and independent ERB members has allowed for progressive innovations based on a trustful and respectful partnership between the ERB and the researchers. In the future, three areas merit particular attention. First, the impact of the new framework should be assessed. Second, the impact of research needs to be defined more precisely as a first step towards being meaningfully assessed, including changes of impact over time. Finally, the dialogue between the MSF ERB and the ethics committees in the study countries should be enhanced. We hope that the innovations in research ethics governance described may be relevant for other organisations carrying out
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Applying for ethical approval for research: the main issues.
Gelling, Leslie
2016-01-13
The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.
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Essack, Zaynab; Wassenaar, Douglas R
2018-04-01
HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prevention research. For this reason, it is critical to study the implementation of relevant ethical-legal frameworks for such research in South Africa. This qualitative study used in-depth interviews to explore the practices and perspectives of eight members of South African research ethics committees (RECs) who have reviewed protocols for HIV vaccine trials. Their practices and perspectives are compared with ethics guideline requirements for standards of prevention.
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Attitudes Toward the Ethics of Research Using Social Media: A Systematic Review
Ahmed, Shahd; Norman, Gill; Booth, Andrew
2017-01-01
Background Although primarily used for social networking and often used for social support and dissemination, data on social media platforms are increasingly being used to facilitate research. However, the ethical challenges in conducting social media research remain of great concern. Although much debated in the literature, it is the views of the public that are most pertinent to inform future practice. Objective The aim of our study was to ascertain attitudes on the ethical considerations of using social media as a data source for research as expressed by social media users and researchers. Methods A systematic review was conducted, wherein 16 databases and 2 Internet search engines were searched in addition to handsearching, reference checking, citation searching, and contacting authors and experts. Studies that conducted any qualitative methods to collect data on attitudes on the ethical implications of research using social media were included. Quality assessment was conducted using the quality of reporting tool (QuaRT) and findings analyzed using inductive thematic synthesis. Results In total, 17 studies met the inclusion criteria. Attitudes varied from overly positive with people expressing the views about the essential nature of such research for the public good, to very concerned with views that social media research should not happen. Underlying reasons for this variation related to issues such as the purpose and quality of the research, the researcher affiliation, and the potential harms. The methods used to conduct the research were also important. Many respondents were positive about social media research while adding caveats such as the need for informed consent or use restricted to public platforms only. Conclusions Many conflicting issues contribute to the complexity of good ethical practice in social media research. However, this should not deter researchers from conducting social media research. Each Internet research project requires an
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Ethics in Educational Research
Directory of Open Access Journals (Sweden)
Alirio José Abreu Suarez
2017-05-01
Full Text Available This essay is a theoretical reflection about ethics in educational research. The same is done under a documentary approach with a literature review. Ethics in teaching is important because this is a reference for all undergraduate or graduate, as well as the need to consider education authorities at different levels and modalities in order to guide the actors in the educational process. At the same time, it can be expressed that the issue will serve as background for further studies and investigations that have to do with the issues raised. It also provides basic elements for teachers who want to make some related ethical codes, principles and injury caused the researcher studies. Similarly, ethics for being a discipline where are immersed fundamental human values such as honesty, solidarity, respect, tolerance among other aspects must be taken into account by researchers. Finally, it is worth noting that if you really want relevant research to provide new knowledge seeking social and educational transformation must begin with ethics as a relevant factor during all stages of a study.
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Thomas, Margaret
2009-01-01
Two recent books provide varied resources for exploring ethical issues in the social sciences. Reflection on ethical issues aims to sensitize scholars to a range of consequences of their research, and to scholars' responsibilities to their discipline, their colleagues, and the public. This review article assesses the utility of these texts (and of…
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Tansey, Catherine M; Anderson, James; Boulanger, Renaud F; Eckenwiler, Lisa; Pringle, John; Schwartz, Lisa; Hunt, Matthew
2017-06-28
The conduct of research in settings affected by disasters such as hurricanes, floods and earthquakes is challenging, particularly when infrastructures and resources were already limited pre-disaster. However, since post-disaster research is essential to the improvement of the humanitarian response, it is important that adequate research ethics oversight be available. We aim to answer the following questions: 1) what do research ethics committee (REC) members who have reviewed research protocols to be conducted following disasters in low- and middle-income countries (LMICs) perceive as the key ethical concerns associated with disaster research?, and 2) in what ways do REC members understand these concerns to be distinct from those arising in research conducted in non-crisis situations? This qualitative study was developed using interpretative description methodology; 15 interviews were conducted with REC members. Four key ethical issues were identified as presenting distinctive considerations for disaster research to be implemented in LMICs, and were described by participants as familiar research ethics issues that were amplified in these contexts. First, REC members viewed disaster research as having strong social value due to its potential for improving disaster response, but also as requiring a higher level of justification compared to other research settings. Second, they identified vulnerability as an overarching concern for disaster research ethics, and a feature that required careful and critical appraisal when assessing protocols. They noted that research participants' vulnerabilities frequently change in the aftermath of a disaster and often in unpredictable ways. Third, they identified concerns related to promoting and maintaining safety, confidentiality and data security in insecure or austere environments. Lastly, though REC members endorsed the need and usefulness of community engagement, they noted that there are significant challenges in a disaster
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Reijers, Wessel; Wright, David; Brey, Philip; Weber, Karsten; Rodrigues, Rowena; O’Sullivan, Declan; Gordijn, Bert
2017-01-01
This paper provides a systematic literature review, analysis and discussion of methods that are proposed to practise ethics in research and innovation (R&I). Ethical considerations concerning the impacts of R&I are increasingly important, due to the quickening pace of technological innovation and
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Action Researchers Encountering Ethical Review: A Literature Synthesis on Challenges and Strategies
Fouché, Christa B.; Chubb, Laura A.
2017-01-01
Action research (AR) comprises a diverse family of methodologies. Common amongst most types of AR are both an emergent design--leading to action or change--and participation or community involvement. While this type of research has expanded considerably since the early 2000s, the criteria used for ethical review have apparently been slow to adapt…
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'Wicked' ethics: Compliance work and the practice of ethics in HIV research.
Heimer, Carol A
2013-12-01
Using ethnographic material collected between 2003 and 2007 in five HIV clinics in the US, South Africa, Uganda, and Thailand, this article examines "official ethics" and "ethics on the ground." It compares the ethical conundrums clinic staff and researchers confront in their daily work as HIV researchers with the dilemmas officially identified as ethical issues by bioethicists and people responsible for ethics reviews and compliance with ethics regulations. The tangled relation between ethical problems and solutions invites a comparison to Rittel and Webber's "wicked problems." Official ethics' attempts to produce universal solutions often make ethics problems even more wickedly intractable. Ethics on the ground is in part a reaction to this intractability. Copyright © 2012 Elsevier Ltd. All rights reserved.
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Ethics and the ethnography of medical research in Africa
Molyneux, Sassy; Geissler, P. Wenzel
2008-01-01
The ethics of medical research have grown as an area of expertise and debate in recent years, with two broad approaches emerging in relation to transnational research: (1) the refinement of guidelines and strengthening of review, processes primarily to protect the right of individual research participants and strengthen interpersonal relations at the micro-level; and (2) considering more centrally, as crucial ethical concerns, the wider interests of whole populations, the functioning of research institutions, the processes of collaboration, and the ethics of inequitable international relations. We see the two areas of debate and action as complementary, and believe that social science conducted in and around transnational medical research environments can bring these two perspectives together in a more ‘situated ethics’ of research. To explore this idea for medical research in Africa, we organized a conference in December 2005 in Kilifi, Kenya. In this introduction we outline the two emerging approaches to medical ethics, summarise each of seven papers selected from the conference for inclusion in this special issue on ethics and ethnography, and finally highlight two areas of lively debate at the conference itself: the appropriateness and value of ethics guidelines and review boards for medical research; and the ethical review of social science research. Together, the papers and debates point to the importance of focusing on the ethics of relationships and on justice in both biomedicine and social science research, and on giving greater voice and visibility to the field staff who often play a crucial and under-supported role in ‘doing ethics’ in the field. They also point to the potential value of social science research on the range of relationships operating at different levels and time scales in medical research, including those surrounding community engagement activities, and the role and functioning of ethics review boards. We conclude by highlighting
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Attitudes Toward the Ethics of Research Using Social Media: A Systematic Review.
Golder, Su; Ahmed, Shahd; Norman, Gill; Booth, Andrew
2017-06-06
Although primarily used for social networking and often used for social support and dissemination, data on social media platforms are increasingly being used to facilitate research. However, the ethical challenges in conducting social media research remain of great concern. Although much debated in the literature, it is the views of the public that are most pertinent to inform future practice. The aim of our study was to ascertain attitudes on the ethical considerations of using social media as a data source for research as expressed by social media users and researchers. A systematic review was conducted, wherein 16 databases and 2 Internet search engines were searched in addition to handsearching, reference checking, citation searching, and contacting authors and experts. Studies that conducted any qualitative methods to collect data on attitudes on the ethical implications of research using social media were included. Quality assessment was conducted using the quality of reporting tool (QuaRT) and findings analyzed using inductive thematic synthesis. In total, 17 studies met the inclusion criteria. Attitudes varied from overly positive with people expressing the views about the essential nature of such research for the public good, to very concerned with views that social media research should not happen. Underlying reasons for this variation related to issues such as the purpose and quality of the research, the researcher affiliation, and the potential harms. The methods used to conduct the research were also important. Many respondents were positive about social media research while adding caveats such as the need for informed consent or use restricted to public platforms only. Many conflicting issues contribute to the complexity of good ethical practice in social media research. However, this should not deter researchers from conducting social media research. Each Internet research project requires an individual assessment of its own ethical issues
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Public titles of clinical trials should have ethics review.
Saenz, Carla; Reveiz, Ludovic; Tisdale, John F
2015-09-01
A key aspect to guarantee that research with human subjects is ethical is being overlooked. Ethics review committees invest great effort examining the informed consent documents of research protocols to ensure that potential participants can provide consent validly and are not deluded into thinking that the experimental intervention they may sign up for is already known to be therapeutic. However, these efforts to avoid what is called the "therapeutic misconception" might be in vain if the title with which the studies are being introduced to the potential participants escapes ethics review. Research participants might be deceived by clinical trials entitled "novel therapy" when the point of the trial is precisely to find out whether the intervention at stake is therapeutic or not. Providing potential research participants with such misleading information hampers their ability to make informed decisions. The well-established scrutiny that ethics review committees exercise with regard to consent forms is limited if the registration of clinical trials, for which a public title is chosen, constitutes a process that is independent from the ethics review. In this article, we examine this problem, assess recent measures to integrate clinical trial registration with ethics review processes, and provide specific recommendations to solve the problem and ultimately enhance the accountability, transparency, and ethics of research with human subjects. Copyright © 2015 Pan American Health Organization. Published by Elsevier Inc. All rights reserved.
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Organizational ethics: a literature review.
Suhonen, Riitta; Stolt, Minna; Virtanen, Heli; Leino-Kilpi, Helena
2011-05-01
The aim of the study was to report the results of a systematically conducted literature review of empirical studies about healthcare organizations' ethics and management or leadership issues. Electronic databases MEDLINE and CINAHL yielded 909 citations. After a two stage application of the inclusion and exclusion criteria 56 full-text articles were included in the review. No large research programs were identified. Most of the studies were in acute hospital settings from the 1990s onwards. The studies focused on ethical challenges, dilemmas in practice, employee moral distress and ethical climates or environments. Study samples typically consisted of healthcare practitioners, operational, executive and strategic managers. Data collection was mainly by questionnaires or interviews and most of the studies were descriptive, correlational and cross-sectional. There is need to develop conceptual clarity and a theoretical framework around the subject of organizational ethics and the breadth of the contexts and scope of the research needs to be increased. © The Author(s) 2011
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Human research ethics committees in technical universities.
Koepsell, David; Brinkman, Willem-Paul; Pont, Sylvia
2014-07-01
Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although mandated in the United States, the United Kingdom, Canada, and Australia, non-medical research involving humans need not receive ethics review in much of Europe, Asia, Latin America, and Africa. Our survey of the top 50 technical universities in the world shows that, where not specifically mandated by law, most technical universities do not employ ethics committees to review human studies. As the domains of basic and applied sciences expand, ethics committees are increasingly needed to guide and oversee all such research regardless of legal requirements. We offer as examples, from our experience as an ethics committee in a major European technical university, ways in which such a committee provides needed services and can help ensure more ethical studies involving humans outside the standard medical context. We provide some arguments for creating such committees, and in our supplemental article, we provide specific examples of cases and concerns that may confront technical, engineering, and design research, as well as outline the general framework we have used in creating our committee. © The Author(s) 2014.
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Steps to strengthen ethics in organizations: research findings, ethics placebos, and what works.
Pope, Kenneth S
2015-01-01
Research shows that many organizations overlook needs and opportunities to strengthen ethics. Barriers can make it hard to see the need for stronger ethics and even harder to take effective action. These barriers include the organization's misleading use of language, misuse of an ethics code, culture of silence, strategies of justification, institutional betrayal, and ethical fallacies. Ethics placebos tend to take the place of steps to see, solve, and prevent problems. This article reviews relevant research and specific steps that create change.
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Knowledge about the research and ethics committee at Makerere ...
African Journals Online (AJOL)
Background: All research involving human participants should be reviewed by a competent and independent institutional research and ethics committee. Research conducted at Makerere University College of Health Sciences should be subjected to a rigorous review process by the ethics committee in order to protect ...
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Stevenson, Fiona A; Gibson, William; Pelletier, Caroline; Chrysikou, Vasiliki; Park, Sophie
2015-05-08
UK-based research conducted within a healthcare setting generally requires approval from the National Research Ethics Service. Research ethics committees are required to assess a vast range of proposals, differing in both their topic and methodology. We argue the methodological benchmarks with which research ethics committees are generally familiar and which form the basis of assessments of quality do not fit with the aims and objectives of many forms of qualitative inquiry and their more iterative goals of describing social processes/mechanisms and making visible the complexities of social practices. We review current debates in the literature related to ethical review and social research, and illustrate the importance of re-visiting the notion of ethics in healthcare research. We present an analysis of two contrasting paradigms of ethics. We argue that the first of these is characteristic of the ways that NHS ethics boards currently tend to operate, and the second is an alternative paradigm, that we have labelled the 'iterative' paradigm, which draws explicitly on methodological issues in qualitative research to produce an alternative vision of ethics. We suggest that there is an urgent need to re-think the ways that ethical issues are conceptualised in NHS ethical procedures. In particular, we argue that embedded in the current paradigm is a restricted notion of 'quality', which frames how ethics are developed and worked through. Specific, pre-defined outcome measures are generally seen as the traditional marker of quality, which means that research questions that focus on processes rather than on 'outcomes' may be regarded as problematic. We show that the alternative 'iterative' paradigm offers a useful starting point for moving beyond these limited views. We conclude that a 'one size fits all' standardisation of ethical procedures and approach to ethical review acts against the production of knowledge about healthcare and dramatically restricts what can be
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Feleke, Yeweyenhareg; Addissie, Adamu; Wamisho, Biruk L; Davey, Gail
2015-01-01
Health research in Ethiopia is increasing both in volume and type, accompanied with expansion of higher education and research since the past few years. This calls for a proportional competence in the governance of medical research ethics in Ethiopia in the respective research and higher learning institutes. The paper highlights the evolution and progress ofthe ethics review at Addis Ababa University - College of Health Sciences (AAU-CHS) in the given context of health research review system in Ethiopia. Reflections are made on the key lessons to be drawnfrom the formative experiences of the Institutional Review Board (IRB) and their implications to the Ethiopian health research review system. This article is a review paper based on review of published and un published documents on research ethics in Ethiopia and the AAU-CHS (2007-2012). Thematic summaries of review findings are presented in thematic areas - formation of ethics review and key factors in the evolution of ethics review and implications. The IRB at AAU-CHS has been pivotal in providing review and follow-up for important clinical studies in Ethiopia. It has been one of the first IRBs to get WHO/SIDCER recognition from Africa and Ethiopia. Important factors in the successes of the IRB among others included leadership commitment, its placement in institutional structure, and continued capacity building. Financial challenges and sustainability issues need to be addressed for the sustained gains registered so far. Similar factors are considered important for the new and younger IRBs within the emergent Universities and research centers in the country.
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Experiential Learning and Research Ethics: Enhancing Knowledge through Action
Teixeira-Poit, Stephanie M.; Cameron, Abigail E.; Schulman, Michael D.
2011-01-01
How can instructors use experiential learning strategies to enhance student understanding of research ethics and responsible research conduct? In this article, the authors review literature on using experiential learning to teach research ethics and responsible research conduct. They present a three-step exercise for teaching research ethics and…
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Coetzee, Tanya; Hoffmann, Willem A; de Roubaix, Malcolm
2015-10-01
The amended research ethics policy at a South African University required the ethics review of undergraduate research projects, prompting the need to explore the content and teaching approach of research ethics education in health science undergraduate programs. Two qualitative data collection strategies were used: document analysis (syllabi and study guides) and semi-structured interviews with research methodology coordinators. Five main themes emerged: (a) timing of research ethics courses, (b) research ethics course content, (c) sub-optimal use of creative classroom activities to facilitate research ethics lectures, (d) understanding the need for undergraduate project research ethics review, and (e) research ethics capacity training for research methodology lecturers and undergraduate project supervisors. © The Author(s) 2015.
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Research ethics consultation: ethical and professional practice challenges and recommendations.
Sharp, Richard R; Taylor, Holly A; Brinich, Margaret A; Boyle, Mary M; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin
2015-05-01
The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.
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Ethical Guideline to Authors,Editors,and Reviewers
Institute of Scientific and Technical Information of China (English)
Editorial office of CHM
2016-01-01
Drug products are specific goods with safety and effectiveness in medical health case.All of researchers(authors),reviewers,and editors must abide by medical ethical obligation,and also must deter to the ethical obligation for publication.These guidelines are offered as ethical
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Fisher, Celia B.; Yuko, Elizabeth
2018-01-01
The responsible conduct of HIV/drug abuse prevention research requires investigators with both the knowledge of and ability to generate empirical data that can enhance global ethical practices and policies. This article describes a multidisciplinary program offering early-career professionals a 2-year intensive summer curriculum along with funding to conduct a mentored research study on a wide variety of HIV/drug abuse research ethics topics. Now in its fifth year, the program has admitted 29 trainees who have to date demonstrated increased knowledge of research ethics, produced 17 peer-reviewed publications, 46 professional presentations, and submitted or been awarded five related federal grants. The institute also hosts a global information platform providing general and HIV/drug abuse relevant research ethics educational and research resources that have had more than 38,800 unique visitors from more than 150 countries. PMID:26564944
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A review of ethical issues in dementia.
Johnson, Rebecca A; Karlawish, Jason
2015-10-01
Dementia raises many ethical issues. The present review, taking note of the fact that the stages of dementia raise distinct ethical issues, focuses on three issues associated with stages of dementia's progression: (1) how the emergence of preclinical and asymptomatic but at-risk categories for dementia creates complex questions about preventive measures, risk disclosure, and protection from stigma and discrimination; (2) how despite efforts at dementia prevention, important research continues to investigate ways to alleviate clinical dementia's symptoms, and requires additional human subjects protections to ethically enroll persons with dementia; and (3) how in spite of research and prevention efforts, persons continue to need to live with dementia. This review highlights two major themes. First is how expanding the boundaries of dementias such as Alzheimer's to include asymptomatic but at-risk persons generate new ethical questions. One promising way to address these questions is to take an integrated approach to dementia ethics, which can include incorporating ethics-related data collection into the design of a dementia research study itself. Second is the interdisciplinary nature of ethical questions related to dementia, from health policy questions about insurance coverage for long-term care to political questions about voting, driving, and other civic rights and privileges to economic questions about balancing an employer's right to a safe and productive workforce with an employee's rights to avoid discrimination on the basis of their dementia risk. The review highlights these themes and emerging ethical issues in dementia.
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Factors influencing the effectiveness of research ethics committees.
Schuppli, C A; Fraser, D
2007-05-01
Research ethics committees - animal ethics committees (AECs) for animal-based research and institutional research boards (IRBs) for human subjects - have a key role in research governance, but there has been little study of the factors influencing their effectiveness. The objectives of this study were to examine how the effectiveness of a research ethics committee is influenced by committee composition and dynamics, recruitment of members, workload, participation level and member turnover. As a model, 28 members of AECs at four universities in western Canada were interviewed. Committees were selected to represent variation in the number and type of protocols reviewed, and participants were selected to include different types of committee members. We found that a bias towards institutional or scientific interests may result from (1) a preponderance of institutional and scientist members, (2) an intimidating atmosphere for community members and other minority members, (3) recruitment of community members who are affiliated with the institution and (4) members joining for reasons other than to fulfil the committee mandate. Thoroughness of protocol review may be influenced by heavy workloads, type of review process and lack of full committee participation. These results, together with results from the literature on research ethics committees, suggested potential ways to improve the effectiveness of research ethics committees.
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Gorman, Susanna M
2011-09-01
Australian Human Research Ethics Committees (HRECs) have to contend with ever-increasing workloads and responsibilities which go well beyond questions of mere ethics. In this article, I shall examine how the roles of HRECs have changed, and show how this is reflected in the iterations of the National Statement on Ethical Conduct in Human Research 2007 (NS). In particular I suggest that the focus of the National Statement has shifted to concentrate on matters of research governance at the expense of research ethics, compounded by its linkage to the Australian Code for the Responsible Conduct of Research (2007) in its most recent iteration. I shall explore some of the challenges this poses for HRECs and institutions and the risks it poses to ensuring that Australian researchers receive clear ethical guidance and review.
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Justice in human research ethics. A conceptual and practical guide.
Pieper, Ian; Thomson, Colin J H
2013-03-01
One of the core values to be applied by a body reviewing the ethics of human research is justice. The inclusion of justice as a requirement in the ethical review of human research is relatively recent and its utility had been largely unexamined until debates arose about the conduct of international biomedical research in the late 1990s. The subsequent amendment of authoritative documents in ways that appeared to shift the meaning of conceptions of justice generated a great deal of controversy. Another difficulty has been that both the theory and the substance of justice that are applied by researchers or reviewers can be frequently seen to be subjective. Both the concept of justice--hether distributive or commutative--and what counts as a just distribution or exchange--are given different weight and meanings by different people. In this paper, the origins and more recent debates about the requirement to consider justice as a criterion in the ethical review of human research are traced, relevant conceptions of justice are distinguished, and the manner in which they can be applied meaningfully in the ethical review of all human research is identified. We also explain the way that these concepts are articulated in, and the intent and function of, specific paragraphs of the National Statement on Ethical Conduct in Human Research (2007). The National Statement identifies a number of issues that should be considered when a human research ethics committee is reviewing the justice aspects of an application. We provide guidance to researchers as to how they can show that there is a fair distribution of burdens and benefits in the participant experience and the research outcomes. We also provide practical guidance to researches on how to think through issues of justice so that they can demonstrate that the design of their research projects meets this ethical requirement.
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Trends in nursing ethics research: Mapping the literature production.
Blažun Vošner, Helena; Železnik, Danica; Kokol, Peter; Vošner, Janez; Završnik, Jernej
2017-12-01
There have been a number of debates in the field of nursing ethics. Researchers have focused on various aspects of nursing ethics, such as professional ethics, professional, nursing and ethical values. Within this research, a variety of literature reviews have been conducted, but to the best of our knowledge, bibliometric mapping has not yet been used. This article aims to analyse the production of literature within nursing ethics research. In order to examine publishing patterns, we focused on publishing dynamics, prolific research entities and the most-cited articles. We additionally visualised the content of the literature using a novel mixed-method approach, combining bibliometric analysis and mapping with thematic analysis. Ethical considerations: In our study, ethical review was not required. A total of 1416 information sources were found in the Scopus database. Overall, literature production has increased; however, in recent years, the quantity of published material has begun to decrease. The most prolific countries are the United States, the United Kingdom and Canada, and the most prolific source titles are Nursing Ethics, Journal of Advanced Nursing and Nursing Times. Lately, research in the field of nursing ethics has been focused more on life care (providing for the basic needs of older residents), moral distress and community nursing. The dynamics of research literature production showed an exponential rise in the number of published information sources - a rise which started in the period between 1974 and 1998. Since that period, the trend has stabilised, which might indicate that nursing ethics research is starting a transition to a mature phase. The innovative use of bibliometric analysis and mapping, together with thematic analysis, is a useful tool for analysis of research production in the field of nursing ethics. The results presented can be an excellent starting point for literature reviews and more exhaustive data, information and knowledge
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Research Ethics Consultation: Ethical and Professional Practice Challenges and Recommendations
Sharp, Richard R.; Taylor, Holly A.; Brinich, Margaret A.; Boyle, Mary M.; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin
2015-01-01
The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include: assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical Translational Science Award (CTSA) Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: 1) managing multiple institutional roles and responsibilities, 2) managing sensitive information, and 3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services. PMID:25607942
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In defence of governance: ethics review and social research.
Sheehan, Mark; Dunn, Michael; Sahan, Kate
2017-10-10
There is a growing body of literature that has sought to undermine systems of ethical regulation, and governance more generally, within the social sciences. In this paper, we argue that any general claim for a system of research ethics governance in social research depends on clarifying the nature of the stake that society has in research. We show that certain accounts of this stake-protecting researchers' freedoms; ensuring accountability for resources; safeguarding welfare; and supporting democracy-raise relevant ethical considerations that are reasonably contested. However, these accounts cannot underpin a general claim in favour of, or against, a system of research ethics governance. Instead, we defend governance in social research on the grounds that research, as an institutionalised form of enquiry, is a constitutive element of human flourishing, and that society ought to be concerned with the flourishing of its members. We conclude by considering the governance arrangements that follow from, and are justified by, our arguments. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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Professional ethics in nursing: an integrative review.
Kangasniemi, Mari; Pakkanen, Piiku; Korhonen, Anne
2015-08-01
To conduct an integrative review and synthesize current primary studies of professional ethics in nursing. Professional ethics is a familiar concept in nursing and provides an ethical code for nursing practice. However, little is known about how professional ethics has been defined and studied in nursing science. Systematic literature searches from 1948-February 2013, using the CINAHL, PubMed and Scopus electronic databases to look at previously published peer-reviewed studies. A modified version of Cooper's five-stage integrative review was used to review and synthesize current knowledge. Fourteen papers were included in this research. According to our synthesis, professional ethics is described as an intra-professional approach to care ethics and professionals commit to it voluntarily. Professional ethics consist of values, duties, rights and responsibilities, regulated by national legislation and international agreements and detailed in professional codes. Professional ethics is well established in nursing, but is constantly changing due to internal and external factors affecting the profession. Despite the obvious importance of professional ethics, it has not been studied much in nursing science. Greater knowledge of professional ethics is needed to understand and support nurses' moral decision-making and to respond to the challenges of current changes in health care and society. © 2015 John Wiley & Sons Ltd.
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Fisher, Celia B; Yuko, Elizabeth
2015-12-01
The responsible conduct of HIV/drug abuse prevention research requires investigators with both the knowledge of and ability to generate empirical data that can enhance global ethical practices and policies. This article describes a multidisciplinary program offering early-career professionals a 2-year intensive summer curriculum along with funding to conduct a mentored research study on a wide variety of HIV/drug abuse research ethics topics. Now in its fifth year, the program has admitted 29 trainees who have to date demonstrated increased knowledge of research ethics, produced 17 peer-reviewed publications, 46 professional presentations, and submitted or been awarded five related federal grants. The institute also hosts a global information platform providing general and HIV/drug abuse relevant research ethics educational and research resources that have had more than 38,800 unique visitors from more than 150 countries. © The Author(s) 2015.
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Ethical conduct for research : a code of scientific ethics
Marcia Patton-Mallory; Kathleen Franzreb; Charles Carll; Richard Cline
2000-01-01
The USDA Forest Service recently developed and adopted a code of ethical conduct for scientific research and development. The code addresses issues related to research misconduct, such as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results, as well as issues related to professional misconduct, such...
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Zulu, Joseph M; Ali, Joseph; Hallez, Kristina; Kass, Nancy; Michelo, Charles; Hyder, Adnan A
2018-05-02
An increase in post abortion care (PAC) research with adolescents, particularly in low- and middle-income countries, has brought to attention several associated research ethics challenges. In order to better understand the ethics context of PAC research with adolescents, we conducted a scoping review of published literature. Following a systematic search of PubMed, HINARI, and Google Scholar, we analysed articles meeting inclusion criteria to determine common themes across both the ethical challenges related to PAC research with adolescents and any available guidance on the identified challenges. The literature search identified an initial 3321 records of which 14 were included in analysis following screening. Several ethical challenges stem from abortion being a controversial, sensitive, and stigmatized topic in many settings. Ethical dilemmas experienced by researchers conducting adolescent PAC research included: difficulties in convincing local health providers to permit PAC research; challenges in recruiting and seeking consent due to sensitivity of the subject; effectively protecting confidentiality; managing negative effects of interventions; creating a non-prejudicial atmosphere for research; managing emotional issues among adolescents; and dealing with uncertainty regarding the role of researchers when observing unethical health care practices. Suggested strategies for addressing some of these challenges include: using several sources to recruit study participants, using research to facilitate dialogue on abortion, briefing health workers on any observed unethical practices after data collection, fostering a comprehensive understanding of contextual norms and values, selecting staff with experience working with study populations, and avoiding collection of personal identifiers. Addressing ethical challenges that researchers face when conducting PAC research with adolescents requires guidance at the individual, institutional, community, and international
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Ethical aspects of registry-based research in the Nordic countries
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Ludvigsson JF
2015-11-01
Full Text Available Jonas F Ludvigsson,1,2 Siri E Håberg,3 Gun Peggy Knudsen,3 Pierre Lafolie,4,5 Helga Zoega,6 Catharina Sarkkola,7 Stephanie von Kraemer,7 Elisabete Weiderpass,1,7–10 Mette Nørgaard11 1Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, 2Department of Pediatrics, Örebro University Hospital, Örebro, Sweden; 3Norwegian Institute of Public Health, Oslo, Norway; 4Department of Medicine, Clinical Pharmacology Unit, 5The Stockholm Regional Ethical Review Board, Karolinska Institutet, Stockholm, Sweden; 6Center of Public Health Sciences, Faculty of Medicine, University of Iceland, Reykjavík, Iceland; 7Genetic Epidemiology Group, Folkhälsan Research Center, Helsinki, Finland; 8Department of Community Medicine, Faculty of Health Sciences, University of Tromsø, 9The Arctic University of Norway, Tromsø, 10Department of Research, Cancer Registry of Norway, Oslo, Norway; 11Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark Abstract: National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and
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Ethics in nursing: A systematic review of the framework of evidence perspective.
Yıldız, Erman
2017-01-01
To determine the current state of knowledge on nursing and ethics and to assess the knowledge and experience based on the evidence in this regard. Although ethics is at the center of the nursing profession and the ethical issues affecting nurses are given much importance, few studies have focused on professional ethics in nursing. In this respect, ethics has become a concept that contains controversial and ambiguous situations. The Preferred Reporting Items for Systematic Reviews and Meta-analyses guide, a basic search algorithm, was taken. Cochrane, PubMed, CINAHL Complete, PsycINFO, and ULAKBIM from 2012 to 2016. Following a systematic search strategy, all papers were assessed in relation to inclusion criteria and type of study. When sufficient information was not available in the title and summary of the works, the necessary data were evaluated in full texts. This review was completed with 27 articles meeting the research criteria. The evaluation identified six themes: (1) ethics and nursing, (2) ethical difficulties/ethical dilemmas and nursing, (3) ethical competence and nursing, (4) professional ethics and nursing, (5) ethics, education, and nursing, and (6) ethics in health research. As a result of the review, a synthesis of high evidence-level research relating to nursing ethics was obtained. The emphasis was on the importance of further research and education so that the ethical aspects of nursing can be better understood throughout the studies. Nursing researchers' level of evidence on ethics and their orientation to high research design will shed light on uncertain and controversial aspects of the subject. Ethical consideration: Since this was a systematic review, no ethical approval was required. There is no conflict of interest in this literature review.
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Ethical responsibilities in nursing: research findings and issues.
Cassidy, V R
1991-01-01
Discussions in the literature assert that nurses are becoming increasingly cognizant of their ethical responsibilities, but that they are often ill prepared to participate in ethical decision making. A review of selected research literature from 1970 to 1987 was undertaken to validate these assertions. A total of 12 studies related to ethical responsibilities was identified in the review; all studies were published between 1980 and 1987. The majority of studies were at the descriptive and exploratory levels and employed Kohlberg's cognitive theory of moral development as their conceptual framework. Significant findings related to educational level and ethical responsibilities were consistent across studies. Findings related to age and clinical experience were mixed; the effects of economic level, religion-religiosity, ethnicity, and other variables on ethical responsibilities were not significant. Issues raised in the light of the existing research include the use of Kohlberg's theory as a conceptual orientation in nursing groups and limited data on the reliability and validity of instruments used in measuring ethical constructs. Recommendations for future research on ethical responsibilities include the validation of Kohlberg's theory for nursing investigations, exploration of other frameworks for developing a multidimensional view of ethical responsibilities, and the use of qualitative research designs.
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Ethical issues in research with homeless youths.
Ensign, Josephine; Ammerman, Seth
2008-05-01
This paper is a report of a study to document researcher, healthcare provider and programme administrators' experiences with ethical issues in research with homeless youths in North America. While there are legal and ethical guidelines for research with adolescents and with vulnerable populations in general, there are no specific guidelines for the ethical conduct of research with homeless youths. Using a web-based questionnaire, healthcare and social service providers, programme administrators and researchers working with homeless young people throughout the United States of America and Canada were surveyed in 2005. The survey group consisted of 120 individuals; a total of 72 individuals completed the survey. Survey questions included experiences with using incentives in research with homeless youths, consent and experiences with ethics review boards. Numerical data were analysed using frequencies and cross-tabulations. Text data were analysed qualitatively. Researchers doing mental health and/or substance use research tended to use money as a research incentive, whereas healthcare providers and programme administrators tended to use non-monetary incentives. The majority of respondents reported using written consent for research from homeless youths, including minors. Respondents reporting difficulties with ethics review boards were mainly involved with intervention research. Consensus is needed from a variety of stakeholders, including homeless youths and service providers, on use of various types of research incentives for different types of research, as well as use of consent for homeless youths who are minors.
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Research governance: new hope for ethics committees?
Frew, Deborah; Martlew, Ainsley
2007-01-01
For many years there has been discussion regarding the problems confronting our current ethics review system. Commentators have identified numerous issues that threaten the sustainability of Australia's voluntary HREC system. Various ad hoc solutions to these problems have been posed, but have not resulted in any significant advances. However, in recent years, discourse regarding research governance has become prominent in the Australian research environment. The application of research governance principles is gaining momentum amongst the regulators of research, including research institutions and their governing bureaucracies. We argue that this is potentially the most significant development in several years towards creating a sustainable HREC system in Australia. The recognition by research institutions and their governing bureaucracies that the responsibility for overall research governance lies with them, rather than solely with their HRECs, is leading to a range of initiatives which should significantly lessen the burden on Australian ethics committees, and improve their ability to undertake their core task of reviewing the ethical aspects of research proposals.
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Qualitative research ethics on the spot: Not only on the desktop.
Øye, Christine; Sørensen, Nelli Øvre; Glasdam, Stinne
2016-06-01
The increase in medical ethical regulations and bureaucracy handled by institutional review boards and healthcare institutions puts the researchers using qualitative methods in a challenging position. Based on three different cases from three different research studies, the article explores and discusses research ethical dilemmas. First, and especially, the article addresses the challenges for gatekeepers who influence the informant's decisions to participate in research. Second, the article addresses the challenges in following research ethical guidelines related to informed consent and doing no harm. Third, the article argues for the importance of having research ethical guidelines and review boards to question and discuss the possible ethical dilemmas that occur in qualitative research. Research ethics must be understood in qualitative research as relational, situational, and emerging. That is, that focus on ethical issues and dilemmas has to be paid attention on the spot and not only at the desktop. © The Author(s) 2015.
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How not to argue against mandatory ethics review.
Hunter, David
2013-08-01
There is considerable controversy about the mandatory ethics review of research. This paper engages with the arguments offered by Murray Dyck and Gary Allen against mandatory review, namely, that this regulation fails to reach the standards that research ethics committees apply to research since it is harmful to the ethics of researchers, has little positive evidence base, leads to significant harms (through delaying valuable research) and distorts the nature of research. As these are commonplace arguments offered by researchers against regulation it is useful to assess their strength and the conclusion that they are taken to support, namely, that we ought to move back to a system of trust in researchers without compulsory regulation. Unfortunately, these arguments are at best weak and to some degree come into conflict in terms of supporting the desired conclusion.
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Ethical Issues in Qualitative E-Learning Research
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Heather Kanuka
2007-06-01
Full Text Available In the mid 1980s education researchers began exploring the use of the Internet within teaching and learning practices, now commonly referred to as e-learning. At the same time, many e-learning researchers were discovering that the application of existing ethical guidelines for qualitative research was resulting in confusion and uncertainty among both researchers and ethics review board members. Two decades later we continue to be plagued by these same ethical issues. On reflection on our research practices and examination of the literature on ethical issues relating to qualitative Internet- and Web-based research, the authors conclude that there are three main areas of confusion and uncertainty among researchers in the field of e-learning: (a participant consent, (b public versus private ownership, and (c confidentiality and anonymity.
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Human research ethics committees: examining their roles and practices.
Guillemin, Marilys; Gillam, Lynn; Rosenthal, Doreen; Bolitho, Annie
2012-07-01
Considerable time and resources are invested in the ethics review process. We present qualitative data on how human research ethics committee members and health researchers perceive the role and function of the committee. The findings are based on interviews with 34 Australian ethics committee members and 54 health researchers. Although all participants agreed that the primary role of the ethics committee was to protect participants, there was disagreement regarding the additional roles undertaken by committees. Of particular concern were the perceptions from some ethics committee members and researchers that ethics committees were working to protect the institution's interests, as well as being overprotective toward research participants. This has the potential to lead to poor relations and mistrust between ethics committees and researchers.
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Ethical aspects of registry-based research in the Nordic countries.
Ludvigsson, Jonas F; Håberg, Siri E; Knudsen, Gun Peggy; Lafolie, Pierre; Zoega, Helga; Sarkkola, Catharina; von Kraemer, Stephanie; Weiderpass, Elisabete; Nørgaard, Mette
2015-01-01
National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and Sweden. Both ethical values and conditions for registry-based research are similar in the Nordic countries. While Denmark, Finland, Iceland, Norway, and Sweden have chosen different legal frameworks, these differences can be resolved through mutual recognition of ethical applications and by harmonizing the different systems, likely leading to increased collaboration and enlarged studies.
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Directory of Open Access Journals (Sweden)
Sonia Maria Oliveira de Barros
2005-03-01
Full Text Available This is a review article on the origin of the ethical analysis ofresearch protocols, the Brazilian and International legislation,including the Research Ethics Committee of Hospital IsraelitaAlbert Einstein. Since 1997, when the Committee was validatedits role has been recognized as that of a consultant and educator,participating on local and national scientific events andcollaborating with researchers in order to improve their projectsand learn to recognize ethical dilemmas in their protocols.
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Ethics in clinical research: the Indian perspective.
Sanmukhani, J; Tripathi, C B
2011-03-01
Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.
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Conway, Mike
2014-12-22
The rise of social media and microblogging platforms in recent years, in conjunction with the development of techniques for the processing and analysis of "big data", has provided significant opportunities for public health surveillance using user-generated content. However, relatively little attention has been focused on developing ethically appropriate approaches to working with these new data sources. Based on a review of the literature, this study seeks to develop a taxonomy of public health surveillance-related ethical concepts that emerge when using Twitter data, with a view to: (1) explicitly identifying a set of potential ethical issues and concerns that may arise when researchers work with Twitter data, and (2) providing a starting point for the formation of a set of best practices for public health surveillance through the development of an empirically derived taxonomy of ethical concepts. We searched Medline, Compendex, PsycINFO, and the Philosopher's Index using a set of keywords selected to identify Twitter-related research papers that reference ethical concepts. Our initial set of queries identified 342 references across the four bibliographic databases. We screened titles and abstracts of these references using our inclusion/exclusion criteria, eliminating duplicates and unavailable papers, until 49 references remained. We then read the full text of these 49 articles and discarded 36, resulting in a final inclusion set of 13 articles. Ethical concepts were then identified in each of these 13 articles. Finally, based on a close reading of the text, a taxonomy of ethical concepts was constructed based on ethical concepts discovered in the papers. From these 13 articles, we iteratively generated a taxonomy of ethical concepts consisting of 10 top level categories: privacy, informed consent, ethical theory, institutional review board (IRB)/regulation, traditional research vs Twitter research, geographical information, researcher lurking, economic value
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Continuing Education in Research Ethics for the Clinical Nurse.
Jeffers, Brenda Recchia
2002-01-01
Review of professional nursing statements, federal policy, and recommendations for protection of human research subjects resulted in a topic and content outline for research ethics training for nurses. Suggestions for continuing education programs on research ethics were formulated. (SK)
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Sikweyiya, Yandisa; Jewkes, Rachel
2011-10-01
Does research on gender-based violence (GBV) pose greater than minimal risk to researchers and participants? This question needs to be understood particularly in light of hesitancy by Institutional Review Boards to approve research on GBV. The safety and risks of doing GBV studies and the implications for the ethical review process have not been a focus of much research. This qualitative study collected data through in-depth interviews with 12 experienced GBV researchers from various countries and a desk review. This paper explores researchers' interpretation of and meanings of the safety recommendations as provided in the WHO guidelines and whether there is empirical evidence on the presence of risks and safety concerns unique to GBV research. Informants raised a number of safety concerns about GBV research, yet in the interviews there were very few examples of problems having occurred, possibly because of the precautions applied. This paper argues that the notion that GBV studies carry greater than minimal risk when ethics precautions are followed is based on speculation, not evidence. It highlights the need for empirical evidence to support assertions of risk in research.
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Alirol, Emilie; Kuesel, Annette C; Guraiib, Maria Magdalena; de la Fuente-Núñez, Vânia; Saxena, Abha; Gomes, Melba F
2017-06-26
Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee (WHO-ERC) was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including interventional (drug, vaccine) and observational studies. WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues (benefit-risk assessment, study design, exclusion of pregnant women and children from interventional studies, data and sample sharing, collaborative partnerships including international and local researchers and communities, community engagement and participant information) are presented. To accelerate study approval in future public health emergencies, we recommend: (1) internally consistent and complete submissions with information documents in language participants are likely to understand, (2) close collaboration between local and international researchers from research inception, (3) generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, (4) formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, (5) formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to
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Ethics in Animal-Based Research.
Gross, Dominik; Tolba, René H
2015-01-01
In recent years, there have been a number of new demands and regulations which have reignited the discussion on ethics in animal-based research. In the light of this development, the present review first presents an overview of underlying core ethical questions and issues. This is followed by an outline of the current discussion on whether animals (used for experimentation) should have rights ascribed to them and whether animals need to have certain characteristics in order to be the beneficiaries of rights. The discourse on concepts of sentience and the 'sociozoological scale' in particular is mapped out in this regard. There follows an outline of relevant ethical positions and current moral approaches to animal-based research (animal rights position, utilitarianism, 'convergence position', intrinsic cultural value of fundamental research, 'contractarianism', anthropocentrism, principle of the three Rs). 2015 S. Karger AG, Basel.
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De Smit, Elisabeth; Kearns, Lisa S; Clarke, Linda; Dick, Jonathan; Hill, Catherine L; Hewitt, Alex W
2016-01-01
Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs) and Research Governance Offices (RGOs) across Australia. In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA), for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a "National Ethics Application Form" and three a "Low Negligible Risk" form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22) and panel review turnaround time (range nine to 136 days). We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently.
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Directory of Open Access Journals (Sweden)
Elisabeth De Smit
2016-02-01
Full Text Available Background Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. Aims To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs and Research Governance Offices (RGOs across Australia. Methods In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA, for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Results Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a “National Ethics Application Form” and three a “Low Negligible Risk” form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22 and panel review turnaround time (range nine to 136 days. Conclusion We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently
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Sewage epidemiology and illicit drug research: the development of ethical research guidelines.
Prichard, Jeremy; Hall, Wayne; de Voogt, Pim; Zuccato, Ettore
2014-02-15
To discuss the need to develop ethical guidelines for researchers using sewage epidemiology to monitor drug use in the general population and specific precincts, including prisons, schools and workplaces. Describe current applications of sewage epidemiology, identify potential ethical risks associated with this science, and identify key means by which these risks may be mitigated through proportionate ethical guidance that allows this science to be fully developed. A rapidly advancing field of research is sewage epidemiology (SE) - the analysis of wastewater samples to monitor illicit drug use and other substances. Typically this research involves low ethical risks because individual participants cannot be identified and, consequently, review has been waived by human research ethics committees. In the absence of such oversight, ethical research guidelines are recommended for SE teams, peer reviewers and journal editors; guidelines will assist them to mitigate any risks in general population studies and studies of prisons, schools and workplaces. Potential harms include the stigmatisation of participants and, in the prison setting, austere policy responses to SE data that impact negatively upon inmate-participants. The risk of harm can be managed through research planning, awareness of the socio-political context in which results will be interpreted (or, in the case of media, sensationalised) and careful relations with industry partners. Ethical guidelines should be developed in consultation with SE scholars and be periodically amended. They should include publication processes that safeguard scientific rigour and be promulgated through existing research governance structures. Guidelines will assist to promote an ethical research culture among SE teams and scholars involved in the publication process and this will work to protect the reputation of the field. Copyright © 2014 Elsevier B.V. All rights reserved.
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The ethics of HIV research with people who inject drugs in Africa: a desk review.
Mamotte, Nicole
2012-03-01
Injecting drug use is a growing problem in Africa and a growing risk factor for contracting HIV in the region. It is imperative that HIV research includes injecting drug users so that they too are able to benefit from safe and effective behavioural interventions and biomedical HIV prevention and treatment products. This article relates a critical review of the findings of a desk review of previously published literature. The article examines injecting drug use in relation to HIV-related risk and research in Kenya, Mauritius, Nigeria, South Africa and Tanzania. The ethical challenges of including people who inject drugs in HIV research in Africa are also presented. The review found injecting drug use to be on the increase in all the countries reviewed. HIV-risk behaviour among people who inject drugs, such as needle-sharing and higher-risk sexual behaviour, was also found to be widespread. Furthermore, criminalisation of drug use and strict anti-drug laws are common in the countries reviewed, while harm-reduction programmes for people who inject drugs were found to be limited. The review identified a number of ethical challenges to the involvement of people who inject drugs in HIV research in Africa. This includes the illegal status and stigma surrounding injecting drug use, which may complicate participant recruitment, enrolment and retention. In addition, a lack of funding for supportive programmes to help injecting drug users may hinder the provision of appropriate standards of prevention and care and treatment for those who seroconvert.
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Balanced Ethics Review: A Guide for Institutional Review Board Members
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Ames Dhai
2016-12-01
Full Text Available The aim of this pocket-book size manual is to assist Institutional Review Board (IRB members and chairs conduct ethics review by balancing the two major morally relevant considerations in health research
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Ethical considerations in the study of online illness narratives: a qualitative review.
Heilferty, Catherine McGeehin
2011-05-01
This aim of the review was to describe differences in ethical approaches to research on Internet communication during illness and to report conclusions drawn relevant to a proposed narrative analysis of parent blogs of childhood illness. As the study of the online expression of illness experiences becomes more expansive, discussion of related ethical issues is central to promoting research trustworthiness and rigour. Ethical considerations are central to the patient-provider relationship. The EBSCO Host, CINAHL, Medline, Communication & Mass Media Complete, and Google Scholar databases were searched from January 1990 to September 2009 using the terms 'Internet research and ethics', 'Internet research, illness and ethics' and 'blog, Internet research and ethics'. Of the 4114 references found, 21 met the inclusion criteria for the review. The review was designed to be a comprehensive assessment of the concepts analysed and the qualitative research measures taken concerning ethics in Internet research across formats. Three main approaches to ethical conduct in Internet research on illness experiences were found: human subjects, representation and open source approaches. The personal and sensitive nature of online illness narratives demand their consideration in health care as 'human subjects' research. The best hope for ethical treatment of author-participants is the creation of a comprehensive plan for addressing any and all potential ethical conflicts that may arise in the collection, analysis and reporting of data, taking into consideration rapid changes in technology. © 2011 Blackwell Publishing Ltd.
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[Bioethical Approach for Nursing Research -Focused on the Use of Research Ethics Committees].
Jeong, Ihn Sook
2015-06-01
This paper was written to introduce methods of using the research ethics committee (RES) from requesting the initial review to reporting the close-out for nursing researchers. General ethical principles were described by reviewing the 'Bioethics and Safety Act' and other related guidelines, and constructing some questions and answers. The results were composed of three parts; definition of RES, steps in using RES, and archiving. The 7 steps for using RES were; identifying whether the study needed to be reviewed, by the RES identifying whether the study could be exempted, requesting the initial review after preparing documents, requesting the re-review, requesting an amendment review, requesting a continuing review and reporting the close-out. Nursing researchers need to receive RES approval before starting nursing research involving human subjects. Nursing researchers are urged to use the steps reported in this paper to receive RES approval easily and quickly.
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Horner, Jennifer; Minifie, Fred D.
2011-01-01
Purpose: In this series of articles--"Research Ethics I", "Research Ethics II", and "Research Ethics III"--the authors provide a comprehensive review of the 9 core domains for the responsible conduct of research (RCR) as articulated by the Office of Research Integrity. In "Research Ethics I", they present a historical overview of the evolution of…
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Ethical Issues Surrounding Personalized Medicine: A Literature Review.
Salari, Pooneh; Larijani, Bagher
2017-03-01
More than a decade ago, personalized medicine was presented in modern medicine. Personalized medicine means that the right drug should be prescribed for the right patient based on genetic data. No doubt is developing medical sciences, and its shift into personalized medicine complicates ethical challenges more than before. In this review, we categorized all probable ethical considerations of personalized medicine in research and development and service provision. Based on our review, extensive changes in healthcare system including ethical changes are needed to overcome the ethical obstacles including knowledge gap and informed consent, privacy and confidentiality and availability of healthcare services. Furthermore social benefit versus science development and individual benefit should be balanced. Therefore guidelines and regulations should be compiled to represent the ethical framework; also ethical decision making should be day-to-day and individualized.
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2012-01-01
Background Many studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies. Methods The data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004–2009 (n = 688). These included a total of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning. Results The researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research. Conclusion The written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies. PMID:22873761
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Suzuki, Mika; Sato, Keiko
2016-07-01
Research Ethics Committees (RECs) are designed to protect human subjects in research. It is essential to recognize whether the RECs are achieving this goal. Several studies have reported on RECs; however, detailed data regarding the quality of research protocols and the review process of RECs have not been reported in Japan. We examine research protocols reviewed by RECs and the review processes at three institutions using a novel checklist we developed. The data show that approximately half of all examined protocols lacked a clearly written "Background" section that defines the study rationale and design. These results reiterate suggestions made in previous research regarding educational programs and support departments that could enhance responsible conduct in clinical research to protect human subjects in Japan. © The Author(s) 2016.
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Ethics and regulation in organ procurement research.
Ackerman, Terrence F; Winsett, Rebecca P
2002-12-01
This article explores the role of ethics and regulation in human research conducted by organ procurement agencies; basic ethical principles for human research are outlined. Organ procurement agencies are not required to observe federal regulations; however, voluntary adherence will ensure that procurement research is conducted according to current standards of ethical practice. Although most organ procurement research will qualify for exempt status, this determination should be made by an institutional review board. Even if studies qualify for exempt status, there is a moral presumption that informed consent should be sought, unless certain narrow conditions for waiver of consent are satisfied. Finally, when future research utilizing organ procurement records is anticipated, procurement coordinators should provide sufficiently detailed information to families about such plans to permit their advance informed consent to research activities.
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Makhoul, Jihad; Chehab, Rana F; Shaito, Zahraa; Sibai, Abla M
2018-05-15
Ethical research conduct is a cornerstone of research practice particularly when research participants include vulnerable populations. This study mapped the extent of reporting ethical research practices in studies conducted among refugees and war-affected populations in the Arab World, and assessed variations by time, country of study, and study characteristics. An electronic search of eight databases resulted in 5668 unique records published between 2000 and 2013. Scoping review yielded 164 eligible articles for analyses. Ethical research practices, including obtaining institutional approval, access to the community/research site, and informed consent/assent from the research participants, were reported in 48.2, 54.9, and 53.7% of the publications, respectively. Institutional approval was significantly more likely to be reported when the research was biomedical in nature compared to public health and social (91.7% vs. 54.4 and 32.4%), when the study employed quantitative compared to qualitative or mixed methodologies (61.7% vs. 26.8 and 42.9%), and when the journal required a statement on ethical declarations (57.4% vs. 27.1%). Institutional approval was least likely to be reported in papers that were sole-authored (9.5%), when these did not mention a funding source (29.6%), or when published in national journals (0%). Similar results were obtained for access to the community site and for seeking informed consent/assent from study participants. The responsibility of inadequacies in adherence to ethical research conduct in crisis settings is born by a multitude of stakeholders including funding agencies, institutional research boards, researchers and international relief organizations involved in research, as well as journal editors, all of whom need to play a more proactive role for enhancing the practice of ethical research conduct in conflict settings.
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Human Participants in Engineering Research: Notes from a Fledgling Ethics Committee.
Koepsell, David; Brinkman, Willem-Paul; Pont, Sylvia
2015-08-01
For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social-psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices (Martensen in J Hist Med Allied Sci 56(2):168-175, 2001). Institutions such as Institutional Review Boards (in the U.S.) and Ethics Committees (in Europe and elsewhere) oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki (World Medical Association 2008). Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, the U.K. and Australia to oversee all governmental-funded research, and in other jurisdictions, the range of research covered by such committees is expanding. Social science, anthropology, and other fields are falling under more clear directives to conduct a formal ethical review for basic research involving human participants (Federman et al. in Responsible research: a systems approach to protecting research participants. National Academies Press, Washington, 2003, p. 36). The legal and institutional response for protecting human subjects in the course of developing non-medical technologies, engineering, and design is currently vague, but some universities are establishing ethics committees to oversee their human subjects research even where the experiments involved are non-medical and not technically covered by the Declaration of Helsinki. In The Netherlands, as in most of Europe, Asia, Latin America, or Africa, no laws mandate an ethical review of non-medical research. Yet, nearly 2
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A critical review of health research ethical guidelines regarding ...
African Journals Online (AJOL)
Trials, 2006;[22] and Ethics in Health Research Principles, Structures and Procedures, 2015[15]) regarding caregivers' consent in research involving minors as research ..... 11. Jeff H, Ramesh R, Sanjay MB. Pediatric airway management.
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Ethical Issues Surrounding Personalized Medicine: A Literature Review
Directory of Open Access Journals (Sweden)
Pooneh Salari
2017-03-01
Full Text Available More than a decade ago, personalized medicine was presented in modern medicine. Personalized medicine means that the right drug should be prescribed for the right patient based on genetic data. No doubt is developing medical sciences, and its shift into personalized medicine complicates ethical challenges more than before. In this review, we categorized all probable ethical considerations of personalized medicine in research and development and service provision. Based on our review, extensive changes in healthcare system including ethical changes are needed to overcome the ethical obstacles including knowledge gap and informed consent, privacy and confidentiality and availability of healthcare services. Furthermore social benefit versus science development and individual benefit should be balanced. Therefore guidelines and regulations should be compiled to represent the ethical framework; also ethical decision making should be day-to-day and individualized.
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From global bioethics to ethical governance of biomedical research collaborations.
Wahlberg, Ayo; Rehmann-Sutter, Christoph; Sleeboom-Faulkner, Margaret; Lu, Guangxiu; Döring, Ole; Cong, Yali; Laska-Formejster, Alicja; He, Jing; Chen, Haidan; Gottweis, Herbert; Rose, Nikolas
2013-12-01
One of the features of advanced life sciences research in recent years has been its internationalisation, with countries such as China and South Korea considered 'emerging biotech' locations. As a result, cross-continental collaborations are becoming common generating moves towards ethical and legal standardisation under the rubric of 'global bioethics'. Such a 'global', 'Western' or 'universal' bioethics has in turn been critiqued as an imposition upon resource-poor, non-Western or local medical settings. In this article, we propose that a different tack is necessary if we are to come to grips with the ethical challenges that inter-continental biomedical research collaborations generate. In particular we ask how national systems of ethical governance of life science research might cope with increasingly global research collaborations with a focus on Sino-European collaboration. We propose four 'spheres' - deliberation, regulation, oversight and interaction - as a helpful way to conceptualise national systems of ethical governance. Using a workshop-based mapping methodology (workshops held in Beijing, Shanghai, Changsha, Xian, Shenzen and London) we identified three specific ethical challenges arising from cross-continental research collaborations: (1) ambiguity as to which regulations are applicable; (2) lack of ethical review capacity not only among ethical review board members but also collaborating scientists; (3) already complex, researcher-research subject interaction is further complicated when many nationalities are involved. Copyright © 2013 Elsevier Ltd. All rights reserved.
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Using Short Videos to Teach Research Ethics
Loui, M. C.
2014-12-01
Created with support from the National Science Foundation, EthicsCORE (www.natonalethicscenter.org) is an online resource center for ethics in science and engineering. Among the resources, EthicsCORE hosts short video vignettes produced at the University of Nebraska - Lincoln that dramatize problems in the responsible conduct of research, such as peer review of journal submissions, and mentoring relationships between faculty and graduate students. I will use one of the video vignettes in an interactive pedagogical demonstration. After showing the video, I will ask participants to engage in a think-pair-share activity on the professional obligations of researchers. During the sharing phase, participants will supply the reasons for these obligations.
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Ethics and epistemology of accurate prediction in clinical research.
Hey, Spencer Phillips
2015-07-01
All major research ethics policies assert that the ethical review of clinical trial protocols should include a systematic assessment of risks and benefits. But despite this policy, protocols do not typically contain explicit probability statements about the likely risks or benefits involved in the proposed research. In this essay, I articulate a range of ethical and epistemic advantages that explicit forecasting would offer to the health research enterprise. I then consider how some particular confidence levels may come into conflict with the principles of ethical research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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Individual Scholar Productivity Rankings in Business Ethics Research
Directory of Open Access Journals (Sweden)
Benjamin J. Warnick
2014-09-01
Full Text Available The last two decades have been a time of significant development for the academic business ethics community. While a number of scholars have contributed to advances in the field, the work of the individuals who have contributed to its progress and growth through their business ethics research is still not comprehensively understood within the academic business ethics community. This study identifies those individuals who have made major contributions to the business ethics field by ranking authors who have published business ethics-related research in the following six journals over the past 20 years: the Journal of Business Ethics, the Academy of Management Review, the Academy of Management Journal, the Business Ethics Quarterly, the Administrative Science Quarterly; and Business & Society. The results of the study should be of interest to a number of constituencies as they provide the academic business ethics community with a better understanding of the history and evolution of the field and its development towards academic maturity.
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A systematic review of ethics knowledge in audiology (1980-2010).
Naudé, Alida Maryna; Bornman, Juan
2014-06-01
The purpose of this research was to apply multiple perspectives as part of a systematic review to analyze literature regarding ethics in audiology. Audiologists are particularly vulnerable to the changing requirements of the discipline that compel them to straddle both professional obligations and business principles, creating a hybrid professional. The authors used a 2-phase mixed-method approach to analyze publications. Publications were sorted into categories, namely, ethics approach, author, decade, role of the audiologist, component of morality, and common themes. The sample consisted of peer-reviewed articles cited in MEDLINE, CINAHL, ERIC, MasterFILE Premier, E-Journals, Africa-Wide Information, and Academic Search Premier electronic databases and non-peer-reviewed articles in Seminars in Hearing. The publications were predominantly philosophical, focused on the rehabilitative role of the audiologist, and addressed the moral judgment component of moral behavior. Despite the fact that knowledge of ethics grew between 1980 and 2010, this retrospective analysis identified gaps in current knowledge. Research is needed to address the unique ethical problems commonly encountered in all 8 roles of the audiologist; patient perspectives on ethics; ethical approaches; factors affecting moral judgment, sensitivity, motivation, and courage; and cultural dimensions of ethical practice in audiology.
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Ethical and regulatory aspects of embryonic stem cell research.
Jain, Kewal K
2002-12-01
Ethical and regulatory issues concerning embryonic stem (ES) cell research are reviewed here a year after the controversy became a public and political issue in the US. The background of various issues are examined and the current regulations in various countries are reviewed. In the US, the debate is linked with abortion, as well as the status of a fetus as a human being, and is politically driven. Obtaining stem cells from embryonic tissues involves destruction of the embryo, to which objections are raised. Religious beliefs are examined and no serious impediments to ES cell research could be identified. Regulations vary from one country to another and it is unlikely that there will ever be any universally uniform ethical and regulatory standards for ES cell research. Currently, the most liberal and favourable environments for ES cell research are in the UK, Singapore, Sweden, India, Israel and China. Unless the US liberalises ES cell research, it may lose its lead in ES cell research and investments in this area may drift to countries with better environments for research. Suggestions are offered in this review to improve the ethical environment for ES cell research.
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Goldstein, Cory E; Weijer, Charles; Brehaut, Jamie C; Fergusson, Dean A; Grimshaw, Jeremy M; Horn, Austin R; Taljaard, Monica
2018-02-27
Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question
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Ethical aspects of brain computer interfaces: a scoping review.
Burwell, Sasha; Sample, Matthew; Racine, Eric
2017-11-09
Brain-Computer Interface (BCI) is a set of technologies that are of increasing interest to researchers. BCI has been proposed as assistive technology for individuals who are non-communicative or paralyzed, such as those with amyotrophic lateral sclerosis or spinal cord injury. The technology has also been suggested for enhancement and entertainment uses, and there are companies currently marketing BCI devices for those purposes (e.g., gaming) as well as health-related purposes (e.g., communication). The unprecedented direct connection created by BCI between human brains and computer hardware raises various ethical, social, and legal challenges that merit further examination and discussion. To identify and characterize the key issues associated with BCI use, we performed a scoping review of biomedical ethics literature, analyzing the ethics concerns cited across multiple disciplines, including philosophy and medicine. Based on this investigation, we report that BCI research and its potential translation to therapeutic intervention generate significant ethical, legal, and social concerns, notably with regards to personhood, stigma, autonomy, privacy, research ethics, safety, responsibility, and justice. Our review of the literature determined, furthermore, that while these issues have been enumerated extensively, few concrete recommendations have been expressed. We conclude that future research should focus on remedying a lack of practical solutions to the ethical challenges of BCI, alongside the collection of empirical data on the perspectives of the public, BCI users, and BCI researchers.
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Review of national research ethics regulations and guidelines in Middle Eastern Arab countries
2012-01-01
Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. PMID:23234422
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Ethical evaluation of research proposals by ethics panels advising the European Commission.
Kolar, Roman
2004-06-01
Ethical principles with regard to animal experimentation are referred to in European Union (EU) legislation and other official documents. Therefore, applications for funding of research under the EU's research programme may undergo an ethical review that is carried out by so-called ethics panels, consisting of experts chosen by the European Commission. The work of these panels differs substantially from that of other ethical committees, as they exist on the institutional, local, regional or national level. Their main purpose is not to decide whether a proposed research can be regarded legal, and therefore should be endorsed or licensed; instead, it is to help the Commission in prioritising its funding. The panels may examine other ethical aspects than those of animal experimentation or animal welfare alone, such as the use of human volunteers. This is reflected by the composition of the panels. Their decisions are normally based on consensus. Even though these decisions may refer to EU legislation, the criteria applied are not restricted to those provided by this legislation. Nevertheless, the various aspects of the Commission's ethical evaluation system (e.g. formal and practical basic conditions, information content of applications, type of decisions taken, lacking of any quality control) offers opportunities for improvement.
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Ethical Risk Management Education in Engineering: A Systematic Review.
Guntzburger, Yoann; Pauchant, Thierry C; Tanguy, Philippe A
2017-04-01
Risk management is certainly one of the most important professional responsibilities of an engineer. As such, this activity needs to be combined with complex ethical reflections, and this requirement should therefore be explicitly integrated in engineering education. In this article, we analyse how this nexus between ethics and risk management is expressed in the engineering education research literature. It was done by reviewing 135 articles published between 1980 and March 1, 2016. These articles have been selected from 21 major journals that specialize in engineering education, engineering ethics and ethics education. Our review suggests that risk management is mostly used as an anecdote or an example when addressing ethics issues in engineering education. Further, it is perceived as an ethical duty or requirement, achieved through rational and technical methods. However, a small number of publications do offer some critical analyses of ethics education in engineering and their implications for ethical risk and safety management. Therefore, we argue in this article that the link between risk management and ethics should be further developed in engineering education in order to promote the progressive change toward more socially and environmentally responsible engineering practices. Several research trends and issues are also identified and discussed in order to support the engineering education community in this project.
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Will the new code help researchers to be more ethical?
Sieber, J E
1994-11-01
A code of ethics has 2 largely incompatible objectives: to set forth enforceable minimal standards of conduct and to teach about or invoke ethical conduct. The section of the new American Psychological Association code dealing with research ethics achieves the former to some degree. However, it neither provides needed education in the ethics of research nor states where the reader might turn for such information. The code is particularly deficient in the following areas: privacy and confidentiality; institutional review boards; deception; debriefing; data sharing; and research on marginal populations, on children and adolescents, and in organizational contexts. Suggestions are offered for providing a bibliographic resource, in hard copy and on-line, that would stimulate independent interest, scholarship, education, and research on research ethics.
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McKenzie, Joanne E; Herbison, G Peter; Roth, Paul; Paul, Charlotte
2010-03-21
Recent cohort studies of randomised controlled trials have provided evidence of within-study selective reporting bias; where statistically significant outcomes are more likely to be more completely reported compared to non-significant outcomes. Bias resulting from selective reporting can impact on meta-analyses, influencing the conclusions of systematic reviews, and in turn, evidence based clinical practice guidelines.In 2006 we received funding to investigate if there was evidence of within-study selective reporting in a cohort of RCTs submitted to New Zealand Regional Ethics Committees in 1998/99. This research involved accessing ethics applications, their amendments and annual reports, and comparing these with corresponding publications. We did not plan to obtain informed consent from trialists to view their ethics applications for practical and scientific reasons. In November 2006 we sought ethical approval to undertake the research from our institutional ethics committee. The Committee declined our application on the grounds that we were not obtaining informed consent from the trialists to view their ethics application. This initiated a seventeen month process to obtain ethical approval. This publication outlines what we planned to do, the issues we encountered, discusses the legal and ethical issues, and presents some potential solutions. Methodological research such as this has the potential for public benefit and there is little or no harm for the participants (trialists) in undertaking it. Further, in New Zealand, there is freedom of information legislation, which in this circumstance, unambiguously provided rights of access and use of the information in the ethics applications. The decision of our institutional ethics committee defeated this right and did not recognise the nature of this observational research. Methodological research, such as this, can be used to develop processes to improve quality in research reporting. Recognition of the potential
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Sacarlal, Jahit; Muchanga, Vasco; Mabutana, Carlos; Mabui, Matilde; Mariamo, Arlete; Cuamba, Assa Júlio; Fumo, Leida Artur; Silveira, Jacinta; Heitman, Elizabeth; Moon, Troy D
2018-05-23
Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique (CNBS) encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine (FM) of University Eduardo Mondlane (UEM) and the Maputo Central Hospital (MCH) established a joint Institutional Committee on Bioethics for Health (CIBS FM & MCH). This study examines the experience of the first 4 years of the CIBS FM & MCH. This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee's respective reviews and actions. A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master's degree research (42%). Descriptive cross-sectional studies were the most frequently reviewed research (61%). The majority were prospective (71%) and used quantitative methodologies (51%). The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS's average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS. Our results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training
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Dooly, Melinda; Moore, Emilee; Vallejo, Claudia
2017-01-01
Qualitative research, especially studies in educational contexts, often brings up questions of ethics because the study design involves human subjects, some of whom are under age (e.g. data collected in primary education classrooms). It is not always easy for young researchers to anticipate where ethical issues might emerge while designing their…
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Gefenas, E; Dranseika, V; Cekanauskaite, A; Hug, K; Mezinska, S; Peicius, E; Silis, V; Soosaar, A; Strosberg, M
2011-01-01
We analyse the system of ethical review of human research in the Baltic States by introducing the principle of equivalent stringency of ethical review, that is, research projects imposing equal risks and inconveniences on research participants should be subjected to equally stringent review procedures. We examine several examples of non-equivalence or asymmetry in the system of ethical review of human research: (1) the asymmetry between rather strict regulations of clinical drug trials and relatively weaker regulations of other types of clinical biomedical research and (2) gaps in ethical review in the area of non-biomedical human research where some sensitive research projects are not reviewed by research ethics committees at all. We conclude that non-equivalent stringency of ethical review is at least partly linked to the differences in scope and binding character of various international legal instruments that have been shaping the system of ethical review in the Baltic States. Therefore, the Baltic example could also serve as an object lesson to other European countries which might be experiencing similar problems. PMID:20606000
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Ethical issues experienced by healthcare workers in nursing homes: Literature review.
Preshaw, Deborah Hl; Brazil, Kevin; McLaughlin, Dorry; Frolic, Andrea
2016-08-01
Ethical issues are increasingly being reported by care-providers; however, little is known about the nature of these issues within the nursing home. Ethical issues are unavoidable in healthcare and can result in opportunities for improving work and care conditions; however, they are also associated with detrimental outcomes including staff burnout and moral distress. The purpose of this review was to identify prior research which focuses on ethical issues in the nursing home and to explore staffs' experiences of ethical issues. Using a systematic approach based on Aveyard (2014), a literature review was conducted which focused on ethical and moral issues, nurses and nursing assistants, and the nursing home. The most salient themes identified in the review included clashing ethical principles, issues related to communication, lack of resources and quality of care provision. The review also identified solutions for overcoming the ethical issues that were identified and revealed the definitional challenges that permeate this area of work. The review highlighted a need for improved ethics education for care-providers. © The Author(s) 2015.
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Taljaard, Monica; Hemming, Karla; Shah, Lena; Giraudeau, Bruno; Grimshaw, Jeremy M; Weijer, Charles
2017-08-01
Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants-yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28
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Review of Ethics in Mental Health Research by James M. DuBois
Directory of Open Access Journals (Sweden)
Pies Ronald
2008-04-01
Full Text Available Abstract The burgeoning field of medical ethics raises complicated questions for mental health researchers. The critical issues of risk assessment, beneficence, and the moral duties researchers owe their patients are analyzed in James DuBois's well written Ethics in Mental Health Research.
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Ethical issues in the use of in-depth interviews: literature review and discussion
Allmark, Peter; Boote, Jonathan; Chambers, E.; Clarke, Amanda; McDonnell, A.; Thompson, Andrew; Tod, Angela
2009-01-01
This paper reports a literature review on the topic of ethical issues in in-depth interviews. The review returned three types of article: general discussion, issues in particular studies, and studies of interview-based research ethics. Whilst many of the issues discussed in these articles are generic to research ethics, such as confidentiality, they often had particular manifestations in this type of research. For example, privacy was a significant problem as interviews sometimes probe unexpe...
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Real-time Responsiveness for Ethics Oversight During Disaster Research.
Eckenwiler, Lisa; Pringle, John; Boulanger, Renaud; Hunt, Matthew
2015-11-01
Disaster research has grown in scope and frequency. Research in the wake of disasters and during humanitarian crises--particularly in resource-poor settings--is likely to raise profound and unique ethical challenges for local communities, crisis responders, researchers, and research ethics committees (RECs). Given the ethical challenges, many have questioned how best to provide research ethics review and oversight. We contribute to the conversation concerning how best to ensure appropriate ethical oversight in disaster research and argue that ethical disaster research requires of researchers and RECs a particular sort of ongoing, critical engagement which may not be warranted in less exceptional research. We present two cases that typify the concerns disaster researchers and RECs may confront, and elaborate upon what this ongoing engagement might look like--how it might be conceptualized and utilized--using the concept of real-time responsiveness (RTR). The central aim of RTR, understood here as both an ethical ideal and practice, is to lessen the potential for research conducted in the wake of disasters to create, perpetuate, or exacerbate vulnerabilities and contribute to injustices suffered by disaster-affected populations. Well cultivated and deployed, we believe that RTR may enhance the moral capacities of researchers and REC members, and RECs as institutions where moral agency is nurtured and sustained. © 2015 John Wiley & Sons Ltd.
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Iedema, Rick A M; Allen, Suellen; Britton, Kate; Hor, Suyin
2013-05-01
This paper describes the ethics approval processes for two multicentre, nationwide, qualitative health service research projects. The paper explains that the advent of the National Ethics Application Form has brought many improvements, but that attendant processes put in place at local health network and Human Research Ethics Committee levels may have become significantly more complicated, particularly for innovative qualitative research projects. The paper raises several questions based on its analysis of ethics application processes currently in place. WHAT IS KNOWN ABOUT THE TOPIC? The complexity of multicentre research ethics applications for research in health services has been addressed by the introduction of the National Ethics Application Form. Uptake of the form across the country's human research ethics committees has been uneven. WHAT DOES THIS PAPER ADD? This paper adds detailed insight into the ethics application process as it is currently enacted across the country. The paper details this process with reference to difficulties faced by multisite and qualitative studies in negotiating access to research sites, ethics committees' relative unfamiliarity with qualitative research , and apparent tensions between harmonisation and local sites' autonomy in approving research. WHAT ARE THE IMPLICATIONS FOR PRACTITIONERS? Practitioners aiming to engage in research need to be aware that ethics approval takes place in an uneven procedural landscape, made up of variable levels of ethics approval harmonization and intricate governance or site-specific assessment processes.
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Directory of Open Access Journals (Sweden)
Salai Suzana
2006-01-01
Full Text Available The ethics is the inner law of the individual. Its application is controlled and sacked by the self-awareness and the surrounding (by ethical codecs. The self-awareness is the inner law produced by everyday life, and is therefore changeable and adaptable to the outer reality. The ethics is a common field of marketing research, within the processes of ethical dilemmas and the marketing research process itself (identified target segments: the public the consumer, the subject ordering marketing research and marketing researchers.
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Smith, T; Moore, E J; Tunstall-Pedoe, H
1997-05-31
To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace. Tayside, Scotland (mixed rural and urban population). 30 research projects approved by Tayside local medical research ethics committee. Adherence to the agreed protocol, particularly for recruitment (obtaining and recording informed consent) and for specific requirements of the ethics committee, including notification of changes to the protocol and of adverse events. In one project only oral consent had been obtained, and in a quarter of the studies one or more consent forms were incorrectly completed. Inadequate filing of case notes in five studies and of consent forms in six made them unavailable for scrutiny. Adverse events were reported, but there was a general failure to report the abandoning or non-starting of projects in two studies the investigators failed to notify a change in the responsible researcher. Monitoring of medical research by local medical research ethics committees promotes and preserves ethical standards, protects subjects and researchers, discourages fraud, and has the support of investigators. We recommend that 10% of projects should undergo on-site review, with all others monitored by questionnaire. This would require about six person hours of time and a salary bill of 120 pounds per study monitored.
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Ethical concerns of nursing reviewers: an international survey.
Broome, Marion; Dougherty, Molly C; Freda, Margaret C; Kearney, Margaret H; Baggs, Judith G
2010-11-01
Editors of scientific literature rely heavily on peer reviewers to evaluate the integrity of research conduct and validity of findings in manuscript submissions. The purpose of this study was to describe the ethical concerns of reviewers of nursing journals. This descriptive cross-sectional study was an anonymous online survey. The findings reported here were part of a larger investigation of experiences of reviewers. Fifty-two editors of nursing journals (six outside the USA) agreed to invite their review panels to participate. A 69-item forced-choice and open-ended survey developed by the authors based on the literature was pilot tested with 18 reviewers before being entered into SurveyMonkey(TM). A total of 1675 reviewers responded with useable surveys. Six questions elicited responses about ethical issues, such as conflict of interest, protection of human research participants, plagiarism, duplicate publication, misrepresentation of data and 'other'. The reviewers indicated whether they had experienced such a concern and notified the editor, and how satisfied they were with the outcome. They provided specific examples. Approximately 20% of the reviewers had experienced various ethical dilemmas. Although the majority reported their concerns to the editor, not all did so, and not all were satisfied with the outcomes. The most commonly reported concern perceived was inadequate protection of human participants. The least common was plagiarism, but this was most often reported to the editor and least often led to a satisfactory outcome. Qualitative responses at the end of the survey indicate this lack of satisfaction was most commonly related to feedback provided on resolution by the editor. The findings from this study suggest several areas that editors should note, including follow up with reviewers when they identify ethical concerns about a manuscript.
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Balancing Ethics and Quality in Educational Research--The Ethical Matrix Method
Tangen, Reidun
2014-01-01
This paper addresses ethical issues in educational research with a focus on the interplay between research ethics and both internal and external quality of research. Research ethics is divided into three domains: (1) ethics "within" the research community; (2) ethics concerning relationships with "individuals and groups directly…
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Directory of Open Access Journals (Sweden)
Mark Williams
2001-05-01
Full Text Available In order to reflect on some ethical improprieties which I had committed during the data collection phase of an information systems research study, I conducted an heuristic and psychologically-oriented self-study. As part of this heuristic reflection, I engaged in a number of self dialogues in the form of a conversation between various characters. Reported in this paper is one of these dialogues, concerning broad issues of ethics and research and discussing the notion of wisdom, maturity, meaning, and virtue. Ethical considerations are always of primary importance, and I would assert that this is even more so when considering research investigating and using new media, such as the world wide web, in which acceptable ethical practices have yet to be established and consolidated.
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Dresser, Rebecca
2006-01-01
Pharmaceutical companies are major sponsors of biomedical research. Most scholars and policymakers focus their attention on government and academic oversight activities, however. In this article, I consider the role of pharmaceutical companies' internal ethics statements in guiding decisions about corporate research and development (R&D). I review materials from drug company websites and contributions from the business and medical ethics literature that address ethical responsibilities of businesses in general and pharmaceutical companies in particular. I discuss positive and negative uses of pharmaceutical companies' ethics materials and describe shortcomings in the companies' existing ethics programs. To guide employees and reassure outsiders, companies must add rigor, independence, and transparency to their R&D ethics programs.
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Directory of Open Access Journals (Sweden)
Rod Gerber
2004-05-01
Full Text Available This publication basically represents a collection of former conference papers and some other contributions mainly by North American social scientists on the dilemmas that qualitative researchers encounter when they submit research applications to research ethics committees. Collectively, the contributions demonstrate the tensions that exist in the policy and practice of applied research ethics in qualitative research. Thirteen chapters are included in this volume. They focus on the themes of: differentiating between ethics and morality; dealing with ethics committees and policies; research processes; research ethics trends; and, ethical issues when submitting research applications. The emphasis is on research policy in a North American context (Canada and the United States, but can be relevant for qualitative researchers in other parts of the world. One challenge to this context is that it does not capture the essence of some European perspectives, especially those from Continental Europe. However, it does raise the issue of ethics in qualitative research to a high level. URN: urn:nbn:de:0114-fqs040214
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Mondragón Barrios, Liliana; Guarneros García, Tonatiuh; Jiménez Tapia, Alberto
2017-07-01
The objective of this article is to compare various ethical issues considered by social scientists and research ethics committees in the evaluation of mental health social research protocols. We contacted 47 social scientists and 10 members of ethics committees in Mexico with two electronic national surveys that requested information from both groups related to the application of ethical principles in mental health social research. The results showed no significant difference between these groups in the value placed on the ethical issues explored. Based on this finding, we make proposals to strengthen the collaboration between the two groups.
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Many worlds, one ethic: design and development of a global research ethics training curriculum.
Rivera, Roberto; Borasky, David; Rice, Robert; Carayon, Florence
2005-05-01
The demand for basic research ethics training has grown considerably in the past few years. Research and education organizations face the challenge of providing this training with limited resources and training tools available. To meet this need, Family Health International (FHI), a U.S.-based international research organization, recently developed a Research Ethics Training Curriculum (RETC). It was designed as a practical, user-friendly tool that provides basic, up-to-date, standardized training on the ethics of human research. The curriculum can easily be adapted to different audiences and training requirements. The RETC was reviewed by a group of international experts and field tested in five countries. It is available in English, French, and Spanish as a three-ring binder and CD-ROM, as well as on the Web. It may be used as either an interactive self-study program or for group training.
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The ethics in qualitative health research: special considerations.
Peter, Elizabeth
2015-09-01
A sound knowledge of the nature of qualitative research, along with an appreciation of some special ethical considerations, is needed for rigorous reviews to be conducted. The overall character of qualitative research is described with an emphasis on the tendency of qualitative researchers to explore sensitive topics using theoretically informed methods. A number of specific features of qualitative that require additional ethical attention and awareness are also examined including the following: 1) participants are frequently quite vulnerable and require protection because the data collection methods, such as in-depth interviews, can delve into personally and politically charged matters; 2) naturalistic observation can raise concerns regarding privacy and consent; 3) the potential for the identifiability of the results of this research may require extra efforts to maintain confidentiality. Ultimately, Reseach Ethics Committee members must be knowledgeable about qualitative approaches to be able to assess the potential harms and benefits in a protocol carefully. Without this knowledge gaining ethics approval can be overly difficult for researchers and the best practices for protecting human participants can be overlooked.
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The ethics in qualitative health research: special considerations
Directory of Open Access Journals (Sweden)
Elizabeth Peter
2015-09-01
Full Text Available Abstract A sound knowledge of the nature of qualitative research, along with an appreciation of some special ethical considerations, is needed for rigorous reviews to be conducted. The overall character of qualitative research is described with an emphasis on the tendency of qualitative researchers to explore sensitive topics using theoretically informed methods. A number of specific features of qualitative that require additional ethical attention and awareness are also examined including the following: 1 participants are frequently quite vulnerable and require protection because the data collection methods, such as in-depth interviews, can delve into personally and politically charged matters; 2 naturalistic observation can raise concerns regarding privacy and consent; 3 the potential for the identifiability of the results of this research may require extra efforts to maintain confidentiality. Ultimately, Reseach Ethics Committee members must be knowledgeable about qualitative approaches to be able to assess the potential harms and benefits in a protocol carefully. Without this knowledge gaining ethics approval can be overly difficult for researchers and the best practices for protecting human participants can be overlooked.
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Guidelines for an environmental code of ethics for research institutions
International Nuclear Information System (INIS)
Gardusi, Claudia; Aquino, Afonso Rodrigues de
2009-01-01
The purpose of this work is to reflect about actions that may contribute to the creation of mechanisms to protect the environment in the development of research projects at research institutions, specifically the Nuclear and Energy Research Institute - IPEN. A brief review of part of the ethical values applied to the process of scientific development during the old, medieval and modern periods is presented, showing the split of the nature ethical principles. It is also reported an overview of the creation of codes of ethics applied to research institutions. Moreover, criteria are presented to settle guidelines to protect the environment during the development of research projects. (author)
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Introduction: international research ethics education.
Millum, Joseph; Sina, Barbara
2014-04-01
NIH's Fogarty International Center has provided grants for the development of training programs in international research ethics for low- and middle-income (LMIC) professionals since 2000. Drawing on 12 years of research ethics training experience, a group of Fogarty grantees, trainees, and other ethics experts sought to map the current capacity and need for research ethics in LMICs, analyze the lessons learned about teaching bioethics, and chart a way forward for research ethics training in a rapidly changing health research landscape. This collection of papers is the result.
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Ethics and psychological research
DEFF Research Database (Denmark)
Søndergaard, Dorte Marie
Human subjects and social relations are crucial in research psychologists’ ethical considerations. Lists of ethical criteria - including how to anonymize data, avoid causing harm, handle asymmetries – are pivotal. A situated ethics inspired by new materialism and poststructuralism would, however......, elaborate these focuses to include social orders, discursive power, and more comprehensive material-discursive apparatuses. I will draw on concepts developed by Barad, Foucault and Butler to discuss how ethics can be understood as an intra-acting, emergent element of the research apparatus. Barad’s notion...... the researchers’ moral narcissism in relation to the enactment of social-subjective phenomena in research; on the other hand, it leaves researchers with a broader spectrum of phenomena to include in their ethical considerations. This invites new questions: Which perspectives of human and non-human existence...
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Ethical issues in the use of in-depth interviews: literature review and discussion\\ud
Allmark, P.; Boote, J.; Chambers, E.; Clarke, A.; McDonnell, A.; Thompson, A.R.; Tod, A.
2009-01-01
This paper reports a literature review on the topic of ethical issues in in-depth interviews. The review returned three\\ud types of article: general discussion, issues in particular studies, and studies of interview-based research ethics. Whilst\\ud many of the issues discussed in these articles are generic to research ethics, such as confidentiality, they often had particular\\ud manifestations in this type of research. For example, privacy was a significant problem as interviews sometimes\\ud ...
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Research ethics in dissertations: ethical issues and complexity of reasoning.
Kjellström, S; Ross, S N; Fridlund, B
2010-07-01
Conducting ethically sound research is a fundamental principle of scientific inquiry. Recent research has indicated that ethical concerns are insufficiently dealt with in dissertations. To examine which research ethical topics were addressed and how these were presented in terms of complexity of reasoning in Swedish nurses' dissertations. Analyses of ethical content and complexity of ethical reasoning were performed on 64 Swedish nurses' PhD dissertations dated 2007. A total of seven ethical topics were identified: ethical approval (94% of the dissertations), information and informed consent (86%), confidentiality (67%), ethical aspects of methods (61%), use of ethical principles and regulations (39%), rationale for the study (20%) and fair participant selection (14%). Four of those of topics were most frequently addressed: the majority of dissertations (72%) included 3-5 issues. While many ethical concerns, by their nature, involve systematic concepts or metasystematic principles, ethical reasoning scored predominantly at lesser levels of complexity: abstract (6% of the dissertations), formal (84%) and systematic (10%). Research ethics are inadequately covered in most dissertations by nurses in Sweden. Important ethical concerns are missing, and the complexity of reasoning on ethical principles, motives and implications is insufficient. This is partly due to traditions and norms that discount ethical concerns but is probably also a reflection of the ability of PhD students and supervisors to handle complexity in general. It is suggested that the importance of ethical considerations should be emphasised in graduate and post-graduate studies and that individuals with capacity to deal with systematic and metasystematic concepts are recruited to senior research positions.
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Directory of Open Access Journals (Sweden)
Ignacio Segarra
2017-07-01
Full Text Available The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have reviewed preclinical studies of sunitinib that incorporate sex as a covariate to explore possible sex-based differences in pharmacokinetics and drug–drug interactions (DDI to attempt a relationship with published clinical outputs. We observed that covariate sex is lacking in most clinical outcome reports and suggest a series of ethic-based proposals to improve research activities and identify relevant different sex outcomes. We propose a deeper integration of preclinical, clinical, and translational research addressing statistical and clinical significance jointly; to embed specific sex-divergent endpoints to evaluate possible gender differences objectively during all stages of research; to pay greater attention to sex-divergent outcomes in polypharmacy scenarios, DDI and bioequivalence studies; the clear reporting of preclinical and clinical findings regarding sex-divergent outcomes; as well as to encourage the active role of scientists and the pharmaceutical industry to foster a new scientific culture through their research programs, practice, and participation in editorial boards and Institutional Ethics Review Boards (IRBs and Research Ethics Committees (RECs. We establish the IRB/REC as the centerpiece for the implementation of these proposals. We suggest the expansion of its competence to follow up clinical trials to ensure that sex differences are addressed and recognized; to engage in data monitoring committees to improve clinical research cooperation and ethically address those potential clinical outcome differences between male and female patients to analyze their social and clinical implications in research and healthcare policies.
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Advancing Ethical Neuroscience Research.
Borah, B Rashmi; Strand, Nicolle K; Chillag, Kata L
2016-12-01
As neuroscience research advances, researchers, clinicians, and other stakeholders will face a host of ethical challenges. The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has published two reports that provide recommendations on how to advance research endeavors ethically. The commission addressed, among other issues, how to prioritize different types of neuroscience research and how to include research participants who have impaired consent capacity. The Bioethics Commission's recommendations provide a foundation for ethical guidelines as neuroscience research advances and progresses. © 2016 American Medical Association. All Rights Reserved.
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Public health ethics theory: review and path to convergence.
Lee, Lisa M
2012-01-01
Public health ethics is a nascent field, emerging over the past decade as an applied field merging concepts of clinical and research ethics. Because the "patient" in public health is the population rather than the individual, existing principles might be weighted differently, or there might be different ethical principles to consider. This paper reviewed the evolution of public health ethics, the use of bioethics as its model, and the proposed frameworks for public health ethics through 2010. Review of 13 major public health ethics frameworks published over the past 15 years yields a wide variety of theoretical approaches, some similar foundational values, and a few similar operating principles. Coming to a consensus on the reach, purpose, and ends of public health is necessary if we are to agree on what ethical underpinnings drive us, what foundational values bring us to these underpinnings, and what operating principles practitioners must implement to make ethical decisions. If public health is distinct enough from clinical medicine to warrant its own set of ethical and philosophical underpinnings, then a decision must be made as to whether a single approach is warranted or we can tolerate a variety of equal but different perspectives. © 2012 American Society of Law, Medicine & Ethics, Inc.
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Ethical review in Pakistan: the credibility gap.
Jafarey, Aamir Mustafa; Iqbal, Saima Pervaiz; Hassan, Mariam
2012-12-01
The concept of mandatory ethical review of research involving human participants is gradually taking root in Pakistani institutions. Based on the opinions of Institutional Review Board (IRB) members from institutions across the country, the process faces several challenges which threaten its integrity. The lack of registration or accreditation for IRBs has resulted in a wide variation in the calibre and working of such Boards. Despite the recent growth in numbers of people with formal bioethics degrees in the country, a majority of membership remains without any formal training for the work expected from them in ethical review. External pressures to influence deliberations, conflict of interest issues within board leadership and inconsistent application of review requirements all contribute in undermining the reliability of the process. Some of the most significant threats to independent and uninfluenced functioning of such boards arise from institutional leadership itself. In the opinions of IRB members, the review process has to be uniform, consistent and trustworthy if it is to gain the respect of researchers, and IRB need to be given the autonomous space to make independent decisions. Otherwise there is a real danger of IRBs being relegated to being no more than rubber stamping committees.
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Ethics of research for patients in pain.
Waisel, David B
2017-04-01
This review describes advances in rising and continuing ethical issues in research in patients in pain. Although some of the issues focus directly on pain research, such as research in neonatal pain management, others focus on widespread ethical issues that are relevant to pain research, such as scientific misconduct, deception, placebo use and genomics. Scientific misconduct is more widespread than realized and requires greater awareness of the markers of misconduct like irreproducibility. More education about what qualifies as misconduct, such as consent violations, plagiarism and inappropriate patient recruitment along with data falsification needs to be implemented. Wayward researchers may attend a rehabilitation conference to improve their practices. Studies in neonatal pain management do not require comparing an intervention with the inadequate analgesia of a placebo; comparing with a standard approach is sufficient. Deception of research patients may be acceptable under narrow circumstances. The legitimacy of using broad informed consent for biobanking and genomic studies are being challenged as changes to the Common Rule are being considered. Increasing complexity and the desire to further medical knowledge complicates research methods and informed consent. The ethical issues surrounding these and offshoot areas will continue to develop.
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Ethical issues in perinatal mental health research.
Brandon, Anna R; Shivakumar, Geetha; Lee, Simon Craddock; Inrig, Stephen J; Sadler, John Z
2009-11-01
To review the background of current ethical standards for the conduct of perinatal mental health research and describe the ethical challenges in this research domain. Current literature reflects a growing sentiment in the scientific community that having no information regarding the impact of psychiatric treatment on the mother and developing fetus/infant poses dangers that may exceed the risks involved in research. However, without sufficient consensus across the scientific community, both regulatory bodies and perinatal researchers find themselves without a framework for decision making that satisfactorily limits the risks and facilitates the benefits of participation of pregnant and lactating women in clinical research. Psychiatric research in perinatal mental health is critically important as it enables clinicians and patients to participate in informed decision-making concerning treatment for psychiatric disorders. Specific areas of concern include fetal safety, maternal risk, the therapeutic misconception, commercial interests, forensic/legal issues, the informed consent process, and study design. Developing guidelines that address ethical challenges and include the views and concerns of multiple stakeholders could improve the access of perinatal women to the benefits of participation in mental health research in addition to providing evidence-based mental healthcare for this subpopulation.
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[Ethic review on clinical experiments of medical devices in medical institutions].
Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining
2011-07-01
Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.
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Cheluvappa, Rajkumar; Scowen, Paul; Eri, Rajaraman
2017-08-01
Animals have been used in research and teaching for a long time. However, clear ethical guidelines and pertinent legislation were instated only in the past few decades, even in developed countries with Judeo-Christian ethical roots. We compactly cover the basics of animal research ethics, ethical reviewing and compliance guidelines for animal experimentation across the developed world, "our" fundamentals of institutional animal research ethics teaching, and emerging alternatives to animal research. This treatise was meticulously constructed for scientists interested/involved in animal research. Herein, we discuss key animal ethics principles - Replacement/Reduction/Refinement. Despite similar undergirding principles across developed countries, ethical reviewing and compliance guidelines for animal experimentation vary. The chronology and evolution of mandatory institutional ethical reviewing of animal experimentation (in its pioneering nations) are summarised. This is followed by a concise rendition of the fundamentals of teaching animal research ethics in institutions. With the advent of newer methodologies in human cell-culturing, novel/emerging methods aim to minimise, if not avoid the usage of animals in experimentation. Relevant to this, we discuss key extant/emerging alternatives to animal use in research; including organs on chips, human-derived three-dimensional tissue models, human blood derivates, microdosing, and computer modelling of various hues. © 2017 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics.
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Jiang, Lanhui; Shen, Jiantong; Li, Youping; Deng, Shaolin; Wu, Taixiang; Chen, Baoqing; Xie, Zhiyi; Qin, Chaoyi; Yu, Zhiyuan; Qin, Chuan; Huang, Jin; Liu, Xuemei; Li, Yan; Jiang, Jie
2012-05-01
To perform a comparative quantitative and qualitative analysis of Chinese and non-Chinese medical ethics literature using systematic research and literature analysis in order to discern research trends in the area and provide baseline data as a reference for relevant decision making and further study. We retrieved articles using MeSH terms and keywords related to medical ethics in PubMed and CNKI, and then constructed a set of charts by applying word co-occurrence, The Pathfinder Networks algorithms, an included subject chart, a research field relationship chart, and strategy coordination charts. The total of number of papers retrieved from PubMed was six times that retrieved from CNKI. Outside China, medical ethics has been studied in eight fully shaped subject fields, including morals, ethical review, physician-patient relationships, clinical trials, euthanasia, ethics education, clinical ethics, and health policy. In contrast, medical ethics research in China is still confined to five subject fields: morals, physician-patient relations, medical ethics education, ethical review, and medical research. Medical ethics research outside China emphasizes the application of medical ethics to solve emerging problems in clinical and medical research. It is mainly centered on morals, ethical review, and physician-patient relations. By comparison, medical ethics research in China places greater emphasis on morals and medical education. In order to narrow this gap between China and other countries, we should broaden the research scope of medical ethics and add more applied research, such as ethical review and medical education. © 2012 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.
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International Nuclear Information System (INIS)
Grass, Guido
2014-01-01
Taking into account the state of the science, the ethics committee has to decide in research projects with study-related radiation exposure, whether a compelling need for the research project exists. During the critical appraisal, further ethical and legal aspects have to be considered. Even without an application according to X-ray Ordinance (RoeV) or Radiation Protection Ordinance (StrlSchV), the Ethics Committee should advise the applicant whether from their perspective the project requires an approval according to RoeV and StrlSchV. This requires the regular involvement of expert members.
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Directory of Open Access Journals (Sweden)
G.J. Rossouw
2001-08-01
Full Text Available Research in business ethics is vital for the expansion and credibility of this fairly recent academic field. This article argues that there are three factors that are crucially important for research in business ethics. They are (a the ontological assumptions that research in this field is premised upon, (b the choice of research strategies and methodologies and (c the role of theory in research practice. Each of these three factors is explored and pitfalls relating to each of them are identified. The article also suggests guidelines for dealing with each of these factors in business ethics research.
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Internet research: an opportunity to revisit classic ethical problems in behavioral research.
Pittenger, David J
2003-01-01
The Internet offers many new opportunities for behavioral researchers to conduct quantitative and qualitative research. Although the ethical guidelines of the American Psychological Association generalize, in part, to research conducted through the Internet, several matters related to Internet research require further analysis. This article reviews several fundamental ethical issues related to Internet research, namely the preservation of privacy, the issuance of informed consent, the use of deception and false feedback, and research methods. In essence, the Internet offers unique challenges to behavioral researchers. Among these are the need to better define the distinction between private and public behavior performed through the Internet, ensure mechanisms for obtaining valid informed consent from participants and performing debriefing exercises, and verify the validity of data collected through the Internet.
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Ethics and methods for biological rhythm research on animals and human beings.
Portaluppi, Francesco; Smolensky, Michael H; Touitou, Yvan
2010-10-01
This article updates the ethical standards and methods for the conduct of high-quality animal and human biological rhythm research, which should be especially useful for new investigators of the rhythms of life. The editors of Chronobiology International adhere to and endorse the Code of Conduct and Best Practice Guidelines of the Committee On Publication Ethics (COPE), which encourages communication of such updates at regular intervals in the journal. The journal accepts papers representing original work, no part of which was previously submitted for publication elsewhere, except as brief abstracts, as well as in-depth reviews. The majority of research papers published in Chronobiology International entails animal and human investigations. The editors and readers of the journal expect authors of submitted manuscripts to have made an important contribution to the research of biological rhythms and related phenomena using ethical methods/procedures and unbiased, accurate, and honest reporting of findings. Authors of scientific papers are required to declare all potential conflicts of interest. The journal and its editors endorse compliance of investigators to the Guide for the Care and Use of Laboratory Animals of the Institute for Laboratory Animal Research of the National Research Council, relating to the conduct of ethical research on laboratory and other animals, and the principles of the Declaration of Helsinki of the World Medical Association, relating to the conduct of ethical research on human beings. The peer review of manuscripts by Chronobiology International thus includes judgment as to whether or not the protocols and methods conform to ethical standards. Authors are expected to show mastery of the basic methods and procedures of biological rhythm research and proper statistical assessment of data, including the appropriate application of time series data analyses, as briefly reviewed in this article. The journal editors strive to consistently achieve
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Komić, Dubravka; Marušić, Stjepan Ljudevit; Marušić, Ana
2015-01-01
Professional codes of ethics are social contracts among members of a professional group, which aim to instigate, encourage and nurture ethical behaviour and prevent professional misconduct, including research and publication. Despite the existence of codes of ethics, research misconduct remains a serious problem. A survey of codes of ethics from 795 professional organizations from the Illinois Institute of Technology's Codes of Ethics Collection showed that 182 of them (23%) used research integrity and research ethics terminology in their codes, with differences across disciplines: while the terminology was common in professional organizations in social sciences (82%), mental health (71%), sciences (61%), other organizations had no statements (construction trades, fraternal social organizations, real estate) or a few of them (management, media, engineering). A subsample of 158 professional organizations we judged to be directly involved in research significantly more often had statements on research integrity/ethics terminology than the whole sample: an average of 10.4% of organizations with a statement (95% CI = 10.4-23-5%) on any of the 27 research integrity/ethics terms compared to 3.3% (95% CI = 2.1-4.6%), respectively (Porganizations should define research integrity and research ethics issues in their ethics codes and collaborate within and across disciplines to adequately address responsible conduct of research and meet contemporary needs of their communities.
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What do international ethics guidelines say in terms of the scope of medical research ethics?
Bernabe, Rosemarie D L C; van Thiel, Ghislaine J M W; van Delden, Johannes J M
2016-04-26
In research ethics, the most basic question would always be, "which is an ethical issue, which is not?" Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus (or lack thereof). In this manuscript, we attempted to do just that. We extracted the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative. We found that there is no consensus on the majority of the imperatives and that in only 8.2% of the imperatives were there at least moderate consensus (i.e., consensus of at least 3 of the 5 ethics guidelines). Of the 12 clusters (Basic Principles; Research Collaboration; Social Value; Scientific Validity; Participant Selection; Favorable Benefit/Risk Ratio; Independent Review; Informed Consent; Respect for Participants; Publication and Registration; Regulatory Sanctions; and Justified Research on the Vulnerable Population), Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least. There was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences.
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Mockler, Nicole
2014-01-01
The act of engaging in sound and ethical practitioner research, regardless of context, encourages and indeed demands an alignment between the ethical framework employed in the research enterprise and the "everyday ethics" of practice. This paper explores the ethical dimensions of what Cochran-Smith and Lytle have termed the dialectic of…
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Auditing of clinical research ethics in a children's and women's academic hospital.
Bortolussi, Robert; Nicholson, Diann
2002-06-01
Canadian and international guidelines for research ethics practices have advocated that research ethics boards (REBs) should implement mechanisms to review and monitor human research. Despite this, few Canadian REBs fulfil this expectation. The objective of this report is to summarize the results of 6 audits of clinical research ethics conducted between 1992 and 2000 in a children's and women's academic hospital in Canada in an effort to guide other academic centres planning a similar process. Research audits were conducted by members of a research audit review committee made up of REB volunteers. With use of random and selective processes, approximately 10% of research protocols were audited through interviews with research investigators and research coordinators and by sampling research records. Predetermined criteria were used to assess evidence of good record keeping, data monitoring, adherence to protocol, consents and the recording of adverse events during the research study. An estimate of time required to undertake an audit was made by recall of participants and records. Thirty-five research studies were reviewed including 16 multicentre clinical trials and 19 single-site clinical studies. Review of record keeping and research practice revealed some deficiencies: researchers failed to maintain original authorization (7%) or renewal documentation (9%); there was 1 instance of improper storage of medication; in 5% of 174 participants for whom consent was reviewed, an outdated consent form had been used, and in 4% the signature of the enrolee was not properly shown. Other deficiencies in consent documentation occurred in less than 2% of cases. Nineteen recommendations were made with respect to deficiencies and process issues. A total of 9 to 20 person-hours are required to review each protocol in a typical audit of this type. Information from research audits has been useful to develop educational programs to correct deficiencies identified through the audits
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Komić, Dubravka; Marušić, Stjepan Ljudevit; Marušić, Ana
2015-01-01
Professional codes of ethics are social contracts among members of a professional group, which aim to instigate, encourage and nurture ethical behaviour and prevent professional misconduct, including research and publication. Despite the existence of codes of ethics, research misconduct remains a serious problem. A survey of codes of ethics from 795 professional organizations from the Illinois Institute of Technology’s Codes of Ethics Collection showed that 182 of them (23%) used research integrity and research ethics terminology in their codes, with differences across disciplines: while the terminology was common in professional organizations in social sciences (82%), mental health (71%), sciences (61%), other organizations had no statements (construction trades, fraternal social organizations, real estate) or a few of them (management, media, engineering). A subsample of 158 professional organizations we judged to be directly involved in research significantly more often had statements on research integrity/ethics terminology than the whole sample: an average of 10.4% of organizations with a statement (95% CI = 10.4-23-5%) on any of the 27 research integrity/ethics terms compared to 3.3% (95% CI = 2.1–4.6%), respectively (Pethics concepts used prescriptive language in describing the standard of practice. Professional organizations should define research integrity and research ethics issues in their ethics codes and collaborate within and across disciplines to adequately address responsible conduct of research and meet contemporary needs of their communities. PMID:26192805
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Coleman, Carl H; Ardiot, Chantal; Blesson, Séverine; Bonnin, Yves; Bompart, Francois; Colonna, Pierre; Dhai, Ames; Ecuru, Julius; Edielu, Andrew; Hervé, Christian; Hirsch, François; Kouyaté, Bocar; Mamzer-Bruneel, Marie-France; Maoundé, Dionko; Martinent, Eric; Ntsiba, Honoré; Pelé, Gérard; Quéva, Gilles; Reinmund, Marie-Christine; Sarr, Samba Cor; Sepou, Abdoulaye; Tarral, Antoine; Tetimian, Djetodjide; Valverde, Olaf; Van Nieuwenhove, Simon; Strub-Wourgaft, Nathalie
2015-12-01
Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs for Neglected Diseases Initiative (DNDi), an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis (HAT). The project involved the implementation of a novel 'pre-review' process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process. © 2014 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.
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Ethics and research in critical care.
Silverman, Henry J; Lemaire, Francois
2006-11-01
The past few years have witnessed several controversies regarding the ethics of conducting research involving critically ill patients, and such research is ethically challenging. Research ethics is a changing field, one that is influenced by empirical data, contemporary events, and new ideas regarding aspects of clinical trial design and protection of human subjects. We describe recent thoughts regarding several aspects of research ethics in the critical care context. The ability of the research community to conduct research ethically and to maintain public trust would benefit from heightened awareness to the principles and requirements that govern such research.
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Ethics interventions for healthcare professionals and students: A systematic review.
Stolt, Minna; Leino-Kilpi, Helena; Ruokonen, Minka; Repo, Hanna; Suhonen, Riitta
2018-03-01
The ethics and value bases in healthcare are widely acknowledged. There is a need to improve and raise awareness of ethics in complex systems and in line with competing needs, different stakeholders and patients' rights. Evidence-based strategies and interventions for the development of procedures and practice have been used to improve care and services. However, it is not known whether and to what extent ethics can be developed using interventions. To examine ethics interventions conducted on healthcare professionals and healthcare students to achieve ethics-related outcomes. A systematic review. Five electronic databases were searched: CINAHL, the Cochrane Library, Philosopher's Index, PubMed and PsycINFO. We searched for published articles written in English without a time limit using the keywords: ethic* OR moral* AND intervention OR program OR pre-post OR quasi-experimental OR rct OR experimental AND nurse OR nursing OR health care. In the four-phased retrieval process, 23 full texts out of 4675 citations were included in the review. Data were analysed using conventional content analysis. Ethical consideration: This systematic review was conducted following good scientific practice in every phase. It is possible to affect the ethics of healthcare practices through professionals and students. All the interventions were educational in type. Many of the interventions were related to the ethical or moral sensitivity of the professionals, such as moral courage and empowerment. A few of the interventions focused on identifying ethical problems or research ethics. Patient-related outcomes followed by organisational outcomes can be improved by ethics interventions targeting professionals. Such outcomes are promising in developing ethical safety for healthcare patients and professionals.
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What makes public health studies ethical? Dissolving the boundary between research and practice
2014-01-01
Background The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary – whether on grounds of primary purpose, temporality, underlying legal authority, departure from usual practice, or direct benefits to participants – have been unsatisfactory. Public Health Ontario has eschewed this distinction between research and other evaluative activities, choosing to adopt a common framework and process to guide ethical reflection on all public health evaluative projects throughout their lifecycle – from initial planning through to knowledge exchange. Discussion The Public Health Ontario framework was developed by a working group of public health and ethics professionals and scholars, in consultation with individuals representing a wide range of public health roles. The first part of the framework interprets the existing Canadian research ethics policy statement (commonly known as the TCPS 2) through a public health lens. The second part consists of ten questions that guide the investigator in the application of the core ethical principles to public health initiatives. The framework is intended for use by those designing and executing public health evaluations, as well as those charged with ethics review of projects. The goal is to move toward a culture of ethical integrity among investigators, reviewers and decision-makers, rather than mere compliance with rules. The framework is consonant with the perspective of the learning organization and is generalizable to other public health organizations, to health services
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What makes public health studies ethical? Dissolving the boundary between research and practice.
Willison, Donald J; Ondrusek, Nancy; Dawson, Angus; Emerson, Claudia; Ferris, Lorraine E; Saginur, Raphael; Sampson, Heather; Upshur, Ross
2014-08-08
The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary - whether on grounds of primary purpose, temporality, underlying legal authority, departure from usual practice, or direct benefits to participants - have been unsatisfactory.Public Health Ontario has eschewed this distinction between research and other evaluative activities, choosing to adopt a common framework and process to guide ethical reflection on all public health evaluative projects throughout their lifecycle - from initial planning through to knowledge exchange. The Public Health Ontario framework was developed by a working group of public health and ethics professionals and scholars, in consultation with individuals representing a wide range of public health roles. The first part of the framework interprets the existing Canadian research ethics policy statement (commonly known as the TCPS 2) through a public health lens. The second part consists of ten questions that guide the investigator in the application of the core ethical principles to public health initiatives.The framework is intended for use by those designing and executing public health evaluations, as well as those charged with ethics review of projects. The goal is to move toward a culture of ethical integrity among investigators, reviewers and decision-makers, rather than mere compliance with rules. The framework is consonant with the perspective of the learning organization and is generalizable to other public health organizations, to health services organizations, and beyond. Public
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Community Partnered Research Ethics Training in Practice: A Collaborative Approach to Certification.
Yonas, Michael A; Jaime, Maria Catrina; Barone, Jean; Valenti, Shannon; Documét, Patricia; Ryan, Christopher M; Miller, Elizabeth
2016-04-01
This report describes the development and implementation of a tailored research ethics training for academic investigators and community research partners (CRP). The Community Partnered Research Ethics Training (CPRET) and Certification is a free and publicly available model and resource created by a university and community partnership to ensure that traditional and non-traditional research partners may study, define, and apply principles of human subjects' research. To date, seven academic and 34 CRP teams have used this highly interactive, engaging, educational, and relationship building process to learn human subjects' research and be certified by the University of Pittsburgh Institutional Review Board (IRB). This accessible, flexible, and engaging research ethics training process serves as a vehicle to strengthen community and academic partnerships to conduct ethical and culturally sensitive research. © The Author(s) 2016.
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Ethical Issues and Best Practice Considerations for Internet Research
Colvin, Jan; Lanigan, Jane
2005-01-01
With rapidly increasing public use of the Internet and advances in Web technologies, family and consumer sciences researchers have the opportunity to conduct Internet-based research. However, online research raises critical ethical issues concerning human subjects that have an impact on research practices. This article provides a review of the…
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Health Research Ethics: Between Ethics Codes and Culture.
Gheondea-Eladi, Alexandra
2017-10-01
This article is meant to describe and analyze some of the ethical difficulties encountered in a pilot research on treatment decisions of patients with chronic viral hepatitis C infection in Romania. It departs from an overview of the main ethics codes, and it shows that social health research on patients falls in between institutional codes of ethics. Furthermore, the article moves on to analyze so-called "important moments" of empirical research, such as the implementation of the ethical protocol, dealing with informal payments and with information on shady actions, as well as requests of information from interviewed patients and deciding when and if to breach confidentiality. In an attempt to evaluate the ad hoc solutions found in the field, the concluding remarks discuss these issues at the threshold of theory and practice.
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Exploring perceptions and experiences of Bolivian health researchers with research ethics.
Sullivan, Sarah; Aalborg, Annette; Basagoitia, Armando; Cortes, Jacqueline; Lanza, Oscar; Schwind, Jessica S
2015-04-01
In Bolivia, there is increasing interest in incorporating research ethics into study procedures, but there have been inconsistent application of research ethics practices. Minimal data exist regarding the experiences of researchers concerning the ethical conduct of research. A cross-sectional study was administered to Bolivian health leaders with research experience (n = 82) to document their knowledge, perceptions, and experiences of research ethics committees and infrastructure support for research ethics. Results showed that 16% of respondents reported not using ethical guidelines to conduct their research and 66% indicated their institutions did not consistently require ethics approval for research. Barriers and facilitators to incorporate research ethics into practice were outlined. These findings will help inform a comprehensive rights-based research ethics education program in Bolivia. © The Author(s) 2015.
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Ethics Review for a Multi-Site Project Involving Tribal Nations in the Northern Plains.
Angal, Jyoti; Petersen, Julie M; Tobacco, Deborah; Elliott, Amy J
2016-04-01
Increasingly, Tribal Nations are forming ethics review panels, which function separately from institutional review boards (IRBs). The emergence of strong community representation coincides with a widespread effort supported by the U.S. Department of Health & Human Services and other federal agencies to establish a single IRB for all multi-site research. This article underscores the value of a tribal ethics review board and describes the tribal oversight for the Safe Passage Study-a multi-site, community-based project in the Northern Plains. Our experience demonstrates the benefits of tribal ethics review and makes a strong argument for including tribal oversight in future regulatory guidance for multi-site, community-based research. © The Author(s) 2016.
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Ndebele, Paul; Wassenaar, Douglas; Benatar, Solomon; Fleischer, Theodore; Kruger, Mariana; Adebamowo, Clement; Kass, Nancy; Hyder, Adnan A.; Meslin, Eric M.
2014-01-01
The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards’ documents and annual reports supplemented by questionnaires completed by the training program directors. Together, these programs provided long-term training in research ethics to 275 African professionals, strengthened research ethics committees in 19 countries in Sub-Saharan Africa, and created research ethics curricula at many institutions and bioethics centers within Africa. Trainees’ leadership resulted in new national systems and policies on research ethics, human tissue storage and export, and methods of monitoring compliance with research ethics guidelines. Training programs adapted to challenges that arose due to varied trainees’ background knowledge in ethics, duration of time available for training, spoken and written English language skills, administrative obstacles, and the need to sustain post-training research ethics activities. Our report showcases the development of awareness of research ethics and building/strengthening of basic research ethics infrastructure in Sub-Saharan Africa. Nevertheless, the increasing amount and complexity of health research being conducted in Sub-Saharan Africa suggests the need for continued investment in research ethics capacity development in this region. This paper is part of a collection of papers analyzing the Fogarty International Center’s International Research Ethics Education and Curriculum Development program. PMID:24782070
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Ndebele, Paul; Wassenaar, Douglas; Benatar, Solomon; Fleischer, Theodore; Kruger, Mariana; Adebamowo, Clement; Kass, Nancy; Hyder, Adnan A; Meslin, Eric M
2014-04-01
The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards' documents and annual reports supplemented by questionnaires completed by the training program directors. Together, these programs provided long-term training in research ethics to 275 African professionals, strengthened research ethics committees in 19 countries in Sub-Saharan Africa, and created research ethics curricula at many institutions and bioethics centers within Africa. Trainees' leadership resulted in new national systems and policies on research ethics, human tissue storage and export, and methods of monitoring compliance with research ethics guidelines. Training programs adapted to challenges that arose due to varied trainees' background knowledge in ethics, duration of time available for training, spoken and written English language skills, administrative obstacles, and the need to sustain post-training research ethics activities. Our report showcases the development of awareness of research ethics and building/strengthening of basic research ethics infrastructure in Sub-Saharan Africa. Nevertheless, the increasing amount and complexity of health research being conducted in Sub-Saharan Africa suggests the need for continued investment in research ethics capacity development in this region. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program.
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Research ethics and lessons from Hwanggate: what can we learn from the Korean cloning fraud?
Saunders, R; Savulescu, J
2008-03-01
In this review of the Korean cloning scandal involving Woo-Suk Hwang, the nature of the disaster is documented and reasons why it occurred are suggested. The general problems it raises for scientific research are highlighted and six possible ways of improving practice are offered in the light of this case: (1) better education of science students; (2) independent monitoring and validation; (3) guidelines for tissue donation for research; (4) fostering of debate about ethically contentious research in science journals; (5) development of an international code of ethical research practice; (6) fostering of public involvement in ethical review and debate through the web.
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DEFF Research Database (Denmark)
Tiidenberg, Katrin
2017-01-01
This chapter joins the voices that consider research ethics to be a matter of situated, responsible judgment, rather than a matter of universal principles and rigid guidelines. When collecting data about or in digitally saturated contexts, we need to consciously choose between what is available......, findable and collectable, and what should be found, collected and used for research. Thus, this chapter will not offer a set of rules; rather, it advocates for systematic (self) reflexivity in ethical qualitative inquiry. In the following I outline some of the persistent ethical issues that scholars...... involved in internet research are faced with. Classical ethical concepts like informed consent, confidentiality, anonymity, privacy, publicity and harm are difficult to operationalize in a socio-technical context that is persistent, replicable, scalable, and searchable. Examples from my own work...
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Strode, Ann; Slack, Catherine; Mushariwa, Muriel
2005-08-01
An effective ethical-legal framework for the conduct of research is critical. We describe five essential components of such a system, review the extent to which these components have been realised in South Africa, present brief implications for the ethical conduct of clinical trials of HIV vaccines in South Africa and make recommendations. The components of an effective ethical-legal system that we propose are the existence of scientific ethical and policy-making structures that regulate research; research ethics committees (RECs) that ethically review research; national ethical guidelines and standards; laws protecting research participants; and mechanisms to enforce and monitor legal rights and ethical standards. We conclude that the ethical-legal framework has, for the most part, the necessary institutions, and certain necessary guidelines but does not have many of the laws needed to protect and promote the rights of persons participating in research, including HIV vaccine trials. Recommendations made include advocacy measures to finalise and implement legislation, development of regulations, analysis and comparison of ethical guidelines, and the development of measures to monitor ethical-legal rights at trial sites.
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Brief report : ethical problems in research practice
Colnerud, Gunnel
2013-01-01
Most accounts of the ethical problems facing researchers across a broad spectrum of research fields come from ethicists, ethics committees, and specialists committed to the study of ethics in human research. In contrast, this study reports on the ethical questions that researchers, themselves, report facing in their everyday practice. Fifty-five Swedish researchers contributed 109 examples of ethical dilemmas, conflicts, and problems in research. They were all researchers at the postdoctoral ...
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Ethical genetic research in Indigenous communities: challenges and successful approaches.
McWhirter, Rebekah E; Mununggirritj, Djapirri; Marika, Dipililnga; Dickinson, Joanne L; Condon, John R
2012-12-01
Indigenous populations, in common with all populations, stand to benefit from the potential of genetic research to lead to improvements in diagnostic and therapeutic tools for a wide range of complex diseases. However, many Indigenous communities, especially ones that are isolated, are not included in genetic research efforts. This situation is largely a consequence of the challenges of ethically conducting genetic research in Indigenous communities and compounded by Indigenous peoples' negative past experiences with genetic issues. To examine ways of addressing these challenges, we review one investigation of a cancer cluster in remote Aboriginal communities in Arnhem Land, Australia. Our experiences demonstrate that genetic research can be both ethically and successfully conducted with Indigenous communities by respecting the authority of the community, involving community members, and including regular community review throughout the research process. Copyright © 2012 Elsevier Ltd. All rights reserved.
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The Ethical Problems of Reserach : An empirical study of ethics in research practice
Colnerud, Gunnel
2013-01-01
Most accounts of the ethical problems facing researchers across a broad spectrum of research fields come from ethicists, ethics committees and specialists committed to the study of ethics in human research. In contrast, this study reports on the ethical questions that researchers, themselves, report facing in their everyday practice. Fifty-five Swedish researchers contributed 109 examples of ethical dilemmas, conflicts and problems in research. They were all researchers at the post-doctoral l...
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Promoting Ethics and Integrity in Management Academic Research: Retraction Initiative.
Ayodele, Freida Ozavize; Yao, Liu; Haron, Hasnah
2018-02-13
In the management academic research, academic advancement, job security, and the securing of research funds at one's university are judged mainly by one's output of publications in high impact journals. With bogus resumes filled with published journal articles, universities and other allied institutions are keen to recruit or sustain the appointment of such academics. This often places undue pressure on aspiring academics and on those already recruited to engage in research misconduct which often leads to research integrity. This structured review focuses on the ethics and integrity of management research through an analysis of retracted articles published from 2005 to 2016. The study employs a structured literature review methodology whereby retracted articles published between 2005 and 2016 in the field of management science were found using Crossref and Google Scholar. The searched articles were then streamlined by selecting articles based on their relevance and content in accordance with the inclusion criteria. Based on the analysed retracted articles, the study shows evidence of ethical misconduct among researchers of management science. Such misconduct includes data falsification, the duplication of submitted articles, plagiarism, data irregularity and incomplete citation practices. Interestingly, the analysed results indicate that the field of knowledge management includes the highest number of retracted articles, with plagiarism constituting the most significant ethical issue. Furthermore, the findings of this study show that ethical misconduct is not restricted to a particular geographic location; it occurs in numerous countries. In turn, avenues of further study on research misconduct in management research are proposed.
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Directory of Open Access Journals (Sweden)
Mechthild Kiegelmann
2004-01-01
Full Text Available This book is a collection of theoretical thoughts about ethics in qualitative research. A coherent group of feminists propose issues to consider in research from a perspective of an ethics of care. The authors illustrate their arguments with examples from their own research experiences. Examples from actual research, e.g. in the area of health studies are provided. This book is well suited for graduate students to learn about ethics in qualitative research. URN: urn:nbn:de:0114-fqs0401276
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The Ethics of Archival Research
McKee, Heidi A.; Porter, James E.
2012-01-01
What are the key ethical issues involved in conducting archival research? Based on examination of cases and interviews with leading archival researchers in composition, this article discusses several ethical questions and offers a heuristic to guide ethical decision making. Key to this process is recognizing the person-ness of archival materials.…
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Ethics and mental illness research.
Roberts, Laura Weiss
2002-09-01
There are many tasks ahead in the area of ethics and mental illness research. We face unknown challenges in psychiatric genetics projects, studies of psychopharmacological interventions in children, controversial scientific designs (e.g., symptom challenge, medication-free interval), and cross-disciplinary research incorporating goals and methods of health services, epidemiology, and social and behavioral science endeavors. Boundaries between innovative clinical practices and research-related experimentation will become increasingly difficult to distinguish, as will the roles between clinicians, clinical researchers, and basic scientists. Moreover, the institutions and systems in which research occurs are being rapidly and radically revised, raising new questions about oversight responsibilities and standards. Our ability to identify and respond to the ethical questions arising in this uncharted territory will depend on our willingness to self-reflect, to integrate the observations and insights of the past century, to think with great clarity, and to anticipate novel ethical problems that keep company with scientific advancements. It will also depend on data. Empirical study of ethical dimensions of human research is essential to anchor and attune the intuitions and theoretical constructs that we develop. Science and ethics have changed over the past 100 years, as they will over the next century. It is ironic that the ethical acceptability of psychiatric research is so much in question at this time, when it holds so much promise for advancing our understanding of mental illness and its treatment. The tension between the duty to protect vulnerable individuals and the duty to perform human science will continue to grow, as long as ethics and science are seen as separable, opposing forces with different aims championed by different heroes. The profession of psychiatry is poised to move toward a new, more coherent research ethics paradigm in which scientific and
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The ethics of neonatal research: An ethicist's and a parents' perspective.
Janvier, Annie; Farlow, Barbara
2015-12-01
The ethics of neonatal research are complex because vulnerable new parents are asked to provide consent on behalf of their fragile baby. Whereas clinical neonatal care has evolved to value personalized and shared decision-making, the goal of research ethics is still to standardize the informed consent process and make it as complete and thorough as possible. Ethicists, lawyers and physicians have shaped the field of research ethics and consent for research. The goal of detailed informed consent is to protect participants from harm, but procedures were developed without input from the principal stakeholders: ex-neonatal intensive care unit parents/patients. Empirical investigations examining patient and parental perspectives on research and research ethics are lacking. Rigorous investigations are needed to determine how parents of sick neonates want their families to be protected, knowing that a lack of research is also harmful. Large randomized controlled multicenter trials will always be needed to improve neonatal outcomes. These trials are costly and time-consuming. Currently, the way in which research is funded and regulated and the way in which academic merit is recognized lead to inefficiency and a waste of precious resources. Following a review of the history of research ethics, this article examines and discusses the ethics of research in neonatology. In addition, challenges and opportunities are identified and ideas for future investigations are proposed. Copyright © 2015 Elsevier Ltd. All rights reserved.
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An ethical exploration of barriers to research on controlled drugs
ANDREAE, Michael H; RHODES, Evelyn; BOURGOISE, Tylor; CARTER, George; WHITE, Robert S.; INDYK, Debbie; SACKS, Henry; RHODES, Rosamond
2016-01-01
We examine the ethical, social and regulatory barriers that may hamper research on therapeutic potential of certain controversial controlled substances like marijuana, heroin or ketamine. Hazards for individuals and society, and their potential adverse effects on communities may be good reasons for limiting access and justify careful monitoring of certain substances. Overly strict regulations, fear of legal consequences, stigma associated with abuse and populations using illicit drugs, and lack of funding may hinder research on their considerable therapeutic potential. We review the surprisingly sparse literature and address the particular ethical concerns of undue inducement, informed consent, risk to participants, researchers and institutions, justice and liberty germane to the research with illicit and addictive substances. We debate the disparate research stakeholder perspectives and why they are likely to be infected with bias. We propose an empirical research agenda to provide a more evidentiary basis for ethical reasoning. PMID:26982922
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Spotlight on Ethics: Institutional Review Boards as Systemic Bullies
Carr, Caleb T.
2015-01-01
Bullying, often considered an interpersonal or intergroup behaviour, has not been explored as an unintended artefact of organisational structure. Institutional review boards (IRBs), the 'human research ethics committees' at US universities, help oversee the protection of human research subjects, particularly in the social sciences within…
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A Research Agenda for Humanitarian Health Ethics
Hunt, Matthew; Schwartz, Lisa; Pringle, John; Boulanger, Renaud; Nouvet, Elysée; O'Mathúna, Dónal; Arya, Neil; Bernard, Carrie; Beukeboom, Carolyn; Calain, Philippe; de Laat, Sonya; Eckenwiler, Lisa; Elit, Laurie; Fraser, Veronique; Gillespie, Leigh-Anne; Johnson, Kirsten; Meagher, Rachel; Nixon, Stephanie; Olivier, Catherine; Pakes, Barry; Redwood-Campbell, Lynda; Reis, Andreas; Renaldi, Teuku; Singh, Jerome; Smith, Maxwell; Von Schreeb, Johan
2014-01-01
This paper maps key research questions for humanitarian health ethics: the ethical dimensions of healthcare provision and public health activities during international responses to situations of humanitarian crisis. Development of this research agenda was initiated at the Humanitarian Health Ethics Forum (HHE Forum) convened in Hamilton, Canada in November 2012. The HHE Forum identified priority avenues for advancing policy and practice for ethics in humanitarian health action. The main topic areas examined were: experiences and perceptions of humanitarian health ethics; training and professional development initiatives for humanitarian health ethics; ethics support for humanitarian health workers; impact of policies and project structures on humanitarian health ethics; and theoretical frameworks and ethics lenses. Key research questions for each topic area are presented, as well as proposed strategies for advancing this research agenda. Pursuing the research agenda will help strengthen the ethical foundations of humanitarian health action. PMID:25687273
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The full spectrum of ethical issues in dementia care: systematic qualitative review.
Strech, Daniel; Mertz, Marcel; Knüppel, Hannes; Neitzke, Gerald; Schmidhuber, Martina
2013-06-01
Integrating ethical issues in dementia-specific training material, clinical guidelines and national strategy plans requires an unbiased awareness of all the relevant ethical issues. To determine systematically and transparently the full spectrum of ethical issues in clinical dementia care. We conducted a systematic review in Medline (restricted to English and German literature published between 2000 and 2011) and Google books (with no restrictions). We applied qualitative text analysis and normative analysis to categorise the spectrum of ethical issues in clinical dementia care. The literature review retrieved 92 references that together mentioned a spectrum of 56 ethical issues in clinical dementia care. The spectrum was structured into seven major categories that consist of first- and second-order categories for ethical issues. The systematically derived spectrum of ethical issues in clinical dementia care presented in this paper can be used as training material for healthcare professionals, students and the public for raising awareness and understanding of the complexity of ethical issues in dementia care. It can also be used to identify ethical issues that should be addressed in dementia-specific training programmes, national strategy plans and clinical practice guidelines. Further research should evaluate whether this new genre of systematic reviews can be applied to the identification of ethical issues in other cognitive and somatic diseases. Also, the practical challenges in addressing ethical issues in training material, guidelines and policies need to be evaluated.
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Literacy Research, Ethics and Social Responsibility
Delandshere, Ginette
2007-01-01
In this article I examine the ethics of conducting literacy research, beyond what is typically addressed in current ethical guidelines. Using a few studies as examples, I analyse how the conception of research that underlies literacy research is grounded in ethics based on individual autonomy that allow researchers to disregard their social…
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Too much information: visual research ethics in the age of wearable cameras.
Mok, Tze Ming; Cornish, Flora; Tarr, Jen
2015-06-01
When everything you see is data, what ethical principles apply? This paper argues that first-person digital recording technologies challenge traditional institutional approaches to research ethics, but that this makes ethics governance more important, not less so. We review evolving ethical concerns across four fields: Visual ethics; ubiquitous computing; mobile health; and grey literature from applied or market research. Collectively, these bodies of literature identify new challenges to traditional notions of informed consent, anonymity, confidentiality, privacy, beneficence and maleficence. Challenges come from the ever-increasing power, breadth and multi-functional integration of recording technologies, and the ubiquity and normalization of their use by participants. Some authors argue that these evolving relationships mean that institutional ethics governance procedures are irrelevant or no longer apply. By contrast, we argue that the fundamental principles of research ethics frameworks have become even more important for the protection of research participants, and that institutional frameworks need to adapt to keep pace with the ever-increasing power of recording technologies and the consequent risks to privacy. We conclude with four recommendations for efforts to ensure that contemporary visual recording research is held appropriately accountable to ethical standards: (i) minimizing the detail, scope, integration and retention of captured data, and limiting its accessibility; (ii) formulating an approach to ethics that takes in both the 'common rule' approaches privileging anonymity and confidentiality together with principles of contextual judgement and consent as an ongoing process; (iii) developing stronger ethical regulation of research outside academia; (iv) engaging the public and research participants in the development of ethical guidelines.
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Readiness of ethics review systems for a changing public health landscape in the WHO African Region.
Motari, Marion; Ota, Martin Okechukwu; Kirigia, Joses Muthuri
2015-12-02
The increasing emphasis on research, development and innovation for health in providing solutions to the high burden of diseases in the African Region has warranted a proliferation of studies including clinical trials. This changing public health landscape requires that countries develop adequate ethics review capacities to protect and minimize risks to study participants. Therefore, this study assessed the readiness of national ethics committees to respond to challenges posed by a globalized biomedical research system which is constantly challenged by new public health threats, rapid scientific and technological advancements affecting biomedical research and development, delivery and manufacture of vaccines and therapies, and health technology transfer. This is a descriptive study, which used a questionnaire structured to elicit information on the existence of relevant national legal frameworks, mechanisms for ethical review; as well as capacity requirements for national ethics committees. The questionnaire was available in English and French and was sent to 41 of the then 46 Member States of the WHO African Region, excluding the five Lusophone Member States. Information was gathered from senior officials in ministries of health, who by virtue of their offices were considered to have expert knowledge of research ethics review systems in their respective countries. Thirty three of the 41 countries (80.5 %) responded. Thirty (90.9 %) of respondent countries had a national ethics review committee (NEC); 79 % of which were established by law. Twenty-five (83.3 %) NECs had secretarial and administrative support. Over 50 % of countries with NECs indicated a need for capacity strengthening through periodic training on international guidelines for health research (including clinical trials) ethics; and allocation of funds for administrative and secretariat support. Despite the existing training initiatives, the Region still experiences a shortage of professionals
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Whose Ethics, Whose Accountability? A Debate about University Research Ethics Committees
Hoecht, Andreas
2011-01-01
Research ethics approval procedures and research ethics committees (RECs) are now well-established in most Western Universities. RECs base their judgements on an ethics code that has been developed by the health and biomedical sciences research community and that is widely considered to be universally valid regardless of discipline. On the other…
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Ethical virtues in scientific research.
Resnik, David B
2012-01-01
Most approaches to promoting integrity in research are principle-based in that they portray ethical conduct as consisting of adherence to ethical rules, duties, or responsibilities. Bruce MacFarlane has recently criticized the principle-based approach to promoting integrity in research and offered a virtue-based alternative. MacFarlane argues that principle-based approaches do not provide adequate guidance for ethical decision-making and are not very useful in moral education. In this article, I examine and critique MacFarlane's defense of the virtue-based approach. I argue that virtue-based and principle-based approaches to ethics are complementary and that they both can help promote research integrity.
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Hemmings, Annette
2009-12-01
This paper explores ethical dilemmas in situated fieldwork ethics concerning ethnographic studies of adolescent students. While consequentialist and deontological ethics form the basis of the ethical stances shared by ethnographers and research ethics committees, the interpretation of those principles may diverge in school-based ethnography with adolescent students because of the particular role of the adult ethnographer vis-à-vis developmentally immature adolescents not held legally responsible for many of their actions. School ethnographers attempt to build trust with adolescent participants in order to learn about their hidden cultural worlds, which may involve activities that are very harmful to the youths involved. They face many difficult and sometimes unexpected choices, including whether to intervene and how to represent events and adolescents in published findings. Scenarios with examples drawn from research conducted in public high schools are used to illustrate and explicate dilemmas in formal research and latent insider/outsider roles and relations involving harmful adolescent behaviors, advocacy, and psychological trauma. Also examined are analytical procedures used to construct interpretations leading to representations of research participants in the resulting publication.
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Risk and Representation in Research Ethics: The NunatuKavut Experience.
Brunger, Fern; Russell, Todd
2015-10-01
This article examines Canadian policy governing the ethics of research involving Indigenous communities. Academics and community members collaborated in research to examine how best to apply the Tri-Council Policy Statement guidelines in a community with complex and multiple political and cultural jurisdictions. We examined issues of NunatuKavut (Southern Inuit) authority and representation in relation to governance of research in a context where community identity is complex and shifting, and new provincial legislation mandates centralized ethics review. We describe the politics of risk--the ways in which collective identity and research risks are co-constructed. Our case study illustrates that collective consent to research must emphasize shifting identity construction in relation to the particular risks and benefits invoked by the research question, to ascertain with which groups or individuals the negotiation of risk should take place in the first place. We conclude by describing a necessary re-imagining of policy governing research ethics involving Indigenous communities. © The Author(s) 2015.
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Ethical considerations in clinical training, care and research in psychopharmacology.
Strous, Rael D
2011-04-01
Psychopharmacology is a powerful tool in psychiatry; however, it is one that demands responsibility in order to deal with the ethical complexities that accompany advances in the field. It is important that questions are asked and that ethical mindfulness and sensitivity are developed along with clinical skills. In order to cultivate and deepen ethical awareness and subsequently solve issues in optimal fashion, investment should be made in the development of an ethical decision-making process as well as in education in the ethics of psychopharmacology to trainees in the field at all stages of their educational development. A clear approach to identifying ethical problems, engaging various ethical concepts in considering solutions and then applying these principles in problem resolution is demanded. An openness in identifying and exploring issues has become crucial to the future development and maturation of psychopharmacologists, both research and clinical. Consideration must be given to the social implications of psychopharmacological practice, with the best interests of patients always paramount. From both a research and clinical perspective, psychopharmacology has to be practised with fairness, sensitivity and ethical relevance to all. While ethical issues related to psychopharmacological practice are varied and plentiful, this review focuses on advances in technology and biological sciences, personal integrity, special populations, and education and training.
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2013-01-01
Background Recruiting minorities into research studies requires special attention, particularly when studies involve “extra-vulnerable” participants with multiple vulnerabilities, e.g., pregnant women, the fetuses/neonates of ethnic minorities, children in refugee camps, or cross-border migrants. This study retrospectively analyzed submissions to the Ethics Committee of the Faculty of Tropical Medicine (FTM-EC) in Thailand. Issues related to the process and outcomes of proposal review, and the main issues for which clarification/revision were requested on studies, are discussed extensively. Methods The study data were extracted from proposals and amendments submitted to the FTM-EC during the period October 2009 – September 2012, and then analyzed qualitatively and quantitatively. The main issues for clarification/revision were analyzed by thematic content analysis. Results 373 proposals were submitted; 44 studies involved minority groups with 21 extra-vulnerable minorities. All clinical and 2/3 of non-clinical studies submitted for initial review underwent full-board review. For combined clinical and non-clinical study submissions, 92.1% were referred back to the investigators and approved after clarification/revision, while 2.7% were deferred due to major/critical changes, and 2.1% not approved due to substantial violations of ethical principles. The main issues needing clarification/revision differed between all studies and those involving minorities: participant information sheet (62.2% vs. 86.4%), informed consent/assent form (51.2% vs. 86.4%), and research methodology (80.7% vs. 84.1%), respectively. The main ethical issues arising during the meetings, regarding studies involving minorities, included ensuring no exploitation, coercion, or pressure on the minority to participate; methodology not affecting their legal status; considering ethnicity and cultural structure; and providing appropriate compensation. Conclusion Delays in the approval or non
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Research ethics and approval process: A guide for new GP researchers.
Liaw, Siaw-Teng; Tam, Chun Wah Michael
2015-06-01
The underlying moral principles and values, and the virtues held as desirable for a researcher, should be reflected upon and embedded in the research. The foundation step is to download the National Health and Medical Research Council's (NHMRC's) National Statement on Ethical Conduct in Human Research and the NHMRC's Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research to use as references. This paper draws on the experience of The Royal Australian College of General Practitioners' (RACGP's) National Research and Evaluation Ethics Committee to provide an eight-step approach to the research ethics process. The researcher should use the research ethics process as an opportunity to foster and guide the development and conduct of ethical research.
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Progress in centralised ethics review processes: Implications for multi-site health evaluations.
Prosser, Brenton; Davey, Rachel; Gibson, Diane
2015-04-01
Increasingly, public sector programmes respond to complex social problems that intersect specific fields and individual disciplines. Such responses result in multi-site initiatives that can span nations, jurisdictions, sectors and organisations. The rigorous evaluation of public sector programmes is now a baseline expectation. For evaluations of large and complex multi-site programme initiatives, the processes of ethics review can present a significant challenge. However in recent years, there have been new developments in centralised ethics review processes in many nations. This paper provides the case study of an evaluation of a national, inter-jurisdictional, cross-sector, aged care health initiative and its encounters with Australian centralised ethics review processes. Specifically, the paper considers progress against the key themes of a previous five-year, five nation study (Fitzgerald and Phillips, 2006), which found that centralised ethics review processes would save time, money and effort, as well as contribute to more equitable workloads for researchers and evaluators. The paper concludes with insights for those charged with refining centralised ethics review processes, as well as recommendations for future evaluators of complex multi-site programme initiatives. Copyright © 2015 Elsevier Ltd. All rights reserved.
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Understanding bureaucracy in health science ethics: toward a better institutional review board.
Bozeman, Barry; Slade, Catherine; Hirsch, Paul
2009-09-01
Research involving human participants continues to grow dramatically, fueled by advances in medical technology, globalization of research, and financial and professional incentives. This creates increasing opportunities for ethical errors with devastating effects. The typical professional and policy response to calamities involving human participants in research is to layer on more ethical guidelines or strictures. We used a recent case-the Johns Hopkins University/Kennedy Kreiger Institute Lead Paint Study-to examine lessons learned since the Tuskegee Syphilis Study about the role of institutionalized science ethics in the protection of human participants in research. We address the role of the institutional review board as the focal point for policy attention.
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Research Ethics and Ethical Research: Some Observations from the Global South
Zhang, J. J.
2017-01-01
This paper aims to achieve two objectives. Firstly, it elicits some of the concerns for universal research ethics. It is argued that ethical codes are never universal; they are geographically sensitive. As such, it is important to "develop authentic individual responses to potentially unique circumstances". Secondly, in going beyond a…
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The ethics of peer review in bioethics
Wendler, David; Miller, Franklin
2014-01-01
A good deal has been written on the ethics of peer review, especially in the scientific and medical literatures. In contrast, we are unaware of any articles on the ethics of peer review in bioethics. Recognising this gap, we evaluate the extant proposals regarding ethical standards for peer review in general and consider how they apply to bioethics. We argue that scholars have an obligation to perform peer review based on the extent to which they personally benefit from the peer review process. We also argue, contrary to existing proposals and guidelines, that it can be appropriate for peer reviewers to benefit in their own scholarship from the manuscripts they review. With respect to bioethics in particular, we endorse double-blind review and suggest several ways in which the peer review process might be improved. PMID:24131903
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Watts, Logan L; Todd, E Michelle; Mulhearn, Tyler J; Medeiros, Kelsey E; Mumford, Michael D; Connelly, Shane
2017-01-01
Although qualitative research offers some unique advantages over quantitative research, qualitative methods are rarely employed in the evaluation of ethics education programs and are often criticized for a lack of rigor. This systematic review investigated the use of qualitative methods in studies of ethics education. Following a review of the literature in which 24 studies were identified, each study was coded based on 16 best practices characteristics in qualitative research. General thematic analysis and grounded theory were found to be the dominant approaches used. Researchers are effectively executing a number of best practices, such as using direct data sources, structured data collection instruments, non-leading questioning, and expert raters. However, other best practices were rarely present in the courses reviewed, such as collecting data using multiple sources, methods, raters, and timepoints, evaluating reliability, and employing triangulation analyses to assess convergence. Recommendations are presented for improving future qualitative research studies in ethics education.
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Animal models in biological and biomedical research - experimental and ethical concerns.
Andersen, Monica L; Winter, Lucile M F
2017-09-04
Animal models have been used in experimental research to increase human knowledge and contribute to finding solutions to biological and biomedical questions. However, increased concern for the welfare of the animals used, and a growing awareness of the concept of animal rights, has brought a greater focus on the related ethical issues. In this review, we intend to give examples on how animals are used in the health research related to some major health problems in Brazil, as well as to stimulate discussion about the application of ethics in the use of animals in research and education, highlighting the role of National Council for the Control of Animal Experimentation (Conselho Nacional de Controle de Experimentação Animal - CONCEA) in these areas. In 2008, Brazil emerged into a new era of animal research regulation, with the promulgation of Law 11794, previously known as the Arouca Law, resulting in an increased focus, and rapid learning experience, on questions related to all aspects of animal experimentation. The law reinforces the idea that animal experiments must be based on ethical considerations and integrity-based assumptions, and provides a regulatory framework to achieve this. This review describes the health research involving animals and the current Brazilian framework for regulating laboratory animal science, and hopes to help to improve the awareness of the scientific community of these ethical and legal rules.
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Research ethics in physical education
Directory of Open Access Journals (Sweden)
Júlio César Schmitt Rocha
2009-06-01
Full Text Available The objective here is to point out ethics in Physical Education research against a backdrop of individual and collective human conduct. Since Plato, the question of ethics in the Western world has been an incessant search for the virtues to harmonize personal and social wellbeing and for the absolute principles of conduct: Autonomy, Beneficence and Justice. Physical Education cannot exempt itself from these and its countless areas of research. In addition to the moral education that develops and solidifies within social groups, the characteristic of which is action on an individual level, we must also consider ethical principles such as those defended by the Physical Education World Manifesto and those that regulate the professional activities of Physical Education professionals. Irrespective of the area investigated, Research in Physical Education will always clash with institutionalized ethical principles enforced by ethics committees, councils and the values accepted by the researchers. Committees strive to preserve the integrity and dignity of the people enrolled on research studies while the researchers challenge the limits of knowledge at an uncomfortable frontier between the acceptable and the unacceptable within a given context of academic vision and needs.
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Experts, meta-expertise and mediators. Ethical oversight of research in multidisciplinary scenarios
Directory of Open Access Journals (Sweden)
Wilfredo Betancourt Mosquera
2016-07-01
Full Text Available Based on a case study drawn from the written records of a Colombian Research Ethics Committee (rec, this article discusses the impact that its multidisciplinary nature has on its decision-making processes. recs are analyzed as “boundary organizations” in which experts from different disciplines can meet. Additionally, recs are viewed as contemporary socio-epistemic arenas in which research ethics are produced. It was found that multiple expertise is often seen by some of its members as an «anomaly» which impedes ordinary work and ideally should be avoided. During the assessment of research projects the rec sought to manage this task through homogenizing decision-making processes in accordance with the expertise of some of its members, avoiding the convergence of «communities of practice.» Furthermore, the members of the rec frequently base their decisions either on their own ethical judgments, or by mirroring those of more qualified reviewers. This dynamic is largely a consequence of «meta-expertise,» that is to say, rec members’ ability or legitimacy to judge expert knowledge which they do not possess. It is concluded that researchers have wide possibilities to interpret and define the ethical dimension of their work. Within local practices of ethical reviews, researchers act as «interactional» actors able to assess and communicate recs about their own ethics. Paradoxically, despite their character as a public setting for multidisciplinary dialogue, recs end up being spaces in which the professional esotericism of disciplinary communities is reaffirmed and the socio-epistemic authority of experts reinforced.
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TOXICOLOGICAL RESEARCH INVOLVING HUMANS: ETHICAL AND REGULATORY CONSIDERATIONS
This paper discusses the need for the Society of Toxicology (SOT) to develop a policy for ethical research in humans, and a review for publication of these studies. Observations on human beings have been the foundation upon which toxicologic knowledge has been built since the in...
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[Discussion on solutions to ethical issues of clinical researches in a real world].
Wang, Si-Cheng; Liu, Bao-Yan; Xiong, Ning-Ning; Xie, Qi; Zhang, Run-Shun; Zhou, Xue-Zhong; Qiao, Jie
2013-04-01
The paradigm of a real world study has become the frontiers of clinical researches, especially in the field of Chinese medicine, all over the world in recent years. In this paper, ethical issues which probably exist in real-world studies are raised and reviewed. Moreover, some preliminary solutions to these issues such as protecting subjects during the process of real-world studies and performing ethical review are raised based on recent years' practices to enhance the scientificity and ethical level of real-world studies.
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Ethical dilemmas in malaria vector research in Africa: Making the ...
African Journals Online (AJOL)
Malaria vector research presents several dilemmas relating to the various ways in which humans are used in the malaria vector research enterprise. A review of the past and present practices reveals much about the prevailing attitudes and assumptions with regard to the ethical conduct of research involving humans.
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Ethics education for pediatric residents: a review of the literature
Directory of Open Access Journals (Sweden)
Raywat Deonandan
2015-04-01
Full Text Available Background: Ethics education and research on medical residents is needed because, unlike medical students or experienced doctors, medical residents have to perform multiple roles simultaneously – student, teacher and clinician – thus exposing them to unique ethical stressors. In this paper we reviewed the literature concerning ethics education in postgraduate pediatrics training programs. Our goal was not to simply describe educational strategies and programs, but also to explore measurements and experiences of current practices to address gaps in ethics education during residency. Method: We conducted a structured literature review to explore the extent of ethics education in pediatric residency programs. Results: Twelve relevant studies were found. The studies suggest that existing training regimens are insufficient to meet the real life ethical challenges experienced in actual practice, particularly with respect to palliative care and the commission of clinical errors. Conclusions: The increasing diversity of culture and beliefs in the clinical workplace is also serving to complicate educational needs. An interdisciplinary approach, spread over the entirety of a physician’s training, is a proposed solution worthy of more attention.
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Mental health research, ethics and multiculturalism.
Bailes, Marion J; Minas, I Harry; Klimidis, Steven
2006-01-01
In this paper we examine ethical issues relevant to conducting mental health research with refugees and immigrant communities that have cultural orientations and social organisation that are substantially different to those of the broader Australian community, and we relate these issues to NH&MRC Guidelines. We describe the development and conduct of a mental health research project carried out recently in Melbourne with the Somali community, focusing on ethical principles involved, and relating these to the NH&MRC National Statement on Ethical Conduct in Research Involving Humans, and the NH&MRC document Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research. The experience of conducting mental health research with the Somali community highlights the fact that the principles of inclusion and benefit enunciated in the NH&MRC document Values and Ethics are particularly pertinent when conducting research with refugees and immigrant communities that are culturally distant to those of the broader Australian community. These principles inform issues of research design and consent, as well as guiding respectful engagement with the participating community and communication of the research findings.
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RESEARCH ON ENVIRONMENTAL HEALTH INTERVENTIONS: ETHICAL PROBLEMS AND SOLUTIONS
RESNIK, DAVID B.; ZELDIN, DARRYL C.; SHARP, RICHARD R.
2014-01-01
This article reviews a variety of ethical issues one must consider when conducting research on environmental health interventions on human subjects. The paper uses the Kennedy Krieger Institute lead abatement study as well as a hypothetical asthma study to discuss questions concerning benefits and risks, risk minimization, safety monitoring, the duty to warn, the duty to report, the use of control groups, informed consent, equitable subject selection, privacy, conflicts of interest, and community consultation. Research on environmental health interventions can make an important contribution to our understanding of human health and disease prevention, provided it is conducted in a manner that meets prevailing scientific, ethical, and legal standards for research on human subjects. PMID:16220621
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Directory of Open Access Journals (Sweden)
de Vries Martine C
2011-09-01
Full Text Available Abstract Background Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. Methodology An empirical ethical approach, combining (1 a narrative review of (primarily qualitative studies on parents' and physicians' experiences of the pediatric oncology research practice, and (2 comparison of these experiences with existing theoretical ethical concepts about (pediatric research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice. Results Analysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist. True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the
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Horner, Jennifer; Minifie, Fred D
2011-02-01
In this series of articles--Research Ethics I, Research Ethics II, and Research Ethics III--the authors provide a comprehensive review of the 9 core domains for the responsible conduct of research (RCR) as articulated by the Office of Research Integrity. In Research Ethics I, they present a historical overview of the evolution of RCR in the United States then examine the evolution of human and animal experimentation from the birth of scientific medicine through World War II to the present day. They relied on authoritative documents, both historical and contemporary, insightful commentary, and empirical research in order to identify current issues and controversies of potential interest to both faculty and students. The authors have written this article from a historical perspective because they think all readers interested in RCR should appreciate how the history of science and all the good--and harm--it has produced can inform how researchers practice responsible research in the 21st century and beyond.
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Ethical challenges in conducting research in humanitarian crisis ...
African Journals Online (AJOL)
... culturally sensitive to the needs of the victims of the humanitarian crisis. In emergency situations, the roles of Institutional Review Boards (IRBs) may have to be modified without compromising the ethical standards that health researchers have globally attempted to achieve. Malawi Medical Journal Vol. 20 (2) 2008: pp.
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Broome, Marion E.
2017-01-01
Background The past twenty years have seen distinct shifts in the way the participation of children and adolescents in research is viewed. This has been emphasized by the growing pediatric research enterprise. Additional information on children’s and adolescents’ experiences during research participation is needed to better inform researchers on the ethical conduct of research with this vulnerable population. Aims The objective of this analysis was to examine ethical issues in research with children and adolescents from their perspective as participants, including: assent, parental consent, risk perception, impact of research participation, and incentives. Methods This systematic review was conducted per the Long et al. framework by means of an iterative searching process. Using the key words ‘research ethics’ and ‘child or pediatric or adolescent’, PubMed, CINAHL, and EBSCOhost databases were searched to identify articles. Limitations placed on the original searches were: English language, year of publication between 2003–2014, humans, abstract available, and age birth–18 years. Findings Twenty-three empiric studies were identified and formed the sample. Included studies represented a diverse range of areas of research, methods, settings, sample demographics, authors, and journals. Discussion Even young children demonstrated the ability to understand essential elements of research, although there is variability in children’s level of understanding. Trust was a significant contributing factor to children’s and adolescents’ participation in research, and also shaped their assessments of risk. Research participation was mainly beneficial for children and adolescents. Incentives were mainly viewed positively, although concerns of possible undue influence were expressed. Linking Evidence to Action This systematic review highlights the importance of including the perspectives of children and adolescents and provides researchers and nurse clinicians
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The ethical challenges of animal research.
Ferdowsian, Hope R; Gluck, John P
2015-10-01
In 1966, Henry K. Beecher published an article entitled "Ethics and Clinical Research" in the New England Journal of Medicine, which cited examples of ethically problematic human research. His influential paper drew attention to common moral problems such as inadequate attention to informed consent, risks, and efforts to provide ethical justification. Beecher's paper provoked significant advancements in human research policies and practices. In this paper, we use an approach modeled after Beecher's 1966 paper to show that moral problems with animal research are similar to the problems Beecher described for human research. We describe cases that illustrate ethical deficiencies in the conduct of animal research, including inattention to the issue of consent or assent, incomplete surveys of the harms caused by specific protocols, inequitable burdens on research subjects in the absence of benefits to them, and insufficient efforts to provide ethical justification. We provide a set of recommendations to begin to address these deficits.
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(Un)ethical behavior in organizations.
Treviño, Linda Klebe; den Nieuwenboer, Niki A; Kish-Gephart, Jennifer J
2014-01-01
This review spotlights research related to ethical and unethical behavior in organizations. It builds on previous reviews and meta-analyses of the literature on (un)ethical behavior in organizations and discusses recent advances in the field. The review emphasizes how this research speaks to the influence of the organizational context on (un)ethical behavior, proceeding from a more macro to a more micro view on (un)ethical behavior and covering ethical infrastructures, interpersonal influences, individual differences, and cognitive and affective processes. The conclusion highlights opportunities for future research.
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Dixon-Woods, Mary; Foy, Chris; Hayden, Charlotte; Al-Shahi Salman, Rustam; Tebbutt, Stephen; Schroter, Sara
2016-01-01
Objective Frustration continues to be directed at delays in gaining approvals for undertaking health research in the UK. We aimed to evaluate the impact of an ethics officer intervention on rates of favourable opinions (approval) and provisional opinions (requiring revision and resubmission) and on the time taken to reach a final opinion by research ethics committees (RECs), to characterise how the role operated in practice, and to investigate applicants' views. Design Mixed-method study involving (i) a 2-group, non-randomised before-and-after intervention study of RECs assigned an ethics officer and a matched comparator group; (ii) a process evaluation involving a survey of applicants and documentary analysis. Participants 6 RECs and 3 associated ethics officers; 18 comparator RECs; REC applicants. Results Rates of provisional and favourable opinions between ethics officer and comparator RECs did not show a statistically significant effect of the intervention (logistic regression, p=0.26 for favourable opinions and p=0.31 for provisional opinions). Mean time to reach a decision showed a non-significant reduction (ANOVA, p=0.22) from 33.3 to 32.0 days in the ethics officer RECs compared with the comparator RECs (32.6 to 32.9 days). The survey (30% response rate) indicated applicant satisfaction and also suggested that ethics officer support might be more useful before submission. Ethics officers were successful in identifying many issues with applications, but the intervention did not function exactly as designed: in 31% of applicants, no contact between the applicants and the ethics officer took place before REC review. Limitations This study was a non-randomised comparison cohort study. Some data were missing. Conclusions An ethics officer intervention, as designed and implemented in this study, did not increase the proportion of applications to RECs that were approved on first review and did not reduce the time to a committee decision. PMID:27580832
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Ethics of social media research: common concerns and practical considerations.
Moreno, Megan A; Goniu, Natalie; Moreno, Peter S; Diekema, Douglas
2013-09-01
Social media Websites (SMWs) are increasingly popular research tools. These sites provide new opportunities for researchers, but raise new challenges for Institutional Review Boards (IRBs) that review these research protocols. As of yet, there is little-to-no guidance regarding how an IRB should review the studies involving SMWs. The purpose of this article was to review the common risks inherent in social media research and consider how researchers can consider these risks when writing research protocols. We focused this article on three common research approaches: observational research, interactive research, and survey/interview research. Concomitant with these research approaches, we gave particular attention to the issues pertinent to SMW research, including privacy, consent, and confidentiality. After considering these challenges, we outlined key considerations for both researchers and reviewers when creating or reviewing SMW IRB protocols. Our goal in this article was to provide a detailed examination of relevant ethics and regulatory issues for both researchers and those who review their protocols.
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Ethics of Social Media Research: Common Concerns and Practical Considerations
Goniu, Natalie; Moreno, Peter S.; Diekema, Douglas
2013-01-01
Abstract Social media Websites (SMWs) are increasingly popular research tools. These sites provide new opportunities for researchers, but raise new challenges for Institutional Review Boards (IRBs) that review these research protocols. As of yet, there is little-to-no guidance regarding how an IRB should review the studies involving SMWs. The purpose of this article was to review the common risks inherent in social media research and consider how researchers can consider these risks when writing research protocols. We focused this article on three common research approaches: observational research, interactive research, and survey/interview research. Concomitant with these research approaches, we gave particular attention to the issues pertinent to SMW research, including privacy, consent, and confidentiality. After considering these challenges, we outlined key considerations for both researchers and reviewers when creating or reviewing SMW IRB protocols. Our goal in this article was to provide a detailed examination of relevant ethics and regulatory issues for both researchers and those who review their protocols. PMID:23679571
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Teaching ethical aptitude to graduate student researchers.
Weyrich, Laura S; Harvill, Eric T
2013-01-01
Limited time dedicated to each training areas, irrelevant case-studies, and ethics "checklists" have resulted in bare-bones Responsible Conduct of Research (RCR) training for present biomedical graduate student researchers. Here, we argue that science graduate students be taught classical ethical theory, such as virtue ethics, consequentialist theory, and deontological theory, to provide a basic framework to guide researchers through ethically complex situations and examine the applicability, implications, and societal ramifications of their research. Using a relevant biomedical research example to illustrate this point, we argue that proper ethics training for graduate student researchers not only will enhance current RCR training, but train more creative, responsible scientists.
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[Educational needs assessment on research ethics among nursing researchers].
Jeong, Ihn Sook; Gu, Mee Ock; Kim, Keum Soon; Lee, Kwang Ja; Yang, Soo
2010-08-01
This study aimed to investigate the educational needs of research ethics among nursing researchers. Convenience sample of 161 nursing professors and 262 master or doctoral nursing students participated in the study. Data was collected with self-reported questionnaire from June to August 2009, and analyzed with descriptive statistics using SPSS WIN (version 14.0). Among 161 nursing professors, about 31.7% has educated nursing ethics in the postgraduate course. The most common course was nursing research or methodology (62.7%), and median education time was 2 hr. Areas that showed difficulty in understanding was the conflict of interest and plagiarism for professors and falsification and fabrication for graduate students. Average knowledge on the research ethics was 75.4 points for professors and 61.6 points for students based on the 100 points. Educational needs of research ethics among nursing professors and students in the postgraduate course was high. We recommend both basic and advanced research ethics educational programs for the nursing researchers. The basic course should be at least 6 hr and include various cases and something to discuss.
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Nursing research ethics, guidance and application in practice.
Doody, Owen; Noonan, Maria
2016-07-28
Ethics is fundamental to good research practice and the protection of society. From a historical point of view, research ethics has had a chequered past and without due cognisance there is always the potential for research to do harm. Research ethics is fundamental to research practice, nurse education and the development of evidence. In conducting research, it is important to plan for and anticipate any potential or actual risks. To engage in research, researchers need to develop an understanding and knowledge of research ethics and carefully plan how to address ethics within their research. This article aims to enhance students' and novice researchers' research ethics understanding and its application to nursing research.
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The ethics of peer review in bioethics.
Wendler, David; Miller, Franklin
2014-10-01
A good deal has been written on the ethics of peer review, especially in the scientific and medical literatures. In contrast, we are unaware of any articles on the ethics of peer review in bioethics. Recognising this gap, we evaluate the extant proposals regarding ethical standards for peer review in general and consider how they apply to bioethics. We argue that scholars have an obligation to perform peer review based on the extent to which they personally benefit from the peer review process. We also argue, contrary to existing proposals and guidelines, that it can be appropriate for peer reviewers to benefit in their own scholarship from the manuscripts they review. With respect to bioethics in particular, we endorse double-blind review and suggest several ways in which the peer review process might be improved. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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Methodologic and ethical ramifications of sex and gender differences in public health research.
Lawrence, Kitty; Rieder, Anita
2007-01-01
Experience and investigative studies have shown that inequalities still exist between the sexes as well as in how public health policies and strategies approach the needs of the sexes. Sufficient attention has not been given to gender in public health research. Gender-based differences and similarities need to be promoted, and more structured guidelines are needed to build gender into public health research models. The aim of this review was to investigate and discuss public health research and to answer several related questions on gender biases, ethics and methodologies, and the establishment of guidelines. Using the search terms public health research and gender , or ethics , gender , and public health, a literature search was conducted predominately with, but not limited to, the PubMed database. English- or German-language articles were identified that examined the current status of gender in public health research as well as any relevant ethical guidelines. A review of the current literature showed that much work has been undertaken to promote the inclusion of gender in health research. However, deficiencies in the extent of gender-oriented research have been found in a number of key areas, including ethics committees and public health research methodology. Women were found to be underrepresented in ethics committees, which lack clear guidance, particularly in the European Union, to ensure the inclusion of gender issues in public health research. Data are often not sex disaggregated, and information on gender and social circumstances are frequently lacking. Furthermore, some methodologies, such as those used in the field of occupational health, underestimate men's or women's burden of disease. Recommendations include establishing guidelines for researchers on how to incorporate gender in health research, ensuring that the composition of ethics committees is more representative of society, and recommending that data collection systems or bodies ensure that data
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Permuth-Wey, Jennifer; Borenstein, Amy R
2009-04-01
Although the practice of providing payment to clinical research participants has been ongoing for more than a century, it remains an ethically controversial topic among members of the research community. The aims of this commentary are to summarize ethical and practical considerations regarding financial remuneration of research participants and to make recommendations for researchers contemplating this practice. A PubMed search was conducted to explore the ethical implications surrounding financial remuneration and review the body of empiric data on this topic. Financial remuneration is perceived to be ethically acceptable by many researchers and research participants and can be helpful in the recruitment process. It is recommended that when investigators are contemplating whether to offer payment to research participants, they should consider the nature of the study and the potential benefits and risks to the participants, institutional or organizational guidelines, and cultural and societal norms specific to the population being studied. Financial remuneration has the ability to serve as a sign of appreciation for the contributions of research participants and a way to facilitate clinical and behavioral research.
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Surgical innovation: the ethical agenda: A systematic review.
Broekman, Marike L; Carrière, Michelle E; Bredenoord, Annelien L
2016-06-01
The aim of the present article was to systematically review the ethics of surgical innovation and introduce the components of the learning health care system to guide future research and debate on surgical innovation.Although the call for evidence-based practice in surgery is increasingly high on the agenda, most surgeons feel that the format of the randomized controlled trial is not suitable for surgery. Innovation in surgery has aspects of, but should be distinguished from both research and clinical care and raises its own ethical challenges.To answer the question "What are the main ethical aspects of surgical innovation?", we systematically searched PubMed and Embase. Papers expressing an opinion, point of view, or position were included, that is, normative ethical papers.We included 59 studies discussing ethical aspects of surgical innovation. These studies discussed 4 major themes: oversight, informed consent, learning curve, and vulnerable patient groups. Although all papers addressed the ethical challenges raised by surgical innovation, surgeons hold no uniform view of surgical innovation, and there is no agreement on the distinction between innovation and research. Even though most agree to some sort of oversight, they offer different alternatives ranging from the formation of new surgical innovation committees to establishing national registries. Most agree that informed consent is necessary for innovative procedures and that surgeons should be adequately trained to assure their competence to tackle the learning curve problem. All papers agree that in case of vulnerable patients, alternatives must be found for the informed consent procedure.We suggest that the concept of the learning health care system might provide guidance for thinking about surgical innovation. The underlying rationale of the learning health care system is to improve the quality of health care by embedding research within clinical care. Two aspects of a learning health care system might
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Nurses' ethical conflicts in performance of utilization reviews.
Bell, Sue Ellen
2003-09-01
This article describes the ethical conflicts that a sample of US nurse utilization reviewers faced in their work, and also each nurse's self-reported ethical orientation that was used to resolve the dilemmas. Data were collected from a sample of 97 registered nurses who were working at least 20 hours per week as utilization reviewers. Respondents were recruited from three managed care organizations that conduct utilization reviews in a large midwestern city. A cross-sectional survey design was used to collect demographic data and to ask closed-response, short-answer and open-ended questions. Ethical conflicts reported by nurses were similar across utilization review settings and many were justice orientated. Self-reported ethical orientations were similar across organizations, with beneficence dominating. Implications of these findings are discussed.
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Oladinrin, Olugbenga Timo; Ho, Christabel Man-Fong
2016-08-01
Several researchers have identified codes of ethics (CoEs) as tools that stimulate positive ethical behavior by shaping the organisational decision-making process, but few have considered the information needed for code implementation. Beyond being a legal and moral responsibility, ethical behavior needs to become an organisational priority, which requires an alignment process that integrates employee behavior with the organisation's ethical standards. This paper discusses processes for the responsible implementation of CoEs based on an extensive review of the literature. The internationally recognized European Foundation for Quality Management Excellence Model (EFQM model) is proposed as a suitable framework for assessing an organisation's ethical performance, including CoE embeddedness. The findings presented herein have both practical and research implications. They will encourage construction practitioners to shift their attention from ethical policies to possible enablers of CoE implementation and serve as a foundation for further research on ethical performance evaluation using the EFQM model. This is the first paper to discuss the model's use in the context of ethics in construction practice.
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Animal Models in Forensic Science Research: Justified Use or Ethical Exploitation?
Mole, Calvin Gerald; Heyns, Marise
2018-05-01
A moral dilemma exists in biomedical research relating to the use of animal or human tissue when conducting scientific research. In human ethics, researchers need to justify why the use of humans is necessary should suitable models exist. Conversely, in animal ethics, a researcher must justify why research cannot be carried out on suitable alternatives. In the case of medical procedures or therapeutics testing, the use of animal models is often justified. However, in forensic research, the justification may be less evident, particularly when research involves the infliction of trauma on living animals. To determine how the forensic science community is dealing with this dilemma, a review of literature within major forensic science journals was conducted. The frequency and trends of the use of animals in forensic science research was investigated for the period 1 January 2012-31 December 2016. The review revealed 204 original articles utilizing 5050 animals in various forms as analogues for human tissue. The most common specimens utilized were various species of rats (35.3%), pigs (29.3%), mice (17.7%), and rabbits (8.2%) although different specimens were favored in different study themes. The majority of studies (58%) were conducted on post-mortem specimens. It is, however, evident that more needs to be done to uphold the basic ethical principles of reduction, refinement and replacement in the use of animals for research purposes.
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Directory of Open Access Journals (Sweden)
Jacob Dahl Rendtorff
2016-03-01
Full Text Available This paper presents the concept of ethical economy (Wirtschaftsethik and the relation between ethics and economics on the basis of the work of the German ethical economist Peter Koslowski. The concept of ethical economy includes three levels: micro, meso and macro levels; and it also deals with the philosophical analysis of the ethical foundations of the economy. After the discussion of these elements of the ethical economy, the paper presents some possible research topics for a research agenda about economic ethics or ethical economy.
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DEFF Research Database (Denmark)
Douglas-Jones, Rachel
2013-01-01
Research ethics has become integrated into what it means to conduct good science. This thesis is about the nature of that integration, which I argue is not neutral, carrying with it ideas of duty, moral obligations, organisational mechanisms, and processes of monitoring. For developing countries...... to participate in global research, the pre-requisite of ethical review has necessitated a growth in capacity building exercises. The chapters aim to elucidate ethnographically the activities and implications of 'capacity building' activities in biomedical research ethics, through following the trainings......, assessments and networking of the Forum of Ethics Review Committees of Asia and the Pacific (FERCAP), a Non-Governmental Organisation. The work provides a critical reflection on the spread and uptake of ethics, contributing particularly to literatures in medical anthropology, organisational studies...
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The ethics of psychopharmacological research in legal minors
Directory of Open Access Journals (Sweden)
Koelch Michael
2008-12-01
Full Text Available Abstract Research in psychopharmacology for children and adolescents is fraught with ethical problems and tensions. This has practical consequences as it leads to a paucity of the research that is essential to support the treatment of this vulnerable group. In this article, we will discuss some of the ethical issues which are relevant to such research, and explore their implications for both research and standard care. We suggest that finding a way forward requires a willingness to acknowledge and discuss the inherent conflicts between the ethical principles involved. Furthermore, in order to facilitate more, ethically sound psychopharmacology research in children and adolescents, we suggest more ethical analysis, empirical ethics research and ethics input built into psychopharmacological research design.
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Sharkey, Siobhan; Jones, Ray; Smithson, Janet; Hewis, Elaine; Emmens, Tobit; Ford, Tamsin; Owens, Christabel
2011-12-01
The internet is widely used for health information and support, often by vulnerable people. Internet-based research raises both familiar and new ethical problems for researchers and ethics committees. While guidelines for internet-based research are available, it is unclear to what extent ethics committees use these. Experience of gaining research ethics approval for a UK study (SharpTalk), involving internet-based discussion groups with young people who self-harm and health professionals is described. During ethical review, unsurprisingly, concerns were raised about the vulnerability of potential participants. These were dominated by the issue of anonymity, which also affected participant safety and consent. These ethical problems are discussed, and our solutions, which included: participant usernames specific to the study, a closed website, private messaging facilities, a direct contact email to researchers, information about forum rules displayed on the website, a 'report' button for participants, links to online support, and a discussion room for forum moderators. This experience with SharpTalk suggests that an approach to ethics, which recognises the relational aspects of research with vulnerable people, is particularly useful for internet-based health research. The solutions presented here can act as guidance for researchers developing proposals and for ethics committees reviewing them.
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What Is Everyday Ethics? A Review and a Proposal for an Integrative Concept.
Zizzo, Natalie; Bell, Emily; Racine, Eric
2016-01-01
"Everyday ethics" is a term that has been used in the clinical and ethics literature for decades to designate normatively important and pervasive issues in healthcare. In spite of its importance, the term has not been reviewed and analyzed carefully. We undertook a literature review to understand how the term has been employed and defined, finding that it is often contrasted to "dramatic ethics." We identified the core attributes most commonly associated with everyday ethics. We then propose an integrative model of everyday ethics that builds on the contribution of different ethical theories. This model proposes that the function of everyday ethics is to serve as an integrative concept that (1) helps to detect current blind spots in bioethics (that is, shifts the focus from dramatic ethics) and (2) mobilizes moral agents to address these shortcomings of ethical insight. This novel integrative model has theoretical, methodological, practical, and pedagogical implications, which we explore. Because of the pivotal role that moral experience plays in this integrative model, the model could help to bridge empirical ethics research with more conceptual and normative work. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.
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Research Ethics in Sign Language Communities
Harris, Raychelle; Holmes, Heidi M.; Mertens, Donna M.
2009-01-01
Codes of ethics exist for most professional associations whose members do research on, for, or with sign language communities. However, these ethical codes are silent regarding the need to frame research ethics from a cultural standpoint, an issue of particular salience for sign language communities. Scholars who write from the perspective of…
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Health data research in New Zealand: updating the ethical governance framework.
Ballantyne, Angela; Style, Rochelle
2017-10-27
Demand for health data for secondary research is increasing, both in New Zealand and worldwide. The New Zealand government has established a large research database, the Integrated Data Infrastructure (IDI), which facilitates research, and an independent ministerial advisory group, the Data Futures Partnership (DFP), to engage with citizens, the private sector and non-government organisations (NGOs) to facilitate trusted data use and strengthen the data ecosystem in New Zealand. We commend these steps but argue that key strategies for effective health-data governance remain absent in New Zealand. In particular, we argue in favour of the establishment of: (1) a specialist Health and Disability Ethics Committee (HDEC) to review applications for secondary-use data research; (2) a public registry of approved secondary-use research projects (similar to a clinical trials registry); and (3) detailed guidelines for the review and approval of secondary-use data research. We present an ethical framework based on the values of public interest, trust and transparency to justify these innovations.
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Ethics as Critique: Foucault’s Contribution to Research Ethics
DEFF Research Database (Denmark)
Christensen, Gerd
The aim of my talk is to discuss how we can consider Michel Foucault’s concept of ethos and his endeavor for endless critique as an important contribution to research ethics in educational research. First, I intend to outline Foucault’s concept of ethos and its link to his concept of critique....... Second, I intend to demonstrate how it can fruitfully be applied to the established research ethics within qualitative research. This will occur through examples culled from a qualitative research project on the application of project studies (PBL) as a method at two Danish universities. The findings...... students. This had a significant impact on the possibilities and educational success of the students: while some students were marginalized or even excluded from the groups (and maybe even from the university) others were subjectivated as successful students. Thus, the findings points at ethics in general...
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Hammer, Marilyn J
2017-05-01
The ethical conduct of research includes, in part, patient agreement to participate in studies and the protection of health information. In the evolving world of data science and the accessibility of large quantities of web-based data created by millions of individuals, novel methodologic approaches to answering research questions are emerging. This article explores research ethics in the context of big data.
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Clinical governance and research ethics as barriers to UK low-risk population-based health research?
Directory of Open Access Journals (Sweden)
Douglas Flora
2008-11-01
Full Text Available Abstract Background Since the Helsinki Declaration was introduced in 1964 as a code of practice for clinical research, it has generally been agreed that research governance is also needed in the field of public health and health promotion research. Recently, a range of factors led to the development of more stringent bureaucratic procedures, governing the conduct of low-risk population-based health research in the United Kingdom. Methods Our paper highlights a case study of the application process to medical research ethics committees in the United Kingdom for a study of the promotion of physical activity by health care providers. The case study presented here is an illustration of the challenges in conducting low-risk population-based health research. Results Our mixed-methods approach involved a questionnaire survey of and semi-structured interviews with health professionals (who were all healthy volunteers. Since our study does not involve the participation of either patients or the general population, one would expect the application to the relevant research ethics committees to be a formality. This proved not to be the case! Conclusion Research ethics committees could be counter-productive, rather than protecting the vulnerable in the research process, they can stifle low-risk population-based health research. Research ethics in health services research is first and foremost the responsibility of the researcher(s, and we need to learn to trust health service researchers again. The burden of current research governance regulation to address the perceived ethical problems is neither appropriate nor adequate. Senior researchers/academics need to educate and train students and junior researchers in the area of research ethics, whilst at the same time reducing pressures on them that lead to unethical research, such as commercial funding, inappropriate government interference and the pressure to publish. We propose that non-invasive low
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Instrumental and ethical aspects of experimental research with animal models
Directory of Open Access Journals (Sweden)
Mirian Watanabe
2014-02-01
Full Text Available Experimental animal models offer possibilities of physiology knowledge, pathogenesis of disease and action of drugs that are directly related to quality nursing care. This integrative review describes the current state of the instrumental and ethical aspects of experimental research with animal models, including the main recommendations of ethics committees that focus on animal welfare and raises questions about the impact of their findings in nursing care. Data show that, in Brazil, the progress in ethics for the use of animals for scientific purposes was consolidated with Law No. 11.794/2008 establishing ethical procedures, attending health, genetic and experimental parameters. The application of ethics in handling of animals for scientific and educational purposes and obtaining consistent and quality data brings unquestionable contributions to the nurse, as they offer subsidies to relate pathophysiological mechanisms and the clinical aspect on the patient.
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Ethics of Research into Learning and Teaching with Web 2.0: Reflections on Eight Case Studies
Chang, Rosemary L.; Gray, Kathleen
2013-01-01
The unique features and educational affordances of Web 2.0 technologies pose new challenges for conducting learning and teaching research in ways that adequately address ethical issues of informed consent, beneficence, respect, justice, research merit and integrity. This paper reviews these conceptual bases of human research ethics and gives…
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Ethical issues when involving people newly diagnosed with dementia in research.
Holland, Suzanne; Kydd, Angela
2015-03-01
To discuss the methodological and ethical review challenges encountered by researchers who want to enable people with dementia to be involved in research. There has been increasing recognition of the importance of involving people with dementia in research. However, an argument has centred on the protection of these vulnerable clients versus their freedom to be involved as participants in research. People with dementia do have the right to have their experiences explored. Involving this client group in research is essential to gain a true understanding of their needs. The lead author's experience of conducting a study in which people newly diagnosed with dementia were recruited as research participants. An interpretive phenomenological approach was adopted during this qualitative study, with data collected by means of one to one interviews with people newly diagnosed with dementia. This study was completed within the set timeframe, but a large part of the work was spent gaining ethical approval. This meant that the timeframe of the study period was reduced and as a result, it was only possible to recruit three participants. However, people with dementia are perhaps one of the most vulnerable client groups and it is only right that they should not be subjected to harm. Ethical review is an important part of research. Meeting the ethical requirements of research involving people with dementia requires time and careful preparation to ensure that researchers safeguard the interests of this vulnerable client group, while also allowing the participants the opportunity to exercise their autonomy to their fullest potential. Conducting research that involves people with dementia may be time consuming, but it is only fair that this client group are afforded the freedom to be involved in research. This small time-limited study points to the need for larger pilot studies to hear from individuals what needs they have following a diagnosis of dementia.
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Racine, Eric; Dubljević, Veljko; Jox, Ralf J; Baertschi, Bernard; Christensen, Julia F; Farisco, Michele; Jotterand, Fabrice; Kahane, Guy; Müller, Sabine
2017-06-01
Neuroethics is an interdisciplinary field that arose in response to novel ethical challenges posed by advances in neuroscience. Historically, neuroethics has provided an opportunity to synergize different disciplines, notably proposing a two-way dialogue between an 'ethics of neuroscience' and a 'neuroscience of ethics'. However, questions surface as to whether a 'neuroscience of ethics' is a useful and unified branch of research and whether it can actually inform or lead to theoretical insights and transferable practical knowledge to help resolve ethical questions. In this article, we examine why the neuroscience of ethics is a promising area of research and summarize what we have learned so far regarding its most promising goals and contributions. We then review some of the key methodological challenges which may have hindered the use of results generated thus far by the neuroscience of ethics. Strategies are suggested to address these challenges and improve the quality of research and increase neuroscience's usefulness for applied ethics and society at large. Finally, we reflect on potential outcomes of a neuroscience of ethics and discuss the different strategies that could be used to support knowledge transfer to help different stakeholders integrate knowledge from the neuroscience of ethics. © 2017 John Wiley & Sons Ltd.
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International Nuclear Information System (INIS)
Jonker, Leon; Cox, Diane; Marshall, Gill
2011-01-01
Substantial changes have been made in recent years to the process of obtaining ethical and research governance approval for research projects in the NHS. The advent of the Integrated Research Application System (IRAS) has streamlined the process, providing a single point of entry. Ethical approval gained in one part of the country is now valid throughout the UK. The previous process of gaining research governance approval in NHS Trusts was maligned and it has been overhauled with the introduction of the National Institute of Health Research (NIHR) Coordinated System for gaining NHS Permission. In addition to updating the reader about the new processes around gaining ethical and Trust approval for research within an NHS setting, essential research project documentation needed for submission are discussed. The aspects of a proposal that Ethics Committees and Trust R and D Departments consider when reviewing applications are highlighted. The implemented changes to the research approval processes will mostly benefit large multi-centre studies; small scale unfunded studies and student projects are potentially at risk of being marginalised in the quest for a streamlined ethics and NHS Trust research governance approval process. However, researchers' familiarity with the approval system should minimise rejection rates and delays.
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Energy Technology Data Exchange (ETDEWEB)
Jonker, Leon, E-mail: leon.jonker@cumbria.ac.uk [Faculty of Health and Wellbeing, University of Cumbria, Lancaster LA1 3JD (United Kingdom); Research and Development Department, North Cumbria University Hospitals NHS Trust, Carlisle CA2 7HY (United Kingdom); Cox, Diane; Marshall, Gill [Faculty of Health and Wellbeing, University of Cumbria, Lancaster LA1 3JD (United Kingdom)
2011-08-15
Substantial changes have been made in recent years to the process of obtaining ethical and research governance approval for research projects in the NHS. The advent of the Integrated Research Application System (IRAS) has streamlined the process, providing a single point of entry. Ethical approval gained in one part of the country is now valid throughout the UK. The previous process of gaining research governance approval in NHS Trusts was maligned and it has been overhauled with the introduction of the National Institute of Health Research (NIHR) Coordinated System for gaining NHS Permission. In addition to updating the reader about the new processes around gaining ethical and Trust approval for research within an NHS setting, essential research project documentation needed for submission are discussed. The aspects of a proposal that Ethics Committees and Trust R and D Departments consider when reviewing applications are highlighted. The implemented changes to the research approval processes will mostly benefit large multi-centre studies; small scale unfunded studies and student projects are potentially at risk of being marginalised in the quest for a streamlined ethics and NHS Trust research governance approval process. However, researchers' familiarity with the approval system should minimise rejection rates and delays.
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An evaluation of a data linkage training workshop for research ethics committees.
Tan, Kate M; Flack, Felicity S; Bear, Natasha L; Allen, Judy A
2015-03-04
In Australia research projects proposing the use of linked data require approval by a Human Research Ethics Committee (HREC). A sound evaluation of the ethical issues involved requires understanding of the basic mechanics of data linkage, the associated benefits and risks, and the legal context in which it occurs. The rapidly increasing number of research projects utilising linked data in Australia has led to an urgent need for enhanced capacity of HRECs to review research applications involving this emerging research methodology. The training described in this article was designed to respond to an identified need among the data linkage units in the Australian Population Health Research Network (PHRN) and HREC members in Australia. Five one-day face to face workshops were delivered in the study period to a total of 98 participants. Participants in the workshops represented all six categories of HREC membership composition listed in the National Health and Medical Research Centres' (NHMRC) National Statement on Ethical Conduct in Human Research. Participants were assessed at three time points, prior to the training (T1), immediately after the training (T2) and 8 to 17 months after the training (T3). Ninety participants completed the pre and post questionnaires; 58 of them completed the deferred questionnaire. Participants reported significant improvements in levels of knowledge, understanding and skills in each of the eight areas evaluated. The training was beneficial for those with prior experience in the area of ethics and data linkage as well as those with no prior exposure. Our preliminary work in this area demonstrates that the provision of intensive face to face ethics training in data linkage is feasible and has a significant impact on participant's confidence in reviewing HREC applications.
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Capon, Hannah; Hall, Wayne; Fry, Craig; Carter, Adrian
2016-10-01
Smartphone technologies and mHealth applications (or apps) promise unprecedented scope for data collection, treatment intervention, and relapse prevention when used in the field of substance abuse and addiction. This potential also raises new ethical challenges that researchers, clinicians, and software developers must address. This paper aims to identify ethical issues in the current uses of smartphones in addiction research and treatment. A search of three databases (PubMed, Web of Science and PsycInfo) identified 33 studies involving smartphones or mHealth applications for use in the research and treatment of substance abuse and addiction. A content analysis was conducted to identify how smartphones are being used in these fields and to highlight the ethical issues raised by these studies. Smartphones are being used to collect large amounts of sensitive information, including personal information, geo-location, physiological activity, self-reports of mood and cravings, and the consumption of illicit drugs, alcohol and nicotine. Given that detailed information is being collected about potentially illegal behaviour, we identified the following ethical considerations: protecting user privacy, maximising equity in access, ensuring informed consent, providing participants with adequate clinical resources, communicating clinically relevant results to individuals, and the urgent need to demonstrate evidence of safety and efficacy of the technologies. mHealth technology offers the possibility to collect large amounts of valuable personal information that may enhance research and treatment of substance abuse and addiction. To realise this potential researchers, clinicians and app-developers must address these ethical concerns to maximise the benefits and minimise risks of harm to users. Copyright © 2016 Elsevier B.V. All rights reserved.
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What Price Ethics: New Research Directions in Counselor Ethical Behavior
Paradise, Louis V.
1978-01-01
This paper briefly examines research on the ethical behavior of counselors, demonstrating that new directions in this area are needed, and that new research questions must be asked if significant information relating to counseling and ethics is to advance. Areas of inquiry and methods for investigation are suggested. (Author)
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Ethical Challenges when Interviewing Close Relatives Together – An Integrative Review
DEFF Research Database (Denmark)
Voltelen, Barbara; Konradsen, Hanne; Østergaard, Birte
and search terms. Results In total 17 articles were located, 9 containing relevant information about dyadic interviewing, only dealing subtly with questions of ethics. Another 8 articles addressed both dyadic interviewing and ethical considerations. Findings were divided into three different themes......Background and purpose Interviewing two interrelated persons (or more) simultaneously might pose different ethical considerations than interviewing just one person. Such ethical considerations, however, remain largely undescribed in literature, challenging the researcher who wishes to conduct them....... The purpose of this study is to describe the special ethical perspectives concerning joint interviews with interrelated persons. Method An integrative review was performed. A search was conducted in Pub Med, Cinahl, Philosophers Index and Academic Search from 1980 -2014. Data corpus from the 17 articles...
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Knopman, David; Alford, Eli; Tate, Kaitlin; Long, Mark; Khachaturian, Ara S
2017-08-01
For nearly 50 years, institutional review boards (IRB) and independent ethics committees have featured local oversight as a core function of research ethics reviews. However growing complexity in Alzheimer's clinical research suggests current approaches to research volunteer safety is hampering development of new therapeutics. As a partial response to this challenge, the NIH has mandated that all NIH-funded multi-site studies will use a single Institutional Review Board. The perspective describes a joint program to provide a single IRB of record (sIRB) for phases of multi-site studies. The approach follows two steps. One, an expert Scientific Review Committee (SRC) of senior researchers in the field will conduct the review principally of scientific merit, significance, feasibility, and the likelihood of meaningful results. The second step will be the IRB's regulatory and ethics review. The IRB will apply appropriate regulatory criteria for approval including minimization of risks to subjects and risks reasonable in relation to anticipated benefits, equitable subject selection, informed consent, protections for vulnerable populations, and application of local context considerations, among others. There is a steady demand for scientific, ethical and regulatory review of planned Alzheimer's studies. As of January 15, 2017, there are nearly 400 open studies, Phase II and III, industry and NIH sponsored trials on disease indications affecting memory, movement and mood in the US. The effort will initially accept protocols for studies of Alzheimer's disease, dementia, and related disorders effecting memory, movement and mood. Future aims will be to provide scientific review and, where applicable, regulatory and ethical review in an international context outside North America with sites possibly in Asia, Europe and Australia. Copyright © 2017 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.
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"Living" Ethical Dilemmas for Researchers When Researching with Children
Mortari, Luigina; Harcourt, Deborah
2012-01-01
This article will explore some of the ethical dilemmas that confront researchers when they seek to invite children's participation in research. It firstly tracks the historical landscape of ethical research and will examine the influence of the United Nations Convention on the Rights of the Child (UNCRC) on participatory research with children.…
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Ethics, Governance, Research and Enterprise
Lategan, Laetus; Hooper, Peter
2009-01-01
The focus of this paper is to reflect on research ethics practices at universities and particularly on the additional considerations needed as "enterprise" becomes a key driver across the sector internationally. The outcome of the paper is to identify suitable guidelines for dealing with the management of research ethics in this changing…
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Nursing ethical values and definitions: A literature review.
Shahriari, Mohsen; Mohammadi, Eesa; Abbaszadeh, Abbas; Bahrami, Masoud
2013-01-01
Ethical values offer a framework for behavior assessment, and nursing values influence nurses' goals, strategies, and actions. A literature review was adopted in order to determine and define ethical values for nurses. This literature review was conducted based on the Centre for Reviews and Dissemination guidelines. The key words used to search relevant sources were nursing, ethics, ethical values, and nursing values. The search of articles in English was carried out in Medline, CINAHL, PubMed, Scopus, Ovid, and Proquest databases. The search of articles in Persian was conducted in databases of Magiran, SID, and Irandoc publications. After assessing and analyzing the obtained data, 17 articles which had a distinct definition of ethical values were chosen and subjected to a thorough study. The search yielded 10 nursing ethical values: Human dignity, privacy, justice, autonomy in decision making, precision and accuracy in caring, commitment, human relationship, sympathy, honesty, and individual and professional competency. This study showed that common ethical values are generally shared within the global community. However, in several areas, influences of social, cultural, and economical status and religious beliefs on values result in a different definition of these values. This study revealed that based on humanistic nature of nursing, common values in nursing protect human dignity and respect to the patients. Recognizing and definition of ethical values can help to improve nursing practice and develop codes of ethics.
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National scientific literature on nursing ethics: a systematic Review
Directory of Open Access Journals (Sweden)
Ilka Nicéia D’Aquino Oliveira Teixeira
2010-03-01
Full Text Available Objective: To identify the most prevalent nursing ethical issues published in scientific Brazilian journals. Methods: A systematic literature review with the following inclusion criteria: (1 articles on Nursing Ethics written in Portuguese, English, French, and Spanish; (2 published in Brazilian journals; (3 in the period from January 1997 to February 2009. The search was carried out in four databases BDENF, LILACS, MEDLINE, and SCIELO. The key-words were ethics AND nursing. The selected studies were classified into categories. The content of the articles were analyzed using the Collective Subject Discourse. The categories generated discourses by organizing the main excerpts from the abstracts of the selected studies, which are the “key expressions”. Results: A hundred and thirty three articles that met the inclusion criteria were classified into eight categories: 1. Nursing Care; 2. Dilemmas and Controversies; 3. Education; 4. Legal Aspects; 5. Research; 6. Management; 7. Values and Beliefs; 8. Perspectives and Health Policies. The category “Nursing Care” prevailed in 36% of the selected articles, and it was classified into six subcategories. “Dilemmas and Controversies” was the second most prevalent category (15%. Conclusion: The number of theoretical papers on ethical issues is high, but there is little research on the ethical experiences in nursing practice.
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Dixon-Woods, Mary; Foy, Chris; Hayden, Charlotte; Al-Shahi Salman, Rustam; Tebbutt, Stephen; Schroter, Sara
2016-08-31
Frustration continues to be directed at delays in gaining approvals for undertaking health research in the UK. We aimed to evaluate the impact of an ethics officer intervention on rates of favourable opinions (approval) and provisional opinions (requiring revision and resubmission) and on the time taken to reach a final opinion by research ethics committees (RECs), to characterise how the role operated in practice, and to investigate applicants' views. Mixed-method study involving (i) a 2-group, non-randomised before-and-after intervention study of RECs assigned an ethics officer and a matched comparator group; (ii) a process evaluation involving a survey of applicants and documentary analysis. 6 RECs and 3 associated ethics officers; 18 comparator RECs; REC applicants. Rates of provisional and favourable opinions between ethics officer and comparator RECs did not show a statistically significant effect of the intervention (logistic regression, p=0.26 for favourable opinions and p=0.31 for provisional opinions). Mean time to reach a decision showed a non-significant reduction (ANOVA, p=0.22) from 33.3 to 32.0 days in the ethics officer RECs compared with the comparator RECs (32.6 to 32.9 days). The survey (30% response rate) indicated applicant satisfaction and also suggested that ethics officer support might be more useful before submission. Ethics officers were successful in identifying many issues with applications, but the intervention did not function exactly as designed: in 31% of applicants, no contact between the applicants and the ethics officer took place before REC review. This study was a non-randomised comparison cohort study. Some data were missing. An ethics officer intervention, as designed and implemented in this study, did not increase the proportion of applications to RECs that were approved on first review and did not reduce the time to a committee decision. Published by the BMJ Publishing Group Limited. For permission to use (where not
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Campbell, Rebecca
2016-12-01
In the 50 years since the 1965 Swampscott conference, the field of community psychology has not yet developed a well-articulated ethical framework to guide research and practice. This paper reviews what constitutes an "ethical framework"; considers where the field of community psychology is at in its development of a comprehensive ethical framework; examines sources for ethical guidance (i.e., ethical principles and standards) across multiple disciplines, including psychology, evaluation, sociology, and anthropology; and recommends strategies for developing a rich written discourse on how community psychology researchers and practitioners can address ethical conflicts in our work. © Society for Community Research and Action 2016.
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Evaluating clinical ethics support in mental healthcare: a systematic literature review.
Hem, Marit Helene; Pedersen, Reidar; Norvoll, Reidun; Molewijk, Bert
2015-06-01
A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five studies were included. The ethics support activities described were moral case deliberations and ethics rounds. Different qualitative and quantitative research methods were utilized. The results show that (a) participants felt that they gained an increased insight into moral issues through systematic reflection; (b) there was improved cooperation among multidisciplinary team members; (c) it was uncertain whether clinical ethics support services led to better patient care; (d) the issue of patient and client participation is complex; and (e) the implementation process is challenging. Clinical ethics support services have mainly been studied through the experiences of the participating facilitators and healthcare professionals. Hence, there is limited knowledge of whether and how various types of clinical ethics support services influence the quality of care and how patients and relatives may evaluate clinical ethics support services. Based on the six excluded 'grey zone articles', in which there was an implicit focus on ethics reflection, other ways of working with ethical reflection in practice are discussed. Implementing and evaluating clinical ethics support services as approaches to clinical ethics support that are more integrated into the development of good practice are in focus. In order to meet some of the shortcomings of the field of clinical ethics support services, a research project that aims to strengthen ethics support in the mental health services, including patients' and caregivers' views on ethical challenges, is presented. © The Author(s) 2014.
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Ethics of reviewing scientific publications.
Napolitani, Federica; Petrini, Carlo; Garattini, Silvio
2017-05-01
The approval or rejection of scientific publications can have important consequences for scientific knowledge, so considerable responsibility lies on those who have to assess or review them. Today it seems that the peer review process, far from being considered an outdated system to be abandoned, is experiencing a new upturn. This article proposes criteria for the conduct of reviewers and of those who select them. While commenting on new emerging models, it provides practical recommendations for improving the peer-review system, like strengthening the role of guidelines and training and supporting reviewers. The process of peer review is changing, it is getting more open and collaborative, but those same ethical principles which guided it from its very origin should remain untouched and be firmly consolidated. The paper highlights how the ethics of reviewing scientific publications is needed now more than ever, in particular with regard to competence, conflict of interest, willingness to discuss decisions, complete transparency and integrity. Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
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“Just Chatting”: Research Ethics and Cyberspace
Directory of Open Access Journals (Sweden)
Ellen Whiteman
2007-06-01
Full Text Available Research conducted through computer-mediated communication is challenging traditional definitions of what is ethical research. In this article the author examines the changing role of assent/consent, confidentiality, and participant observation in qualitative research conducted in cyberspace. She concludes that REBs (research ethic boards might be becoming more conservative in their decisions at the very moment that Internet research requires more flexibility and broader ethical definitions.
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Ethics in clinical research: The Indian perspective
J Sanmukhani; C B Tripathi
2011-01-01
Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organiza...
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Psychology Ethics in Introductory Psychology Textbooks
Zucchero, Renee' A.
2011-01-01
Previous research revealed that introductory psychology textbooks included limited information about psychology ethics. This study reviewed 48 current introductory psychology textbooks for research and other APA ethics content. These textbooks included slightly more total ethics content and were more thorough in their review of research ethics…
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Reuse of samples: ethical issues encountered by two institutional ethics review committees in Kenya.
Langat, Simon K
2005-10-01
There is growing concern about the reuse and exploitation of biological materials (human tissues) for use in research worldwide. Most discussions about samples have taken place in developed countries, where genetic manipulation techniques have greatly advanced in recent years. There is very little discussion in developing countries, although collaborative research with institutions from developed countries is on the increase. The study sought to identify and describe ethical issues arising in the storage, reuse and exportation of samples in a developing country. Research protocols presented to two Ethics Review Committees in Kenya during a period of two years were reviewed. A record was made of the protocol title, sample collected, request for storage, reuse or exportation and whether or not subject consent was sought. The findings indicated that about 25% out of the 388 protocols sought permission for reuse and only half of those actually informed subjects of the contemplated re-use. Less than 20% requested storage and again, about half of them sought consent from subjects. There is an indication that investigators do not see the need to seek consent for storage, reuse and exportation of samples. It is proposed that these issues should be addressed through policy interventions at both the national and global levels.
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Developments in stem cell research and therapeutic cloning: Islamic ethical positions, a review.
Fadel, Hossam E
2012-03-01
Stem cell research is very promising. The use of human embryos has been confronted with objections based on ethical and religious positions. The recent production of reprogrammed adult (induced pluripotent) cells does not - in the opinion of scientists - reduce the need to continue human embryonic stem cell research. So the debate continues. Islam always encouraged scientific research, particularly research directed toward finding cures for human disease. Based on the expectation of potential benefits, Islamic teachings permit and support human embryonic stem cell research. The majority of Muslim scholars also support therapeutic cloning. This permissibility is conditional on the use of supernumerary early pre-embryos which are obtained during infertility treatment in vitro fertilization (IVF) clinics. The early pre-embryos are considered in Islamic jurisprudence as worthy of respect but do not have the full sanctity offered to the embryo after implantation in the uterus and especially after ensoulment. In this paper the Islamic positions regarding human embryonic stem cell research and therapeutic cloning are reviewed in some detail, whereas positions in other religious traditions are mentioned only briefly. The status of human embryonic stem cell research and therapeutic cloning in different countries, including the USA and especially in Muslim countries, is discussed. © 2010 Blackwell Publishing Ltd.
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Hibbin, R A; Samuel, G; Derrick, G E
2018-04-01
Social media (SM) research presents new challenges for research ethics committees (RECs) who must balance familiar ethical principles with new notions of public availability. This article qualitatively examines how U.K. REC members view this balance in terms of risk and consent. While it found significant variance overall, there were discernible experience-based trends. REC members with less experience of reviewing SM held inflexible notions of consent and risk that could be categorized as either relying on traditional notions of requiring direct consent, or viewing publicly available data as "fair game." More experienced REC members took a more nuanced approach to data use and consent. We conclude that the more nuanced approach should be best practice during ethical review of SM research.
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Pitak-Arnnop, P; Sader, R; Hervé, C; Dhanuthai, K; Bertrand, J-Ch; Hemprich, A
2009-07-01
This retrospective observational study investigated the frequency of reporting ethical approval and informed consent in recently published oral and maxillofacial surgery (OMS) research involving human subjects. All research involving human subjects published in the International Journal of Oral and Maxillofacial Surgery, Journal of Oral and Maxillofacial Surgery, British Journal of Oral and Maxillofacial Surgery, and Journal of Cranio-Maxillofacial Surgery during January to June 2005-2007 were analysed for disclosure of ethical approval by a local ethical committee and obtaining informed consent from the subjects. 534 articles were identified; ethical approval was documented in 118 (22%) and individual patient consent in 135 (25%). 355 reports (67%) did not include a statement on ethical approval or informed consent and only 74 reports (14%) disclosed statements of both. Ethical documentation in retrospective and observational studies was scant; 12% of randomised controlled trials and 38% of non-random trials did not report both of ethical protections. Most recent OMS publications involving humans failed to mention ethical review or subjects' consent. Authors must adhere to the international research ethics guidelines and journal instructions, while editors should play a gatekeeper role to protect research participants, uphold scientific integrity and maintain public trust in the experimental process and OMS profession.
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Ethical issues in research on children
Directory of Open Access Journals (Sweden)
Đurić Slađana
2012-01-01
Full Text Available Ethical issues that appear in researching children are the subject matter of relatively rich scientific literature, as well as a multitude of national and professional ethical codices. The broad thematization of ethical principles is indeed instigated by the rise of awareness of the seriousness of this problem, as well as by growing fears of potential abuse of children in contemporary research projects. General assertion that children are a vulnerable category of subjects that require special attention and protection from misuse in research projects prevails in literature. The main objective of this paper is to present general ethical issues that various areas of expertise researchers face when children and youth are the subjects of their studies. The principle of voluntary participation, the principle of balanced researcher - respondent relationship, and the principles of privacy, confidentiality and anonymity in studies of children are particularly presented.
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Research Ethics with Undergraduates in Summer Research Training Programs
Cheung, I.; Yalcin, K.
2016-02-01
Many undergraduate research training programs incorporate research ethics into their programs and some are required. Engaging students in conversations around challenging topics such as conflict of interest, cultural and gender biases, what is science and what is normative science can difficult in newly formed student cohorts. In addition, discussing topics with more distant impacts such as science and policy, intellectual property and authorship, can be difficult for students in their first research experience that have more immediate concerns about plagiarism, data manipulation, and the student/faculty relationship. Oregon State University's Research Experience for Undergraduates (REU) in Ocean Sciences: From Estuaries to the Deep Sea as one model for incorporating a research ethics component into summer undergraduate research training programs. Weaved into the 10-week REU program, undergraduate interns participate in a series of conversations and a faculty mentor panel focused on research ethics. Topics discussed are in a framework for sharing myths, knowledge and personal experiences on issues in research with ethical implications. The series follows guidelines and case studies outlined from the text, On Being A Scientist: Responsible Conduct In Research Committee on Science, Engineering, and Public Policy, National Academy of Sciences.
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Professional Ethics Education for Future Teachers: A Narrative Review of the Scholarly Writings
Maxwell, Bruce; Schwimmer, Marina
2016-01-01
This article provides a narrative review of the scholarly writings on professional ethics education for future teachers. Against the background of a widespread belief among scholars working in this area that longstanding and sustained research and reflection on the ethics of teaching have had little impact on the teacher education curriculum, the…
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Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations.
Gelinas, Luke; Pierce, Robin; Winkler, Sabune; Cohen, I Glenn; Lynch, Holly Fernandez; Bierer, Barbara E
2017-03-01
The use of social media as a recruitment tool for research with humans is increasing, and likely to continue to grow. Despite this, to date there has been no specific regulatory guidance and there has been little in the bioethics literature to guide investigators and institutional review boards (IRBs) faced with navigating the ethical issues such use raises. We begin to fill this gap by first defending a nonexceptionalist methodology for assessing social media recruitment; second, examining respect for privacy and investigator transparency as key norms governing social media recruitment; and, finally, analyzing three relatively novel aspects of social media recruitment: (i) the ethical significance of compliance with website "terms of use"; (ii) the ethics of recruiting from the online networks of research participants; and (iii) the ethical implications of online communication from and between participants. Two checklists aimed at guiding investigators and IRBs through the ethical issues are included as appendices.
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Ethics and Truth in Archival Research
Tesar, Marek
2015-01-01
The complexities of the ethics and truth in archival research are often unrecognised or invisible in educational research. This paper complicates the process of collecting data in the archives, as it problematises notions of ethics and truth in the archives. The archival research took place in the former Czechoslovakia and its turbulent political…
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Directory of Open Access Journals (Sweden)
Chaudhry Shazia H
2009-07-01
Full Text Available Abstract Background Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities – rather than individual themselves – are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1 identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2 understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK; (3 elicit the views and experiences of trial participants and cluster representatives; (4 develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5 disseminate the guidelines to researchers, research ethics boards (REBs, journal editors, and research funders. Methods We will use a mixed-methods (qualitative and quantitative approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An
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Pharmacological cognitive enhancement-how neuroscientific research could advance ethical debate.
Maslen, Hannah; Faulmüller, Nadira; Savulescu, Julian
2014-01-01
THERE ARE NUMEROUS WAYS PEOPLE CAN IMPROVE THEIR COGNITIVE CAPACITIES: good nutrition and regular exercise can produce long-term improvements across many cognitive domains, whilst commonplace stimulants such as coffee temporarily boost levels of alertness and concentration. Effects like these have been well-documented in the medical literature and they raise few (if any) ethical issues. More recently, however, clinical research has shown that the off-label use of some pharmaceuticals can, under certain conditions, have modest cognition-improving effects. Substances such as methylphenidate and modafinil can improve capacities such as working memory and concentration in some healthy individuals. Unlike their more mundane predecessors, these methods of "cognitive enhancement" are thought to raise a multitude of ethical issues. This paper presents the six principal ethical issues raised in relation to pharmacological cognitive enhancers (PCEs)-issues such as whether: (1) the medical safety-profile of PCEs justifies restricting or permitting their elective or required use; (2) the enhanced mind can be an "authentic" mind; (3) individuals might be coerced into using PCEs; (4), there is a meaningful distinction to be made between the treatment vs. enhancement effect of the same PCE; (5) unequal access to PCEs would have implications for distributive justice; and (6) PCE use constitutes cheating in competitive contexts. In reviewing the six principal issues, the paper discusses how neuroscientific research might help advance the ethical debate. In particular, the paper presents new arguments about the contribution neuroscience could make to debates about justice, fairness, and cheating, ultimately concluding that neuroscientific research into "personalized enhancement" will be essential if policy is to be truly informed and ethical. We propose an "ethical agenda" for neuroscientific research into PCEs.
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The Ethics of Sports Medicine Research.
Stewart, Robert J; Reider, Bruce
2016-04-01
This article explores the background and foundations of ethics in research. Some important documents and codes are mentioned, such as The Belmont Report and the International Conference of Harmonisation. Some influential historical events involving research ethics are recounted. The article provides a detailed discussion of the Declaration of Helsinki, which is considered the international standard for guidelines in medical research ethics. The most salient features of the Declaration are described and related to orthopaedic surgery and sports medicine. Some of the most controversial aspects of the Declaration are discussed, which helps examine contentious areas of research in sports medicine. Copyright © 2016 Elsevier Inc. All rights reserved.
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Reporting ethics committee approval in public administration research.
Jordan, Sara R; Gray, Phillip W
2014-03-01
While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration journals over the period from 2000 to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research.
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Directory of Open Access Journals (Sweden)
Luis Fernando Aragón-Vargas
2015-12-01
Full Text Available This paper reviews how we arrived at the current state of affairs in the ethical practice of scientific research, discussing some issues that are particularly pertinent to the exercise scientist. The paper focuses on two major areas of ethics in science. The ethical principles for biomedical research involving human subjects are presented and discussed using the three basic principles from the Belmont Report (autonomy, beneficence, and justice as a guide. The ethical presentation and publication of data are discussed as an update or expanded comment on the ten topics covered by Roy Shephard in his Ethics in Exercise Science Research paper from 2002. The manuscript closes with a reflection on personal responsibility and its importance in every scientific endeavor: placing all responsibility for action on those scientists or physicians doing the experiments was not sufficient to prevent all types of human research abuses in the first half of the twentieth century. However, intricate and cumbersome external review and approval procedures generate the perception that the system should be more than enough to ensure good practices, a perception that may dangerously prevent the scientists from assuming their individual responsibility.
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Research Integrity and Peer Review-past highlights and future directions.
Boughton, Stephanie L; Kowalczuk, Maria K; Meerpohl, Joerg J; Wager, Elizabeth; Moylan, Elizabeth C
2018-01-01
In May 2016, we launched Research Integrity and Peer Review , an international, open access journal with fully open peer review (reviewers are identified on their reports and named reports are published alongside the article) to provide a home for research on research and publication ethics, research reporting, and research on peer review. As the journal enters its third year, we reflect on recent events and highlights for the journal and explore how the journal is faring in terms of gender and diversity in peer review. We also share the particular interests of our Editors-in-Chief regarding models of peer review, reporting quality, common research integrity issues that arise during the publishing process, and how people interact with the published literature. We continue to encourage further research into peer review, research and publication ethics and research reporting, as we believe that all new initiatives should be evidence-based. We also remain open to constructive discussions of the developments in the field that offer new solutions.
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When reviews attack: ethics, free speech, and the peer review process.
Hadjistavropoulos, T; Bieling, P J
2000-08-01
The peer review process, whether formally applied in publication and grant review, or informally, such as exchange of ideas in scientific and professional newsgroups, has sparked controversy. Writers in this area agree that scholarly reviews that are inappropriate in tone are not uncommon. Indeed, commentators have suggested rules and guidelines that can be used to improve the review process and to make reviewers more accountable. In this paper, we examine the relevance and impact of ethical codes on the conduct of peer review. It is our contention that the peer review process can be improved, not by a new set of rules but through closer attention to the ethical principles to which we, as psychologists, already subscribe.
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de Lecuona, Itziar
2018-05-31
The current model for reviewing research with human beings basically depends on decision-making processes within research ethics committees. These committees must be aware of the importance of the new digital paradigm based on the large-scale exploitation of datasets, including personal data on health. This article offers guidelines, with the application of the EU's General Data Protection Regulation, for the appropriate evaluation of projects that are based on the use of big data analytics in healthcare. The processes for gathering and using this data constitute a niche where current research is developed. In this context, the existing protocols for obtaining informed consent from participants are outdated, as they are based not only on the assumption that personal data are anonymized, but that they will continue to be so in the future. As a result, it is essential that research ethics committees take on new capabilities and revisit values such as privacy and freedom, updating protocols, methodologies and working procedures. This change in the work culture will provide legal security to the personnel involved in research, will make it possible to guarantee the protection of the privacy of the subjects of the data, and will permit orienting the exploitation of data to avoid the commodification of personal data in this era of deidentification, so that research meets actual social needs and not spurious or opportunistic interests disguised as research. Copyright © 2018 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.
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Ethical Issues in Cross-Cultural Research
Honan, Eileen; Hamid, M. Obaidul; Alhamdan, Bandar; Phommalangsy, Phouvanh; Lingard, Bob
2013-01-01
The gap between theoretical expectations of research ethics as outlined in the bureaucratic processes associated with University Ethics Committees and the situated realities of students undertaking studies within their own sociocultural contexts is explored in this paper. In particular, the authors investigate differences in ethical norms and…
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Human Research Ethics Committees in Technical Universities
Koepsell, D.R.; Brinkman, W.P.; Pont, S.C.
2014-01-01
Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although
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Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.
Lawrence, Dana J
2011-11-01
To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers. Copyright © 2011 National University of Health Sciences. Published by Mosby
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Directory of Open Access Journals (Sweden)
Caroline A. Smith
2011-01-01
Full Text Available Despite the growth of traditional Chinese medicine (TCM and western herbal medicine (WHM research in Australia, little is known about how ethics committees (HRECs assess the ethics of TCM or WHM research. The objectives of this study were to examine the experiences of TCM and WHM researchers and HRECs with the evaluation of ethics applications. Two cross-sectional surveys were undertaken of HRECs and TCM and WHM researchers in Australia. Anonymous self-completion questionnaires were administered to 224 HRECs and 117 researchers. A response confirming involvement in TCM or WHM research applications was received from 20 HRECs and 42 researchers. The most frequent ethical issues identified by HRECs related to herbal products including information gaps relating to mode of action of herbal medicines and safety when combining herbal ingredients. Researchers concurred that they were frequently requested to provide additional information on multiple aspects including safety relating to the side effects of herbs and herb-drug interactions. Overall adherence with the principles of ethical conduct was high among TCM and WHM researchers although our study did identify the need for additional information regarding assessment of risk and risk management.
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Uterine transplantation: Review in human research.
Favre-Inhofer, A; Rafii, A; Carbonnel, M; Revaux, A; Ayoubi, J M
2018-06-01
Uterine transplantation is the solution to treat absolute uterine fertility. In this review, we present the historical, medical, technical, psychological and ethical perspectives in human uterine transplantation research. We reviewed the PubMed database following PRISMA guidelines and added data presented by several research teams during the first international congress on uterine transplantation. Copyright © 2018. Published by Elsevier Masson SAS.
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Sathar, Aslam; Dhai, Amaboo; van der Linde, Stephan
2014-12-01
Human Biological Materials (HBMs) are an invaluable resource in biomedical research. To determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Ethically approved retrospective cross-sectional descriptive audit. Of the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. © 2013 John Wiley & Sons Ltd.
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e-Government Ethics : a Synergy of Computer Ethics, Information Ethics, and Cyber Ethics
Arief Ramadhan; Dana Indra Sensuse; Aniati Murni Arymurthy
2011-01-01
Ethics has become an important part in the interaction among humans being. This paper specifically discusses applied ethics as one type of ethics. There are three applied ethics that will be reviewed in this paper, i.e. computer ethics, information ethics, and cyber ethics. There are two aspects of the three applied ethics that were reviewed, i.e. their definition and the issues associated with them. The reviewing results of the three applied ethics are then used for defining e-Government eth...
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Ethics and the practice of qualitative research
DEFF Research Database (Denmark)
Shaw, Ian Frank
2016-01-01
Ethics and the practice of qualitative research? Qualitative Social Work 7 (4): 400-414. Reprinted......Ethics and the practice of qualitative research? Qualitative Social Work 7 (4): 400-414. Reprinted...
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Strangers at the Benchside: Research Ethics Consultation
Cho, Mildred K.; Tobin, Sara L.; Greely, Henry T.; McCormick, Jennifer; Boyce, Angie; Magnus, David
2008-01-01
Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. PMID:18570086
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Pharmacological cognitive enhancement—how neuroscientific research could advance ethical debate
Maslen, Hannah; Faulmüller, Nadira; Savulescu, Julian
2014-01-01
There are numerous ways people can improve their cognitive capacities: good nutrition and regular exercise can produce long-term improvements across many cognitive domains, whilst commonplace stimulants such as coffee temporarily boost levels of alertness and concentration. Effects like these have been well-documented in the medical literature and they raise few (if any) ethical issues. More recently, however, clinical research has shown that the off-label use of some pharmaceuticals can, under certain conditions, have modest cognition-improving effects. Substances such as methylphenidate and modafinil can improve capacities such as working memory and concentration in some healthy individuals. Unlike their more mundane predecessors, these methods of “cognitive enhancement” are thought to raise a multitude of ethical issues. This paper presents the six principal ethical issues raised in relation to pharmacological cognitive enhancers (PCEs)—issues such as whether: (1) the medical safety-profile of PCEs justifies restricting or permitting their elective or required use; (2) the enhanced mind can be an “authentic” mind; (3) individuals might be coerced into using PCEs; (4), there is a meaningful distinction to be made between the treatment vs. enhancement effect of the same PCE; (5) unequal access to PCEs would have implications for distributive justice; and (6) PCE use constitutes cheating in competitive contexts. In reviewing the six principal issues, the paper discusses how neuroscientific research might help advance the ethical debate. In particular, the paper presents new arguments about the contribution neuroscience could make to debates about justice, fairness, and cheating, ultimately concluding that neuroscientific research into “personalized enhancement” will be essential if policy is to be truly informed and ethical. We propose an “ethical agenda” for neuroscientific research into PCEs. PMID:24999320
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The ethical tightrope: politics of intimacy and consensual method in sexuality research.
Zago, Luiz F; Holmes, Dave
2015-06-01
This paper seeks to analyze the construction of ethics in sexuality research in which qualitative methods are employed in the field of social sciences. Analyses are based on a bibliographic review of current discussions on research methods of queer theory and on the authors' own experiences of past research on sexuality. The article offers a theoretical perspective on the ways ethnography and in-depth interviews become methods that can rely on a consensual method and create a politics of intimacy between the researchers and research participants. The politics of intimacy may contribute to the production of a politically engaged knowledge while escaping from the moral matrix that usually governs the relationship between researchers and research participants. It is argued here that the researcher's sexed and gendered body matters for fieldwork; that the consensual method among participants may be employed in sexuality research as a fruitful tool; and that the relationships created among researchers and participants can pose a challenge to predetermined ethical guidelines in research. As a result, discussions problematize the existence of a politics of intimacy in sexuality research that is characterized by ethical relations among research participants. © 2014 John Wiley & Sons Ltd.
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[Patents and scientific research: an ethical-legal approach].
Darío Bergel, Salvador
2014-01-01
This article aims to review the relationship between patents and scientific research from an ethical point of view. The recent developments in the law of industrial property led in many cases to patent discoveries, contributions of basic science, and laws of nature. This trend, which denies the central principles of the discipline, creates disturbances in scientific activity, which requires the free movement of knowledge in order to develop their potentialities.
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Ethics committees and the changed clinical research environment in India in 2016: A perspective!
Davis, Sanish; Sule, Poonam; Bughediwala, Murtuza; Pandya, Vrunda; Sinha, Shilpi
2017-01-01
Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs Standard Control Organization has in the period 2013-2016 introduced several new regulations and amendments to existing regulations overseeing the conduct of Research in India. Several of these have direct effect on the functioning of the EC from a review, approval, and oversight mechanism. The Ethics Council of Indian Society for Clinical Research conducted a questionnaire survey among EC members to understand the impact of these changes in their functioning. The domains surveyed included awareness about recent changes/amendments and impacts, serious adverse events (SAEs) and compensation, informed consent and audio-video recording, monitoring and auditing of research, and future working of ECs. Seventy-nine percent of ECs are of the opinion that the new regulations/guidelines will add to their existing burden in the process of review and approval, providing subject protection and research oversight. Even though 68% of ECs stated that they are comfortable with SAE assessment and compensation determination, they state that there is variability in calculation of compensation amount using the formulae. An overwhelming majority (80%) of ECs stated that they were not in favor of centralized EC for providing review, approval, and oversight of clinical studies. Ethics Committees act as local regulator for clinical trials at sites providing Human Subject protection. The survey captures the contemporary issues faced by the ECs and also raises important questions on the ease of doing research, oversight of approved research, and administrative burden on the EC. Recent changes in regulations have on the one hand empowered Ethics committees but brought in challenges in the way that they provide oversight and monitor research carried out at the site.
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Research Award: Advisory Committee on Research Ethics
International Development Research Centre (IDRC) Digital Library (Canada)
IDRC CRDI
ACRE seeks a Research Awardee to study research ethics in an ... The following topics are examples of issues that could be ... advance their career goals, and recognize the dual nature of the position—applied research activity and general ...
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Teaching medical students to discern ethical problems in human clinical research studies.
Roberts, Laura Weiss; Warner, Teddy D; Green Hammond, Katherine A; Brody, Janet L; Kaminsky, Alexis; Roberts, Brian B
2005-10-01
Investigators and institutional review boards are entrusted with ensuring the conduct of ethically sound human studies. Assessing ethical aspects of research protocols is a key skill in fulfilling this duty, yet no empirically validated method exists for preparing professionals to attain this skill. The authors performed a randomized controlled educational intervention, comparing a criteria-based learning method, a clinical-research- and experience-based learning method, and a control group. All 300 medical students enrolled at the University of New Mexico School of Medicine in 2001 were invited to participate. After a single half-hour educational session, a written posttest of ability to detect ethical problems in hypothetical protocol vignettes was administered. The authors analyzed responses to ten protocol vignettes that had been evaluated independently by experts. For each vignette, a global assessment of the perceived significance of ethical problems and the identification of specific ethical problems were evaluated. Eighty-three medical students (27%) volunteered: 50 (60%) were women and 55 (66%) were first- and second-year students. On global assessments, the criteria-focused group perceived ethical problems as more significant than did the other two groups (p evaluation skills. This work supports the potential value of empirically derived methods for preparing professionals to discern ethical aspects of human studies.
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[Clinical research XXIV. From clinical judgment to ethics in research on humans].
Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Rivas-Ruiz, Rodolfo; Talavera, Juan O
2014-01-01
Bioethics in research is an essential part of the structured review process of an article and it is based on three fundamental principles: respect for persons, beneficence and justice. In addition to not providing valid knowledge, a research with inadequate design, execution and statistical analysis is not ethical either, since these methodological deficiencies will produce information that will not be useful and, therefore, the risks that the participants were exposed to will have been in vain. Beyond scientific validity, there are other aspects that outline if an investigation is ethical, such as the clinical and social value of a study, a fair selection of participants, favorable risk-benefit balance, an independent review, the informed consent and respect for participants and potential participants. Throughout the article here presented, the documents that profile the behavior of investigators to protect the participants, such as the Declaration of Helsinki, the national regulations that rule us and the differences between research without risk, with minimal risk and with greater than minimal risk are discussed. That like in daily life, behavior in research involving human participants must be self-regulated, ie, people with knowledge of the existence of the law discover that the man is outside the realm of nature where work is done under the necessity of natural causality, and falls within the scope of the will; only if the man is free to decide their actions may be a law regulating their action.
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Clinical Ethics Support for Healthcare Personnel: An Integrative Literature Review.
Rasoal, Dara; Skovdahl, Kirsti; Gifford, Mervyn; Kihlgren, Annica
2017-12-01
This study describes which clinical ethics approaches are available to support healthcare personnel in clinical practice in terms of their construction, functions and goals. Healthcare personnel frequently face ethically difficult situations in the course of their work and these issues cover a wide range of areas from prenatal care to end-of-life care. Although various forms of clinical ethics support have been developed, to our knowledge there is a lack of review studies describing which ethics support approaches are available, how they are constructed and their goals in supporting healthcare personnel in clinical practice. This study engages in an integrative literature review. We searched for peer-reviewed academic articles written in English between 2000 and 2016 using specific Mesh terms and manual keywords in CINAHL, MEDLINE and Psych INFO databases. In total, 54 articles worldwide described clinical ethics support approaches that include clinical ethics consultation, clinical ethics committees, moral case deliberation, ethics rounds, ethics discussion groups, and ethics reflection groups. Clinical ethics consultation and clinical ethics committees have various roles and functions in different countries. They can provide healthcare personnel with advice and recommendations regarding the best course of action. Moral case deliberation, ethics rounds, ethics discussion groups and ethics reflection groups support the idea that group reflection increases insight into ethical issues. Clinical ethics support in the form of a "bottom-up" perspective might give healthcare personnel opportunities to think and reflect more than a "top-down" perspective. A "bottom-up" approach leaves the healthcare personnel with the moral responsibility for their choice of action in clinical practice, while a "top-down" approach risks removing such moral responsibility.
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GETTING PERSONAL: ETHICS AND IDENTITY IN GLOBAL HEALTH RESEARCH
Simon, Christian; Mosavel, Maghboeba
2011-01-01
‘Researcher identity’ affects global health research in profound and complex ways. Anthropologists in particular have led the way in portraying the multiple, and sometimes tension-generating, identities that researchers ascribe to themselves, or have ascribed to them, in their places of research. However, the central importance of researcher identity in the ethical conduct of global health research has yet to be fully appreciated. The capacity of researchers to respond effectively to the ethical tensions surrounding their identities is hampered by lack of conceptual clarity, as to the nature and scope of the issues involved. This paper strives to provide some clarification of these ethical tensions by considering researcher identity from the perspective of (1) Guillemin and Heggen’s (2009) key distinction between procedural ethics and ethics in practice, and (2) our own distinction between perceptions of identity that are either symmetrical or asymmetrical, with the potential to shift research relationships toward greater or lesser ethical harmony. Discussion of these concepts is supported with ethnographic examples from relevant literature and from our own (United States (US) Government-funded) research in South Africa. A preliminary set of recommendations is provided in an effort to equip researchers with a greater sense of organization and control over the ethics of researcher identity. The paper concludes that the complex construction of researcher identity needs to be central among the ethical concerns of global health researchers, and that the conceptual tools discussed in the paper are a useful starting point for better organizing and acting on these ethical concerns. PMID:21426482
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Social Representations on ethical and bioethic aspects in research
Directory of Open Access Journals (Sweden)
Maísa Araujo Costa
2017-03-01
Full Text Available Objective: the study aims to analyze the social representations on the ethical and bioethical aspects in the research elaborated by academics of the Dentistry Course. Methods: it is a qualitative research based on the Theory of Social Representations carried out with 80 academics of the Dentistry course. The data were collected through a semi-structured interview script, processed in the IRaMuTeQ and analyzed by the Descending Hierarchical Classification. The study followed the ethical standards recommended by Resolution n. 466/2012, obtaining approval from the Ethics Committee of UNINOVAFAPI University Center. Results: The corpus analyzed in the study is composed of 79 units of initial context (UCI with use of 62%. The results are presented in four classes, namely: 4. The understanding of Ethics and Bioethics in research; 3. Researcher's social position; 1. Legal responsibilities of the researcher and 2. Normative aspects of research ethics - legal basis. Conclusion: Scholars represent ethical and bioethical aspects in research as essential to respect human dignity and protect the lives of research participants, with a focus on normative aspects of research ethics through Research Committees. Their attitudes are guided by their conditions of life, their beliefs and cultures of different social contexts. Keywords: Bioethics, ethics, social psychology.
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Directory of Open Access Journals (Sweden)
von Dadelszen Peter
2010-07-01
Full Text Available Abstract Background For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs. In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN, to gain insight into the Canadian system. Methods The applications forms of 16 different REBs were abstracted for a list of standardized items. The application process across sites was compared. Correspondence between the REB and the investigators was documented in order to construct a timeline to approval, identify the specific issues raised by each board, and describe how they were resolved. Results Each REB had a different application form. Most (n = 9 had a two or three step application process. Overall, it took a median of 31 days (range 2-174 days to receive an initial response from the REB. Approval took a median of 42 days (range 4-443 days. Privacy and consent were the two major issues raised. Several additional minor or administrative issues were raised which delayed approval. Conclusions For CPN, the Canadian REB process of ethical review proved challenging. REBs acted independently and without unified application forms or submission procedures. We call for a critical examination of the ethical, privacy and institutional review processes in Canada, to determine the best way to undertake multicentre review.
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State-of-the-Art Report on Ethics of Research Integrity
International Nuclear Information System (INIS)
Kwon, Hyuk; Hahn, K. W.; Nam, Y. M.; You, B. H.; Min, B. J.
2006-04-01
The report briefly considers the generous ethical issues such as the background of philosophy, the issues of research ethics, the research integrity, the role of citation, the program and the code of research ethics. The report introduces the background of philosophy of science and elements of research ethics. It also considers the precedents of misconduct in research ethics and the ingredients to preserve the research integrity. Especially, the citation with obscure boundary between proper citation and plagiarism is carefully explored through several examples. Finally, the domestic ethics conditions are investigated on the research integrity and educational program on the responsible conduct of research. To compare the domestic situation, the educational program and the system of research integrity in EU and USA are deeply searched in Ch. 6 and Appendix III and V. To develop an educational program of research ethics and integrity, Nuclear Training Centre(NTC) collects and arranges the material and resource for research ethics
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State-of-the-Art Report on Ethics of Research Integrity
Energy Technology Data Exchange (ETDEWEB)
Kwon, Hyuk; Hahn, K. W.; Nam, Y. M.; You, B. H.; Min, B. J
2006-04-15
The report briefly considers the generous ethical issues such as the background of philosophy, the issues of research ethics, the research integrity, the role of citation, the program and the code of research ethics. The report introduces the background of philosophy of science and elements of research ethics. It also considers the precedents of misconduct in research ethics and the ingredients to preserve the research integrity. Especially, the citation with obscure boundary between proper citation and plagiarism is carefully explored through several examples. Finally, the domestic ethics conditions are investigated on the research integrity and educational program on the responsible conduct of research. To compare the domestic situation, the educational program and the system of research integrity in EU and USA are deeply searched in Ch. 6 and Appendix III and V. To develop an educational program of research ethics and integrity, Nuclear Training Centre(NTC) collects and arranges the material and resource for research ethics.
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Reengineering Biomedical Translational Research with Engineering Ethics.
Sunderland, Mary E; Nayak, Rahul Uday
2015-08-01
It is widely accepted that translational research practitioners need to acquire special skills and knowledge that will enable them to anticipate, analyze, and manage a range of ethical issues. While there is a small but growing literature that addresses the ethics of translational research, there is a dearth of scholarship regarding how this might apply to engineers. In this paper we examine engineers as key translators and argue that they are well positioned to ask transformative ethical questions. Asking engineers to both broaden and deepen their consideration of ethics in their work, however, requires a shift in the way ethics is often portrayed and perceived in science and engineering communities. Rather than interpreting ethics as a roadblock to the success of translational research, we suggest that engineers should be encouraged to ask questions about the socio-ethical dimensions of their work. This requires expanding the conceptual framework of engineering beyond its traditional focus on "how" and "what" questions to also include "why" and "who" questions to facilitate the gathering of normative, socially-situated information. Empowering engineers to ask "why" and "who" questions should spur the development of technologies and practices that contribute to improving health outcomes.
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The ethics of research using electronic mail discussion groups.
Kralik, Debbie; Warren, Jim; Price, Kay; Koch, Tina; Pignone, Gino
2005-12-01
The aim of this paper is to identify and discuss the ethical considerations that have confronted and challenged the research team when researchers facilitate conversations using private electronic mail discussion lists. The use of electronic mail group conversations, as a collaborative data generation method, remains underdeveloped in nursing. Ethical challenges associated with this approach to data generation have only begun to be considered. As receipt of ethics approval for a study titled; 'Describing transition with people who live with chronic illness' we have been challenged by many ethical dilemmas, hence we believe it is timely to share the issues that have confronted the research team. These discussions are essential so we can understand the possibilities for research interaction, communication, and collaboration made possible by advanced information technologies. Our experiences in this study have increased our awareness for ongoing ethical discussions about privacy, confidentiality, consent, accountability and openness underpinning research with human participants when generating data using an electronic mail discussion group. We describe how we work at upholding these ethical principles focusing on informed consent, participant confidentiality and privacy, the participants as threats to themselves and one another, public-private confusion, employees with access, hackers and threats from the researchers. A variety of complex issues arise during cyberspace research that can make the application of traditional ethical standards troublesome. Communication in cyberspace alters the temporal, spatial and sensory components of human interaction, thereby challenging traditional ethical definitions and calling to question some basic assumptions about identity and ones right to keep aspects of it confidential. Nurse researchers are bound by human research ethics protocols; however, the nature of research by electronic mail generates moral issues as well as ethical
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Detecting, preventing, and responding to "fraudsters" in internet research: ethics and tradeoffs.
Teitcher, Jennifer E F; Bockting, Walter O; Bauermeister, José A; Hoefer, Chris J; Miner, Michael H; Klitzman, Robert L
2015-01-01
Internet-based health research is increasing, and often offers financial incentives but fraudulent behavior by participants can result. Specifically, eligible or ineligible individuals may enter the study multiple times and receive undeserved financial compensation. We review past experiences and approaches to this problem and propose several new strategies. Researchers can detect and prevent Internet research fraud in four broad ways: (1) through the questionnaire/instrument (e.g., including certain questions in survey; and software for administering survey); (2) through participants' non-questionnaire data and seeking external validation (e.g., checking data for same email addresses, usernames, passwords, and/or fake addresses or phone numbers; (3) through computer information, (e.g., IP addresses and cookies), and 4) through study design (e.g., avoid lump sum compensation and interviewing participants). These approaches each have pros and cons, and raise ethical, legal, and logistical questions, given that ethical tensions can emerge between preserving the integrity of research vs. protecting the privacy and confidentiality of study respondents. While past discussions concerning the ethics of online research have tended to focus on the participants' ability to trust the researchers, needs now arise to examine researchers' abilities to trust the participants. This analysis has several critical implications for future practice, policy, and research. © 2015 American Society of Law, Medicine & Ethics, Inc.
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Ethical tensions: A qualitative systematic review of new graduate perceptions.
Hazelwood, Tori; Murray, Carolyn M; Baker, Amy; Stanley, Mandy
2017-01-01
New graduate transition into the workforce is challenging and can involve managing ethical tensions. Ethical tensions cause new graduates to doubt their capabilities due to their lack of experience. To support new graduates, we need to know what these ethical tensions are. To explore the ethical tensions perceived to occur in practice for new graduate health professionals. This qualitative systematic review involved a search of five databases (Medline, EMBASE, AMED, CINAHL and Scopus) which resulted in the retrieval of 3554 papers. After the two-phased screening process, eight studies were identified that met the inclusion criteria and had rich data on the review question. Articles were read several times, critically appraised and analysed through thematic analysis. Ethical considerations: No ethical approval was required for the systematic review. The review was conducted following well-established reporting guidelines enabling transparency and rigour. Studies originated from Australia, United States, Iran and China. One study included speech pathologists and seven were with nurses. Four themes included the following: (1) enduring an unknown workplace culture that generates uncertainty without support for new graduates; (2) being vulnerable because of distress from bullying, exclusion and being a scapegoat; (3) constraining systems and institutional restrictions that cause dilemmas; and (4) experiencing disillusionment from lost ideals about ethical practice. This review has brought to light the vulnerability of new graduates to negative workplace culture and collegial incivility. In addition, new graduates are subjected to ethical tensions created by institutional constraints which can create dilemmas and uncertainties through practice that does not align with what they anticipated. Understanding ethical tensions experienced by new graduates enables provision of informed support. There needs to be considerable cultural change for orientation and socialisation of
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Payment of research participants: current practice and policies of Irish research ethics committees.
LENUS (Irish Health Repository)
Roche, Eric
2013-09-01
Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking.
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Ethics Research in Environmental Education | Jickling | Southern ...
African Journals Online (AJOL)
This paper takes a research orientation towards ethics and, in so doing, frames ethics as processes of inquiry and stories to be told. First, it explores ways that ethics might be 'reimagined', situated in everyday contexts and interpreted in ways that allow its stories to do work and invite readers and listeners to consider ethics.
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Meslin, Eric M; Were, Edwin; Ayuku, David
2013-09-01
It is a sine qua non that research and health care provided in international settings raise profound ethical questions when different cultural and political values are implicated. Yet ironically, as international health research expands and as research on ethical issues in international health research broadens and deepens, we appear to have moved away from discussing the moral foundations of these activities. For international health research to thrive and lead to the kind of benefits it is capable of, it is helpful to occasionally revisit the foundational premises that justify the enterprise as a whole. We draw on the experience of the Indiana University-Moi University Academic Research Ethics Partnership, an innovative bioethics training program co-located in Indianapolis and Eldoret, Kenya to highlight the changing nature of ethical issues in international health research and the ongoing practical challenges.
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Ethics and observational studies in medical research: various rules in a common framework
Claudot, Frédérique; Alla, François; Fresson, Jeanne; Calvez, Thierry; Coudane, Henry; Bonaïti-Pellié, Catherine
2009-01-01
Background Research ethics have become universal in their principles through international agreements. The standardization of regulations facilitates the internationalization of research concerning drugs. However, in so-called observational studies (i.e. from data collected retrospectively or prospectively, obtained without any additional therapy or monitoring procedure), the modalities used for applying the main principles vary from one country to the other. This situation may entail problems for the conduct of multi-centric international studies, as well as for the publication of results if the authors and editors come from countries governed by different regulations. In particular, several French observational studies were rejected or retracted by United States peer reviewed journals, because their protocols have not been submitted to an Institutional Review Board/Independent Ethics Committee (IRB/IEC). Methods national legislation case analysis Results In accordance with European regulation, French observational studies from data obtained without any additional therapy or monitoring procedure, do not need the approval of an IRB/IEC. Nevertheless, these researches are neither exempt from scientific opinion nor from ethical and legal authorization. Conclusion We wish to demonstrate through the study of this example that different bodies of law can provide equivalent levels of protection that respect the same ethical principles. Our purpose in writing this paper was to encourage public bodies, scientific journals, and researchers to gain a better understanding of the various sets of specific national regulations and to speak a common language. PMID:19336436
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Ethical issues in neonatal research involving human subjects.
Fleischman, Alan R
2016-06-01
Research involving critically ill neonates creates many ethical challenges. Neonatal clinical research has always been hard to perform, is very expensive, and may generate some unique ethical concerns. This article describes some examples of historical and modern controversies in neonatal research, discusses the justification for research involving such vulnerable and fragile patients, clarifies current federal regulations that govern research involving neonates, and suggests ways that clinical investigators can develop and implement ethically grounded human subjects research. Copyright © 2016 Elsevier Inc. All rights reserved.
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La investigación éticamente reflexionada / Ethically pondered research
Directory of Open Access Journals (Sweden)
Samuel Arias-Valencia
2015-10-01
has been bureaucratized. For both researchers and ethical review boards, this is a process in which compliance with a requirements checklist is verified. This checklist is what is left of the codes of ethics research provided by the four principles approach after being synthesized in practice. Moreover, this checklist generally disregards the discussion of social justice as a priority for health research. For this reason, the authors consider it necessary to propose other frameworks for addressing the ethics of research that are not limited to applying regulations but rather invite ethical reflection in the processes of health research. Likewise, the authors believe that conceiving ethics as a reflection on justice creates a broader framework for understanding the ethics of research. This makes it possible to avoid assuming a position that is limited to external rules and regulations and instead recognizes it as a vital issue that involves the researcher as a moral subject.
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Ethical issues in action-oriented research in Indonesia.
Rachmawaty, Rini
2017-09-01
Action-oriented research is one of the most frequent research types implemented to transform community health in Indonesia. Three researchers and 11 graduate students from a developed country in East Asia conducted a fieldwork program in a remote area in South Sulawesi Province. Although the project was completed, whether or not the international standards for human subject research were applied into that study remains unclear. This study aimed to examine ethical issues raised from that case, analyze constraints to the problems, and recommend alternatives to protect vulnerable populations from being exploited by local/international researchers. A problem-solving approach was used in this study. It began with problem identification, evaluation of the action-oriented research goal, investigation of the constraints to the problem, and recommendation of some relevant alternatives to address the central issue. Ethical Consideration: The approval for conducting the action-oriented research that being investigated in this work was only obtained from the Head of local district. Some ethical issues were found in this case. No special protection for this population, no informed consent was obtained from the participants, exposure to social and economic risks, no future benefits for the subjects, and conflict of interests. Lack of control from the local research ethics committee and lack of competence of local researchers on human subject research were considered as the constraints to the problems. Creating an independent research ethics committee, providing research ethics training to the local researchers, obtaining written/video consents from underserved populations, and meeting local health needs were recommended alternatives to solve these problems. Indonesian government bodies should reform their international collaborative system on research involving human subjects. Exploitation may not occur if all participants as well as all local and national governing bodies
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Brogt, Erik; Foster, Tom; Dokter, Erin; Buxner, Sanlyn; Antonellis, Jessie
2009-01-01
We present an argument for, and suggested implementation of, a code of ethics for the astronomy education research community. This code of ethics is based on legal and ethical considerations set forth by U.S. federal regulations and the existing code of conduct of the American Educational Research Association. We also provide a fictitious research…
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Cloyes, Kristin Gates
2006-01-01
Nursing literature is replete with discussions about the ethics of research interviews. These largely involve questions of method, and how careful study design and data collection technique can render studies more ethical. Analysis, the perennial black box of the research process, is rarely discussed as an ethical practice. In this paper, I introduce the idea that analysis itself is an ethical practice. Specifically, I argue that political discourse analysis of research interviews is an ethical practice. I use examples from my own research in a prison control unit to illustrate what this might look like, and what is at stake.
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Salloch, Sabine; Vollmann, Jochen; Schildmann, Jan
2014-09-01
Empirical studies on people's moral attitudes regarding ethically challenging topics contribute greatly to research in medical ethics. However, it is not always clear in which ways this research adds to medical ethics as a normative discipline. In this article, we aim to provide a systematic account of the different ways in which attitudinal research can be used for normative reflection. In the first part, we discuss whether ethical judgements can be based on empirical work alone and we develop a sceptical position regarding this point, taking into account theoretical, methodological and pragmatic considerations. As empirical data should not be taken as a direct source for normative justification, we then delineate different ways in which attitudes research can be combined with theoretical accounts of normative justification in the second part of the article. Firstly, the combination of attitudes research with normative-ethical theories is analysed with respect to three different aspects: (a) The extent of empirical data which is needed, (b) the question of which kind of data is required and (c) the ways in which the empirical data are processed within the framework of an ethical theory. Secondly, two further functions of attitudes research are displayed which lie outside the traditional focus of ethical theories: the exploratory function of detecting and characterising new ethical problems, and the field of 'moral pragmatics'. The article concludes with a methodological outlook and suggestions for the concrete practice of attitudinal research in medical ethics. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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Research Award: Advisory Committee on Research Ethics Deadline ...
International Development Research Centre (IDRC) Digital Library (Canada)
Jean-Claude Dumais
2012-09-12
Sep 12, 2012 ... Research Award: Advisory Committee on Research Ethics. Deadline: ... The Research Awardee will spend one year at IDRC and work approximately 50% of the time on her/his own research and 50% on ACRE-related tasks.
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Mertz, Marcel; Strech, Daniel; Kahrass, Hannes
2017-12-19
(Semi-)systematic approaches to finding, analysing, and synthesising ethics literature on medical topics are still in their infancy. However, our recent systematic review showed that the rate of publication of such (semi-)systematic reviews has increased in the last two decades. This is not only true for reviews of empirical ethics literature, but also for reviews of normative ethics literature. In the latter case, there is currently little in the way of standards and guidance available. Therefore, the methods and reporting strategies of such reviews vary greatly. The purpose of the follow-up study we present was to obtain deeper methodological insight into the ways reviews of normative literature are actually conducted and to analyse the methods used. Our search in the PubMed, PhilPapers, and Google Scholar databases led to the identification of 183 reviews of ethics literature published between 1997 and 2015, of which 84 were identified as reviews of normative and mixed literature. Qualitative content analysis was used to extract and synthesise descriptions of search, selection, quality appraisal, analysis, and synthesis methods. We further assessed quantitatively how often certain methods (e.g. search strategies, data analysis procedures) were used by the reviews. The overall reporting quality varies among the analysed reviews and was generally poor even for major criteria regarding the search and selection of literature. For example, only 24 (29%) used a PRISMA flowchart. Also, only 55 (66%) reviews mentioned the information unit they sought to extract, and 12 (14%) stated an ethical approach as the theoretical basis for the analysis. Interpretable information on the synthesis method was given by 47 (60%); the most common methods applied were qualitative methods commonly used in social science research (83%). Reviews which fail to provide sufficient relevant information to readers have reduced methodological transparency regardless of actual methodological
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Translational ethics? The theory-practice gap in medical ethics.
Cribb, Alan
2010-04-01
Translational research is now a critically important current in academic medicine. Researchers in all health-related fields are being encouraged not only to demonstrate the potential benefits of their research but also to help identify the steps through which their research might be 'made practical'. This paper considers the prospects of a corresponding movement of 'translational ethics'. Some of the advantages and disadvantages of focusing upon the translation of ethical scholarship are reviewed. While emphasising the difficulties of crossing the gap between scholarship and practice, the paper concludes that a debate about the business of translation would be useful for medical ethics.
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Analytical and ethical complexities in video game research
DEFF Research Database (Denmark)
Andersen, Mads Lund; Chimiri, Niklas Alexander; Søndergaard, Dorte Marie
Session: Sociomaterial complexities in digital-analog spaces Abstract: Analytical and ethical complexities in video game research A central issue that video game research seldom explicitly articulates is the ethical complexities involved in its empirical and analytical work. The presentation...... explores common research questions posed and analytical foci chosen by video game researchers subscribing to either the media effects tradition, represented by (ref.) or to interdisciplinary Game Studies. Both fields, which tend to depict themselves as polar-opposites, build on ethical assumptions...... of theoretical or analytical arrogance. The relevance of acknowledging and situating ethical complexity becomes pertinent when alternatively taking a sociomaterial perspective on doing empirical and analytical work on video gaming. From an agential realist point of view, for instance, a researcher...
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Greeff, Minrie; Rennie, Stuart
2016-04-01
Health researchers conducting research in the community are often faced with unanticipated ethical issues that arise in the course of their research and that go beyond the scope of ethical approval by the research ethics committee. Eight expert researchers were selected through extreme intensity purposive sampling, because they are representative of unusual manifestations of the phenomenon related to their research in the community. They were selected to take part in a semi-structured focus group discussion on whether practical wisdom (phronesis) is used as a decision-making skill to solve unanticipated ethical issues during research in the community. Although the researchers were not familiar with the concept phronesis, it became obvious that it formed an integral part of their everyday existence and decision making during intervention research. They could balance research ethics with practical considerations. The capacity of practical wisdom as a crucial decision-making skill should be assimilated into a researcher's everyday reality, and also into the process of mentoring young researchers to become phronimos. Researchers should be taught this skill to handle unanticipated ethical issues. © The Author(s) 2016.
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Ethical challenges for accountable care organizations: a structured review.
DeCamp, Matthew; Farber, Neil J; Torke, Alexia M; George, Maura; Berger, Zackary; Keirns, Carla C; Kaldjian, Lauris C
2014-10-01
Accountable care organizations (ACOs) are proliferating as a solution to the cost crisis in American health care, and already involve as many as 31 million patients. ACOs hold clinicians, group practices, and in many circumstances hospitals financially accountable for reducing expenditures and improving their patients' health outcomes. The structure of health care affects the ethical issues arising in the practice of medicine; therefore, like all health care organizational structures, ACOs will experience ethical challenges. No framework exists to assist key ACO stakeholders in identifying or managing these challenges. We conducted a structured review of the medical ACO literature using qualitative content analysis to inform identification of ethical challenges for ACOs. Our analysis found infrequent discussion of ethics as an explicit concern for ACOs. Nonetheless, we identified nine critical ethical challenges, often described in other terms, for ACO stakeholders. Leaders could face challenges regarding fair resource allocation (e.g., about fairly using ACOs' shared savings), protection of professionals' ethical obligations (especially related to the design of financial incentives), and development of fair decision processes (e.g., ensuring that beneficiary representatives on the ACO board truly represent the ACO's patients). Clinicians could perceive threats to their professional autonomy (e.g., through cost control measures), a sense of dual or conflicted responsibility to their patients and the ACO, or competition with other clinicians. For patients, critical ethical challenges will include protecting their autonomy, ensuring privacy and confidentiality, and effectively engaging them with the ACO. ACOs are not inherently more or less "ethical" than other health care payment models, such as fee-for-service or pure capitation. ACOs' nascent development and flexibility in design, however, present a time-sensitive opportunity to ensure their ethical operation
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Ethical considerations for peer review in forensic neuropsychology.
Johnson-Greene, Doug; Bechtold, Kathleen T
2002-02-01
The role of an expert is to assist the trier of fact in weighing evidence and reaching conclusions. Critical evaluation of opposing experts is an integral part of this process. In more recent times, cross-examination has given way to critical evaluation of opposing experts outside of the courtroom, a tactic we refer to as peer review in this paper. Though neuropsychologists frequently review the work of their colleagues, we are concerned here primarily with commentary that is at best misleading, and occasionally malicious, unethical, and unprofessional. Despite a growing trend to use experts as peer reviewers in the medicolegal arena, expectations concerning ethical and professional conduct of neuropsychologists have been absent. Enforcement of appropriate conduct is further complicated by the ambiguity of existing ethical standards and state statutes, and their limited applicability to all neuropsychologists who provide forensic services. This article provides an overview of ethical and professional issues pertaining to forensic peer review and concludes with recommendations for appropriate professional conduct.
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Evaluating institutional capacity for research ethics in Africa: a case study from Botswana
2013-01-01
Background The increase in the volume of research conducted in Low and Middle Income Countries (LMIC), has brought a renewed international focus on processes for ethical conduct of research. Several programs have been initiated to strengthen the capacity for research ethics in LMIC. However, most such programs focus on individual training or development of ethics review committees. The objective of this paper is to present an approach to institutional capacity assessment in research ethics and application of this approach in the form of a case study from an institution in Africa. Methods We adapted the Octagon model originally used by the Swedish International Development Cooperation Agency to assess an organization along eight domains in research ethics: basic values and identity; structure and organization; ability to carry out activities; relevance of activities to stated goals; capacity of staff and management; administrative, financing and accounting systems; its relations with target groups; and the national context. We used a mixed methods approach to collect empirical data at the University of Botswana from March to December 2010. Results The overall shape of the external evaluation Octagon suggests that strengths of the University of Botswana are in the areas of structure, relevance, production and identity; while the university still needs more work in the areas of systems of finance, target groups, and environment. The Octagons also show the similarities and discrepancies between the 'external' and 'internal' evaluations and provide an opportunity for exploration of these different assessments. For example, the discrepant score for 'identity' between internal and external evaluations allows for an exploration of what constitutes a strong identity for research ethics at the University of Botswana and how it can be strengthened. Conclusions There is a general lack of frameworks for evaluating research ethics capacity in LMICs. We presented an approach that
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Evaluating institutional capacity for research ethics in Africa: a case study from Botswana.
Hyder, Adnan A; Zafar, Waleed; Ali, Joseph; Ssekubugu, Robert; Ndebele, Paul; Kass, Nancy
2013-07-30
The increase in the volume of research conducted in Low and Middle Income Countries (LMIC), has brought a renewed international focus on processes for ethical conduct of research. Several programs have been initiated to strengthen the capacity for research ethics in LMIC. However, most such programs focus on individual training or development of ethics review committees. The objective of this paper is to present an approach to institutional capacity assessment in research ethics and application of this approach in the form of a case study from an institution in Africa. We adapted the Octagon model originally used by the Swedish International Development Cooperation Agency to assess an organization along eight domains in research ethics: basic values and identity; structure and organization; ability to carry out activities; relevance of activities to stated goals; capacity of staff and management; administrative, financing and accounting systems; its relations with target groups; and the national context. We used a mixed methods approach to collect empirical data at the University of Botswana from March to December 2010. The overall shape of the external evaluation Octagon suggests that strengths of the University of Botswana are in the areas of structure, relevance, production and identity; while the university still needs more work in the areas of systems of finance, target groups, and environment. The Octagons also show the similarities and discrepancies between the 'external' and 'internal' evaluations and provide an opportunity for exploration of these different assessments. For example, the discrepant score for 'identity' between internal and external evaluations allows for an exploration of what constitutes a strong identity for research ethics at the University of Botswana and how it can be strengthened. There is a general lack of frameworks for evaluating research ethics capacity in LMICs. We presented an approach that stresses evaluation from both internal
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Early-career researchers' views on ethical dimensions of patient engagement in research.
Bélisle-Pipon, Jean-Christophe; Rouleau, Geneviève; Birko, Stanislav
2018-03-07
Increasing attention and efforts are being put towards engaging patients in health research, and some have even argued that patient engagement in research (PER) is an ethical imperative. Yet there is relatively little empirical data on ethical issues associated with PER. A three-round Delphi survey was conducted with a panel of early-career researchers (ECRs) involved in PER. One of the objectives was to examine the ethical dimensions of PER as well as ECRs' self-perceived level of preparedness to conduct PER ethically. The study was conducted among awardees of the Québec SPOR-SUPPORT Unit in Canada, who represent the next generation of researchers involved in PER. Many themes were addressed throughout the study, such as definition, values, patients' roles, expected characteristics of patients, and anticipated challenges (including ethical issues). Open-ended questions were used, and all quantitative data were collected through statements using 7-point Likert scales. Between April and November 2016, 25 ECRs were invited to participate; 18 completed both the first and second rounds, and 16 completed the third round. Panelists consisted of nine women and seven men with various backgrounds (general practitioners and postgraduate students). The majority were between 25 and 44 years old. Panelists' responses showed PER raises important ethical issues: 1) professionalization of patients involved in research (with risks of patients becoming less representative); 2) adequate remuneration of patients; 3) fair recognition of patients' experiential knowledge; and 4) tokenism (engaging patients only for symbolic appeal). While the panelists felt moderately prepared to confront these ethical issues, they reported being uncomfortable applying for an ethics certificate for a PER project. If PER is an ethical imperative, it is vital to establish clear ethical standards and to train and support the PER community to identify and resolve ethical issues. Despite their overall
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Ethical Business Cultures: A Literature Review and Implications for HRD
Ardichvili, Alexandre; Jondle, Douglas
2009-01-01
This literature review identifies characteristics of ethical business cultures, describes factors, considered to be important in developing such cultures, describes current practices of developing ethical culture programs, and discusses the role of HRD in developing ethical business cultures. We argue that ethical thinking and behavior can be…
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Ethics education in research involving human beings in undergraduate medicine curriculum in Brazil.
Novaes, Maria Rita Garbi; Guilhem, Dirce; Barragan, Elena; Mennin, Stewart
2013-12-01
The Brazilian national curriculum guidelines for undergraduate medicine courses inspired and influenced the groundwork for knowledge acquisition, skills development and the perception of ethical values in the context of professional conduct. The evaluation of ethics education in research involving human beings in undergraduate medicine curriculum in Brazil, both in courses with active learning processes and in those with traditional lecture learning methodologies. Curricula and teaching projects of 175 Brazilian medical schools were analyzed using a retrospective historical and descriptive exploratory cohort study. Thirty one medical schools were excluded from the study because of incomplete information or a refusal to participate. Active research for information from institutional sites and documents was guided by terms based on 69 DeCS/MeSH descriptors. Curriculum information was correlated with educational models of learning such as active learning methodologies, tutorial discussions with integrated curriculum into core modules, and traditional lecture learning methodologies for large classes organized by disciplines and reviewed by occurrence frequency of ethical themes and average hourly load per semester. Ninety-five medical schools used traditional learning methodologies. The ten most frequent ethical themes were: 1--ethics in research (26); 2--ethical procedures and advanced technology (46); 3--ethic-professional conduct (413). Over 80% of schools using active learning methodologies had between 50 and 100 hours of scheduled curriculum time devoted to ethical themes whereas more than 60% of traditional learning methodology schools devoted less than 50 hours in curriculum time to ethical themes. The data indicates that medical schools that employ more active learning methodologies provide more attention and time to ethical themes than schools with traditional discipline-based methodologies. Given the importance of ethical issues in contemporary medical
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“Just one animal among many?” Existential phenomenology, ethics, and stem cell research
2010-01-01
Stem cell research and associated or derivative biotechnologies are proceeding at a pace that has left bioethics behind as a discipline that is more or less reactionary to their developments. Further, much of the available ethical deliberation remains determined by the conceptual framework of late modern metaphysics and the correlative ethical theories of utilitarianism and deontology. Lacking, to any meaningful extent, is a sustained engagement with ontological and epistemological critiques, such as with “postmodern” thinking like that of Heidegger’s existential phenomenology. Some basic “Heideggerian” conceptual strategies are reviewed here as a way of remedying this deficiency and adding to ethical deliberation about current stem cell research practices. PMID:20521117
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Institutional Ethics Committee Regulations and Current Updates in India.
Mahuli, Amit V; Mahuli, Simpy A; Patil, Shankargouda; Bhandi, Shilpa
2017-08-01
The aim of the review is to provide current updates on regulations for ethics committees and researchers in India. Ethical dilemmas in research since time immemorial have been a major concern for researchers worldwide. The question "what makes clinical research ethical" is significant and difficult to answer as multiple factors are involved. The research involving human participants in clinical trials should follow the required rules, regulations, and guidelines in one's own country. It is a dynamic process, and updates have to be learned by researcher and committee members. The review highlights the ethical regulation from the Drug Controller General of India, Clinical Trial Registry of India, and Indian Council of Medical Research guidelines. In this article, the updates on Indian scenario of the Ethical Committee and guidelines are compiled. The review comes handy for clinical researchers and ethics committee members in academic institutions to check on the current updates and keep abreast with the knowledge on regulations of ethics in India.
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Ethical Considerations in Research Participation Virality.
Ellis-Barton, Carol
2016-07-01
This article seeks to commence and encourage discussion around the upcoming ethical challenges of virality in network structures. When the call for participation in a research project on lupus in Ireland went from an advertisement in a newsletter to a meme (unit of transmissible information) on a closed Facebook page, the ethical considerations of virality were raised. The article analyzes the Association of Internet Researchers guidelines, Facebook policies, and the context of privacy in relation to virality. Virality creates the leverage for methodological pluralism. The nature of the inquiry can determine the method rather than the other way around. Viral ethical considerations are evolving due to the cyber world becoming the primary meme of communication, with flexibility in the researcher's protocol providing opportunities for efficient, cost-effective, and diverse recruitment. © The Author(s) 2016.
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Overall Assessment of Human Research and Ethics Committees in the United Arab Emirates.
Abdulrahman, Mahera; Nair, Satish Chandrasekhar
2017-04-01
Growing demand for human health research in the United Arab Emirates (UAE) has prompted the need to develop a robust research ethics oversight. Examination of the structure, function, and practices of the human research ethics committees (HRECs), followed by evaluation of standards for measuring research output, was conducted. Results indicate that among the HRECs, 90% followed International Council for Harmonization-Good Clinical Practice guidelines, 66.6% have been in operation for more than 5 years, 95% reviewed proposals within 8 weeks, and 56% reviewed for scientific merit apart from ethics. However, systems to recognize accomplishments of researchers, funding transparency, and adverse event reporting were deployed in less than 30% of all HRECs. Research was incorporated into the vision and mission statements of many (65%) organizations. Research publications, collaborations, and recognitions were used to measure research output and report key performance indicators. In spite, resources to generate research output such as dedicated budget (20%), support staff (20%), and continuous training and mentoring program for medical residents (15%) and HREC members (25%) were somehow lacking. HREC structure and operations in the UAE are similar to other regions of the world. Systems to conduct research and report outcomes are defined in the UAE. Regulatory legislation and allocation of resources to support the clinical research enterprise will not only help to meet growing demand for clinical trials but also transform the quality of patient care in the UAE. It is anticipated that the results of this study will benefit investigators, regulators, pharmaceutical sponsors, and the policy makers in the region.
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The history of ethics in research with human subjects
Kottow, Miguel
2008-01-01
This article contextualizes the emergence of the field of research ethics in historical, social, and political events over the last 60 years. It draws a distinction between professional ethics and bioethics, focusing on the historical and philosophical precedents of the latter field. It also presents the appearance of research ethics as a result of the disclosure of cases of scientific misconduct, discussing the first regulations on research ethics, the guidelines contained in the Belmont Rep...
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Beyond Compliance Checking: A Situated Approach to Visual Research Ethics.
Lenette, Caroline; Botfield, Jessica R; Boydell, Katherine; Haire, Bridget; Newman, Christy E; Zwi, Anthony B
2018-03-19
Visual research methods like photography and digital storytelling are increasingly used in health and social sciences research as participatory approaches that benefit participants, researchers, and audiences. Visual methods involve a number of additional ethical considerations such as using identifiable content and ownership of creative outputs. As such, ethics committees should use different assessment frameworks to consider research protocols with visual methods. Here, we outline the limitations of ethics committees in assessing projects with a visual focus and highlight the sparse knowledge on how researchers respond when they encounter ethical challenges in the practice of visual research. We propose a situated approach in relation to visual methodologies that encompasses a negotiated, flexible approach, given that ethical issues usually emerge in relation to the specific contexts of individual research projects. Drawing on available literature and two case studies, we identify and reflect on nuanced ethical implications in visual research, like tensions between aesthetics and research validity. The case studies highlight strategies developed in-situ to address the challenges two researchers encountered when using visual research methods, illustrating that some practice implications are not necessarily addressed using established ethical clearance procedures. A situated approach can ensure that visual research remains ethical, engaging, and rigorous.
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Analysis of research ethics board approval times in an academic department of medicine.
Tsang, Teresa S M; Jones, Meaghan; Meneilly, Graydon S
2015-04-01
As part of an ongoing effort to better understand barriers to academic research, we reviewed and analyzed the process of research ethics applications, focusing on ethics approval time, within the Department of Medicine from 2006 to 2011. A total of 1,268 applications for approval to use human subjects in research were included in our analysis. Three variables, risk category (minimal vs. non-minimal risk), type of funding, and year of submission, were statistically significant for prediction of ethics approval time, with risk status being the most important of these. The covariate-adjusted mean time for approval for minimal risk studies (35.7 days) was less than half that of non-minimal risk protocols (76.5 days). Studies funded through a for-profit sponsor had significantly longer approval times than those funded through other means but were also predominantly (87%) non-minimal risk protocols. Further investigations of the reasons underlying the observed differences are needed to determine whether improved training for research ethics board (REB) members and/or greater dialogue with investigators may reduce the lengthy approval times associated with non-minimal risk protocols. © The Author(s) 2015.
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Do we need a special ethics for research?
Hansson, Sven Ove
2011-03-01
Research is subject to more stringent ethical requirements than most other human activities, and a procedure that is otherwise allowed may be forbidden in research. Hence, risk-taking is more restricted in scientific research than in most non-research contexts, and privacy is better protected in scientific questionnaires than in marketing surveys. Potential arguments for this difference are scrutinized. The case in its favour appears to be weak. A stronger case can be made in favour of a difference in the opposite direction: If perilous or otherwise problematic activities have to be performed it is usually better to perform them in a research context where they are properly evaluated so that guidance is obtained for the future. However, retreating from current ethical demands on research is not a desirable direction to go. Instead, research ethics can serve to inspire the introduction of more stringent ethical principles in other social sectors.
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Towards improving the ethics of ecological research.
Crozier, G K D; Schulte-Hostedde, Albrecht I
2015-06-01
We argue that the ecological research community should develop a plan for improving the ethical consistency and moral robustness of the field. We propose a particular ethics strategy--specifically, an ongoing process of collective ethical reflection that the community of ecological researchers, with the cooperation of applied ethicists and philosophers of biology, can use to address the needs we identify. We suggest a particular set of conceptual (in the form of six core values--freedom, fairness, well being, replacement, reduction, and refinement) and analytic (in the forms of decision theoretic software, 1000Minds) tools that, we argue, collectively have the resources to provide an empirically grounded and conceptually complete foundation for an ethics strategy for ecological research. We illustrate our argument with information gathered from a survey of ecologists conducted at the 2013 meeting of the Canadian Society of Ecology and Evolution.
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Directory of Open Access Journals (Sweden)
Elisabeta Ioana Hiriscau
2016-05-01
Full Text Available Research with minors, especially for preventive purposes, e.g., suicide prevention, investigating risk or self-destructive behaviors such as deviance, drug abuse, or suicidal behavior, is ethically sensitive. We present a Delphi study exploring the ethical implications of the needs formulated by researchers in an international pre-conference who would benefit from ethics support and guidance in conducting Mental Health Research with minors. The resulting List of Ethical Issues (LEI was submitted to a 2-rounds Delphi process via the Internet, including 34 multidisciplinary experts. In the first round, the experts reviewed the LEI and completed a questionnaire. Results from this round were analyzed and grouped in nine categories comprising 40 items. In the second round, the experts had to agree/disagree with the needs expressed in the LEI leading to a final list of 25 ethical issues considered relevant for Mental Health Research with minors such as: confidentiality of the sensitive data, competence for consenting alone and risk of harm and stigma related to the methodology used in research. It was shown that studies like SEYLE (Saving and Empowering Young Lives in Europe trigger among researchers wishes to obtain specific recommendations helping to comply with standards for good practice in conducting research with minors.
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Hiriscau, Elisabeta Ioana; Stingelin-Giles, Nicola; Wasserman, Danuta; Reiter-Theil, Stella
2016-05-11
Research with minors, especially for preventive purposes, e.g., suicide prevention, investigating risk or self-destructive behaviors such as deviance, drug abuse, or suicidal behavior, is ethically sensitive. We present a Delphi study exploring the ethical implications of the needs formulated by researchers in an international pre-conference who would benefit from ethics support and guidance in conducting Mental Health Research with minors. The resulting List of Ethical Issues (LEI) was submitted to a 2-rounds Delphi process via the Internet, including 34 multidisciplinary experts. In the first round, the experts reviewed the LEI and completed a questionnaire. Results from this round were analyzed and grouped in nine categories comprising 40 items. In the second round, the experts had to agree/disagree with the needs expressed in the LEI leading to a final list of 25 ethical issues considered relevant for Mental Health Research with minors such as: confidentiality of the sensitive data, competence for consenting alone and risk of harm and stigma related to the methodology used in research. It was shown that studies like SEYLE (Saving and Empowering Young Lives in Europe) trigger among researchers wishes to obtain specific recommendations helping to comply with standards for good practice in conducting research with minors.
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Hiriscau, Elisabeta Ioana; Stingelin-Giles, Nicola; Wasserman, Danuta; Reiter-Theil, Stella
2016-01-01
Research with minors, especially for preventive purposes, e.g., suicide prevention, investigating risk or self-destructive behaviors such as deviance, drug abuse, or suicidal behavior, is ethically sensitive. We present a Delphi study exploring the ethical implications of the needs formulated by researchers in an international pre-conference who would benefit from ethics support and guidance in conducting Mental Health Research with minors. The resulting List of Ethical Issues (LEI) was submitted to a 2-rounds Delphi process via the Internet, including 34 multidisciplinary experts. In the first round, the experts reviewed the LEI and completed a questionnaire. Results from this round were analyzed and grouped in nine categories comprising 40 items. In the second round, the experts had to agree/disagree with the needs expressed in the LEI leading to a final list of 25 ethical issues considered relevant for Mental Health Research with minors such as: confidentiality of the sensitive data, competence for consenting alone and risk of harm and stigma related to the methodology used in research. It was shown that studies like SEYLE (Saving and Empowering Young Lives in Europe) trigger among researchers wishes to obtain specific recommendations helping to comply with standards for good practice in conducting research with minors. PMID:27187425
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Everyday Ethics: Reflections on Practice
Rossman, Gretchen B.; Rallis, Sharon F.
2010-01-01
This introductory article frames the contributions for this issue on everyday ethics--moments that demand moral considerations and ethical choices that researchers encounter. We discuss concerns raised within the research community about the tendency to observe merely obligatory ethical procedures as outlined in Human Subjects Review regulations.…
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Yanagawa, Hiroaki; Katashima, Rumi; Takeda, Noriaki
2015-01-01
The first Japanese ethics committee for biomedical research involving human subjects was established at Tokushima University in 1982. Although this committee was not formed as a response to national directives, the government eventually developed ethical guidelines, such as the Ethical Guidelines for Clinical Studies that were established in 2003. The practical impact of such guidelines was a rapid increase in the number of protocols seeking ethics committee approval and, accordingly, an increase in the workload of ethics committees. This review describes the activity of the ethics committee at Tokushima University during the last thirty years and discusses the infrastructure that best supports the activities of this committee. In addition, we address the issues that ethics committees now face and discuss future directions. J. Med. Invest. 62: 114-118, August, 2015.
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Towards a community effort to identify ethical principles for research in hydrology
Montanari, Alberto
2010-05-01
The hydrological community in Europe is growing rapidly in both size and, more importantly, scientific relevance and integrity. The Hydrological Sciences (HS) Division of EGU actively is promoting the above development by identifying research targets, stimulating the involvement of young scientists and managing a scientific open access journal based on a public peer review process. The management of the Division itself and the organisation of the General Assembly are carried out transparently, with the aim to seek an improved involvement of top and young scientists, with a bottom up approach. I believe the HS community is animated by a strong enthusiasm which, however, is not adequately supported by economical funding. In my opinion this is a major problem which HS should consider and discuss. The relevance of the societal and environmental problems dealt with by hydrologists, in a professional way and with exceptional scientific skills, is without doubt and therefore the limited amount of funding is not justified in practice. In my opinion, in order to refine the structure of the HS community, and promote its visibility, we should formally identify HS ethical principles for research in environmental science. The principles should highlight the role of hydrology as well as the ethical and scientific solidity of the HS community. Establishing ethical principles is even more important in view of the transparent approach HS is adopting for reviewing and publishing contributions and in view of the increasing need to transparently prove how public funding for research is administered. Establishing ethical principles for hydrology is not a trivial task. Hydrology is characterised by a relevant uncertainty in data, models and parameters. Hydrology is also relying on a large variety of approaches, ranging from statistical to physically based. The purpose of this poster is to present a collection of ethical principles for scientific research presented by the literature and
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Directory of Open Access Journals (Sweden)
Thomas Richardson
Full Text Available Objective: To determine to what extent each trial met criteria specified in three research frameworks for ethical trial conduct. Design: Systematic review and narrative analysis.Data sources: MEDBASE and EMBASE databases were searched using a specific search strategy. The Cochrane database for systematic reviews, the PROSPERO database and trial registries were examined. A grey literature search and citation search were also carried out. Eligibility criteria for selecting studies: Studies were included where the intervention was being used to treat Ebola in human subjects regardless of study design, comparator or outcome measured. Studies were eligible if they had taken place after the 21st March 2014. Unpublished as well as published studies were included. Included studies: Sixteen studies were included in the data synthesis. Data was extracted on study characteristics as well as any information relating to ten ethical areas of interest specified in the three research frameworks for ethical trial conduct and an additional criterion of whether the study received ethics approval from a research ethics committee. Synthesis of results: Eight studies were judged to fully comply with all eleven criteria. The other eight studies all had at least one criteria where there was not enough information available to draw any conclusions. In two studies there were ethical concerns regarding the information provided in relation to at least one ethical criteria. Description of the effect: One study did not receive ethical approval as the authors argued that treating approximately one hundred patients consecutively for compassionate reasons did not constitute a clinical trial. Furthermore, after the patients were treated, physicians in Sierra Leone did not release reports of treatment results and so study conclusions had to be made based on unpublished observations. In another study the risk-benefit ratio of the trial drug does not appear to be favourable and the
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International Nuclear Information System (INIS)
Johnson, C.A.; Toms, A.P.
2009-01-01
Aim: To determine whether there is evidence of a reduction in radiology research activity in the UK following the implementation of the European research ethics legislation, which came in to force in 2001 and has been widely criticised as an impediment to research. Materials and methods: A bibliometric analysis was performed by searching PubMed for all first-author publications from UK departments of 'radiology' or 'medical imaging' between 1995 and 2007. Results were subcategorized into those papers published in the highest cited general radiology journals and by publication type: original research, reviews, and case reports. Results: From 1995 to 2007 the total number of publications rose by 6.5% from 137 to 146 with the increase occurring in non-general radiology journals. Original articles fell from 18 in 1995 to 12 in 2003, but then rose to 24 by 2007 (33% rise). This dip was paralleled by a fall and then recovery in case report publications. The most dramatic change has been in the number of review articles, which has increased more than eightfold from seven in 1995 to 65 in 2007 to become the most common form of publication. Conclusion: The overall number of original scientific articles, published by first-author UK radiologists, has increased slightly over the last 12 years despite a temporary fall associated with the introduction of new research ethics legislation.
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Herbal medicine research and global health: an ethical analysis.
Tilburt, Jon C; Kaptchuk, Ted J
2008-08-01
Governments, international agencies and corporations are increasingly investing in traditional herbal medicine research. Yet little literature addresses ethical challenges in this research. In this paper, we apply concepts in a comprehensive ethical framework for clinical research to international traditional herbal medicine research. We examine in detail three key, underappreciated dimensions of the ethical framework in which particularly difficult questions arise for international herbal medicine research: social value, scientific validity and favourable risk-benefit ratio. Significant challenges exist in determining shared concepts of social value, scientific validity and favourable risk-benefit ratio across international research collaborations. However, we argue that collaborative partnership, including democratic deliberation, offers the context and process by which many of the ethical challenges in international herbal medicine research can, and should be, resolved. By "cross-training" investigators, and investing in safety-monitoring infrastructure, the issues identified by this comprehensive framework can promote ethically sound international herbal medicine research that contributes to global health.
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The "Subject of Ethics" and Educational Research OR Ethics or Politics? Yes Please!
Bazzul, Jesse
2017-01-01
This paper outlines a theoretical context for research into "the subject of ethics" in terms of how students come to see themselves as self-reflective actors. I maintain that the "subject of ethics," or ethical subjectivity, has been overlooked as a necessary aspect of creating politically transformative spaces in education. At…
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Tsoka-Gwegweni, Joyce M; Wassenaar, Douglas R
2014-12-01
The Emanuel, Wendler, and Grady framework was designed as a universal tool for use in many settings including developing countries. However, it is not known whether the work of African health research ethics committees (RECs) is compatible with this framework. The absence of any normative or empirical weighting of the eight principles within this framework suggests that different health RECs may raise some ethical issues more frequently than others when reviewing protocols. We used the Emanuel et al. framework to assess, code, and rank the most frequent ethical issues considered by a biomedical REC during review of research protocols for the years 2008 to 2012. We extracted data from the recorded minutes of a South African biomedical REC for the years 2008 to 2012, designed the data collection sheet according to the Emanuel et al. framework, and removed all identifiers during data processing and analysis. From the 98 protocols that we assessed, the most frequent issues that emerged were the informed consent, scientific validity, fair participant selection, and ongoing respect for participants. This study represents the first known attempt to analyze REC responses/minutes using the Emanuel et al. framework, and suggests that this framework may be useful in describing and categorizing the core activities of an REC. © The Author(s) 2014.
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An Overview of Research on Marketing Ethics Education
Directory of Open Access Journals (Sweden)
Daniela Hrehová
2016-12-01
Full Text Available Purpose – Last two decades have seen a marked increase in the interest given to the field of business ethics, particularly, marketing ethics. Marketing ethics provides an innumerable amount of materials and topics for open discussion, as well as for application in practice. Our intention is to open up a space within which to promote timely debate on contemporary marketing education. Design/Methodology/Approach – Monitoring of academic journals in the area of marketing ethics tuition accessible in electronic databases (EBSCO, ProQuest, Web of Science, Google Scholar by means of the Centre for scientific-technical information SR portal. The work is based on the analysis of thematic categories, and the number of publications and citations. Results are presented in a comprehensive and illustrative manner. Findings and implications – Discussions about marketing ethics and ethical issues are useful. Students need preparation, mentoring and counselling while solving ethical problems, which occur during marketing ethics tuition in the academic field, but also in practice. Academic and scientific sources in the area of marketing ethics education are an excellent “instruction”. Limitations – The limitation of this research can be seen in the fact that we focused especially on the marketing aspect of the ethics education. In further research, other fields of interest should be addressed, for example management or practices in commerce, etc. Originality – The aim of the article is to map current trends in research in the field of marketing ethics education, as presented in scientific journals.
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Rahim, Anika; Knights Née Jones, Felicity; Fyfe, Molly; Alagarajah, Janagan; Baraitser, Paula
2016-09-01
International health electives pose specific ethical challenges for students travelling from to low and middle income countries. We undertook a systematic review of the literature on interventions to prepare students to identify ethical issues addressed, educational approaches and to collate evidence on the effectiveness of different strategies. We searched nine electronic databases of peer-reviewed literature and identified grey literature through key word searches; supplemented through citation mapping and expert consultation. Articles that described ethical training conducted by universities or professional bodies were included for review. We reviewed forty-four full text articles. Ten sources of published literature and seven sources of grey literature met our inclusion criteria. We identified thirteen ethical situations that students should be prepared to manage and eight generic skills to support this process. Most interventions were delivered before the elective, used case studies or guidelines. Some suggested ethical principles or a framework for analysis of ethical issues. Only two papers evaluated the intervention described. Our paper collates a small but growing body of work on education to prepare students to manage ethical issues. Ethical training should have elements that are delivered before, during and after the elective. Interventions should include case studies covering thirteen ethical issues identified here, linked to ethical principles and a process for responding to ethical issues. We suggest that evaluations of interventions are an important area for future research.
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Kotecha, Jyoti A; Manca, Donna; Lambert-Lanning, Anita; Keshavjee, Karim; Drummond, Neil; Godwin, Marshall; Greiver, Michelle; Putnam, Wayne; Lussier, Marie-Thérèse; Birtwhistle, Richard
2011-10-01
To describe the challenges the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) experienced with institutional research ethics boards (IREBs) when seeking approvals across jurisdictions and to provide recommendations for overcoming challenges of ethical review for multisite and multijurisdictional surveillance and research. The CPCSSN project collects and validates longitudinal primary care health information (relating to hypertension, diabetes, depression, chronic obstructive lung disease, and osteoarthritis) from electronic medical records across Canada. Privacy and data storage security policies and processes have been developed to protect participants' privacy and confidentiality, and IREB approval is obtained in each participating jurisdiction. Inconsistent interpretation and application of privacy and ethical issues by IREBs delays and impedes research programs that could better inform us about chronic disease. The CPCSSN project's experience with gaining approval from IREBs highlights the difficulty of conducting pan-Canadian health surveillance and multicentre research. Inconsistent IREB approvals to waive explicit individual informed consent produced particular challenges for researchers. The CPCSSN experience highlights the need to develop a better process for researchers to obtain timely and consistent IREB approvals for multicentre surveillance and research. We suggest developing a specialized, national, centralized IREB responsible for approving multisite studies related to population health research.
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Herbal medicine research and global health: an ethical analysis
Tilburt, Jon C; Kaptchuk, Ted J
2008-01-01
Governments, international agencies and corporations are increasingly investing in traditional herbal medicine research. Yet little literature addresses ethical challenges in this research. In this paper, we apply concepts in a comprehensive ethical framework for clinical research to international traditional herbal medicine research. We examine in detail three key, underappreciated dimensions of the ethical framework in which particularly difficult questions arise for international herbal me...
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Simpson, Bob; Khatri, Rekha; Ravindran, Deapica; Udalagama, Tharindi
2015-04-01
Ethical review by expert committee continues to be the first line of defence when it comes to protecting human subjects recruited into clinical trials. Drawing on a large scale study of biomedical experimentation across South Asia, and specifically on interviews with 24 ethical review committee [ERC] members across India, Sri Lanka and Nepal, this article identifies some of the tensions that emerge for ERC members as the capacity to conduct credible ethical review of clinical trials is developed across the region. The article draws attention to fundamental issues of scope and authority in the operation of ethical review. On the one hand, ERC members experience a powerful pull towards harmonisation and a strong alignment with international standards deemed necessary for the global pharmaceutical assemblage to consolidate and extend. On the other hand, they must deal with what is in effect the double jeopardy of ethical review in developing world contexts. ERC members must undertake review but are frequently made aware of their responsibility to protect interests that go beyond the 'human subject' and into the realms of development and national interest [for example, in relation to literacy and informed consent]. These dilemmas are indicative of broader questions about where ethical review sits in institutional terms and how it might develop to best ensure improved human subject protection given growth of industry-led research. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.
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Ethical Issues in the Research of Group Work
Goodrich, Kristopher M.; Luke, Melissa
2017-01-01
This article provides a primer for researchers exploring ethical issues in the research of group work. The article begins with an exploration of relevant ethical issues through the research process and current standards guiding its practice. Next, the authors identify resources that group work researchers can consult prior to constructing their…
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The Ethical Behavior of Counselors: New Directions in Ethical Behavior Research.
Paradise, Louis V.
The ethical behavior of counselors is an issue of current importance to those in the profession. This paper briefly examines the literature in this area. While considerable descriptive research on ethical behavior exists, the conspicuous absence of any experimental methodologies and theoretically-based investigations were noted. The need for new…
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Ethics in research; Ethik in der Forschung
Energy Technology Data Exchange (ETDEWEB)
Grass, Guido [Koeln Univ. (Germany). Ethik-Kommission der Medizinischen Fakultaet
2014-07-01
Taking into account the state of the science, the ethics committee has to decide in research projects with study-related radiation exposure, whether a compelling need for the research project exists. During the critical appraisal, further ethical and legal aspects have to be considered. Even without an application according to X-ray Ordinance (RoeV) or Radiation Protection Ordinance (StrlSchV), the Ethics Committee should advise the applicant whether from their perspective the project requires an approval according to RoeV and StrlSchV. This requires the regular involvement of expert members.
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Solving Ethical Dilemmas with Children: Empowering Classroom Research
Parr, Michelann
2010-01-01
This article identifies and discusses ethical dilemmas inherent when undertaking research with children or other vulnerable populations: power relations, risks and benefits, and informed consent and confidentiality (Maguire, 2005). Ethical dilemmas often arise when researchers attempt to merge the interests of their research and the interests of…
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Engaging Maori in Biobanking and Genetic Research: Legal, Ethical, and Policy Challenges
Directory of Open Access Journals (Sweden)
Angela Beaton
2015-06-01
Full Text Available Publically funded biobanking initiatives and genetic research should contribute towards reducing inequalities in health by reducing the prevalence and burden of disease. It is essential that Maori and other Indigenous populations share in health gains derived from these activities. The Health Research Council of New Zealand has funded a research project (2012-2015 to identify Maori perspectives on biobanking and genetic research, and to develop cultural guidelines for ethical biobanking and genetic research involving biospecimens. This review describes relevant values and ethics embedded in Maori indigenous knowledge, and how they may be applied to culturally safe interactions between biobanks, researchers, individual participants, and communities. Key issues of ownership, privacy, and consent are also considered within the legal and policy context that guides biobanking and genetic research practices within New Zealand. Areas of concern are highlighted and recommendations of international relevance are provided. To develop a productive environment for "next-generation" biobanking and genomic research,"‘next-generation" regulatory solutions will be required.
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The status of research ethics in social work.
Ferguson, Aidan; Clark, James J
2018-01-01
Research ethics provide important and necessary standards related to the conduct and dissemination of research. To better understand the current state of research ethics discourse in social work, a systematic literature search was undertaken and numbers of publications per year were compared between STEM, social science, and social work disciplines. While many professions have embraced the need for discipline-specific research ethics subfield development, social work has remained absent. Low publication numbers, compared to other disciplines, were noted for the years (2006-2016) included in the study. Social work published 16 (1%) of the 1409 articles included in the study, contributing 3 (>1%) for each of the disciplines highest producing years (2011 and 2013). Comparatively, psychology produced 75 (5%) articles, psychiatry produced 64 (5%) articles, and nursing added 50 (4%) articles. The STEM disciplines contributed 956 (68%) articles between 2006 and 2016, while social science produced 453 (32%) articles. Examination of the results is provided in an extended discussion of several misconceptions about research ethics that may be found in the social work profession. Implications and future directions are provided, focusing on the need for increased engagement, education, research, and support for a new subfield of social work research ethics.
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Rattling the Cage: Moving beyond Ethical Standards to Ethical Praxis in Self-Study Research
Brandenburg, Robyn; Gervasoni, Ann
2012-01-01
The ethical practice underpinning self-study research has been addressed extensively in the literature of self-study of teacher education practices. Less attention has been paid to how researchers deal with ethical tensions and dilemmas when they arise unexpectedly during self-study research. In this article, we examine how the extrapolation and…
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Directory of Open Access Journals (Sweden)
Jennifer B McCormick
Full Text Available Research ethics consultation programs are being established with a goal of addressing the ethical, societal, and policy considerations associated with biomedical research. A number of these programs are modelled after clinical ethics consultation services that began to be institutionalized in the 1980s. Our objective was to determine biomedical science researchers' perceived need for and utility of research ethics consultation, through examination of their perceptions of whether they and their institutions faced ethical, social or policy issues (outside those mandated by regulation and examination of willingness to seek advice in addressing these issues. We conducted telephone interviews and focus groups in 2006 with researchers from Stanford University and a mailed survey in December 2006 to 7 research universities in the U.S.A total of 16 researchers were interviewed (75% response rate, 29 participated in focus groups, and 856 responded to the survey (50% response rate. Approximately half of researchers surveyed (51% reported that they would find a research ethics consultation service at their institution moderately, very or extremely useful, while over a third (36% reported that such a service would be useful to them personally. Respondents conducting human subjects research were more likely to find such a service very to extremely useful to them personally than respondents not conducting human subjects research (20% vs 10%; chi(2 p<0.001.Our findings indicate that biomedical researchers do encounter and anticipate encountering ethical and societal questions and concerns and a substantial proportion, especially clinical researchers, would likely use a consultation service if they were aware of it. These findings provide data to inform the development of such consultation programs in general.
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Ethics Management: How to Achieve Ethical Organizations and Management?
Directory of Open Access Journals (Sweden)
Carita Lilian Snellman
2015-12-01
Full Text Available The last decades’ serious organizational scandals that mainly stem from corruption and conflicting interests but also from bribery, favoritism and other wrongdoings have ac-centuated the need for finding instruments for achieving more ethical organizations and management. Ethics management is particularly important in the public sector because public employees and holders of public office are responsible for increasing wellbeing and providing common good for all citizens. Only accountable management striving for integrity through ethical practices and decision making will guarantee ethical organiza-tional behavior. In spite of increasing research on ethics in general and ethics manage-ment in particular, increase in organizational scandals indicates that there is knowledge gap concerning ethical instruments that help to solve ethical problems. The aim of this paper is to shed light on ethical theories and instruments, and wrongdoings in public sec-tor organizations. The main questions are; why is there so much wrongdoing; how can it be reduced; and how can more ethical organization and management be achieved. This is a review paper aiming to provide a review of ethical theories and instruments and dis-cuss serious wrongdoings and the role of ethics in the public sector. The paper contrib-utes to the fields of management and organization, ethics, and public management.
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Improving the Level and Quality of Ethics Review in Chinese Medicine and Integrative Medicine.
Zhang, Cheng-Bin; Li, En-Chang
2018-04-01
Three features of ethics review in Chinese medicine (CM) and integrative medicine (IM) were put forward in this paper. It is consistent with the principles of ethical review in Western medicine; it has to be compliant with the laws of CM and IM; emphasis should be laid on the review of clinical practice facts and experience. Three problems were pointed out. The characteristics of CM and IM are not distinctive enough, operation procedures need to be refined and effectiveness remains to be improved. Based on the mentioned above, seven measures were proposed to improve the level and quality of ethics review in CM and IM, including better brand awareness, considerable tolerance, treatment based on disease differentiation and syndrome differentiation, scientific review and toxicity and side effects of CM, perfection of the ethics review system, reasonable procedures of ethics review and more specialized ethics review workers.
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Ethics support in institutional elderly care: a review of the literature.
van der Dam, Sandra; Molewijk, Bert; Widdershoven, Guy A M; Abma, Tineke A
2014-09-01
Clinical ethics support mechanisms in healthcare are increasing but little is known about the specific developments in elderly care. The aim of this paper is to present a systematic literature review on the characteristics of existing ethics support mechanisms in institutional elderly care. A review was performed in three electronic databases (Pubmed, CINAHL/PsycINFO, Ethxweb). Sixty papers were included in the review. The ethics support mechanisms are classified in four categories: 'institutional bodies' (ethics committee and consultation team); 'frameworks' (analytical tools to assist care professionals); 'educational programmes and moral case deliberation'; and 'written documents and policies'. For each category the goals, methods and ways of organising are described. Ethics support often serves several goals and can be targeted at various levels: case, professional or organisation. Over the past decades a number of changes have taken place in the development of ethics support in elderly care. Considering the goals, ethics support has become more outreaching and proactive, aiming to qualify professionals to integrate ethics in daily care processes. The approaches in clinical ethics support have become more diverse, more focused on everyday ethical issues and better adapted to the concrete learning style of the nursing staff. Ethics support has become less centrally organised and more connected to local contexts and primary process within the organisation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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Decisions by Finnish Medical Research Ethics Committees: A Nationwide Study of Process and Outcomes.
Hemminki, Elina; Virtanen, Jorma I; Regushevskaya, Elena
2015-10-01
Review by research ethics committees (RECs) is the key in medical research regulation. Data from meeting notes and project summaries were abstracted from all projects submitted in 2002 (n = 1,004) and 2007 (n = 1,045) to the official medical RECs in Finland. Data from consecutive submissions were combined per project. When comparing RECs, logistic regression was used to adjust for application characteristics. The number of projects handled varied notably by REC. In the first handling, 85% of applications in 2002 and 77% in 2007 were approved, while 13% and 20% were tabled. For 61% of the projects, the review time was 89 days, and 6% had 6 months or longer. The variation by REC in approval rates, number of handlings, or long review times was not explained by project characteristics. In the last handling, 94% of the projects in both years were approved or concluded not to need a statement from that REC. The most common reason for tabling or not approving an application was patient autonomy, usually centered on the patient leaflet. The next most common reasons were requests for further information and dissatisfaction with the scientific aspects of the project. The reasons classified as "ethics" in the narrow sense were rare. The REC focus was to assure that researchers follow the various rules on medical research and to improve the quality of research and project documents. REC considerations could be divided into decisions based on ethics and recommendations covering other aspects. © The Author(s) 2015.
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Can Mary Shelley's Frankenstein be read as an early research ethics text?
Davies, H
2004-06-01
The current popular view of the novel Frankenstein is that it describes the horrors consequent upon scientific experimentation; the pursuit of science leading inevitably to tragedy. In reality the importance of the book is far from this. Although the evil and tragedy resulting from one medical experiment are its theme, a critical and fair reading finds a more balanced view that includes science's potential to improve the human condition and reasons why such an experiment went awry. The author argues that Frankenstein is an early and balanced text on the ethics of research upon human subjects and that it provides insights that are as valid today as when the novel was written. As a narrative it provides a gripping story that merits careful analysis by those involved in medical research and its ethical review, and it is more enjoyable than many current textbooks! To support this thesis, the author will place the book in historical, scientific context, analyse it for lessons relevant to those involved in research ethics today, and then draw conclusions.
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Inclusion and exclusion in nutrigenetics clinical research: ethical and scientific challenges.
Hurlimann, T; Stenne, R; Menuz, V; Godard, B
2011-01-01
There are compelling reasons to ensure the participation of ethnic minorities and populations of all ages worldwide in nutrigenetics clinical research. If findings in such research are valid for some individuals, groups, or communities, and not for others, then ethical questions of justice--and not only issues of methodology and external validity--arise. This paper aims to examine inclusion in nutrigenetics clinical research and its scientific and ethical challenges. In total, 173 publications were identified through a systematic review of clinical studies in nutrigenetics published between 1998 and 2007. Data such as participants' demographics as well as eligibility criteria were extracted. There is no consistency in the way participants' origins (ancestry, ethnicity, or race) and ages are described in publications. A vast majority of the studies identified was conducted in North America and Europe and focused on 'white' participants. Our results show that pregnant women (and fetuses), minors, and the elderly (≥ 75 years old) remain underrepresented. Representativeness in nutrigenetics research is a challenging ethical and scientific issue. Yet, if nutrigenetics is to benefit whole populations and be used in public and global health agendas, fair representation as well as clear descriptions of participants in publications are crucial. Copyright © 2012 S. Karger AG, Basel.
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Vulnerable participants in health research: methodological and ethical challenges
DEFF Research Database (Denmark)
Nordentoft, Helle Merete; Kappel, Nanna
2011-01-01
, leaving both professionals and researchers in ethical and moral dilemmas. In this article, we specifically focus on the methodological challenges of obtaining informed consent from drug users and terminally ill cancer patients in our PhD research. The question is how to illuminate the needs and problems......Ethical guidelines for conducting research are embedded in the Helsinki Declaration of 1964. We contend that these abstract and intentionally universal guidelines need to be appropriated for social and healthcare research, in which purpose and methods often deviate from medical research....... The guidelines appear to be instrumental and over-simplistic representations of the often ‘messy’ realities surrounding the research process that is often guided by relational and local negotiations of ethical solutions. Vulnerable participants, for instance, challenge both professional and research ethics...
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Use of narratives to enhance learning of research ethics in residents and researchers.
Sim, Kang; Sum, Min Yi; Navedo, Deborah
2015-03-10
Past didactic pedagogy on biomedical research ethics and informed consent in our program had resulted in passive memorization of information and disengaged learning within psychiatry residents and clinical researchers. The question is how do we better motivate and engage learners within the session. Thus, we incorporated narratives into the learning environment and hypothesised that the use of narratives in the teaching of biomedical research ethics and informed consent would be associated with greater engagement, motivation, understanding, reflective learning and effectiveness of the teaching session. The narratives were chosen from the history of research ethics and the humanities literature related to human subject research. Learners were asked to provide post-session feedback through an anonymised questionnaire on their learning session. An outcomes logic model was used for assessment with focus on immediate outcomes such as engagement, motivation, understanding and reflective learning. Overall, 70.5% (N = 273) of the learners responded to the questionnaire. Amongst the respondents, 92.6% (N = 253) of the participants ranked use of narratives as most helpful in appreciating the historical context of research ethics and informed consent in research. The majority felt engaged (89.8%, N = 245), more motivated to learn (77.5%, N = 212) and better equipped (86.4%, N = 236) about the subject matter. Better appreciation of the learning topic, engagement, motivation to learn, equipping were strongly correlated with the promotion of reflective learning, effectiveness of teaching, promotion of critical thinking and overall positive rating of the teaching session on research ethics (all p ethics and informed consent, and address underlying motivational factors behind learning and understanding of research ethics.
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Ponterotto, Joseph G
2010-10-01
This article reviews the current and emerging status of qualitative research in psychology. The particular value of diverse philosophical paradigms and varied inquiry approaches to the advancement of psychology generally, and multicultural psychology specifically, is emphasized. Three specific qualitative inquiry approaches anchored in diverse philosophical research paradigms are highlighted: consensual qualitative research, grounded theory, and participatory action research. The article concludes by highlighting important ethical considerations in multicultural qualitative research. PsycINFO Database Record (c) 2010 APA, all rights reserved.
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Payment of research participants: current practice and policies of Irish research ethics committees.
Roche, Eric; King, Romaine; Mohan, Helen M; Gavin, Blanaid; McNicholas, Fiona
2013-09-01
Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking. Our aim was to examine REC policies, experiences and concerns with respect to the payment of participants in research projects in Ireland. Postal survey of all RECs in Ireland. Response rate was 62.5% (n=50). 80% of RECs reported not to have any established policy on the payment of research subjects while 20% had refused ethics approval to studies because the investigators proposed to pay research participants. The most commonly cited concerns were the potential for inducement and undermining of voluntary consent. There is considerable variability among RECs on the payment of research participants and a lack of clear consensus guidelines on the subject. The development of standardised guidelines on the payment of research subjects may enhance recruitment of research participants.
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Directory of Open Access Journals (Sweden)
Hannah eMaslen
2014-06-01
Full Text Available There are numerous ways people can improve their cognitive capacities: good nutrition and regular exercise can produce long-term improvements across many cognitive domains, whilst commonplace stimulants such as coffee temporarily boost levels of alertness and concentration. Effects like these have been well-documented in the medical literature and they raise few (if any ethical issues. More recently, however, clinical research has shown that the off-label use of some pharmaceuticals can, under certain conditions, have modest cognition-improving effects. Substances such as methylphenidate and modafinil can improve capacities such as working memory and concentration in some healthy individuals. Unlike their more mundane predecessors, these methods of ‘cognitive enhancement’ are thought to raise a multitude of ethical issues. This paper presents the six principal ethical issues raised in relation to pharmacological cognitive enhancers (PCEs – issues such as whether: (1 the medical safety-profile of PCEs justifies restricting or permitting their elective or required use; (2 the enhanced mind can be an ‘authentic’ mind; (3 individuals might be coerced into using PCEs; (4, there is a meaningful distinction to be made between the treatment versus enhancement effect of the same PCE; (5 unequal access to PCEs would have implications for distributive justice; and (6 PCE use constitutes cheating in competitive contexts. In reviewing the six principal issues, the paper discusses how future neuroscientific research might help advance the ethical debate. In particular, the paper presents new arguments about the contribution neuroscience could make to debates about justice, fairness and cheating, ultimately concluding that neuroscientific research into ‘personalised enhancement’ will be essential if policy is to be truly informed and ethical. We propose an ‘ethical agenda’ for neuroscientific research into PCEs.
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Research Ethics Education in Post-Graduate Medical Curricula in I.R. Iran.
Nikravanfard, Nazila; Khorasanizadeh, Faezeh; Zendehdel, Kazem
2017-08-01
Research ethics training during post-graduate education is necessary to improve ethical standards in the design and conduct of biomedical research. We studied quality and quantity of research ethics training in the curricula of post-graduate programs in the medical science in I.R. Iran. We evaluated curricula of 125 post-graduate programs in medical sciences in I.R. Iran. We qualitatively studied the curricula by education level, including the Master and PhD degrees and analyzed the contents and the amount of teaching allocated for ethics training in each curriculum. We found no research ethics training in 72 (58%) of the programs. Among the 53 (42%) programs that considered research ethics training, only 17 programs had specific courses for research ethics and eight of them had detailed topics on their courses. The research ethics training was optional in 25% and mandatory in 76% of the programs. Post-graduate studies that were approved in the more recent years had more attention to the research ethics training. Research ethics training was neglected in most of the medical post-graduate programs. We suggest including sufficient amount of mandatory research ethics training in Master and PhD programs in I.R. Iran. Further research about quality of research ethics training and implementation of curricula in the biomedical institutions is warranted. © 2016 John Wiley & Sons Ltd.
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Ethnocentric ethics in anthropological research
van der Geest, S.
2011-01-01
The paper discusses the application of ethnocentric ethical rules in anthropological research. The ethnocentrism lies in the fact that North American and European definitions of right and wrong are imposed on anthropological research everywhere in the world. Apparently - and ironically - some
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Research across the disciplines: a road map for quality criteria in empirical ethics research.
Mertz, Marcel; Inthorn, Julia; Renz, Günter; Rothenberger, Lillian Geza; Salloch, Sabine; Schildmann, Jan; Wöhlke, Sabine; Schicktanz, Silke
2014-03-01
Research in the field of Empirical Ethics (EE) uses a broad variety of empirical methodologies, such as surveys, interviews and observation, developed in disciplines such as sociology, anthropology, and psychology. Whereas these empirical disciplines see themselves as purely descriptive, EE also aims at normative reflection. Currently there is literature about the quality of empirical research in ethics, but little or no reflection on specific methodological aspects that must be considered when conducting interdisciplinary empirical ethics. Furthermore, poor methodology in an EE study results in misleading ethical analyses, evaluations or recommendations. This not only deprives the study of scientific and social value, but also risks ethical misjudgement. While empirical and normative-ethical research projects have quality criteria in their own right, we focus on the specific quality criteria for EE research. We develop a tentative list of quality criteria--a "road map"--tailored to interdisciplinary research in EE, to guide assessments of research quality. These quality criteria fall into the categories of primary research question, theoretical framework and methods, relevance, interdisciplinary research practice and research ethics and scientific ethos. EE research is an important and innovative development in bioethics. However, a lack of standards has led to concerns about and even rejection of EE by various scholars. Our suggested orientation list of criteria, presented in the form of reflective questions, cannot be considered definitive, but serves as a tool to provoke systematic reflection during the planning and composition of an EE research study. These criteria need to be tested in different EE research settings and further refined.
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Ethics in Research on Learning: Dialectics of Praxis and Praxeology
Directory of Open Access Journals (Sweden)
SungWon Hwang
2005-01-01
Full Text Available Qualitative social research designed to develop ways of understanding and explaining lived experience of human beings is a reflexive human endeavor. It is reflexive in that as researchers attempt to better understand their participants, they also come to better understand themselves. Consequently, research ethics itself becomes an ethical project, for it pertains to participant and researcher at the same time: Both are subjects, knower and known. Particularly in case of research on learning, reflexivity arises from the fact that the research itself constitutes learning about learning. How is ethics in research on learning reflexive of, in its praxis and praxeology, ongoing events and changes of the human learning? In this study, from our experience of conducting a project designed to inquire into "learning in unfamiliar environments," we develop pertinent ethical issues through a dialectical process—not unlike that used by G.W.F. HEGEL in Phenomenology of Spirit—grounded in our lived experience and developed in three theoretical claims concerning a praxeology of ethics. First, ethics is an ongoing historical event; second, ethics is based on the communicative praxis of material bodies; and third, ethics involves the creation of new communicative configurations. We conclude that ethics is grounded in a fundamental answerability of human beings for their actions, which requires communicative action that itself is a dialectical process in opening up possibilities for acting in an answerable manner. URN: urn:nbn:de:0114-fqs0501198
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de la Garza, Santiago; Phuoc, Vania; Throneberry, Steven; Blumenthal-Barby, Jennifer; McCullough, Laurence; Coverdale, John
2017-08-01
One objective was to identify and review studies on teaching medical ethics to psychiatry residents. In order to gain insights from other disciplines that have published research in this area, a second objective was to identify and review studies on teaching medical ethics to residents across all other specialties of training and on teaching medical students. PubMed, EMBASE, and PsycINFO were searched for controlled trials on teaching medical ethics with quantitative outcomes. Search terms included ethics, bioethics, medical ethics, medical students, residents/registrars, teaching, education, outcomes, and controlled trials. Nine studies were found that met inclusion criteria, including five randomized controlled trails and four controlled non-randomized trials. Subjects included medical students (5 studies), surgical residents (2 studies), internal medicine house officers (1 study), and family medicine preceptors and their medical students (1 study). Teaching methods, course content, and outcome measures varied considerably across studies. Common methodological issues included a lack of concealment of allocation, a lack of blinding, and generally low numbers of subjects as learners. One randomized controlled trial which taught surgical residents using a standardized patient was judged to be especially methodologically rigorous. None of the trials incorporated psychiatry residents. Ethics educators should undertake additional rigorously controlled trials in order to secure a strong evidence base for the design of medical ethics curricula. Psychiatry ethics educators can also benefit from the findings of trials in other disciplines and in undergraduate medical education.
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Scientists' perspectives on the ethical issues of stem cell research.
Longstaff, Holly; Schuppli, Catherine A; Preto, Nina; Lafrenière, Darquise; McDonald, Michael
2009-06-01
This paper describes findings from an ethics education project funded by the Canadian Stem Cell Network (SCN). The project is part of a larger research initiative entitled "The Stem Cell Research Environment: Drawing the Evidence and Experience Together". The ethics education study began with a series of focus groups with SCN researchers and trainees as part of a "needs assessment" effort. The purpose of these discussions was to identify the main ethical issues associated with stem cell (SC) research from the perspective of the stem cell community. This paper will focus on five prominent themes that emerged from the focus group data including: (1) the source of stem cells; (2) the power of stem cells; (3) working within a charged research environment; (4) the regulatory context; and (5) ethics training for scientists. Additional discussions are planned with others involved in Canadian stem cell research (e.g., research ethics board members, policy makers) to supplement initial findings. These assessment results combined with existing bioethics literature will ultimately inform a web-based ethics education module for the SCN. We believe that our efforts are important for those analyzing the ethical, legal, and social issues (ELSI) in this area because our in depth understanding of stem cell researcher perspectives will enable us to develop more relevant and effective education material, which in turn should help SC researchers address the important ethical challenges in their area.
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Mijaljica, Goran
2014-03-01
Ethics has an established place within the medical curriculum. However notable differences exist in the programme characteristics of different schools of medicine. This paper addresses the main differences in the curricula of medical schools in South East Europe regarding education in medical ethics and bioethics, with a special emphasis on research ethics, and proposes a model curriculum which incorporates significant topics in all three fields. Teaching curricula of Medical Schools in Bulgaria, Bosnia and Herzegovina, Croatia, Serbia, Macedonia and Montenegro were acquired and a total of 14 were analyzed. Teaching hours for medical ethics and/or bioethics and year of study in which the course is taught were also analyzed. The average number of teaching hours in medical ethics and bioethics is 27.1 h per year. The highest national average number of teaching hours was in Croatia (47.5 h per year), and the lowest was in Serbia (14.8). In the countries of the European Union the mean number of hours given to ethics teaching throughout the complete curriculum was 44. In South East Europe, the maximum number of teaching hours is 60, while the minimum number is 10 teaching hours. Research ethics topics also show a considerable variance within the regional medical schools. Approaches to teaching research ethics vary, even within the same country. The proposed model for education in this area is based on the United Nations Educational, Scientific and Cultural Organization Bioethics Core Curriculum. The model curriculum consists of topics in medical ethics, bioethics and research ethics, as a single course, over 30 teaching hours.
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Ali, Joseph; Califf, Robert; Sugarman, Jeremy
2016-01-01
PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.
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Situated ethics in collaborative research with children
DEFF Research Database (Denmark)
Chimirri, Niklas Alexander
an epistemological as well as an ontological necessity. The paper discusses how a renegotiation of ethics is particularly difficult whilst engaging in a project investigating everyday media experiences of young children (aged 3-6) at a German day care centre. Albeit the children were explicitly considered co......-researchers to the research questions, the most visible negotiations of enacted ethics took place among the participating adults: researcher, parents, and pedagogues – thereby potentially shunning the children’s perspectives on the research process. Nevertheless does the paper argue that an iterative renegotiation of ethics...... took place also with the children, and that the principle challenge lies in rendering these renegotiations visible in academic publications. It proposes conceptual developments that draw on both New Materialism and the Psychology from the Standpoint of the Subject in order to tackle this challenge....
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[Ethics and laws related to human subject research].
Chiu, Hui-Ju; Lee, Ya-Ling; Chang, Su-Fen
2011-10-01
Advances in medical technology rely on human subject research to test the effects on real patients of unproven new drugs, equipment and techniques. Illegal human subject research happens occasionally and has led to subject injury and medical disputes. Familiarity with the laws and established ethics related to human subject research can minimize both injury and disputes. History is a mirror that permits reflection today on past experience. Discussing the Nuremberg Code, the Declaration of Helsinki and Belmont Report, this article describes the laws, ethics, history and news related to human subject research as well as the current definition and characteristics of human subject research. Increasing numbers of nurses serve as research nurses and participate in human subject research. The authors hope this article can increase research nurse knowledge regarding laws and ethics in order to protect human research subjects adequately.
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Hack, Catherine J.
2012-01-01
Undergraduate research projects in the life sciences encompass a broad range of studies, some of which may require the participation of human subjects or other activities which may raise ethical concerns. As universities are accountable for all projects undertaken under their auspices they must ensure that these projects adhere to legal…
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Peppoloni, Silvia; Di Capua, Giuseppe; Haslinger, Florian
2016-04-01
ENVRI PLUS is a Horizon 2020 project bringing together Environmental and Earth System Research Infrastructures (RIs), projects and networks with technical specialist partners to create a more coherent, interdisciplinary and interoperable cluster of Environmental Research Infrastructures across Europe (http://www.envriplus.eu/). One theme of the project deals with the societal relevance and understanding, and within that theme an entire work-package (WP) aims at developing an ethical framework for RIs. Objectives of this WP are: • increase the awareness of both the scientists and the public on the importance of ethical aspects in Earth sciences; • establish a shared ethical framework of reference, to be adopted by RIs governing bodies; • increase the awareness of RIs management and operational levels and of the individual involved scientists on their social role in conducting research activities and research work environment; • assess the ethical and social aspects related to the results achieved and deliverables released within the project. The ongoing activities include: • reviewing the state of art on ethical issues useful for the goals of the project (collection and analysis of materials already existing within scientific organizations, institutions all over the world); • the creation of a questionnaire, through which to investigate how each RI participating in ENVRI PLUS faces ethical issues in relation to its activities, and so to understand the level of perception that researchers and technicians involved in the project have on the ethical implications of their scientific activities; • the definition of ethics guidelines to be used by partners for building their policies and their own codes of conduct; • the elaboration of an ethical label template to characterize each product of the project, that partners will be able to use in order to give essential information about the ethical and social implications of their products; • the
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Ethical Perspectives on Qualitative Research in Applied Psychology
Haverkamp, Beth E.
2005-01-01
The present article explores ethical issues that emerge in qualitative research conducted by applied psychologists. The utility and relevance of the Ethical Principles of Psychologists and Code of Conduct (American Psychological Association, 2002) for qualitative research are examined. The importance of psychology's fiduciary relationship with…
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Professional ethics in biomedical engineering practice and research.
Monzon, Jorge E; Monzon-Wyngaard, Alvaro
2008-01-01
This paper discusses some guidelines for use with the accepted fundamental canons of ethics for engineers. We present some rules of practice and professional obligations emerging from these canons. Basic recommendations for engineers dissenting on ethical grounds are also presented. Ethical issues relating to Biomedical Engineering research are illustrated. We mention some cases that could be used to further understanding the ethical implications of biomedical engineering practice.
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You Must Participate: Violating Research Ethical Principles through Role-Play
Kraus, Rachel
2008-01-01
The author discusses the use of role-play to teach research ethics in three semesters of a research methods class. Small groups of students were assigned one of nine ethical norms discussed in the course textbook and the American Sociological Association Code of Ethics. Each group role-played the violation of their assigned ethic to the class. The…
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The Satisfaction and Use of Research Ethics Board Information Systems in Canada.
Detlor, Brian; Wilson, Michael J
2015-10-01
This article reports findings from a national survey of Research Ethics Board (REB) personnel across Canada on the satisfaction and use of information systems that support the review and administration of research ethics protocols. Findings indicate that though a wide variety of REB systems are utilized, the majority fall short of desired characteristics. Despite these shortcomings, most respondents are satisfied with their current REB systems. Satisfaction is dependent on the volume of protocols processed in relation to the robustness of the system. Boards with higher volumes are more satisfied with full-fledged systems; however, the satisfaction of REBs with lower volumes is not affected by the robustness of the REB system used. Recommendations are provided. © The Author(s) 2015.
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Newman, Anne; Glass, Ronald David
2014-01-01
Criticisms of IRBs are proliferating. In response, we compare the ethical and epistemic standards of two closely related forms of inquiry, investigative journalism and equity-oriented collaborative community-based research (EOCCBR). We argue that a university affiliation justifies formal ethical review of research and suggest how institutionalized…
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Philosophy of organ donation: Review of ethical facets.
Dalal, Aparna R
2015-06-24
Transplantation ethics is a philosophy that incorporates systematizing, defending and advocating concepts of right and wrong conduct related to organ donation. As the demand for organs increases, it is essential to ensure that new and innovative laws, policies and strategies of increasing organ supply are bioethical and are founded on the principles of altruism and utilitarianism. In the field of organ transplantation, role of altruism and medical ethics values are significant to the welfare of the society. This article reviews several fundamental ethical principles, prevailing organ donation consent laws, incentives and policies related to the field of transplantation. The Ethical and Policy Considerations in Organ Donation after Circulatory Determination of Death outline criteria for death and organ retrieval. Presumed consent laws prevalent mostly in European countries maintain that the default choice of an individual would be to donate organs unless opted otherwise. Explicit consent laws require organ donation to be proactively affirmed with state registries. The Declaration of Istanbul outlines principles against organ trafficking and transplant tourism. World Health Organization's Guiding Principles on Human Cell, Tissue and Organ Transplantation aim at ensuring transparency in organ procurement and allocation. The ethics of financial incentives and non-financial incentives such as incorporation of non-medical criteria in organ priority allocation have also been reviewed in detail.
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Research across the disciplines: a road map for quality criteria in empirical ethics research
2014-01-01
Background Research in the field of Empirical Ethics (EE) uses a broad variety of empirical methodologies, such as surveys, interviews and observation, developed in disciplines such as sociology, anthropology, and psychology. Whereas these empirical disciplines see themselves as purely descriptive, EE also aims at normative reflection. Currently there is literature about the quality of empirical research in ethics, but little or no reflection on specific methodological aspects that must be considered when conducting interdisciplinary empirical ethics. Furthermore, poor methodology in an EE study results in misleading ethical analyses, evaluations or recommendations. This not only deprives the study of scientific and social value, but also risks ethical misjudgement. Discussion While empirical and normative-ethical research projects have quality criteria in their own right, we focus on the specific quality criteria for EE research. We develop a tentative list of quality criteria – a “road map” – tailored to interdisciplinary research in EE, to guide assessments of research quality. These quality criteria fall into the categories of primary research question, theoretical framework and methods, relevance, interdisciplinary research practice and research ethics and scientific ethos. Summary EE research is an important and innovative development in bioethics. However, a lack of standards has led to concerns about and even rejection of EE by various scholars. Our suggested orientation list of criteria, presented in the form of reflective questions, cannot be considered definitive, but serves as a tool to provoke systematic reflection during the planning and composition of an EE research study. These criteria need to be tested in different EE research settings and further refined. PMID:24580847
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Ethical Considerations for Teacher-Education Researchers of Coteaching
Directory of Open Access Journals (Sweden)
Stephen M. Ritchie
2006-09-01
Full Text Available In small-scale studies of coteaching, there are few genuine ethical dilemmas for researchers providing participants are engaged in ongoing dialogue about the purposes and emerging results of the research. When studies are up-scaled for teacher education programs, the territory is uncharted. This adds uncertainty about the ethical codes of practice for a teacher education program director who initiates such research. If the research is likely to lead to valued learning experiences for participating interns without harm to other participants, it may be ethical to proceed. In this paper I suggest that even though getting the balance right will continue to challenge researchers, it will be essential to establish and maintain dialogue between all participants. URN: urn:nbn:de:0114-fqs0604218
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Research ethics and private harms.
Koocher, Gerald P
2014-12-01
This commentary addresses the emotionally powerful account of Nicole Taus Kluemper from the perspective of a psychologist familiar with the administrative operation of the American Psychological Association (APA) and the ethics of the profession. The application of the APA's Ethical Principles of Psychologists and Code of Conduct to the case is discussed, and alternative methods of response that researchers who have concerns about case studies might use are offered. The author concludes that existing ethical principles-the aspirational standards in particular-do bear upon the matter in question. However, the enforceable code of conduct is not sufficiently clear about obligations to those whom psychologists publicly discuss when the psychologist does not have a specific duty of care to an individual. © The Author(s) 2014.
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Gonorazky, Sergio E
2008-01-01
The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT) requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the assumed autonomy of the former can be reduced to merely a relationship of "service provider-customer". The Institutional Review Board of the Mar del Plata s Community Hospital has evaluated, between 2005 and 2006, thirty three research protocols (with their corresponding information sheets for patients and informed consent forms) previously approved by a non-institutional Independent Ethics Committee. The median number of objections made by the Institutional Review Board, which prompted the previously mentioned protocols to be modified in order to be approved, was of three per protocol. In other words, the accreditation of an Independent Ethics Committee requires a system that guarantees actual independence from the sponsors and/or researchers, as well as management control mechanisms that may lead them into an eventual loss of accreditation. Several measures are proposed in order to correct the deficiencies of the present system.
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Informed consent in Sri Lanka: A survey among ethics committee members
Sumathipala, Athula; Siribaddana, Sisira; Hewage, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin
2008-01-01
Abstract Background Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research. However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. Methods We obtained ethical ap...
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Thayer, Erin K; Rathkey, Daniel; Miller, Marissa Fuqua; Palmer, Ryan; Mejicano, George C; Pusic, Martin; Kalet, Adina; Gillespie, Colleen; Carney, Patricia A
2016-01-01
Medical educators and educational researchers continue to improve their processes for managing medical student and program evaluation data using sound ethical principles. This is becoming even more important as curricular innovations are occurring across undergraduate and graduate medical education. Dissemination of findings from this work is critical, and peer-reviewed journals often require an institutional review board (IRB) determination. IRB data repositories, originally designed for the longitudinal study of biological specimens, can be applied to medical education research. The benefits of such an approach include obtaining expedited review for multiple related studies within a single IRB application and allowing for more flexibility when conducting complex longitudinal studies involving large datasets from multiple data sources and/or institutions. In this paper, we inform educators and educational researchers on our analysis of the use of the IRB data repository approach to manage ethical considerations as part of best practices for amassing, pooling, and sharing data for educational research, evaluation, and improvement purposes. Fostering multi-institutional studies while following sound ethical principles in the study of medical education is needed, and the IRB data repository approach has many benefits, especially for longitudinal assessment of complex multi-site data.
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Ethical challenges embedded in qualitative research interviews with close relatives.
Haahr, Anita; Norlyk, Annelise; Hall, Elisabeth Oc
2014-02-01
Nurse researchers engaged in qualitative interviews with patients and spouses in healthcare may often experience being in unforeseen ethical dilemmas. Researchers are guided by the bioethical principles of justice, beneficence, non-maleficence, respect for human rights and respect for autonomy through the entire research process. However, these principles are not sufficient to prepare researchers for unanticipated ethical dilemmas related to qualitative research interviews. We describe and discuss ethically challenging and difficult moments embedded in two cases from our own phenomenological interview studies. We argue that qualitative interviews involve navigation between being guided by bioethics as a researcher, being a therapist/nurse and being a fellow human being or even a friend. The researchers' premises to react to unexpected situations and act in a sound ethical manner must be enhanced, and there is a need for an increased focus on the researchers' ethical preparation and to continually address and discuss cases from their own interviews.
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The ethics of complexity. Genetics and autism, a literature review.
Hens, Kristien; Peeters, Hilde; Dierickx, Kris
2016-04-01
It is commonly believed that the etiology of autism is at least partly explained through genetics. Given the complexity of autism and the variability of the autistic phenotype, genetic research and counseling in this field are also complex and associated with specific ethical questions. Although the ethics of autism genetics, especially with regard to reproductive choices, has been widely discussed on the public fora, an in depth philosophical or bioethical reflection on all aspects of the theme seems to be missing. With this literature review we wanted to map the basic questions and answers that exist in the bioethical literature on autism genetics, research, counseling and reproduction, and provide suggestions as to how the discussion can proceed. We found 19 papers that fitted the description of "bioethics literature focusing on autism genetics," and analyzed their content to distill arguments and themes. We concluded that because of the complexity of autism, and the uncertainty with regard to its status, more ethical reflection is needed before definite conclusions and recommendations can be drawn. Moreover, there is a dearth of bioethical empirical studies querying the opinions of all parties, including people with autism themselves. Such empirical bioethical studies should be urgently done before bioethical conclusions regarding the aims and desirability of research into autism genes can be done. Also, fundamental philosophical reflection on concepts of disease should accompany research into the etiology of autism. © 2016 Wiley Periodicals, Inc.
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Ogunrin, Olubunmi A; Daniel, Folasade; Ansa, Victor
2016-12-01
Responsibility for protection of research participants from harm and exploitation rests on Research Ethics Committees and principal investigators. The Nigerian National Code of Health Research Ethics defines responsibilities of stakeholders in research so its knowledge among researchers will likely aid ethical conduct of research. The levels of awareness and knowledge of the Code among biomedical researchers in southern Nigerian research institutions was assessed. Four institutions were selected using a stratified random sampling technique. Research participants were selected by purposive sampling and completed a pre-tested structured questionnaire. A total of 102 biomedical researchers completed the questionnaires. Thirty percent of the participants were aware of the National Code though 64% had attended at least one training seminar in research ethics. Twenty-five percent had a fairly acceptable knowledge (scores 50%-74%) and 10% had excellent knowledge of the code (score ≥75%). Ninety-five percent expressed intentions to learn more about the National Code and agreed that it is highly relevant to the ethical conduct of research. Awareness and knowledge of the Code were found to be very limited among biomedical researchers in southern Nigeria. There is need to improve awareness and knowledge through ethics seminars and training. Use of existing Nigeria-specific online training resources is also encouraged.
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DEFF Research Database (Denmark)
Rønn, Kira Vrist
2016-01-01
Questions concerning what constitutes a morally justified conduct of intelligence activities have received increased attention in recent decades. However, intelligence ethics is not yet homogeneous or embedded as a solid research field. The aim of this article is to sketch the state of the art...... of intelligence ethics and point out subjects for further scrutiny in future research. The review clusters the literature on intelligence ethics into two groups: respectively, contributions on external topics (i.e., the accountability of and the public trust in intelligence agencies) and internal topics (i.......e., the search for an ideal ethical framework for intelligence actions). The article concludes that there are many holes to fill for future studies on intelligence ethics both in external and internal discussions. Thus, the article is an invitation – especially, to moral philosophers and political theorists...
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Ethical Issues in Addressing Inequity in/through ESL Research
Lee, Ena
2011-01-01
This article outlines a researcher's struggles with conducting "ethical" research when her case study reveals racializations faced by a minority teacher in a Canadian ESL program. How might becoming privy to research participants' experiences of inequity in ESL education complicate the notion of research ethics when "doing the right…
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Smith, T.; Moore, E. J.; Tunstall-Pedoe, H.
1997-01-01
OBJECTIVE: To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. DESIGN: Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace. SETTING: Tayside, Scotland (mixed rural and urban population). SUBJECTS: 30 research projects app...
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Ethics of international clinical research collaboration - the experience of AlloStem.
Chaplin, C
2006-02-01
This paper examines the ethics of international clinical collaboration in stem cell research by focusing on the AlloStem project. AlloStem is an international research programme, financed by the European Union under the Sixth Framework Programme, with the aim of advancing the use of stem cells in treating leukaemia and other haematological diseases. Several areas of ethical importance are explored. Research justification and the need to consider both deontological and teleological aspects are examined. Ethical sensitivity in research and the requirement to respond to areas of ethical concern identified by the European Commission, such as the involvement of human beings, the use of human tissue, and the use of animals are also explored. Ethical issues around project structure and management, such as ethical standardization in international research, and achieving set targets are discussed. The ethical importance of dissemination of findings and teaching in clinical research is also considered. Finally, the distribution of benefits is addressed and the importance of distributive justice is emphasized.
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E-WASTE: ETHICAL IMPLICATIONS FOR EDUCATION AND RESEARCH
Directory of Open Access Journals (Sweden)
MUAZ HAWARI
2010-09-01
Full Text Available “E-waste” is a popular, informal name for electronic products nearing the end of their “useful life”. This includes discarded computers, televisions, VCRs, stereos, copiers, fax machines, electric lamps, cell phones, audio equipment and batteries. E-wastes are considered dangerous, as certain components of some of these electronic products contain materials; such as lead; that are hazardous, depending on their condition and density. If improperly disposed, E-wastes can leach lead and other substances into soil and groundwater posing a threat to human health and environment. Many of these electronic products can be reused, refurbished, or recycled in an environmentally sound manner so that they are less harmful to the ecosystem. This paper highlights the types and hazards of E-wastes particularly the computers’ waste. The dimensions and ethicality of the problem in the third-world countries are reviewed. The needs for the appropriate management of e-waste and options that can be implemented are discussed. After reviewing the Islamic concepts for environmental protection, ethical implications for curriculum development as well research directions are highlighted. Elements for a course on e-waste as well as some across-the-curriculum topics are proposed. This is specially tailored to suit the faculty of Engineering at the International Islamic University-Malaysia.
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Researcher Tales and Research Ethics: The Spaces in Which We Find Ourselves
White, Julie; Fitzgerald, Tanya
2010-01-01
The tales we tell here focus on the ethical issues arising from our research practice with vulnerable young participants and those for whom research has been inextricably linked with European imperialism and colonialism. The importance of relational obligations, temporality and potential for a continuing narrative approach to ethical research…
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Rosenkrantz, Andrew B; Ginocchio, Luke A
2016-07-01
The aim of the present study was to assess the potential usefulness of written instructional vignettes relating to publication and journalism ethics in radiology via a survey of radiology trainees. A literature review was conducted to guide the development of vignettes, each describing a scenario relating to an ethical issue in research and publication, with subsequent commentary on the underlying ethical issue and potential approaches to its handling. Radiology trainees at a single institution were surveyed regarding the vignettes' perceived usefulness. A total of 21 vignettes were prepared, addressing institutional review board and human subjects protection, authorship issues, usage of previous work, manuscript review, and other miscellaneous topics. Of the solicited trainees, 24.7% (16/65) completed the survey. On average among the vignettes, 94.0% of the participants found the vignette helpful; 19.9 received prior formal instruction on the issue during medical training; 40.0% received prior informal guidance from a research mentor; and 42.0% indicated that the issue had arisen in their own or a peer's prior research experience. The most common previously experienced specific issue was authorship order (93.8%). Free-text responses were largely favorable regarding the value of the vignettes, although also indicated numerous challenges in properly handling the ethical issues: impact of hierarchy, pressure to publish, internal politics, reluctance to conduct sensitive conversations with colleagues, and variability in journal and professional society policies. Radiology trainees overall found the vignettes helpful, addressing commonly encountered topics for which formal and informal guidance were otherwise lacking. The vignettes are publicly available through the Association of University Radiologists (AUR) website and may foster greater insights by investigators into ethical aspects of the publication and journalism process, thus contributing to higher quality
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Ethics in published brain-computer interface research
Specker Sullivan, L.; Illes, J.
2018-02-01
Objective. Sophisticated signal processing has opened the doors to more research with human subjects than ever before. The increase in the use of human subjects in research comes with a need for increased human subjects protections. Approach. We quantified the presence or absence of ethics language in published reports of brain-computer interface (BCI) studies that involved human subjects and qualitatively characterized ethics statements. Main results. Reports of BCI studies with human subjects that are published in neural engineering and engineering journals are anchored in the rationale of technological improvement. Ethics language is markedly absent, omitted from 31% of studies published in neural engineering journals and 59% of studies in biomedical engineering journals. Significance. As the integration of technological tools with the capacities of the mind deepens, explicit attention to ethical issues will ensure that broad human benefit is embraced and not eclipsed by technological exclusiveness.
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Farnbach, Sara; Eades, Anne-Marie; Hackett, Maree Lisa
2015-12-30
Research with a focus on Aboriginal and Torres Strait Islander Australian's (hereafter referred to as Indigenous(1)) needs is crucial to ensure culturally appropriate evidence-based strategies are developed to improve health. However, concerns surrounding this research exist, arising from some previous research lacking community consultation, resulting in little community benefit or infringing on important cultural values. Values and Ethics: Guidelines for Ethical conduct in Aboriginal and Torres Strait Islander Health Research (hereafter referred to as Values and Ethics), developed by The National Health and Medical Research Council of Australia in 2003, is the ethical standard for Indigenous-focused health research. Researchers must address its Values in research design and conduct. However, its impact on research processes is unclear. Local Protocols should also be considered. This review aims to systematically examine practices related to Values and Ethics, Local Protocols and the processes of conducting Indigenous-focused primary healthcare research in collaboration with external researchers. The following electronic databases and grey literature will be searched (2003 to current): MEDLINE, EMBASE, CINAHL, Informit and HealthInfoNet--an Indigenous-specific research and program website. Indigenous-focused research will be included. Research must be conducted in one or more primary healthcare services, in collaboration with external researchers and with a focus on social and emotional well being. One reviewer will review titles and abstracts to remove obviously irrelevant research articles. Full-text research articles will be retrieved and independently examined by two reviewers. Data and quality assessment will be completed by one reviewer and verified by a second reviewer. Quality will be assessed using modified versions of established quality assessment tools. This review will provide information on research processes and the impact of Values and Ethics on
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Let's Play it Safe: Ethical Considerations from Participants in a Photovoice Research Project
Directory of Open Access Journals (Sweden)
Karin Hannes PhD
2014-02-01
Full Text Available The use of images and other visual data in qualitative research projects poses new ethical challenges, particularly in the context of participatory research projects that engage research participants in conducting fieldwork. Little is known about how research participants deal with the ethical challenges involved in conducting fieldwork, or whether they succeed in making balanced ethical judgments in collecting images of identifiable people and places. This study aims to increase our understanding of these ethical challenges. From an inductive analysis of interview data generated from nine participants recently involved in a photovoice research project we conclude that raising awareness about ethical aspects of conducting visual research increases research participants' sensitivity toward ethical issues related to privacy, anonymity, and confidentiality of research subjects. However, personal reasons (e.g., cultural, emotional and cautions about potential ethical dilemmas also prompt avoidance behavior. While ethics sessions may empower participants by equipping them with the knowledge of research ethics, ethics sessions may also have an unintentional impact on research.
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Ethical issues in family violence research in healthcare settings.
Paavilainen, Eija; Lepistö, Sari; Flinck, Aune
2014-02-01
Research ethics is always important. However, it is especially crucial with sensitive research topics such as family violence. The aim of this article is to describe and discuss some crucial issues regarding intimate partner violence and child maltreatment, based on the authors' own research experiences. We focus on and discuss examples concerning the definition of family violence, research design, ethical approval, participant recruitment and safety and data collection and processing. During the research process, the significance of teamwork is emphasized. Support provided by the participants to each other and support given by experienced researchers within the team is very important for high ethical standards.
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Ethical Challenges embedded in qualitative research interviews with close relatives
DEFF Research Database (Denmark)
Haahr, Anita; Norlyk, Annelise; Hall, Elisabeth
2013-01-01
Nurse researchers engaged in qualitative interviews with patients and spouses in healthcare may often experience being in unforseen ethical dilemmas. Researchers are guided by the bioethical principles of justice, beneficence, non-maleficence respect for human rights and respect for autonomy...... through the entire research process. However, these principles are not sufficient to prepare researchers for unanticipated ethical dilemmas related to qualitative researchs interviews. We describe and discuss ethically challenging and difficult moments embedded in two cases from our own phenomenological...... interview studies. We argue that qualitative interviews involve navigation between being guided by bioethics as a researcher, being a therapist/nurse and being a fellow human being or even a friend. The researchers' premises to react to unexpected situations and act in a sound ethical manner must...
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A Critical Review of Theories and Measures of Ethics-Related Leadership.
Zhu, Weichun; Zheng, Xiaoming; Riggio, Ronald E; Zhang, Xi
2015-01-01
This chapter reviews the different theoretical perspectives and measurements of ethics-related leadership models, including ethical leadership, transformational leadership, authentic leadership, servant leadership, spiritual leadership, and a virtues-based approach to leadership ethics. The similarities and differences among these theoretical models and measures to ethics-related leadership are discussed. © 2015 Wiley Periodicals, Inc., A Wiley Company.
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Navigating the ethics of cross-cultural health promotion research.
Haintz, Greer Lamaro; Graham, Melissa; McKenzie, Hayley
2015-12-01
Health promotion researchers must consider the ethics of their research, and are usually required to abide by a set of ethical requirements stipulated by governing bodies (such as the Australian National Health and Medical Research Council) and human research ethics committees (HRECs). These requirements address both deontological (rule-based) and consequence-based issues. However, at times there can be a disconnect between the requirements of deontological issues and the cultural sensitivity required when research is set in cultural contexts and settings etic to the HREC. This poses a challenge for health promotion researchers who must negotiate between meeting both the requirements of the HREC and the needs of the community with whom the research is being conducted. Drawing on two case studies, this paper discusses examples from cross-cultural health promotion research in Australian and international settings where disconnect arose and negotiation was required to appropriately meet the needs of all parties. The examples relate to issues of participant recruitment and informed consent, participants under the Australian legal age of consent, participant withdrawal when this seemingly occurs in an ad hoc rather than a formal manner and reciprocity. Although these approaches are context specific, they highlight issues for consideration to advance more culturally appropriate practice in research ethics and suggest ways a stronger anthropological lens can be applied to research ethics to overcome these challenges.
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Ethical issues in HIV prevention research with people who inject drugs.
Sugarman, Jeremy; Rose, Scott M; Metzger, David
2014-04-01
Injection drug use continues to significantly contribute to new infections with HIV. Moreover, conducting HIV prevention research with people who inject drugs (PWIDs) can be complicated for an array of practical, social, legal, and ethical reasons. It is critical that these research efforts are sensitive to the particular vulnerabilities associated with injection drug use as well as those related to being at risk of acquiring HIV so as to minimize harm to participants in research. To describe how we addressed some of these ethical challenges during the course of a large-scale multinational randomized HIV prevention trial involving PWIDs, which was successfully completed. The ethical issues encountered during the life cycle of the trial were cataloged by the principal investigator, study coordinator, and ethicist working on the trial. Relevant study documents were then reviewed to provide pertinent details. The ethical issues unique to the trial were then described. Before implementation, the trial faced particularly complex challenges related to the vulnerability of PWIDs, where HIV seroincidence rates in the population were high and legal policies and stigma regarding injection drug use was severe. Accordingly, a rapid policy assessment was commissioned, and a series of community engagement activities were conducted. During the trial, in addition to using careful standard operating procedures regarding all aspects of trial conduct and extensive staff training, the trial standardized informed consent procedures and assessed them. Furthermore, social harms were monitored along with physical harms and adverse events. Following the decision to close the study, it was critical to develop an orderly and safe process for closing it. The issue of post-trial access to the study medication and a complex intervention also surfaced for consideration. The issues described in this article are necessarily limited to how they manifested themselves within the context of a
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Ethical Aspects of Research in Ultrafast Communication
Driessen, A.; Sollie, Paul; Düwell, Marcus
This chapter summarizes the reflections of a scientist active in optical communication about the need of ethical considerations in technological research. An optimistic definition of ethics, being the art to make good use of technology, is proposed that emphasizes the necessarily involvement of not
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A Systematic Literature Review of US Engineering Ethics Interventions.
Hess, Justin L; Fore, Grant
2018-04-01
Promoting the ethical formation of engineering students through the cultivation of their discipline-specific knowledge, sensitivity, imagination, and reasoning skills has become a goal for many engineering education programs throughout the United States. However, there is neither a consensus throughout the engineering education community regarding which strategies are most effective towards which ends, nor which ends are most important. This study provides an overview of engineering ethics interventions within the U.S. through the systematic analysis of articles that featured ethical interventions in engineering, published in select peer-reviewed journals, and published between 2000 and 2015. As a core criterion, each journal article reviewed must have provided an overview of the course as well as how the authors evaluated course-learning goals. In sum, 26 articles were analyzed with a coding scheme that included 56 binary items. The results indicate that the most common methods for integrating ethics into engineering involved exposing students to codes/standards, utilizing case studies, and discussion activities. Nearly half of the articles had students engage with ethical heuristics or philosophical ethics. Following the presentation of the results, this study describes in detail four articles to highlight less common but intriguing pedagogical methods and evaluation techniques. The findings indicate that there is limited empirical work on ethics education within engineering across the United States. Furthermore, due to the large variation in goals, approaches, and evaluation methods described across interventions, this study does not detail "best" practices for integrating ethics into engineering. The science and engineering education community should continue exploring the relative merits of different approaches to ethics education in engineering.
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Ethical issues in the qualitative researcher--participant relationship.
Eide, Phyllis; Kahn, David
2008-03-01
Qualitative research poses ethical issues and challenges unique to the study of human beings. In developing the interpersonal relationship that is critical to qualitative research, investigator and participant engage in a dialogic process that often evokes stories and memories that are remembered and reconstituted in ways that otherwise would not occur. Ethical issues are raised when this relationship not only provides qualitative research data, but also leads to some degree of therapeutic interaction for the participant. The purpose of this article is to examine some of the controversies inherent in the researcher's dilemma when this occurs, set within the context of a nursing caring theory (Swanson), and the International Council of Nurses Code of ethics for nurses, which provides guidance on global nursing practice.
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Medical ethics research between theory and practice.
ten Have, H A; Lelie, A
1998-06-01
The main object of criticism of present-day medical ethics is the standard view of the relationship between theory and practice. Medical ethics is more than the application of moral theories and principles, and health care is more than the domain of application of moral theories. Moral theories and principles are necessarily abstract, and therefore fail to take account of the sometimes idiosyncratic reality of clinical work and the actual experiences of practitioners. Suggestions to remedy the illness of contemporary medical ethics focus on re-establishing the connection between the internal and external morality of medicine. This article discusses the question how to develop a theoretical perspective on medical ethical issues that connects philosophical reflection with the everyday realities of medical practice. Four steps in a comprehensive approach of medical ethics research are distinguished: (1) examine health care contexts in order to obtain a better understanding of the internal morality of these practices; this requires empirical research; (2) analyze and interpret the external morality governing health care practices; sociological study of prevalent values, norms, and attitudes concerning medical-ethical issues is required; (3) creation of new theoretical perspectives on health care practices; Jensen's theory of healthcare practices will be useful here; (4) develop a new conception of bioethics that illuminates and clarifies the complex interaction between the internal and external morality of health care practices. Hermeneutical ethics can be helpful for integrating the experiences disclosed in the empirical ethical studies, as well as utilizing the insights gained from describing the value-contexts of health care practices. For a critical and normative perspective, hermeneutical ethics has to examine and explain the moral experiences uncovered, in order to understand what they tell us.
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Controversies in nursing ethics: a historical review.
Olsen, D P
1992-09-01
The author critiques the dialectic between justice-based ethics and an ethic of caring from a historical perspective (by analogy with the dialectic between agape and friendship). Justice-based ethics have been problematic for nursing because of the decontextualized approach. The ethic of caring is problematic because caring, being contextual, is particularistic and therefore can be based on morally irrelevant factors, such as liking. There is a tradition of writing which seeks to reconcile the particularistic obligations of friendship with the moral duty to all others equally. Ideas from the following authors are reviewed for relevance to nursing: Aristotle, Aelred of Rievaulx, Augustine, John Cassian, Cicero, George Berkeley, Immanuel Kant, Michel de Montaigne, Jeremy Taylor and Max Weber. The authors concludes by noting that both sides of the dialectic are synthesized in the lived experience of individuals. A synthesis in thought is called for on this basis.
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Students' Involvement in Faculty Research: Ethical and Methodological Issues
Directory of Open Access Journals (Sweden)
Linda M. Ferguson
2004-12-01
Full Text Available Faculty who engage students as participants in their qualitative research often encounter methodological and ethical problems. Ethical issues arise from the fiduciary relationship between faculty and their students, and violations of that relationship occur when the educator has a dual role as researcher with those students. Methodological issues arise from research designs to address these ethical issues. This conflict is particularly evident in faculty research on pedagogy in their own disciplines, for which students are necessary as participants but are captive in the relationship. In this article, the authors explore the issues of double agency when faculty involve students as participants in their research.
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Rewind, review, reflect and fast forward: from Ethics to GeoEthics.
Marone, Eduardo
2017-04-01
Philosophy has as many definitions as philosophers but, at the end of the day, it is no more and no less than the science of thinking using the reason. It gives us tools for rationalizing, following logical paths and with a critical eye, to understand the material and immaterial substance of the universe. It has many branches, and a couple of them, Ethics and Epistemology, are central for the evolution of the human knowledge, among many others. Today, at the XXI Century, it seems that the lack of formal and adequate education on such important matters is making the act of "thinking" not so important when compared with the accumulation of "information", right or wrong, pasteurized or in disconnected pieces, with no much room/time for critical and logical analysis (Philosophy). If the tools to build the knowledge (Epistemology) are not usually familiar to the scientists and, worst, the need of taking the right actions with the generated new and existing knowledge (Ethics) is not a priority; the outputs cannot be the best ones. There have been several academic works and meetings looking into the causes of the scholarly illiteracy on Ethics and Epistemology in Earth Sciences. Among them, our sessions at EGU have endured showing important aspects that need to be tackled and, particularly, insisting in the fact that it is a continuous effort. However, we still need to go back (Rewind) to the main principles of Philosophy, Epistemology and Ethics, looking at them with care (Review), and think (Reflecting) returning to the present (Fast Forward) to make the world better for future generations. Geoethics consists of research and reflection on the values that underpin appropriate behaviours and practices, wherever human activities interact with the Earth system. Although more general ethical issues, which affect other/all sciences practices and behaviours, are included among the Geoethic concerns (as plagiarism, harassment, gender equity, etc.), the focus remains at the
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Evaluating clinical ethics support in mental healthcare: a systematic literature review.
Hem, M.H.; Pedersen, R.; Norvoll, R.; Molewijk, A.C.
2015-01-01
A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five
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Seitzer, F; Kahrass, H; Neitzke, G; Strech, D
2016-02-01
Dealing systematically with ethical issues in amyotrophic lateral sclerosis (ALS) care requires an unbiased awareness of all the relevant ethical issues. The aim of the study was to determine systematically and transparently the full spectrum of ethical issues in ALS care. We conducted a systematic review in Medline and Google Books (restricted to English and German literature published between 1993 and 2014). We applied qualitative text analysis and normative analysis to categorise the spectrum of ethical issues in ALS care. The literature review retrieved 56 references that together mentioned a spectrum of 103 ethical issues in ALS care. The spectrum was structured into six major categories that consist of first and second-order categories of ethical issues. The systematically derived spectrum of ethical issues in ALS care presented in this paper raises awareness and understanding of the complexity of ethical issues in ALS care. It also offers a basis for the systematic development of informational and training materials for health professionals, patients and their relatives, and society as a whole. Finally, it supports a rational and fair selection of all those ethical issues that should be addressed in health policies, position papers and clinical practice guidelines. Further research is needed to identify ways to systematically select the most relevant ethical issues not only in the clinical environment, but also for the development of clinical practice guidelines.
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Reflexive Research Ethics for Environmental Health and Justice: Academics and Movement-Building
Cordner, Alissa; Ciplet, David; Brown, Phil; Morello-Frosch, Rachel
2012-01-01
Community-engaged research on environmental problems has reshaped researcher-participant relationships, academic-community interaction, and the role of community partners in human subjects protection and ethical oversight. We draw on our own and others’ research collaborations with environmental health and justice social movement organizations to discuss the ethical concerns that emerge in community-engaged research. In this paper we introduce the concept of reflexive research ethics: ethical guidelines and decision-making principles that depend on continual reflexivity concerning the relationships between researchers and participants. Seeing ethics in this way can help scientists conduct research that simultaneously achieves a high level of professional conduct and protects the rights, well-being, and autonomy of both researchers and the multiple publics affected by research. We highlight our research with community-based organizations in Massachusetts, California, and Alaska, and discuss the potential impacts of the community or social movement on the research process and the potential impacts of research on community or social movement goals. We conclude by discussing ways in which the ethical concerns that surface in community-engaged research have led to advances in ethical research practices. This type of work raises ethical questions whose answers are broadly relevant for social movement, environmental, and public health scholars. PMID:22690133
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Evaluating Research Ethics Training in the Maryland Sea Grant REU Program
Allen, M. R.; Kumi, G. A.; Kumi, B. C.; Moser, F. C.
2016-02-01
The NSF's Research Experiences for Undergraduates (REU) program is an opportunity to cultivate responsible research practices in researchers at an early stage in their career. However, teaching responsible research conduct and science ethics in this program has been challenging because of a lack of consensus regarding which instructional methods are most effective for educating students about ethical concepts and establishing the process of ethical decision-making. Over the last 15 years, Maryland Sea Grant's REU ethics program has evolved by exploring different teaching models and looking for ways to effectively engage upper level undergraduates throughout their summer experience in ethical responsibility training. Since 2007, we have adopted a concerted experiential learning approach that includes an ethics seminar, role playing, case studies, and reflection. Currently, our summer long ethics training includes: 1) an interactive seminar; 2) a workshop with role playing and case studies; 3) 1-2 readings; and 4) a roundtable discussion with faculty mentors and their mentees to discuss researchers' real-world experiences with ethical dilemmas. Within the last 3 years, we have expanded our student learning outcomes assessments by administering pre- and post-program surveys to assess ethical skills students acquire through the program. Reevaluations administered three and six years after the REU experience will measure long term effectiveness of the training. Results from the first group of students reveal a greater awareness of ethical issues following our summer program. Students show a high level of competence about "black and white" issues (falsification, fabrication, plagiarism), but are more challenged by ethical "gray areas" such as data ownership and authorship. Results suggest many undergraduates come to research programs with basic ethics training, but benefit from our additional focus on complex ethical dilemmas.
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The ethics of animal research: a UK perspective.
Perry, Pauline
2007-01-01
The Nuffield Council on Bioethics, an independent body in the United Kingdom, has published a 2005 report titled The Ethics of Research Involving Animals. The Report, produced by a Working Party that represented a wide range of views, seeks to clarify the debate that surrounds this topic and aims to help people identify and analyze the relevant scientific and ethical issues. The Working Party considered the arguments surrounding whether animal research yields useful results, and recommends that its predictability and transferability should be evaluated more fully, particularly in controversial areas. Commonly encountered ethical questions and arguments were considered in order to understand what lies behind disagreement on the moral justification of animal research. Four possible ethical positions on animal research, which represent points on a continuum, are described. Despite the range of views that exist among members of the Working Party, the Report presents a "Consensus Statement" that identifies agreement on several important issues. Building on this statement, recommendations are made for improving the quality of the debate and promoting the 3Rs (refinement, reduction, and replacement).
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Ethics in family violence research: cross-cultural issues.
Fontes, L A
1998-01-01
This article examines ethical issues in cross-cultural research on family violence. It suggests ways for researchers to increase understanding and avoid abuses of power. Special attention to informed consent, definition of the sample, composition of the research team, research methods, and potential harm and benefit are considered key to designing ethical cross-cultural research. The discussion is illustrated with examples from the literature and from the author's experiences conducting research on sexual abuse in a shanty town in Chile and with Puerto Ricans in the U.S.
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Ethical Issues in the Use of Humans for Research.
Bashaw, W. L.
The APA Ethical Principles, the University of Georgia policy, standard research texts, and research literature on specific methodologies, all in relation to ethical issues in human research, are discussed. The 10 APA principles state, in essence, that the investigator is responsible for what happens, that confidentiality and the protection of the…
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Ethical issues in research involving children and young people
International Nuclear Information System (INIS)
Scally, Andy
2014-01-01
This article identifies the key ethical issues that need to be addressed in any research study involving children and young people, accessed through the NHS. It makes specific reference to the Declaration of Helsinki and to additional guidance developed for researchers from a variety of disciplines, both within healthcare and in other fields of study. The focus of the paper is on defining the key ethical issues, identifying the complexities in the legislative framework underpinning research involving this patient group and offering practical advice on when, and how, ethical approval needs to be sought
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2012-01-01
Background The methodology of medical ethics during the last few decades has shifted from a predominant use of normative-philosophical analyses to an increasing involvement of empirical methods. The articles which have been published in the course of this so-called 'empirical turn' can be divided into conceptual accounts of empirical-normative collaboration and studies which use socio-empirical methods to investigate ethically relevant issues in concrete social contexts. Discussion A considered reference to normative research questions can be expected from good quality empirical research in medical ethics. However, a significant proportion of empirical studies currently published in medical ethics lacks such linkage between the empirical research and the normative analysis. In the first part of this paper, we will outline two typical shortcomings of empirical studies in medical ethics with regard to a link between normative questions and empirical data: (1) The complete lack of normative analysis, and (2) cryptonormativity and a missing account with regard to the relationship between 'is' and 'ought' statements. Subsequently, two selected concepts of empirical-normative collaboration will be presented and how these concepts may contribute to improve the linkage between normative and empirical aspects of empirical research in medical ethics will be demonstrated. Based on our analysis, as well as our own practical experience with empirical research in medical ethics, we conclude with a sketch of concrete suggestions for the conduct of empirical research in medical ethics. Summary High quality empirical research in medical ethics is in need of a considered reference to normative analysis. In this paper, we demonstrate how conceptual approaches of empirical-normative collaboration can enhance empirical research in medical ethics with regard to the link between empirical research and normative analysis. PMID:22500496
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Ethical considerations in biomedical research: a personal view.
Dahlöf, Carl
2013-06-01
Ethical considerations are made when an experiment is planned and take a regulatory system of moral principles into account. Ethical considerations should first and foremost be made in order to protect the individual subject/animal from being exposed to any unethical and perhaps even illegal intervention and to ensure that the experimental conditions used are appropriate. The main role of research ethics committees is to assess the scientific and ethical aspects of submitted protocols and follow up the trial until its closure.
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Salloch, Sabine; Wäscher, Sebastian; Vollmann, Jochen; Schildmann, Jan
2015-04-04
Empirical-ethical research constitutes a relatively new field which integrates socio-empirical research and normative analysis. As direct inferences from descriptive data to normative conclusions are problematic, an ethical framework is needed to determine the relevance of the empirical data for normative argument. While issues of normative-empirical collaboration and questions of empirical methodology have been widely discussed in the literature, the normative methodology of empirical-ethical research has seldom been addressed. Based on our own research experience, we discuss one aspect of this normative methodology, namely the selection of an ethical theory serving as a background for empirical-ethical research. Whereas criteria for a good ethical theory in philosophical ethics are usually related to inherent aspects, such as the theory's clarity or coherence, additional points have to be considered in the field of empirical-ethical research. Three of these additional criteria will be discussed in the article: (a) the adequacy of the ethical theory for the issue at stake, (b) the theory's suitability for the purposes and design of the empirical-ethical research project, and (c) the interrelation between the ethical theory selected and the theoretical backgrounds of the socio-empirical research. Using the example of our own study on the development of interventions which support clinical decision-making in oncology, we will show how the selection of an ethical theory as a normative background for empirical-ethical research can proceed. We will also discuss the limitations of the procedures chosen in our project. The article stresses that a systematic and reasoned approach towards theory selection in empirical-ethical research should be given priority rather than an accidental or implicit way of choosing the normative framework for one's own research. It furthermore shows that the overall design of an empirical-ethical study is a multi-faceted endeavor which has to
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Are students kidding with health research ethics? The case of HIV/AIDS research in Cameroon
Directory of Open Access Journals (Sweden)
Munung Nchangwi
2012-06-01
Full Text Available Abstract Background Universities in Cameroon are playing an active part in HIV/AIDS research and much of this research is carried out by students, usually for the purpose of a dissertation/thesis. Student theses/dissertations present research findings in a much more comprehensive manner and have been described as the stepping-stone of a budding scientist’s potential in becoming an independent researcher. It is therefore important to verify how students handle issues of research ethics. Method Theses/dissertations on HIV/AIDS that described research studies involving the use of human research participants were screened to verify if research ethics approval and informed consent were obtained and documented. The contents of the consent forms were also qualitatively analyzed. Results Of 174 theses/dissertations on HIV, ethics approval was documented in 17 (9.77% and informed consent in 77 (47.83%. Research ethics approval was first mentioned at all in 2002 and highly reported in the year 2007. Evidence of ethics approval was found for the first time in 2005 and informed consent first observed and evidenced in 1997. Ethics approval was mostly reported by students studying for an MD (14.01% and was not reported in any Bachelors’ degree dissertation. Informed consent was also highly reported in MD theses (64.58% followed by undergraduate theses (31.58%. Voluntary participation and potential benefits of the study were some of the common aspects dealt with in most of the consent forms. The right to discontinue participation in the study and management of residual samples were scarcely ever mentioned. Conclusions Overall, and given the current state of the art of research ethics around the world, student-scientists in Cameroon would seem to be merely kidding with research ethics. It is thus essential that training in health research ethics (HRE be incorporated in the curriculum of universities in Cameroon in order that the next generation of
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Molyneux, Sassy; Tsofa, Benjamin; Barasa, Edwine; Nyikuri, Mary Muyoka; Waweru, Evelyn Wanjiku; Goodman, Catherine; Gilson, Lucy
2016-12-01
There is a growing interest in the ethics of Health Policy and Systems Research (HPSR), and especially in areas that have particular ethical salience across HPSR. Hyder et al (2014) provide an initial framework to consider this, and call for more conceptual and empirical work. In this paper, we respond by examining the ethical issues that arose for researchers over the course of conducting three HPSR studies in Kenya in which health managers and providers were key participants. All three studies involved qualitative work including observations and individual and group interviews. Many of the ethical dilemmas researchers faced only emerged over the course of the fieldwork, or on completion, and were related to interactions and relationships between individuals operating at different levels or positions in health/research systems. The dilemmas reveal significant ethical challenges for these forms of HPSR, and show that potential 'solutions' to dilemmas often lead to new issues and complications. Our experiences support the value of research ethics frameworks, and suggest that these can be enriched by incorporating careful consideration of context embedded social relations into research planning and conduct. Many of these essential relational elements of ethical practice, and of producing quality data, are given stronger emphasis in social science research ethics than in epidemiological, clinical or biomedical research ethics, and are particularly relevant where health systems are understood as social and political constructs. We conclude with practical and research implications. © 2016 The Authors Developing World Bioethics Published by John Wiley & Sons Ltd.
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Ethical aspects in clinical trials in the CIS, in particular the setting up of ethical committees.
Kubar, Olga
2005-01-01
The ethical aspects of clinical trials in the CIS are based on the development of systematic ethical review and ethical insight and responsibility on the part of researchers, sponsors, and government agencies and society. This is the main purpose of the Forum for Ethics Committees in the Commonwealth of Independent States (FECCIS) whose establishment and activities are focused on the integration of the CIS into the world system of biomedical research with regard to safeguarding ethical standards of human rights protection and harmonization of regulative and methodological space to safeguard protection of human rights and the dignity of biomedical research participants in the CIS.
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Walker, Marquita
2013-01-01
This summative evaluation is the result of two years' of data reflecting the impact of an ethics class in terms of students' ethical decision-making. The research compares aggregate responses from scenario-based pre- and post-survey open-ended survey questions designed to measure changes in ethical decision-making by comparing students' cognitive…
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Mahieu, Lieslot; Gastmans, Chris
2012-03-01
Admission to a nursing home might challenge the way in which individuals experience their own sexuality, but it does not automatically diminish their need and desire for sexual fulfillment. Despite the fact that sexuality proves to be an intrinsic part of human existence, the sexual expression of geriatric residents remains a sensitive subject for many caregivers and family members. It evokes a variety of ethical issues and concerns, especially when dementia patients are involved. The overall objective of this review was to examine the ethical arguments and concepts about the debate on sexuality within a nursing home environment. We conducted a systematic search for argument-based ethics literature focusing on sexuality in institutionalized elderly people. Twenty-five appropriate studies were identified. A thematic analysis of the included literature led us to distinguish two major groups of ethical arguments: (i) principles and (ii) care. Ethics arguments on sexuality in institutionalized elderly are particularly guided by the principle of respect for autonomy and the concomitant notion of informed consent. Arguments related to care were also apparent within the research literature although they received considerably less attention than the arguments related to the principles of respect for autonomy, beneficence, nonmaleficence and justice. The lack of clarity in the conceptualization of the arguments referred to in the research literature indicates that there is a pressing need for a better defined, more fundamental philosophical-ethical analysis of the values at stake.
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Protecting vulnerable research participants: a Foucault-inspired analysis of ethics committees.
Juritzen, Truls I; Grimen, Harald; Heggen, Kristin
2011-09-01
History has demonstrated the necessity of protecting research participants. Research ethics are based on a concept of asymmetry of power, viewing the researcher as powerful and potentially dangerous and establishing ethics committees as external agencies in the field of research. We argue in favour of expanding this perspective on relationships of power to encompass the ethics committees as one among several actors that exert power and that act in a relational interplay with researchers and participants. We employ Michel Foucault's ideas of power as an omnipresent force which is dynamic and unstable, as well as the notion that knowledge and power are inextricably intertwined. The article discusses how research ethics committees may affect academic freedom. In addition it is pointed out that research participants could be harmed - not only by unfortunate research practices, but also by being subjected to the protective efforts of ethics monitoring bodies.
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Ethics and community-based participatory research: perspectives from the field.
Bastida, Elena M; Tseng, Tung-Sung; McKeever, Corliss; Jack, Leonard
2010-01-01
Exploring the importance of ethical issues in the conduct of community-based participatory research (CBPR) continues to be an important topic for researchers and practitioners. This article uses the Beyond Sabor Project, a CBPR project implemented in the Lower Rio Grande Valley, as a case example to discuss ethical issues such as the importance of increasing community involvement in research, ensuring that communities benefit from the research, sharing leadership roles, and sensitive issues regarding data collection and sharing. Thereafter, this article concludes with a brief discussion of six principles that can inform the practice of ethical conduct when implementing CBPR studies. This article also lists additional reading resources on the importance of ethics in the conduct of CBPR.
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Clinical research ethics in Irish healthcare: diversity, dynamism and medicalization.
LENUS (Irish Health Repository)
Condell, Sarah L
2012-11-01
Gaining ethical clearance to conduct a study is an important aspect of all research involving humans but can be time-consuming and daunting for novice researchers. This article stems from a larger ethnographic study that examined research capacity building in Irish nursing and midwifery. Data were collected over a 28-month time frame from a purposive sample of 16 nurse or midwife research fellows who were funded to undertake full-time PhDs. Gaining ethical clearance for their studies was reported as an early \\'rite of passage\\' in the category of \\'labouring the doctorate\\'. This article penetrates the complexities in Irish clinical research ethics by describing the practices these nurse and midwife researchers encountered and the experiences they had. The key issue of representation that occurred in the context of \\'medicalized\\' research ethics is further explored including its meaning for nursing or midwifery research.
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Dorfman, Robert G; Vaca, Elbert E; Fine, Neil A; Schierle, Clark F
2017-10-01
Recent videos shared by plastic surgeons on social media applications such as Snapchat, Instagram, and YouTube, among others, have blurred the line between entertainment and patient care. This has left many in the plastic surgery community calling for the development of more structured oversight and guidance regarding video sharing on social media. To date, no official guidelines exist for plastic surgeons to follow. Little is known about the ethical implications of social media use by plastic surgeons, especially with regard to video sharing. A systematic review of the literature on social media use in plastic surgery was performed on October 31, 2016, with an emphasis on ethics and professionalism. An ethical analysis was conducted using the four principles of medical ethics. The initial search yielded 87 articles. Thirty-four articles were included for analyses that were found to be relevant to the use of social media in plastic surgery. No peer-reviewed articles were found that mentioned Snapchat or addressed the ethical implications of sharing live videos of plastic surgery on social media. Using the four principles of medical ethics, it was determined that significant ethical concerns exist with broadcasting these videos. This analysis fills an important gap in the plastic surgery literature by addressing the ethical issues concerning live surgery broadcasts on social media. Plastic surgeons may use the guidelines proposed here to avoid potential pitfalls.
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Digital storytelling as a method in health research: a systematic review protocol.
Rieger, Kendra L; West, Christina H; Kenny, Amanda; Chooniedass, Rishma; Demczuk, Lisa; Mitchell, Kim M; Chateau, Joanne; Scott, Shannon D
2018-03-05
Digital storytelling is an arts-based research method with potential to elucidate complex narratives in a compelling manner, increase participant engagement, and enhance the meaning of research findings. This method involves the creation of a 3- to 5-min video that integrates multimedia materials including photos, participant voices, drawings, and music. Given the significant potential of digital storytelling to meaningfully capture and share participants' lived experiences, a systematic review of its use in healthcare research is crucial to develop an in-depth understanding of how researchers have used this method, with an aim to refine and further inform future iterations of its use. We aim to identify and synthesize evidence on the use, impact, and ethical considerations of using digital storytelling in health research. The review questions are as follows: (1) What is known about the purpose, definition, use (processes), and contexts of digital storytelling as part of the research process in health research? (2) What impact does digital storytelling have upon the research process, knowledge development, and healthcare practice? (3) What are the key ethical considerations when using digital storytelling within qualitative, quantitative, and mixed method research studies? Key databases and the grey literature will be searched from 1990 to the present for qualitative, quantitative, and mixed methods studies that utilized digital storytelling as part of the research process. Two independent reviewers will screen and critically appraise relevant articles with established quality appraisal tools. We will extract narrative data from all studies with a standardized data extraction form and conduct a thematic analysis of the data. To facilitate innovative dissemination through social media, we will develop a visual infographic and three digital stories to illustrate the review findings, as well as methodological and ethical implications. In collaboration with national
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A Study on an Effective Education Strategy for Enhancing the Researcher's Ethics
Energy Technology Data Exchange (ETDEWEB)
Min, Byung-Joo; Hwang, In-A; Choi, Sun-Yeong; Kwon, Hyuk; Lee, Dae Sung; Yoo, Jae-Bok
2007-12-15
Pressure on the researcher has been increased by R and D competition and outcome-oriented evaluation system in the circumstance of increased R and D investment of government and high speed of technological development. Education for research ethics and conscience is more needed for the purpose of researcher's healthy and sound research attitude in this high pressured research environment. This textbook and educational module for research ethics are produced in order to satisfy the need. The text book, 'practical research ethics', is consisted of three chapters. Chapter one, Consciousness of the Research Ethics, deals with the background, definition, and importance of the ethics. Second chapter, Communion, discusses responsible research attitudes, and verification process under research ethical guideline. Chapter 3, Practice of Research Ethics, demonstrates practical guideline. Code and Rules of Ministry of Science and Technology related with the issues and foreign cases are compiled in appendix. Educational module for the textbook includes diverse materials, examples, and video. Educational technique for the module adopts participants' discussion, case analysis, and brain-storming. Applying the textbook and education module into each R and D Institute and academy is expected with suitable modification of each situation. The process will bring up internal discussion and consensus on the research ethics. Case analysis and composing network for practical adopting process will be the next step of this study.
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A Study on an Effective Education Strategy for Enhancing the Researcher's Ethics
International Nuclear Information System (INIS)
Min, Byung-Joo; Hwang, In-A; Choi, Sun-Yeong; Kwon, Hyuk; Lee, Dae Sung; Yoo, Jae-Bok
2007-12-01
Pressure on the researcher has been increased by R and D competition and outcome-oriented evaluation system in the circumstance of increased R and D investment of government and high speed of technological development. Education for research ethics and conscience is more needed for the purpose of researcher's healthy and sound research attitude in this high pressured research environment. This textbook and educational module for research ethics are produced in order to satisfy the need. The text book, 'practical research ethics', is consisted of three chapters. Chapter one, Consciousness of the Research Ethics, deals with the background, definition, and importance of the ethics. Second chapter, Communion, discusses responsible research attitudes, and verification process under research ethical guideline. Chapter 3, Practice of Research Ethics, demonstrates practical guideline. Code and Rules of Ministry of Science and Technology related with the issues and foreign cases are compiled in appendix. Educational module for the textbook includes diverse materials, examples, and video. Educational technique for the module adopts participants' discussion, case analysis, and brain-storming. Applying the textbook and education module into each R and D Institute and academy is expected with suitable modification of each situation. The process will bring up internal discussion and consensus on the research ethics. Case analysis and composing network for practical adopting process will be the next step of this study
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Procedure versus process: ethical paradigms and the conduct of qualitative research.
Pollock, Kristian
2012-09-27
Research is fundamental to improving the quality of health care. The need for regulation of research is clear. However, the bureaucratic complexity of research governance has raised concerns that the regulatory mechanisms intended to protect participants now threaten to undermine or stifle the research enterprise, especially as this relates to sensitive topics and hard to reach groups. Much criticism of research governance has focused on long delays in obtaining ethical approvals, restrictions imposed on study conduct, and the inappropriateness of evaluating qualitative studies within the methodological and risk assessment frameworks applied to biomedical and clinical research. Less attention has been given to the different epistemologies underlying biomedical and qualitative investigation. The bioethical framework underpinning current regulatory structures is fundamentally at odds with the practice of emergent, negotiated micro-ethics required in qualitative research. The complex and shifting nature of real world settings delivers unanticipated ethical issues and (occasionally) genuine dilemmas which go beyond easy or formulaic 'procedural' resolution. This is not to say that qualitative studies are 'unethical' but that their ethical nature can only be safeguarded through the practice of 'micro-ethics' based on the judgement and integrity of researchers in the field. This paper considers the implications of contrasting ethical paradigms for the conduct of qualitative research and the value of 'empirical ethics' as a means of liberating qualitative (and other) research from an outmoded and unduly restrictive research governance framework based on abstract prinicipalism, divorced from real world contexts and values.
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Ethical muscle and scientific interests: a role for philosophy in scientific research.
Kaposy, Chris
2008-03-01
Ethics, a branch of philosophy, has a place in the regulatory framework of human subjects research. Sometimes, however, ethical concepts and arguments play a more central role in scientific activity. This can happen, for example, when violations of research norms are also ethical violations. In such a situation, ethical arguments can be marshaled to improve the quality of the scientific research. I explore two different examples in which philosophers and scientists have used ethical arguments to plead for epistemological improvements in the conduct of research. The first example deals with research dishonesty in pharmaceutical development. The second example is concerned with neuropsychological research using fMRI technology.
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Feminist and community psychology ethics in research with homeless women.
Paradis, E K
2000-12-01
This paper presents a feminist and community psychology analysis of ethical concerns that can arise throughout the process of doing research with women who are homeless. The unique contexts of the lives of women who are homeless demand that researchers redefine traditional ethical constructs such as consent, privacy, harm, and bias. Research that fails to do this may perpetuate the stereotyping, marginalization, stigmatization, and victimization homeless women face. Feminist and community research ethics must go beyond the avoidance of harm to an active investment in the well-being of marginalized individuals and communities. Using feminist and community psychology ethics, this paper addresses some common problems in research with women who are homeless, and argues for the transformation of research from a tool for the advancement of science into a strategy for the empowerment of homeless women and their communities.
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[Research Ethics in Partnership with Benin : A call for Solidarity].
Bergeron, Michel
2017-05-22
Over the last decade, research ethics has developed in Benin partly through a partnership with Quebec. This partnership has evolved using TCPS2, the Canadian framework in research ethics. In doing so, three main values were put forward : respect for human dignity, respect for cultural diversity and solidarity. Over that time period, research ethics in Benin has structured through new Research Ethics Committees (REC) and though participation of those involved in research with human beings. REC members, researchers and students have acquired the needed tools to resolve most of the ethical dilemmas that could arise in the future making it one of the positive results of this partnership. Retrospectively, it has also been a situation where the Van Rensselaer Potter's perspective on bioethics has emerged in a French-speaking context where the spoken language and the French cultural approach is of great importance.
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Ethics of clinical trials in Nigeria.
Okonta, Patrick I
2014-05-01
The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.
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Painful dilemmas: the ethics of animal-based pain research
DEFF Research Database (Denmark)
Magalhães-Sant'Ana, M.; Sandøe, Peter; Olsson, I. A. S.
2009-01-01
While it has the potential to deliver important human benefits, animal-based pain research raises ethical questions, because it involves inducing pain in sentient beings. Ethical decision-making, connected with this variety of research, requires informed harm-benefit analysis, and the aim of this...
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Ethical considerations when employing fake identities in online social networks for research.
Elovici, Yuval; Fire, Michael; Herzberg, Amir; Shulman, Haya
2014-12-01
Online social networks (OSNs) have rapidly become a prominent and widely used service, offering a wealth of personal and sensitive information with significant security and privacy implications. Hence, OSNs are also an important--and popular--subject for research. To perform research based on real-life evidence, however, researchers may need to access OSN data, such as texts and files uploaded by users and connections among users. This raises significant ethical problems. Currently, there are no clear ethical guidelines, and researchers may end up (unintentionally) performing ethically questionable research, sometimes even when more ethical research alternatives exist. For example, several studies have employed "fake identities" to collect data from OSNs, but fake identities may be used for attacks and are considered a security issue. Is it legitimate to use fake identities for studying OSNs or for collecting OSN data for research? We present a taxonomy of the ethical challenges facing researchers of OSNs and compare different approaches. We demonstrate how ethical considerations have been taken into account in previous studies that used fake identities. In addition, several possible approaches are offered to reduce or avoid ethical misconducts. We hope this work will stimulate the development and use of ethical practices and methods in the research of online social networks.
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Operational effectiveness of blended e-learning program for nursing research ethics.
Cho, Kap-Chul; Shin, Gisoo
2014-06-01
Since 2006, the Korean Ministry of Education, Science and Technology, and the National Research Foundation of Korea have taken the lead in developing an institutional guideline for research ethics. The purpose was to identify the effectiveness of the Good Research Practice program, developed on a fund granted by the National Research Foundation of Korea, for nurses and nursing students whose knowledge and perception of research ethics were compared before and after the implementation of the Good Research Practice program. This study was conducted to compare the levels of knowledge and perception of research ethics in the participants before and after the program was implemented. The participants included 45 nurses and 69 nursing students from hospitals, colleges of nursing, and the Korean Nurses Association, located in Seoul, Korea. This study was approved by the Institutional Research Board in Korea. Based on the Analysis, Design, Development, Implementation, and Evaluation model, the Good Research Practice program was made up of a total of 30 h of the blended learning both online and off-line. The results of this study showed that there were statistically significant differences in both knowledge and perception of research ethics in nursing students and nurses before and after the program had been implemented. The concepts of professional nursing ethics, moral issues, and bioethics were often confused with one another and not clearly defined. Therefore, the concept and scope of bioethics, moral judgment, and overall nursing ethics should be well defined and conceptualized in the future. This study suggested integrating research ethics education in the nursing curriculum as a required course of study for nursing students and as part of the in-service training program for nurses in order to improve research ethics in nursing research in Korea. © The Author(s) 2013.
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Ethical Issues Surrounding the Use of Modern Human Remains for Research in South Africa.
Briers, N; Dempers, J J
2017-02-01
Chapter 8 of the South African National Health Act 61 of 2003 (NHA) that deals with the donation of human tissue was promulgated in 2012. The new Act is perceived to impose restrictions on low-risk research involving human remains. This study aimed to identify the issues raised by a research ethics committee (REC) when reviewing protocols where human remains are used as data source. REC minutes from 2009 to 2014 were reviewed, and issues raised by the committee were categorized. In total, 127 protocols submitted to the committee over 6 years involved human remains. Queries relating to science (22.2%) and administration (18.9%) were the most common, whereas queries relating to legal issues constituted only 10.2%. Ethical issues centered on informed consent regarding sensitive topics such as HIV, DNA, and deceased children. The change in legislation did not change the number or type of legal issues identified by the REC.
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Salma, Jordana; Ogilvie, Linda; Keating, Norah; Hunter, Kathleen F
Bicultural researchers are well positioned to identify tensions, disrupt binaries of positions, and reconcile differences across cultural contexts to ensure ethical research practices. This article focuses on a bicultural researcher's experiences of ethically important moments in research activities with Muslim immigrant women. Three ethical principles of respect, justice, and concern for welfare are highlighted, revealing the implications of binary constructions of identity, the value of situated knowledge in creating ethical research practices, and the need to recognize agency as a counterforce to oppressive narratives about Muslim women.
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Chan, Sarah; Harris, John
2006-10-01
Recent developments have progressed in areas of science that pertain to gene therapy and its ethical implications. This review discusses the current state of therapeutic gene technologies, including stem cell therapies and genetic modification, and identifies ethical issues of concern in relation to the science of gene therapy and its application, including the ethics of embryonic stem cell research and therapeutic cloning, the risks associated with gene therapy, and the ethics of clinical research in developing new therapeutic technologies. Additionally, ethical issues relating to genetic modification itself are considered: the significance of the human genome, the distinction between therapy and enhancement, and concerns regarding gene therapy as a eugenic practice.
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Ethics research in critically ill patients.
Estella, A
2018-05-01
Research in critical care patients is an ethical obligation. The ethical conflicts of intensive care research arise from patient vulnerability, since during ICU admission these individuals sometimes lose all or part of their decision making capacity and autonomy. We therefore must dedicate effort to ensure that neither treatment (sedation or mechanical ventilation) nor the disease itself can affect the right to individual freedom of the participants in research, improving the conditions under which informed consent must be obtained. Fragility, understood as a decrease in the capacity to tolerate adverse effects derived from research must be taken into account in selecting the participants. Research should be relevant, not possible to carry out in non-critical patients, and a priori should offer potential benefits that outweigh the risks that must be known and assumable, based on principles of responsibility. Copyright © 2018 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.
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Institutional review boards' attitudes towards remuneration in paediatric research
DEFF Research Database (Denmark)
Flege, Marius M; Thomsen, Simon F
2017-01-01
Remuneration in paediatric research poses an ethical dilemma. Too large a sum might cause parents to enrol their children in research projects with no benefit for the child, whereas too modest a sum might hamper recruitment. The institutional review boards have the responsibility to only approve ...
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The ethical desirability of moral bioenhancement: A review of reasons
J. Specker (Jona); F. Focquaert (Farah); K. Raus (Kasper); S. Sterckx (Sigrid); M.H.N. Schermer (Maartje)
2014-01-01
textabstractBackground: The debate on the ethical aspects of moral bioenhancement focuses on the desirability of using biomedical as opposed to traditional means to achieve moral betterment. The aim of this paper is to systematically review the ethical reasons presented in the literature for and
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Parker, Lisa S
2002-02-01
Focusing on bipolar disorders research, this article considers ethical issues of informed consent and privacy arising in genetic pedigree research at two stages: the construction of tentative pedigrees to determine family eligibility for study and, subsequently, the enrollment of subjects in and conduct of the family study. Increasing concern to protect the privacy of family members of primary subjects or probands, following ethical controversy over a survey study at Virginia Commonwealth University, has led some researchers and Institutional Review Boards (IRBs) to apply informed consent requirements to those represented on a tentative pedigree at the initial stage of research. This article analyzes the possible benefits, risks, and burdens to prospective subjects of seeking prospective consent for pedigree construction at this initial stage. It argues that the likely risk-benefit ratio favors granting a waiver of consent requirements for this stage of pedigree research and presents grounds for IRBs to grant such a waiver. The article closes by considering particular ethical concerns that should be addressed in the informed consent discussion when enrolling subjects in pedigree studies of bipolar disorder, including concerns about subjects' competence to consent, management of interim and incidental findings, and issues particular to psychiatric research.
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24 CFR 4.34 - Review of Inspector General's report by the Ethics Law Division.
2010-04-01
... report by the Ethics Law Division. 4.34 Section 4.34 Housing and Urban Development Office of the... Funding Decisions § 4.34 Review of Inspector General's report by the Ethics Law Division. After receipt of the Inspector General's report, the Ethics Law Division shall review the facts and circumstances of...
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Ethics in action: Approving and improving medical research with human subjects
de Jong, J.P.
2013-01-01
In this thesis, Jean Philippe de Jong presents a new understanding of ethical oversight on medical research with human subjects and proposes that two philosophies for ethical oversight exist: '(dis)approving' and 'improving'. Systems for ethical oversight on medical research have been in place for
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Espinoza, Nicolas; Peterson, Martin
2012-08-01
The contention of this paper is that the current ethical debate over embryonic stem cell research is polarised to an extent that is not warranted by the underlying ethical conflict. It is argued that the ethical debate can be rendered more nuanced, and less polarised, by introducing non-binary notions of moral rightness and wrongness. According to the view proposed, embryonic stem cell research--and possibly other controversial activities too--can be considered 'a little bit right and a little bit wrong'. If this idea were to become widely accepted, the ethical debate would, for conceptual reasons, become less polarised.
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Ethical issues in international biomedical research: an overview.
Page, Alice K
2004-01-01
Human subjects research has been the focus of numerous controversies over the years. The dilemma lies between the potential harm to individuals who participate in research and the knowledge to be gained from the research study that might benefit society. When research is conducted in developing countries by researchers and sponsors from the United States and other industrialized countries, differences in history, culture, politics, wealth, and power between the countries give rise to unique challenges. In this Article, the author identifies several ethical issues to be considered when research is conducted in developing countries and provides the legal and ethical framework for their resolution.
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Ethically sustainable governance in the biobanking of eggs and embryos for research.
Stroud, Karla; O'Doherty, Kieran C
2015-12-01
Biobanking of human tissues is associated with a range of ethical, legal, and social (ELS) challenges. These include difficulties in operationalising informed consent protocols, protecting donors' privacy, managing the return of incidental findings, conceptualising ownership of tissues, and benefit sharing. Though largely unresolved, these challenges are well documented and debated in academic literature. One common response to the ELS challenges of biobanks is a call for strong and independent governance of biobanks. Theorists who argue along these lines suggest that since fully informed consent to a single research project is often not feasible, research participants should be given the additional protection of being allowed to consent to the governance framework of the biobank. Such governance therefore needs to be transparent and ethically sustainable. In this paper we review the governance challenges of establishing and maintaining human tissue biobanks. We then discuss how the creation of a biobank for eggs and embryos, in particular, may introduce additional or unique challenges beyond those presented by the biobanking of other human tissues. Following previous work on biobank governance, we argue that ethically sustainable governance needs to be participatory, adaptive, and trustworthy.
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The ethics of wildlife research: a nine R theory.
Curzer, Howard J; Wallace, Mark C; Perry, Gad; Muhlberger, Peter J; Perry, Dan
2013-01-01
The commonsense ethical constraints on laboratory animal research known as the three Rs are widely accepted, but no constraints tailored to research on animals in the wild are available. In this article, we begin to fill that gap. We sketch a set of commonsense ethical constraints on ecosystem research parallel to the constraints that govern laboratory animal research. Then we combine the animal and ecosystem constraints into a single theory to govern research on animals in the wild.
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The Ethics of Qualitative Nursing Research.
Robley, Lois R.
1995-01-01
Ethical issues in qualitative nursing research include the following: what to study, which participants, what methods, how to achieve informed consent, when to terminate interviews and when to probe, when treatment should supersede research, and what and how to document in case studies. (SK)
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Finlay, K A; Fernandez, C V
2008-10-01
The Declaration of Helsinki prohibits the publication of articles that do not meet defined ethical standards for reporting of research ethics board (REB) approval and informed consent. Despite this prohibition and a call to highlight the deficiency for the reader, articles with potential ethical shortcomings continue to be published. To determine what proportion of articles in major medical journals lack statements confirming REB approval and informed consent, and whether accompanying commentary alerts readers to this deficiency. Retrospective, observational study. Online review of five major medical journals. All clinical research articles published online between 1 January 2005 and 31 December 2006 in the BMJ, Lancet, Annals of Internal Medicine, JAMA and the New England Journal of Medicine. Statement of REB approval and informed consent. Of 1780 articles reviewed, 1133 (63.7%) met inclusion criteria (manuscripts reporting human subjects, human tissue or identifiable personal data research), 36 (3.2%) articles lacked a statement of REB approval, 62 (5.5%) lacked disclosure of informed consent and 15 (1.3%) articles lacked both. Articles that did not state REB approval were associated with not stating informed consent (pjournals without editorial statements to alert the reader to this deficiency.
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Health impacts and research ethics in female trafficking.
Dhital, S R; Aro, R A; Sapkota, K
2011-04-01
Female trafficking is a social and public health problem, associated with physical and sexual abuse, psychological trauma, injuries from violence, sexually transmitted infections, adverse reproductive outcomes and substance misuse. It faces several challenges ranging from the hidden nature of the problem to ethical and human rights issues. The objectives of this paper are to analyze health impact of trafficking; ethical and research issues and anti-trafficking strategies in the Nepalese context. We collected published and unpublished data assessing the public health, ethical burden and research needs from different sources. Trafficked female involved in sex-industry that face grave situation as depicted and it might a reservoir of sexually transmitted diseases. Ethical issues related to survey of assessing the burden are difficult to carry out. The best ways to prevent and control these problems are to enhance anti- trafficking laws and raise awareness, empower and mobilize females and establish organizational capacity.
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Partnering with patients in translational oncology research: ethical approach.
Mamzer, Marie-France; Duchange, Nathalie; Darquy, Sylviane; Marvanne, Patrice; Rambaud, Claude; Marsico, Giovanna; Cerisey, Catherine; Scotté, Florian; Burgun, Anita; Badoual, Cécile; Laurent-Puig, Pierre; Hervé, Christian
2017-04-08
The research program CARPEM (cancer research and personalized medicine) brings together the expertise of researchers and hospital-based oncologists to develop translational research in the context of personalized or "precision" medicine for cancer. There is recognition that patient involvement can help to take into account their needs and priorities in the development of this emerging practice but there is currently no consensus about how this can be achieved. In this study, we developed an empirical ethical research action aiming to improve patient representatives' involvement in the development of the translational research program together with health professionals. The aim is to promote common understanding and sharing of knowledge between all parties and to establish a long-term partnership integrating patient's expectations. Two distinct committees were settled in CARPEM: an "Expert Committee", gathering healthcare and research professionals, and a "Patient Committee", gathering patients and patient representatives. A multidisciplinary team trained in medical ethics research ensured communication between the two committees as well as analysis of discussions, minutes and outputs from all stakeholders. The results highlight the efficiency of the transfer of knowledge between interested parties. Patient representatives and professionals were able to identify new ethical challenges and co-elaborate new procedures to gather information and consent forms for adapting to practices and recommendations developed during the process. Moreover, included patient representatives became full partners and participated in the transfer of knowledge to the public via conferences and publications. Empirical ethical research based on a patient-centered approach could help in establishing a fair model for coordination and support actions during cancer research, striking a balance between the regulatory framework, researcher needs and patient expectations. Our approach addresses