WorldWideScience

Sample records for research ethics review

  1. Is mandatory research ethics reviewing ethical?

    Science.gov (United States)

    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.

  2. 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....

  3. Participatory action research: considerations for ethical review.

    Science.gov (United States)

    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.

  4. Communicating Qualitative Research Study Designs to Research Ethics Review Boards

    Science.gov (United States)

    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…

  5. Measuring inconsistency in research ethics committee review

    OpenAIRE

    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...

  6. Research Ethics: Institutional Review Board Oversight of Art Therapy Research

    Science.gov (United States)

    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…

  7. Measuring inconsistency in research ethics committee review.

    Science.gov (United States)

    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.

  8. 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.

  9. Getting the justification for research ethics review right.

    Science.gov (United States)

    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.

  10. Ethical issues in trauma-related research: a review.

    Science.gov (United States)

    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.

  11. Ethical review from the inside: repertoires of evaluation in Research Ethics Committee meetings

    NARCIS (Netherlands)

    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

  12. Human rights, politics, and reviews of research ethics.

    Science.gov (United States)

    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.

  13. Ethical Issues in Radiology Journalism, Peer Review, and Research.

    Science.gov (United States)

    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.

  14. An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review

    Science.gov (United States)

    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

  15. An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review

    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

  16. An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review.

    Science.gov (United States)

    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

  17. Research Ethics II: Mentoring, Collaboration, Peer Review, and Data Management and Ownership

    Science.gov (United States)

    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,…

  18. A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review

    Science.gov (United States)

    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

  19. A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.

    Science.gov (United States)

    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.

  20. A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.

    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.

  1. Feasibility of rapid ethical assessment for the Ethiopian health research ethics review system.

    Science.gov (United States)

    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.

  2. 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.

  3. Resisting the seduction of "ethics creep": using Foucault to surface complexity and contradiction in research ethics review.

    Science.gov (United States)

    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.

  4. 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.

  5. Research Ethics

    Science.gov (United States)

    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…

  6. The Challenge of Timely, Responsive and Rigorous Ethics Review of Disaster Research: Views of Research Ethics Committee Members.

    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

  7. Review of existing issues, ethics and practices in general medical research and in radiation protection research

    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)

  8. Ethics review of health research on human participants in South Africa.

    Science.gov (United States)

    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.

  9. A Selected Review of the Underpinnings of Ethics for Human Performance Technology Professionals--Part One: Key Ethical Theories and Research.

    Science.gov (United States)

    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…

  10. Ethical review of research on human subjects at Unilever: reflections on governance.

    Science.gov (United States)

    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.

  11. In defence of governance: ethics review and social research.

    Science.gov (United States)

    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.

  12. A Review of Research Ethics in Internet-Based Research

    Science.gov (United States)

    Convery, Ian; Cox, Diane

    2012-01-01

    Internet-based research methods can include: online surveys, web page content analysis, videoconferencing for online focus groups and/or interviews, analysis of "e-conversations" through social networking sites, email, chat rooms, discussion boards and/or blogs. Over the last ten years, an upsurge in internet-based research (IBR) has led…

  13. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

    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

  14. Research Ethics: Reforming Postgraduate Formation

    Science.gov (United States)

    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…

  15. Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees – results from a descriptive questionnaire-based study

    OpenAIRE

    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...

  16. Institutional ethical review and ethnographic research involving injection drug users: a case study.

    Science.gov (United States)

    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.

  17. ETHICAL REVIEW OF BIOMEDICAL RESEARCH IN BELARUS: CURRENT STATUS, PROBLEMS AND PERSPECTIVES.

    Science.gov (United States)

    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.

  18. Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand.

    Science.gov (United States)

    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

  19. Methods for Practising Ethics in Research and Innovation : A Literature Review, Critical Analysis and Recommendations

    NARCIS (Netherlands)

    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

  20. Review Article: Ethical Issues in the Study of Second Language Acquisition--Resources for Researchers

    Science.gov (United States)

    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…

  1. The Impact of Ethics Review on a Research-Led University Curriculum: Results of a Qualitative Study in Australia.

    Science.gov (United States)

    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.

  2. A new prescription for empirical ethics research in pharmacy: a critical review of the literature

    OpenAIRE

    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...

  3. Ethics, Ethical Human Research and Human Research Ethics Committees

    Science.gov (United States)

    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…

  4. Ethics in research.

    Science.gov (United States)

    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.

  5. Contesting the science/ethics distinction in the review of clinical research

    Science.gov (United States)

    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

  6. Anthropological Research in Light of Research-Ethics Review: Canadian Master's Theses, 1995-2004.

    Science.gov (United States)

    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.

  7. Research ethics for clinical researchers.

    Science.gov (United States)

    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.

  8. Research Ethics Review and Aboriginal Community Values: Can the Two be Reconciled?

    Science.gov (United States)

    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.

  9. Enhancing Research Ethics Review Systems in Egypt: The Focus of an International Training Program Informed by an Ecological Developmental Approach to Enhancing Research Ethics Capacity.

    Science.gov (United States)

    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.

  10. Ethical dilemmas in community-based participatory research: recommendations for institutional review boards.

    Science.gov (United States)

    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

  11. Ethical Dilemmas in Community-Based Participatory Research: Recommendations for Institutional Review Boards

    Science.gov (United States)

    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

  12. South African Research Ethics Committee Review of Standards of Prevention in HIV Vaccine Trial Protocols.

    Science.gov (United States)

    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.

  13. Ethical issues in research.

    Science.gov (United States)

    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.

  14. Action Researchers Encountering Ethical Review: A Literature Synthesis on Challenges and Strategies

    Science.gov (United States)

    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…

  15. Ethics of health policy and systems research: a scoping review of the literature.

    Science.gov (United States)

    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

  16. Tiny tweaks, big changes: An alternative strategy to empower ethical culture of human research in anesthesia (A Taiwan Acta Anesthesiologica Taiwanica-Ethics Review Task Force Report).

    Science.gov (United States)

    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.

  17. Ethics challenges and guidance related to research involving adolescent post-abortion care: a scoping review.

    Science.gov (United States)

    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

  18. Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries

    Science.gov (United States)

    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

  19. Qualitative Study to improve integrity of NET : Perspectives of Peer review and Authorship in research ethics

    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.

  20. Qualitative Study to improve integrity of NET : Perspectives of Peer review and Authorship in research ethics

    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

  1. Attitudes Toward the Ethics of Research Using Social Media: A Systematic Review

    Science.gov (United States)

    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

  2. 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.

  3. Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees - results from a descriptive questionnaire-based study.

    Science.gov (United States)

    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

  4. Ethics in Higher Education Research

    Science.gov (United States)

    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…

  5. Attitudes Toward the Ethics of Research Using Social Media: A Systematic Review.

    Science.gov (United States)

    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

  6. Description and Evaluation of the Research Ethics Review Process in Japan: Proposed Measures for Improvement.

    Science.gov (United States)

    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.

  7. The ethics of HIV research with people who inject drugs in Africa: a desk review.

    Science.gov (United States)

    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.

  8. Out of the frying pan? Streamlining the ethics review process of multisite qualitative research projects.

    Science.gov (United States)

    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.

  9. Ethics and marketing research

    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.

  10. 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.

  11. Advancing Ethical Neuroscience Research.

    Science.gov (United States)

    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.

  12. Research in business ethics

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    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.

  13. Review: Will van den Hoonaard (Ed. (2002. Walking the Tightrope: Ethical Issues for Qualitative Researchers

    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

  14. Review: Melanie Mauthner, Maxine Birch, Julie Jessop & Tina Miller (Eds. (2002. Ethics in Qualitative Research

    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

  15. 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...

  16. Research ethics and Institutional Review Boards. The influence of moral constraints on emotion research.

    Science.gov (United States)

    Sontag, Michael

    2012-01-01

    Researchers in the twenty-first century face a set of challenges unknown to researchers a half century ago--the need to justify the moral acceptability of their research methods through formal review processes. However, the role that moral constraints play in the development and demise of scientific theories has largely gone unappreciated. The rise of Institutional Review Boards (IRB) in the 1960s compounded the impact of moral constraints on scientific research and on the theories that develop out of such highly monitored research. To demonstrate the effects of moral constraints on scientific theory and research, this paper offers a history and analysis of the interaction between evolving moral standards and twentieth century emotion theory. Recommendations regarding IRB reform are also reviewed. The paper concludes by arguing that, while appropriate IRB reform is important, it cannot eliminate the need for careful reflection on the broader forces that shape scientific practice and understanding.

  17. 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...

  18. Review of national research ethics regulations and guidelines in Middle Eastern Arab countries

    Science.gov (United States)

    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

  19. Ethics in research

    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.

  20. Developments in stem cell research and therapeutic cloning: Islamic ethical positions, a review.

    Science.gov (United States)

    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.

  1. Ethics in Research

    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.

  2. Ethics in Digital Research

    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...

  3. 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.

  4. Internet Research Ethics and the Policy Gap for Ethical Practice in Online Research Settings

    Science.gov (United States)

    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…

  5. Ethics review in compassionate use.

    Science.gov (United States)

    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.

  6. 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....

  7. What Do Ethical Guidelines for Epidemiology Say About an Ethics Review? A Qualitative Systematic Review.

    Science.gov (United States)

    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.

  8. Ethical Review of Undergraduate Student Research Projects: A Proportionate, Transparent and Efficient Process?

    Science.gov (United States)

    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…

  9. Realising the technological promise of smartphones in addiction research and treatment: An ethical review.

    Science.gov (United States)

    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.

  10. Research Ethics Capacity Building in Sub-Saharan Africa: A Review of NIH Fogarty-Funded Programs 2000–2012

    Science.gov (United States)

    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

  11. Research ethics capacity building in Sub-Saharan Africa: a review of NIH Fogarty-funded programs 2000–2012.

    Science.gov (United States)

    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.

  12. 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

  13. Research Ethics III: Publication Practices and Authorship, Conflicts of Interest, and Research Misconduct

    Science.gov (United States)

    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…

  14. Ethical conduct for research : a code of scientific ethics

    Science.gov (United States)

    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...

  15. Organizational ethics: a literature review.

    Science.gov (United States)

    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

  16. Perceptions about safety and risks in gender-based violence research: implications for the ethics review process.

    Science.gov (United States)

    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.

  17. Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees

    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.

  18. Introduction: international research ethics education.

    Science.gov (United States)

    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.

  19. Continuing Education in Research Ethics for the Clinical Nurse.

    Science.gov (United States)

    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)

  20. The Ethics of Archival Research

    Science.gov (United States)

    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.…

  1. Ethical issues in research involving minority populations: the process and outcomes of protocol review by the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, Thailand

    Science.gov (United States)

    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

  2. A scoping review of reporting 'Ethical Research Practices' in research conducted among refugees and war-affected populations in the Arab world.

    Science.gov (United States)

    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.

  3. Ethical Issues in Internet Research: International Good Practice and Irish Research Ethics Documents

    Science.gov (United States)

    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…

  4. Professional ethics in nursing: an integrative review.

    Science.gov (United States)

    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.

  5. A Scoping Study on the Ethics of Health Systems Research.

    Science.gov (United States)

    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.

  6. Ethics in clinical research: the Indian perspective.

    Science.gov (United States)

    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.

  7. Research ethics consultation: ethical and professional practice challenges and recommendations.

    Science.gov (United States)

    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.

  8. Research Ethics Consultation: Ethical and Professional Practice Challenges and Recommendations

    Science.gov (United States)

    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

  9. Balanced Ethics Review: A Guide for Institutional Review Board Members

    Directory of Open Access Journals (Sweden)

    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

  10. Experiential Learning and Research Ethics: Enhancing Knowledge through Action

    Science.gov (United States)

    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…

  11. Understanding Ethical Issues of Research Participation from the Perspective of Participating Children and Adolescents: A Systematic Review

    Science.gov (United States)

    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

  12. Steps to strengthen ethics in organizations: research findings, ethics placebos, and what works.

    Science.gov (United States)

    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.

  13. Trends in Canadian Sociology Master's Theses in Relation to Research Ethics Review, 1995-2004.

    Science.gov (United States)

    van den Hoonaard, Will C

    2006-12-01

    THIS PAPER EXAMINES TRENDS IN CANADIAN Master's theses in sociology, 1995-2004, in the course the implementation of Canada's national research-ethics guidelines (2001), using data available from ProQuest Dissertations. While there has been no decline in the number of theses completed during this period, nearly 1/4 fewer theses now involve research participants. The proportion of theses using quantitative methods shows decline; theses using qualitative methods, however, have increased significantly over time. A closer inspection qualitative theses shows an impressive increase in the proportion of theses using interviews, while the decrease in theses using field work is even more dramatic, from 40% to 5%. The decrease of theses involving field work is particularly alarming for a significant segment of sociology that must derive its material mainly from field work. Data drawn from a larger study supplement the findings in this article.

  14. A review of ethical issues in dementia.

    Science.gov (United States)

    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.

  15. Research Ethics in Big Data.

    Science.gov (United States)

    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.

  16. [Review of the methodological, ethical, legal and social issues of research projects in healthcare with big data].

    Science.gov (United States)

    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.

  17. Human research ethics committees in technical universities.

    Science.gov (United States)

    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.

  18. Internet research and ethics: transformative issues in nursing education research.

    Science.gov (United States)

    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.

  19. Ethics, Governance, Research and Enterprise

    Science.gov (United States)

    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…

  20. Ethical issues in research with homeless youths.

    Science.gov (United States)

    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.

  1. Review paper on research ethics in Ethiopia: experiences and lessons learnt from Addis Ababa University College of Health Sciences 2007-2012.

    Science.gov (United States)

    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.

  2. Ethics approval: responsibilities of journal editors, authors and research ethics committees.

    Science.gov (United States)

    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.

  3. 'Wicked' ethics: Compliance work and the practice of ethics in HIV research.

    Science.gov (United States)

    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.

  4. Applying for ethical approval for research: the main issues.

    Science.gov (United States)

    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.

  5. Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview.

    Science.gov (United States)

    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.

  6. Ethics and mental illness research.

    Science.gov (United States)

    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

  7. Ethical virtues in scientific research.

    Science.gov (United States)

    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.

  8. Ethical modernization: research misconduct and research ethics reforms in Korea following the Hwang affair.

    Science.gov (United States)

    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.

  9. Ethics and regulation in organ procurement research.

    Science.gov (United States)

    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.

  10. Brief report : ethical problems in research practice

    OpenAIRE

    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 ...

  11. 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 ...

  12. 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.

  13. 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

  14. Ethnocentric ethics in anthropological research

    NARCIS (Netherlands)

    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

  15. Ethical aspects in tissue research: thematic analysis of ethical statements to the research ethics committee

    Science.gov (United States)

    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

  16. Research Ethics I: Responsible Conduct of Research (RCR)--Historical and Contemporary Issues Pertaining to Human and Animal Experimentation

    Science.gov (United States)

    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…

  17. Ethics in Animal-Based Research.

    Science.gov (United States)

    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.

  18. Research ethics in dissertations: ethical issues and complexity of reasoning.

    Science.gov (United States)

    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.

  19. Human research ethics committees: examining their roles and practices.

    Science.gov (United States)

    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.

  20. A Research Agenda for Humanitarian Health Ethics

    Science.gov (United States)

    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

  1. 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 ...

  2. Research ethics review at University Eduardo Mondlane (UEM)/Maputo Central Hospital, Mozambique (2013-2016): a descriptive analysis of the start-up of a new research ethics committee (REC).

    Science.gov (United States)

    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

  3. Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

    Science.gov (United States)

    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/

  4. Using Short Videos to Teach Research Ethics

    Science.gov (United States)

    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.

  5. Researching the Ethical Dimensions of Mobile, Ubiquitous and Immersive Technology Enhanced Learning (MUITEL): A Thematic Review and Dialogue

    Science.gov (United States)

    Lally, Vic; Sharples, Mike; Tracy, Frances; Bertram, Neil; Masters, Sherriden

    2012-01-01

    In this article, we examine the ethical dimensions of researching the mobile, ubiquitous and immersive technology enhanced learning (MUITEL), with a particular focus on learning in informal settings. We begin with an analysis of the interactions between mobile, ubiquitous and immersive technologies and the wider context of the digital economy. In…

  6. 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.

  7. Research ethics and private harms.

    Science.gov (United States)

    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.

  8. Book review ‒ “Ethics and Neuromarketing: Implications for Market Research and Business Practice”

    Directory of Open Access Journals (Sweden)

    Silviu Gabriel Szentesi

    2017-08-01

    Full Text Available Conceiving efficient marketing research tools, able to generate accurate and real data helps to prove scientifically the decision making in marketing. Starting from this practical need in market research, in the contemporary informational society, new ways of action and advancement appear due to the development of marketing, as well as the progress of information technology and the human brain scanning and magnetic resonance imaging techniques. In 2013, in the European Union, a flagship project began to support the development of researches concerning the carrying out of a human-type brain entitled: Human Brain Project, as part of Horizon 2020 FET (HBP, 2017. This project will allow the researchers to develop their knowledge in the field of neurosciences and their understanding in the human brain working.

  9. 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.

  10. Research governance: new hope for ethics committees?

    Science.gov (United States)

    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.

  11. Literacy Research, Ethics and Social Responsibility

    Science.gov (United States)

    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…

  12. Ethical concerns and career satisfaction in obstetrics and gynecology: a review of recent findings from the Collaborative Ambulatory Research Network.

    Science.gov (United States)

    Farrow, Victoria A; Leddy, Meaghan A; Lawrence, Hal; Schulkin, Jay

    2011-09-01

    Obstetricians-gynecologists (ob-gyns) are frequently confronted with situations that have ethical implications (e.g., whether to accept gifts or samples from drug companies or disclosing medical errors to patients). Additionally, various factors, including specific job-related tasks, costs, and benefits, may impact ob-gyns' career satisfaction. Ethical concerns and career satisfaction can play a role in the quality of women's health care. This article summarizes the studies published between 2005 and 2009 by the Research Department of the American College of Obstetricians and Gynecologists, which encompass ethical concerns regarding interactions with pharmaceutical representatives and patient safety/medical error reporting, as well as ob-gyn career satisfaction. Additionally, a brief discussion regarding ethical concerns in the ob-gyn field, in general, highlights key topics for the last 30 years. Ethical dilemmas continue to be of concern for ob-gyns. Familiarity with guidelines on appropriate interactions with industry is associated with lower percentages of potentially problematic relationships with pharmaceutical industries. Physicians report that the expense of patient safety initiatives is one of the top barriers for improving patient safety, followed by fear of liability. Overall, respondents reported being satisfied with their careers. However, half of the respondents reported that they were extremely concerned about the impact of professional liability costs on the duration of their careers. Increased familiarity with guidelines may lead to a decreased ob-gyn reliance on pharmaceutical representatives and free samples, whereas specific and practical tools may help them implement patient safety techniques. The easing of malpractice insurance and threat of litigation may enhance career satisfaction among ob-gyns. This article will discuss related findings in recent years. Obstetricians & Gynecologists and Family Physicians. After the completing the CME

  13. Ethics of reviewing scientific publications.

    Science.gov (United States)

    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.

  14. 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...

  15. Towards an ethics safe harbor for global biomedical research

    Science.gov (United States)

    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

  16. Ethics and research in critical care.

    Science.gov (United States)

    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.

  17. What Price Ethics: New Research Directions in Counselor Ethical Behavior

    Science.gov (United States)

    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)

  18. Evaluation of clinical trials by Ethics Committees in Germany: Experience of applicants with the review of requests for opinion of the Ethics Committees - results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA

    Directory of Open Access Journals (Sweden)

    Russ, Hagen

    2009-07-01

    Full Text Available The review of requests for a positive opinion of the ethics committees (application procedure as a requirement to start a clinical trial in Germany has been completely redesigned with the transposition of EU Directive 2001/20/EC in the 12th Amendment of the German Medicines Act in August 2004. The experience of applicants (sponsors, legal representatives of sponsors in the EU and persons or organizations authorized by the sponsors to make the application, respectively in terms of interactions with the ethics committees in Germany has been positive overall, especially with respect to ethics committee adherence to the statutory timelines applicable for review of requests. However, inconsistencies between ethics committees exist in terms of the form and content of the requirements for application documents and their evaluation.With the objective of further improving both the quality of applications and the evaluation of those applications by ethics committees, a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA was conducted from January to April 2008. Based on reasoned opinions issued by the respective ethics committee in charge of the coordinating principal investigator (coordinating ethics committee, the type and frequency of formal and content-related objections to applications according to § 7 of the German Good Clinical Practice (GCP Regulation were systematically documented, and qualitative and quantitative analyses performed. 21 out of 44 members of the VFA participated in the survey. 288 applications for Phase I–IV studies submitted between January and December 2007 to 40 ethics committees were evaluated.This survey shows that about one in six applications is incomplete and has formal and/or content objections, respectively, especially those that pertain to documents demonstrating the qualification of the investigator and/or suitability of the facilities. These objections are attributable to

  19. Teaching ethical aptitude to graduate student researchers.

    Science.gov (United States)

    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.

  20. Ethical assessment of research protocols: the experience of the Research Ethics Committee of the Hospital Israelita Albert Einstein (HIAE

    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.

  1. Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences

    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

  2. Ethical issues in perinatal mental health research.

    Science.gov (United States)

    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.

  3. Ethics of research for patients in pain.

    Science.gov (United States)

    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.

  4. Research Ethics in Sign Language Communities

    Science.gov (United States)

    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…

  5. Ethics creep or governance creep? Challenges for Australian Human Research Ethics Committees (HRECS).

    Science.gov (United States)

    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.

  6. Familiar ethical issues amplified: how members of research ethics committees describe ethical distinctions between disaster and non-disaster research.

    Science.gov (United States)

    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

  7. Innovations in research ethics governance in humanitarian settings.

    Science.gov (United States)

    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

  8. Trends in nursing ethics research: Mapping the literature production.

    Science.gov (United States)

    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

  9. Ethics in clinical research: The Indian perspective

    OpenAIRE

    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...

  10. When "Research Ethics" Become "Everyday Ethics": The Intersection of Inquiry and Practice in Practitioner Research

    Science.gov (United States)

    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…

  11. Ethical Issues in Cross-Cultural Research

    Science.gov (United States)

    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…

  12. Public titles of clinical trials should have ethics review.

    Science.gov (United States)

    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.

  13. 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)

  14. 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.

  15. Ethical Issues Surrounding Personalized Medicine: A Literature Review.

    Science.gov (United States)

    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.

  16. Will the new code help researchers to be more ethical?

    Science.gov (United States)

    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.

  17. Ethical review in Pakistan: the credibility gap.

    Science.gov (United States)

    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.

  18. Reconsidering 'ethics' and 'quality' in healthcare research: the case for an iterative ethical paradigm.

    Science.gov (United States)

    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

  19. Human Research Ethics Committees in Technical Universities

    NARCIS (Netherlands)

    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

  20. Health Research Ethics: Between Ethics Codes and Culture.

    Science.gov (United States)

    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.

  1. Research Review

    OpenAIRE

    Anonymous

    1983-01-01

    Research Reviewed: "The Adjustment of Nominal Interest Rates to Inflation: A Review of Recent Literature"; "Role of Government in a Market Economy"; "Economic Analysis and Agricultural Policy"; "Agricultural Research Policy"

  2. Public health ethics theory: review and path to convergence.

    Science.gov (United States)

    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.

  3. Ethics interventions for healthcare professionals and students: A systematic review.

    Science.gov (United States)

    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.

  4. Real-time Responsiveness for Ethics Oversight During Disaster Research.

    Science.gov (United States)

    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.

  5. Justice in human research ethics. A conceptual and practical guide.

    Science.gov (United States)

    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.

  6. Ethical responsibilities in nursing: research findings and issues.

    Science.gov (United States)

    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.

  7. Ethics and Truth in Archival Research

    Science.gov (United States)

    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…

  8. Balancing Ethics and Quality in Educational Research--The Ethical Matrix Method

    Science.gov (United States)

    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…

  9. From global bioethics to ethical governance of biomedical research collaborations.

    Science.gov (United States)

    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.

  10. Ethical Risk Management Education in Engineering: A Systematic Review.

    Science.gov (United States)

    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.

  11. Strangers at the Benchside: Research Ethics Consultation

    Science.gov (United States)

    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

  12. 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...

  13. The ethical challenges of animal research.

    Science.gov (United States)

    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.

  14. Ethical Issues in Qualitative E-Learning Research

    Directory of Open Access Journals (Sweden)

    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.

  15. An Evaluation of Research Ethics in Undergraduate Health Science Research Methodology Programs at a South African University.

    Science.gov (United States)

    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.

  16. Ethical Issues and Best Practice Considerations for Internet Research

    Science.gov (United States)

    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…

  17. Ethics and the ethnography of medical research in Africa

    Science.gov (United States)

    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

  18. Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative 'Pre-Review' Mechanism for a Study of Fexinidazole for Human African Trypanosomiasis.

    Science.gov (United States)

    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.

  19. HIV/AIDS research conducted in the developing world and sponsored by the developed world: reporting of research ethics committee review in two countries.

    Science.gov (United States)

    Chin, Lisa Judy; Rifai-Bashjawish, Hoda; Kleinert, Kelly; Saltman, Alexandra; Leu, Cheng-Shiun; Klitzman, Robert

    2011-09-01

    We explored how often journal articles reporting HIV research sponsored by a developed country, but conducted in a developing country, mention research ethics committee (REC) approval from both countries, and what factors are involved. Of all such 2007 articles on Medline conducted in one of four developing countries (N = 154), only 52% mentioned such dual approval. Mention of dual vs. single approval was more likely among articles with ≥ 50% sponsor country authors, and the United States as the sponsor country. Also, dual approval was more likely among articles that mentioned informed consent and funding, had ≥ 50% sponsor country authors, were biomedical (vs. psychosocial), and appeared in journals adopting International Committee Medical Journal Editors (ICMJE) guidelines. Dual approval was thus obtained in only half of the articles and was associated with ethical and logistic issues, indicating the need for clearer and more universally accepted guidelines.

  20. The ethics of peer review in bioethics

    Science.gov (United States)

    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

  1. Research Considerations in Ethical Education.

    Science.gov (United States)

    Hogan, Robert

    The author purports the need to treat moral education as a serious academic subject and suggests ways educators can manage it in an intellectually defensible way. Ethical education must avoid indoctrination, yet it should not be a mere training in philosophical ethics. The domain of moral education should include four partially interdependent…

  2. Ethical considerations in clinical training, care and research in psychopharmacology.

    Science.gov (United States)

    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.

  3. Ethics of social media research: common concerns and practical considerations.

    Science.gov (United States)

    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.

  4. How not to argue against mandatory ethics review.

    Science.gov (United States)

    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.

  5. Research Review

    OpenAIRE

    Anonymous

    1981-01-01

    Research Reviewed: "Global Modeling After Its First Decade"; "Monthly Food Price Forecasts"; "Costs of Marketing Slaughter Cattle: Computerized versus Conventional Auction Systems"; "Survival Strategies for Agricultural Cooperatives"

  6. IDRC's Advisory Committee on Research Ethics | IDRC ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    ACRE observes IDRC's Corporate Principles on Research Ethics. ... various published statements on the management of environmental research. ... equity while remaining sensitive to the cultural norms and practices of the localities where the ...

  7. 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.

  8. The Ethics of Sports Medicine Research.

    Science.gov (United States)

    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.

  9. Ethical Aspects of Research in Ultrafast Communication

    NARCIS (Netherlands)

    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

  10. Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview.

    OpenAIRE

    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...

  11. Ethics and epistemology of accurate prediction in clinical research.

    Science.gov (United States)

    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.

  12. Ethical Evaluation of Mental Health Social Research: Agreement Between Researchers and Ethics Committees.

    Science.gov (United States)

    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.

  13. 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.

  14. Factors influencing the effectiveness of research ethics committees.

    Science.gov (United States)

    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.

  15. "Living" Ethical Dilemmas for Researchers When Researching with Children

    Science.gov (United States)

    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.…

  16. 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.

  17. Qualitative research ethics on the spot: Not only on the desktop.

    Science.gov (United States)

    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.

  18. The Ethical Problems of Reserach : An empirical study of ethics in research practice

    OpenAIRE

    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...

  19. Ethical aspects of brain computer interfaces: a scoping review.

    Science.gov (United States)

    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.

  20. Mental health research, ethics and multiculturalism.

    Science.gov (United States)

    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.

  1. 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.

  2. 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.

  3. Necessity for ethics in social engineering research

    CSIR Research Space (South Africa)

    Mouton, F

    2015-11-01

    Full Text Available Social engineering is deeply entrenched in the fields of both computer science and social psychology. Knowledge is required in both these disciplines to perform social engineering based research. Several ethical concerns and requirements need...

  4. Many worlds, one ethic: design and development of a global research ethics training curriculum.

    Science.gov (United States)

    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.

  5. Ethics in nursing: A systematic review of the framework of evidence perspective.

    Science.gov (United States)

    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.

  6. Ethics Research in Environmental Education

    African Journals Online (AJOL)

    jenny

    2006-02-22

    Feb 22, 2006 ... Western cultures' anthropocentrism (or human centeredness), though it .... ethics doesn't have to be paralysed by perpetual self-doubt and/or relativism. .... I didn't ascribe to this story, at least as a complete theory, as a moral ...

  7. Rebuilding a Research Ethics Committee

    Science.gov (United States)

    Biggs, John S. G.; Marchesi, August

    2013-01-01

    The principal ethics committee in Australia's Capital, Canberra, underwent a major revision in the last three years based on changes debated in the literature. Committee or Board structure varies widely; regulations determining minimum size and membership differ between countries. Issues such as the effectiveness of committee management,…

  8. Peter Koslowski’s Ethics and Economics or Ethical Economy: A Framework for a research agenda in business ethics

    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.

  9. Reengineering Biomedical Translational Research with Engineering Ethics.

    Science.gov (United States)

    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.

  10. Spotlight on Ethics: Institutional Review Boards as Systemic Bullies

    Science.gov (United States)

    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…

  11. Towards improving the ethics of ecological research.

    Science.gov (United States)

    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.

  12. An ethical exploration of barriers to research on controlled drugs

    Science.gov (United States)

    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

  13. Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study.

    Science.gov (United States)

    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.

  14. Research Review

    Science.gov (United States)

    Serig, Dan, Ed.

    2010-01-01

    This research review is dedicated to the memory of William Safire (1929-2009). A visionary leader, Safire brought other visionaries, researchers, educators, artists, and policymakers together to explore the confluence of arts education and neuroscience. He fostered the new field of neuroeducation in his work as chair of The Dana Foundation in…

  15. Research Review

    Science.gov (United States)

    Serig, Dan

    2011-01-01

    In this review, the author explores an often-used process in research--the mind map. He uses this method in his own research and artwork. He also uses this extensively with students, particularly master students when they are trying to surround issues in their thesis projects. Mind maps are closely associated with brainstorming, as brainstorming…

  16. Ethical evaluation of research proposals by ethics panels advising the European Commission.

    Science.gov (United States)

    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.

  17. Nursing research ethics, guidance and application in practice.

    Science.gov (United States)

    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.

  18. Medical ethics research between theory and practice.

    Science.gov (United States)

    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.

  19. Controversies in nursing ethics: a historical review.

    Science.gov (United States)

    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.

  20. Ethical issues in the use of in-depth interviews: literature review and discussion

    OpenAIRE

    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...

  1. Ethical issues in the use of in-depth interviews: literature review and discussion\\ud

    OpenAIRE

    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 ...

  2. Ethical challenges for accountable care organizations: a structured review.

    Science.gov (United States)

    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

  3. What do international ethics guidelines say in terms of the scope of medical research ethics?

    Science.gov (United States)

    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.

  4. TOXICOLOGICAL RESEARCH INVOLVING HUMANS: ETHICAL AND REGULATORY CONSIDERATIONS

    Science.gov (United States)

    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...

  5. 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.

  6. The ethics of peer review in bioethics.

    Science.gov (United States)

    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.

  7. 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....

  8. Promoting Ethics and Integrity in Management Academic Research: Retraction Initiative.

    Science.gov (United States)

    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.

  9. Private-sector research ethics: marketing or good conflicts management? The 2005 John J. Conley Lecture on Medical Ethics.

    Science.gov (United States)

    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.

  10. The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research.

    Science.gov (United States)

    Megone, Christopher; Wilman, Eleanor; Oliver, Sandy; Duley, Lelia; Gyte, Gill; Wright, Judy

    2016-09-09

    Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials? In a systematic search, we identified 30 studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature. Between them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment. In addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental 'consent' to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental 'consent' in a perinatal context, parents are authorising infant participation, not giving 'proxy consent'. Finally, there are reasons for giving weight to both parental 'consent' and the infant's best interests in

  11. Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences.

    NARCIS (Netherlands)

    Vries, M.C. de; Houtlosser, M.; Wit, J.M.; Engberts, D.P.; Bresters, D.; Kaspers, G.J.L.; Leeuwen, E. van

    2011-01-01

    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

  12. The Ethics of Qualitative Nursing Research.

    Science.gov (United States)

    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)

  13. Ethical Considerations in Research Participation Virality.

    Science.gov (United States)

    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.

  14. 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.

  15. Ethical considerations in the study of online illness narratives: a qualitative review.

    Science.gov (United States)

    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.

  16. Ethical genetic research in Indigenous communities: challenges and successful approaches.

    Science.gov (United States)

    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.

  17. The HIV and Drug Abuse Prevention Research Ethics Training Institute: Training Early-Career Scientists to Conduct Research on Research Ethics

    Science.gov (United States)

    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

  18. The HIV and Drug Abuse Prevention Research Ethics Training Institute: Training Early-Career Scientists to Conduct Research on Research Ethics.

    Science.gov (United States)

    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.

  19. Research Ethics and Ethical Research: Some Observations from the Global South

    Science.gov (United States)

    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…

  20. Ethical Business Cultures: A Literature Review and Implications for HRD

    Science.gov (United States)

    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…

  1. [Bioethical Approach for Nursing Research -Focused on the Use of Research Ethics Committees].

    Science.gov (United States)

    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.

  2. Ethical and regulatory aspects of embryonic stem cell research.

    Science.gov (United States)

    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.

  3. Research Integrity and Research Ethics in Professional Codes of Ethics: Survey of Terminology Used by Professional Organizations across Research Disciplines.

    Science.gov (United States)

    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.

  4. Research Integrity and Research Ethics in Professional Codes of Ethics: Survey of Terminology Used by Professional Organizations across Research Disciplines

    Science.gov (United States)

    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

  5. Children in Medical Research : Ethical challenges

    NARCIS (Netherlands)

    W. Bos (Wendy)

    2017-01-01

    markdownabstractPaediatric research ethics evolves around a central dilemma. Either one has to accept that many childhood diseases cannot be (properly) treated and that many children receive treatments that are not (properly) tested in children, or one has to accept that children, i.e. vulnerable

  6. Sex Work Research: Methodological and Ethical Challenges

    Science.gov (United States)

    Shaver, Frances M.

    2005-01-01

    The challenges involved in the design of ethical, nonexploitative research projects with sex workers or any other marginalized population are significant. First, the size and boundaries of the population are unknown, making it extremely difficult to get a representative sample. Second, because membership in hidden populations often involves…

  7. Ethics and epidemiological research | Cullinan | Malawi Medical ...

    African Journals Online (AJOL)

    Journal Home > Vol 8, No 2 (1992) >. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register. Ethics and epidemiological research. T Cullinan. Abstract. No Abstract. Full Text: EMAIL FREE FULL TEXT EMAIL FREE FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL ...

  8. Ethical issues in irregular migration research

    NARCIS (Netherlands)

    Duvell, F.; Triandafyllidou, A.; Vollmer, B.

    2008-01-01

    This paper is concerned with the ethical issues arising for researchers engaged in the study of irregular migration. Irregular migration is by definition an elusive phenomenon as it takes place in violation of the law and at the margins of society. This very nature of the phenomenon raises important

  9. Ethics in research involving prisoners.

    Science.gov (United States)

    Pont, Jörg

    2008-01-01

    Research involving prisoners repeatedly went astray during the last century, culminating in the cruel medical experiments inside the Nazi concentration camps that gave rise to the Nuremberg Code. However, prisoners continued to become victims of scientific exploitation by the rapidly evolving biomedical research industry. The common roots of these abuses were the flawed philosophy that the needs of the society outweigh the needs of the individual and the researchers' view that prisoners are cheap, easy to motivate and stable research subjects. Prisoners are vulnerable to exploitation and abuse by research because their freedom for consent can easily be undermined, and because of learning disabilities, illiteracy and language barriers prevailing within prisoner populations. Therefore, penal laws of some countries supported by a number of internationally agreed documents prohibit research involving prisoners completely. However, prisoners must also be regarded as vulnerable to the specific health problems in prisons, e.g. transmissible diseases, mental disorders and suicide - problems that need to be addressed by research involving prisoners. Additionally, the participation of prisoner patients in research they directly can benefit from should be provided. Hence, it must be a common objective to find the right balance between protection from exploitation and access to research beneficial to prisoners.

  10. Ethics and Epistemology in Big Data Research.

    Science.gov (United States)

    Lipworth, Wendy; Mason, Paul H; Kerridge, Ian; Ioannidis, John P A

    2017-12-01

    Biomedical innovation and translation are increasingly emphasizing research using "big data." The hope is that big data methods will both speed up research and make its results more applicable to "real-world" patients and health services. While big data research has been embraced by scientists, politicians, industry, and the public, numerous ethical, organizational, and technical/methodological concerns have also been raised. With respect to technical and methodological concerns, there is a view that these will be resolved through sophisticated information technologies, predictive algorithms, and data analysis techniques. While such advances will likely go some way towards resolving technical and methodological issues, we believe that the epistemological issues raised by big data research have important ethical implications and raise questions about the very possibility of big data research achieving its goals.

  11. Ethics research in critically ill patients.

    Science.gov (United States)

    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.

  12. Whose Ethics, Whose Accountability? A Debate about University Research Ethics Committees

    Science.gov (United States)

    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…

  13. Ethical concerns of nursing reviewers: an international survey.

    Science.gov (United States)

    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.

  14. 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.

  15. Herbal medicine research and global health: an ethical analysis

    OpenAIRE

    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...

  16. Ethical Issues in Stem Cell Research

    OpenAIRE

    Lo, Bernard; Parham, Lindsay

    2009-01-01

    Stem cell research offers great promise for understanding basic mechanisms of human development and differentiation, as well as the hope for new treatments for diseases such as diabetes, spinal cord injury, Parkinson’s disease, and myocardial infarction. However, human stem cell (hSC) research also raises sharp ethical and political controversies. The derivation of pluripotent stem cell lines from oocytes and embryos is fraught with disputes about the onset of human personhood. The reprogramm...

  17. [Ethic review on clinical experiments of medical devices in medical institutions].

    Science.gov (United States)

    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.

  18. Ethics of animal research in human disease remediation, its institutional teaching; and alternatives to animal experimentation.

    Science.gov (United States)

    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.

  19. Ethics of Social Media Research: Common Concerns and Practical Considerations

    Science.gov (United States)

    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

  20. Sewage epidemiology and illicit drug research: the development of ethical research guidelines.

    Science.gov (United States)

    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.

  1. Ethics and Transgenic Crops: a Review

    OpenAIRE

    Robinson, Jonathan

    1999-01-01

    This article represents a review of some of the ethical dilemmas that have arisen as a result of the development and deployment of transgenic crop plants. The potential for transgenic crops to alleviate human hunger and the possible effects on human health are discussed. Risks and benefits to the environment resulting from genetic engineering of crops for resistance to biotic and abiotic stresses are considered, in addition to effects on biodiversity. The socio-economic impacts and distributi...

  2. Research ethics and integrity for social scientists beyond regulatory compliance

    CERN Document Server

    Israel, Mark

    2014-01-01

    This book explores recent developments and debates around researching ethically and with integrity, and complying with ethical requirements, and has been updated and expanded to now cover issues relating to international, indigenous, interdisciplinary and internet research.  

  3. Ethical Medical and Biomedical Practice in Health Research in Africa

    International Development Research Centre (IDRC) Digital Library (Canada)

    Ethical Medical and Biomedical Practice in Health Research in Africa ... of research studies that do not conform with international ethical standards and ... Journal articles ... IDRC congratulates first cohort of Women in Climate Change Science ...

  4. The ethics in qualitative health research: special considerations.

    Science.gov (United States)

    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.

  5. 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.

  6. 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.

  7. [Educational needs assessment on research ethics among nursing researchers].

    Science.gov (United States)

    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.

  8. Regulations and Ethical Considerations for Astronomy Education Research III: A Suggested Code of Ethics

    Science.gov (United States)

    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…

  9. Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study

    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

  10. Ethics of conducting research in conflict settings

    Directory of Open Access Journals (Sweden)

    Mills Edward J

    2009-07-01

    Full Text Available Abstract Humanitarian agencies are increasingly engaged in research in conflict and post-conflict settings. This is justified by the need to improve the quality of assistance provided in these settings and to collect evidence of the highest standard to inform advocacy and policy change. The instability of conflict-affected areas, and the heightened vulnerability of populations caught in conflict, calls for careful consideration of the research methods employed, the levels of evidence sought, and ethical requirements. Special attention needs to be placed on the feasibility and necessity of doing research in conflict-settings, and the harm-benefit ratio for potential research participants.

  11. An ethic of analysis: an argument for critical analysis of research interviews as an ethical practice.

    Science.gov (United States)

    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.

  12. Why to audit to research ethics committees?

    OpenAIRE

    Quiroz, Estela; Médica oftalmóloga, docente de ética y metodología de la investigación, Coordinadora de la Red Peruana de Comités de Ética de la Investigación. Hospital Nacional Hipólito Unanue. Lima, Perú.

    2010-01-01

    Ethics committees in biomedical research have the responsibility to ensure the protection of human participants in the studies. In order to improve the quality of their work they must undergo audit procedures commissioned by the sponsors and inspections done by the regulatory authorities. Through these procedures, improvement of their functions should be guaranteed, so they can optimize their tasks and accomplish in the best way the purpose for which they were created. Los comités de ét...

  13. [Patents and scientific research: an ethical-legal approach].

    Science.gov (United States)

    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.

  14. The history of ethics in research with human subjects

    OpenAIRE

    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...

  15. Research Ethics with Undergraduates in Summer Research Training Programs

    Science.gov (United States)

    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.

  16. "It's the Way That You Do It": Developing an Ethical Framework for Community Psychology Research and Action.

    Science.gov (United States)

    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.

  17. RESEARCH ON ENVIRONMENTAL HEALTH INTERVENTIONS: ETHICAL PROBLEMS AND SOLUTIONS

    Science.gov (United States)

    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

  18. The full spectrum of ethical issues in dementia care: systematic qualitative review.

    Science.gov (United States)

    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.

  19. Ethical Challenges in Infant Feeding Research

    Directory of Open Access Journals (Sweden)

    Colin Binns

    2017-01-01

    Full Text Available Infants have a complex set of nutrient requirements to meet the demands of their high metabolic rate, growth, and immunological and cognitive development. Infant nutrition lays the foundation for health throughout life. While infant feeding research is essential, it must be conducted to the highest ethical standards. The objective of this paper is to discuss the implications of developments in infant nutrition for the ethics of infant feeding research and the implications for obtaining informed consent. A search was undertaken of the papers in the medical literature using the PubMed, Science Direct, Web of Knowledge, Proquest, and CINAHL databases. From a total of 9303 papers identified, the full text of 87 articles that contained discussion of issues in consent in infant feeding trials were obtained and read and after further screening 42 papers were included in the results and discussion. Recent developments in infant nutrition of significance to ethics assessment include the improved survival of low birth weight infants, increasing evidence of the value of breastfeeding and evidence of the lifelong importance of infant feeding and development in the first 1000 days of life in chronic disease epidemiology. Informed consent is a difficult issue, but should always include information on the value of preserving breastfeeding options. Project monitoring should be cognisant of the long term implications of growth rates and early life nutrition.

  20. Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project

    Science.gov (United States)

    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

  1. Developing Ethics and Standards in Action Research

    Directory of Open Access Journals (Sweden)

    Ben Boog

    2008-12-01

    Full Text Available In a globalizing world, what role can social science research – particularly action research – play in order to address the risks of exclusion, poverty, social and physical insecurity and environmental deprivation? More specifically, how can this type of research be conducted in a participatory, responsible, transparent and scientific way? In other words: what about the ethics and standards in action research? This was the main focus of the World Congress on Action Research and Action Learning (August 2006 organized by the University of Groningen and the Higher Education Group of the Northern Netherlands. We begin by discussing the core characteristics of action research with reference to theory and practice. Reflection and action are key constituents of the process through the enactment of action research. The middle section draws upon the research findings presented at the congress and published in a book [B. Boog, J. Preece, M. Slagter and J. Zeelen (Eds. (2008 Towards Quality Improvement of Action Research. Developing Ethics and Standards, Rotterdam/Taipei: Sense Publishers]. Citing authors who contributed chapters to the book mentioned above, we analyze four important subthemes: ‘participation, power and rapport’; ‘quality of research and quality management’; ‘learning to solve your own problems in complex responsive social systems, and ‘heuristics (rules of thumb for action research practice’. Finally, we comment on possible quality improvements for action research. Our remarks relate to the problems of implementing the concept of participation, the ambition of action research to contribute to both knowledge production and social change and the need for systematic reconstruction (scientific validation of action research.

  2. The "Subject of Ethics" and Educational Research OR Ethics or Politics? Yes Please!

    Science.gov (United States)

    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…

  3. Research ethics and lessons from Hwanggate: what can we learn from the Korean cloning fraud?

    Science.gov (United States)

    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.

  4. 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.

  5. Code of ethics for dental researchers.

    Science.gov (United States)

    2014-01-01

    The International Association for Dental Research, in 2009, adopted a code of ethics. The code applies to members of the association and is enforceable by sanction, with the stated requirement that members are expected to inform the association in cases where they believe misconduct has occurred. The IADR code goes beyond the Belmont and Helsinki statements by virtue of covering animal research. It also addresses issues of sponsorship of research and conflicts of interest, international collaborative research, duty of researchers to be informed about applicable norms, standards of publication (including plagiarism), and the obligation of "whistleblowing" for the sake of maintaining the integrity of the dental research enterprise as a whole. The code is organized, like the ADA code, into two sections. The IADR principles are stated, but not defined, and number 12, instead of the ADA's five. The second section consists of "best practices," which are specific statements of expected or interdicted activities. The short list of definitions is useful.

  6. Evaluating the Intervention of an Ethics' Class in Students' Ethical Decision-Making: A Summative Review

    Science.gov (United States)

    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…

  7. Ethnographic research with adolescent students: situated fieldwork ethics and ethical principles governing human research.

    Science.gov (United States)

    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.

  8. Clinical Ethics Support for Healthcare Personnel: An Integrative Literature Review.

    Science.gov (United States)

    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.

  9. Evaluating clinical ethics support in mental healthcare: a systematic literature review.

    Science.gov (United States)

    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.

  10. Surgical innovation: the ethical agenda: A systematic review.

    Science.gov (United States)

    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

  11. Research ethics committees in Japan: A perspective from thirty years of experience at Tokushima University.

    Science.gov (United States)

    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.

  12. “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.

  13. What Is Everyday Ethics? A Review and a Proposal for an Integrative Concept.

    Science.gov (United States)

    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.

  14. Professional Ethics Education for Future Teachers: A Narrative Review of the Scholarly Writings

    Science.gov (United States)

    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…

  15. Subject, function, and trend in medical ethics research: a comparative study of Chinese and non-Chinese literature using bibliometrics.

    Science.gov (United States)

    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.

  16. Ethical aspects of registry-based research in the Nordic countries.

    Science.gov (United States)

    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.

  17. The legal ethics of pediatric research.

    Science.gov (United States)

    Coleman, Doriane Lambelet

    2007-12-01

    Since the mid- to late 1990s, the scientific and medical research community has sought to increase its access to healthy children for research protocols that involve harm or a risk of harm. This move reverses longstanding policy within that community generally to exclude healthy children from such protocols on the grounds that the research as to them is non-therapeutic, that they are particularly vulnerable to research-related abuses, and that they are unable themselves to give informed consent to their participation. The research community's new posture has been supported by prominent pediatric bioethicists who have argued that unless healthy children are included as research subjects in harmful or risky research, the pediatric population will continue to suffer relative to the adult population in the extent to which it benefits from modern advances in science and medicine. In their view, it is possible for the research community to self-administer a rule that strikes a balance between protecting healthy children from research-related abuses and allowing their inclusion in cutting-edge pediatric research. In this scheme, parental consent is central to the research community's claims about child protection. This Article explores the flaws inherent in this ethics of pediatric research. Specifically, it challenges the view from ethics that the law permits parents to consent to their children's inclusion in harmful or risky research to the extent that related invasions would meet legal maltreatment standards. More broadly, it challenges the movement to increase access to healthy children for harmful and risky research on the ground that it risks two important regressions: First, in its willingness to risk harm to individual children in the interests of the group, it threatens the progress the law has made in its development of the concept of the child as an individual worthy of respect in his or her own right, a concept that imagines parents as fiduciaries and that

  18. Ethical considerations in biomedical research: a personal view.

    Science.gov (United States)

    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.

  19. Professional ethics in biomedical engineering practice and research.

    Science.gov (United States)

    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.

  20. [Institutional ethics committees in Mexico: the ambiguous boundary between health care ethics and research ethics].

    Science.gov (United States)

    Valdez-Martínez, Edith; Lifshitz-Guinzberg, Alberto; Medesigo-Micete, José; Bedolla, Miguel

    2008-08-01

    To identify ethics committees in medical practice in Mexico and possible implications stemming from their composition and functions. A cross-sectional descriptive study was conducted from January-December 2005. A survey was sent by e-mail to the hospitals and family medicine centers with at 10 practices within the Mexican Institute for Social Security (Instituto Mexicano del Seguro Social) (n=437) and the Institute for Security and Social Services for State Employees (Seguridad y Servicios Sociales de los Trabajadores del Estado) (n=167) and to the Mexican Ministry of Health's most important health care centers (n=15). The following items were analyzed: name of the committee, date of formation, current status, composition, functions, and level of authority. In all, 116 committees were identified, with various names. Of these, 101 (87.1%) were active. The committees were formed from 1985-2006, with a spike occurring in 2004-2005. Of the active committees, 59 (58.4%) were charged with ethical problems/dilemmas related to clinical practice as well as those related to research projects. Of the committee members, 357 (59.0%) held managing positions in the establishment to which the committee pertained; most were medical professionals (71.5%), followed by nursing staff (11.9%). Among the members of the active committees, 77.9% had not received training in ethics. Legal conflicts can be expected, mainly within the organizations whose committees have the authority to determine a course of action. An integrated plan is needed that will set standards for the composition and proceedings of Mexico's ethics committees and the improved training of committee members.

  1. Global Ethics Applied: Global Ethics, Economic Ethics

    OpenAIRE

    Stückelberger, Christoph

    2016-01-01

    Global Ethics Applied’ in four volumes is a reader of 88 selected articles from the author on 13 domains: Vol. 1 Global Ethics, Economic Ethics; Vol. 2 Environmental Ethics; Vol. 3 Development Ethics, Political Ethics, Dialogue and Peace Ethics, Innovation and Research Ethics, Information and Communication Ethics; Vol. 4 Bioethics and Medical Ethics, Family Ethics and Sexual Ethics, Leadership Ethics, Theological Ethics and Ecclesiology, Methods of Ethics. It concludes with the extended Bibli...

  2. Rattling the Cage: Moving beyond Ethical Standards to Ethical Praxis in Self-Study Research

    Science.gov (United States)

    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…

  3. Exploring perceptions and experiences of Bolivian health researchers with research ethics.

    Science.gov (United States)

    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.

  4. Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.

    Science.gov (United States)

    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

  5. The ethics of complexity. Genetics and autism, a literature review.

    Science.gov (United States)

    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.

  6. Ethical Issues in Addressing Inequity in/through ESL Research

    Science.gov (United States)

    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…

  7. Ethical Issues in the Research of Group Work

    Science.gov (United States)

    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…

  8. Preparing Professionals to Face Ethical Challenges in Today's Workplace: Review of the Literature, Implications for PI, and a Proposed Research Agenda

    Science.gov (United States)

    Frisque, Deloise A.; Lin, Hong; Kolb, Judith A.

    2004-01-01

    Ethics is very much in the news today and on the minds of those who teach and/or train current and future professionals to work successfully in today's workplaces. While there seems to be agreement that organizations need to address the topic of ethics, there is also a concern about how best to proceed. Ethics and compliance offices, professional…

  9. Electronic monitoring of offenders: an ethical review.

    Science.gov (United States)

    Bülow, William

    2014-06-01

    This paper considers electronic monitoring (EM) a promising alternative to imprisonment as a criminal sanction for a series of criminal offenses. However, little has been said about EM from an ethical perspective. To evaluate EM from an ethical perspective, six initial ethical challenges are addressed and discussed. It is argued that since EM is developing as a technology and a punitive means, it is urgent to discuss its ethical implications and incorporate moral values into its design and development.

  10. Reporting ethics committee approval in public administration research.

    Science.gov (United States)

    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.

  11. Understanding bureaucracy in health science ethics: toward a better institutional review board.

    Science.gov (United States)

    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.

  12. 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.

  13. Ethical issues experienced by healthcare workers in nursing homes: Literature review.

    Science.gov (United States)

    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.

  14. Reuse of samples: ethical issues encountered by two institutional ethics review committees in Kenya.

    Science.gov (United States)

    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.

  15. Reporting of ethical protection in recent oral and maxillofacial surgery research involving human subjects.

    Science.gov (United States)

    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.

  16. Community Partnered Research Ethics Training in Practice: A Collaborative Approach to Certification.

    Science.gov (United States)

    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.

  17. Internet research: an opportunity to revisit classic ethical problems in behavioral research.

    Science.gov (United States)

    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.

  18. Ethical Issues in the Use of Humans for Research.

    Science.gov (United States)

    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…

  19. Solving Ethical Dilemmas with Children: Empowering Classroom Research

    Science.gov (United States)

    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…

  20. Beyond Compliance Checking: A Situated Approach to Visual Research Ethics.

    Science.gov (United States)

    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.

  1. Yoga research review.

    Science.gov (United States)

    Field, Tiffany

    2016-08-01

    This paper is a review of empirical studies, review and meta-analysis publications on yoga from the last few years. The review includes demographics/prevalence of yoga as a practice, bibliometric analyses of the yoga publications and the use of yoga for physical fitness and cognitive function. Most of the studies reviewed here involve yoga effects on psychiatric and medical conditions. These include pregnancy, prenatal and postpartum depression; stress, PTSD, anxiety, and obesity; cardiovascular conditions including hypertension; pain syndromes including arthritis, headaches and low back pain; autoimmune conditions including asthma, type II diabetes and multiple sclerosis; immune conditions including HIV and breast cancer; and aging problems including balance, osteoporosis and Parkinson's. The methods and results of those studies are briefly summarized along with their limitations and suggestions for future research. Basically yoga has been more effective than control and waitlist control conditions, although not always more effective than treatment comparison groups such as other forms of exercise. More randomized controlled studies are needed in which yoga is compared to active exercise groups. Having established the physical and mental health benefits of yoga makes it ethically questionable to assign participants to inactive control groups. Shorter sessions should be investigated for cost-effectiveness and for daily practice. Multiple physical and physiological measures need to be added to the self-report research protocols and potential underlying mechanisms need to be further explored. In the interim, the studies reviewed here highlight the therapeutic effects of yoga, a practice that could come to be called yoga therapy. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. Ethical challenges embedded in qualitative research interviews with close relatives.

    Science.gov (United States)

    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.

  3. Herbal medicine research and global health: an ethical analysis.

    Science.gov (United States)

    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.

  4. 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

  5. Uterine transplantation: Review in human research.

    Science.gov (United States)

    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.

  6. The ethics of research using electronic mail discussion groups.

    Science.gov (United States)

    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

  7. Too much information: visual research ethics in the age of wearable cameras.

    Science.gov (United States)

    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.

  8. 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.

  9. Ethical issues in public health surveillance: a systematic qualitative review.

    Science.gov (United States)

    Klingler, Corinna; Silva, Diego Steven; Schuermann, Christopher; Reis, Andreas Alois; Saxena, Abha; Strech, Daniel

    2017-04-04

    Public health surveillance is not ethically neutral and yet, ethics guidance and training for surveillance programmes is sparse. Development of ethics guidance should be based on comprehensive and transparently derived overviews of ethical issues and arguments. However, existing overviews on surveillance ethics are limited in scope and in how transparently they derived their results. Our objective was accordingly to provide an overview of ethical issues in public health surveillance; in addition, to list the arguments put forward with regards to arguably the most contested issue in surveillance, that is whether to obtain informed consent. Ethical issues were defined based on principlism. We assumed an ethical issue to arise in surveillance when a relevant normative principle is not adequately considered or two principles come into conflict. We searched Pubmed and Google Books for relevant publications. We analysed and synthesized the data using qualitative content analysis. Our search strategy retrieved 525 references of which 83 were included in the analysis. We identified 86 distinct ethical issues arising in the different phases of the surveillance life-cycle. We further identified 20 distinct conditions that make it more or less justifiable to forego informed consent procedures. This is the first systematic qualitative review of ethical issues in public health surveillance resulting in a comprehensive ethics matrix that can inform guidelines, reports, strategy papers, and educational material and raise awareness among practitioners.

  10. Nursing ethical values and definitions: A literature review.

    Science.gov (United States)

    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.

  11. Scientists' perspectives on the ethical issues of stem cell research.

    Science.gov (United States)

    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.

  12. What makes public health studies ethical? Dissolving the boundary between research and practice.

    Science.gov (United States)

    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

  13. [Discussion on solutions to ethical issues of clinical researches in a real world].

    Science.gov (United States)

    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.

  14. HIV vaccine research--South Africa's ethical-legal framework and its ability to promote the welfare of trial participants.

    Science.gov (United States)

    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.

  15. Ethics of Research into Learning and Teaching with Web 2.0: Reflections on Eight Case Studies

    Science.gov (United States)

    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…

  16. Rewind, review, reflect and fast forward: from Ethics to GeoEthics.

    Science.gov (United States)

    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

  17. 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...

  18. Ethical Perspectives on Qualitative Research in Applied Psychology

    Science.gov (United States)

    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…

  19. Ethical issues in family violence research in healthcare settings.

    Science.gov (United States)

    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.

  20. Ethical issues in neonatal research involving human subjects.

    Science.gov (United States)

    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.

  1. The Ethical Behavior of Counselors: New Directions in Ethical Behavior Research.

    Science.gov (United States)

    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…

  2. Collaborative international research: ethical and regulatory issues pertaining to human biological materials at a South African institutional research ethics committee.

    Science.gov (United States)

    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.

  3. The ethical desirability of moral bioenhancement: A review of reasons

    NARCIS (Netherlands)

    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

  4. Ethical issues in using Twitter for public health surveillance and research: developing a taxonomy of ethical concepts from the research literature.

    Science.gov (United States)

    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

  5. Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation.

    Science.gov (United States)

    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

  6. Ethical aspects of registry-based research in the Nordic countries

    Directory of Open Access Journals (Sweden)

    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

  7. Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations.

    Science.gov (United States)

    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.

  8. Non-equivalent stringency of ethical review in the Baltic States: a sign of a systematic problem in Europe?

    Science.gov (United States)

    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

  9. The ethics of wildlife research: a nine R theory.

    Science.gov (United States)

    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.

  10. Can Neuroscience Contribute to Practical Ethics? A Critical Review and Discussion of the Methodological and Translational Challenges of the Neuroscience of Ethics.

    Science.gov (United States)

    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.

  11. GETTING PERSONAL: ETHICS AND IDENTITY IN GLOBAL HEALTH RESEARCH

    Science.gov (United States)

    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

  12. 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.

  13. Ethical tensions: A qualitative systematic review of new graduate perceptions.

    Science.gov (United States)

    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

  14. Agriculture’s Ethical Horizon, book review

    Science.gov (United States)

    Roughly 6.5 billion people inhabit the earth, but over 1 billion people regularly go hungry. This food shortfall poses an ethical dilemma for agriculture, and Agriculture's Ethical Horizon grapples with this dilemma. It argues that agricultural productivity has been the quintessential value of agr...

  15. Moral and Ethical Decision Making: Literature Review

    Science.gov (United States)

    2005-08-08

    exploration and elaboration of both rational and intuitive decision making processes. In addition, emotions may also play an important role in...More specifically, it suggests that both rational and intuitive decision making processes are likely to play an important role in ethical decision ...and military literature related to ethical decision making more generally. Specifically, it suggests that both rational and intuitive decision making

  16. Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project.

    Science.gov (United States)

    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

  17. Research Review: Doing Artistic Research

    Science.gov (United States)

    Serig, Dan

    2012-01-01

    In this review, the author focuses on the pragmatic consideration: How do artists do artistic research? Artistic research in the context of this review is about the connections and relationships among three primary domains: (1) the arts; (2) higher education; and (3) arts education. Broadly stated, all artists do research when they do art--whether…

  18. Ethics by opinion poll? The functions of attitudes research for normative deliberations in medical ethics.

    Science.gov (United States)

    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.

  19. Qualitative Evaluation Methods in Ethics Education: A Systematic Review and Analysis of Best Practices.

    Science.gov (United States)

    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.

  20. Medical ethics, bioethics and research ethics education perspectives in South East Europe in graduate medical education.

    Science.gov (United States)

    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.

  1. 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.

  2. Nurses' ethical conflicts in performance of utilization reviews.

    Science.gov (United States)

    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.

  3. The ethics of neonatal research: An ethicist's and a parents' perspective.

    Science.gov (United States)

    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.

  4. A systematic review of ethics knowledge in audiology (1980-2010).

    Science.gov (United States)

    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.

  5. 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...

  6. Do we need a special ethics for research?

    Science.gov (United States)

    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.

  7. 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...

  8. Obstacles to researching the researchers: a case study of the ethical challenges of undertaking methodological research investigating the reporting of randomised controlled trials.

    Science.gov (United States)

    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

  9. Ethics education in research involving human beings in undergraduate medicine curriculum in Brazil.

    Science.gov (United States)

    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

  10. Enabling Ethical Code Embeddedness in Construction Organizations: A Review of Process Assessment Approach.

    Science.gov (United States)

    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.

  11. Biomedical scientists' perceptions of ethical and social implications: is there a role for research ethics consultation?

    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.

  12. Promoting Research of Virtue Ethics: A Review of Zhizheng Du's Ethical Thoughts of Medical Virtue%重视德性伦理的研究——杜治政医学美德伦理观浅析

    Institute of Scientific and Technical Information of China (English)

    郑娟; 安军

    2017-01-01

    杜治政教授是我国当代医学哲学尤其是医学伦理学学科的主要开拓者和奠基人.他直接而清晰地剖析了我国医学伦理学面临的现实危机和道德困境,提出培养医学道德要促进规范伦理与德性伦理的结合,更要高扬医学美德伦理.杜治政教授强调美德伦理首先是医生的美德,美德具有医学伦理学母德的性质,他的医学美德伦理观为我国当代医学道德发展奠定了基础,为解决当今临床实践中的种种现实伦理问题、建立和谐医患关系提供了重要借鉴和有益启示.%Professor Zhizheng Du is one of the pioneers and founders of contemporary philosophy of medicine,especially medical ethics,in mainland China.Based on analysis of the dilemma and crisis of current development of medical ethics,he proposes a unity between the normative ethics and virtue ethics,emphasizing the promotion of medical virtue.In Zhizheng Du's opinion,the virtue ethics should primarily be the doctor's virtue,which is an essential foundation of medical ethics.His theory provides important reference and meaningful inspiration for solving the present ethical problem in clinical practice and establishing a harmonious doctor-patient relationship.

  13. 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.

  14. Preparing students for the ethical challenges on international health electives: A systematic review of the literature on educational interventions.

    Science.gov (United States)

    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.

  15. An Ethical Review of Euthanasia and Physician-assisted Suicide.

    Science.gov (United States)

    Banović, Božidar; Turanjanin, Veljko; Miloradović, Anđela

    2017-02-01

    In the majority of countries, active direct euthanasia is a forbidden way of the deprivation of the patients' life, while its passive form is commonly accepted. This distinction between active and passive euthanasia has no justification, viewed through the prism of morality and ethics. Therefore, we focused on attention on the moral and ethical implications of the aforementioned medical procedures. Data were obtained from the Clinical Hospital Center in Kragujevac, collected during the first half of the 2015. The research included 88 physicians: 57 male physicians (representing 77% of the sample) and 31 female physicians (23% of the sample). Due to the nature, subject and hypothesis of the research, the authors used descriptive method and the method of the theoretical content analysis. A slight majority of the physicians (56, 8%) believe that active euthanasia is ethically unacceptable, while 43, 2% is for another solution (35, 2% took a viewpoint that it is completely ethically acceptable, while the remaining 8% considered it ethically acceptable in certain cases). From the other side, 56, 8% of respondents answered negatively on the ethical acceptability of the physician-assisted suicide, while 33% of them opted for a completely ethic viewpoint of this procedure. Out of the remaining 10, 2% opted for the ethical acceptability in certain cases. Physicians in Serbia are divided on this issue, but a group that considers active euthanasia and physician-assisted suicide as ethically unacceptable is a bit more numerous.

  16. Ethik in der Medizinischen Ausbildungsforschung [Ethics in medical education research

    Directory of Open Access Journals (Sweden)

    Marienhagen, Jörg

    2009-02-01

    Full Text Available [english] Research ethics criteria that are used for reviewing clinical trials are also applicable to research designs used within the field of medical education. Especially the principles of nonmaleficence, informed consent, and freedom to participate are relevant in this area of research. Due to the high impact of university education on tomorrow’s doctors, high-quality ethical and methodological standards are essential in medical education research. A responsible handling of ethical problems in the area of medical education research requires careful handling of issues concerning participants, informed consent, and the methodology used. As it is obligatory in clinical trials, risk-benefit and cost-performance analyses have to be a part of the complete process, from the planning phase onwards, to avoid potential harm to the participants. Every publication of study results should contain information about the methodology used and the reliability of the data. It is important that the contribution of all mentioned co-authors becomes clear. The authors recommend the constitution of an ethics committee within the German Association for Medical Education (Gesellschaft für Medizinische Ausbildung, GMA to support researchers and to meet the interests of all groups involved. Additionally, more and more journals dealing with publications in the area of medical education demand an ethical statement as part of their publication requirements. The GMA is called on to establish such a committee to secure ethical standards for medical education research. [german] Es zeigt sich, dass forschungsethische Kriterien wie in medikamentösen Interventionsstudien auch in der Ausbildungsforschung sinnvoll und ohne große Einschnitte ins Studiendesign applizierbar sind. Das Nichtschadensprinzip, die informierte Einwilligung und Freiwilligkeit der Teilnahme stehen hierbei im Vordergrund. Aus dem hohen Stellenwert der Ausbildung für Studierende begründet sich ein

  17. Teaching Medical Ethics in Graduate and Undergraduate Medical Education: A Systematic Review of Effectiveness.

    Science.gov (United States)

    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.

  18. Feminist and community psychology ethics in research with homeless women.

    Science.gov (United States)

    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.

  19. Ethics Review of Pediatric Multi-Center Drug Trials

    NARCIS (Netherlands)

    Needham, Allison C.; Kapadia, Mufiza Z.; Offringa, Martin

    2015-01-01

    The assessment of safety and efficacy of therapeutics for children and adolescents requires the use of multi-centered designs. However, the need to obtain ethical approval from multiple independent research ethics boards (REBs) presents as a challenge to investigators and sponsors who must consider

  20. 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

  1. The ethical desirability of moral bioenhancement: a review of reasons

    Science.gov (United States)

    2014-01-01

    Background 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 against moral bioenhancement. Discussion A review was performed and resulted in the inclusion of 85 articles. We classified the arguments used in those articles in the following six clusters: (1) why we (don’t) need moral bioenhancement, (2) it will (not) be possible to reach consensus on what moral bioenhancement should involve, (3) the feasibility of moral bioenhancement and the status of current scientific research, (4) means and processes of arriving at moral improvement matter ethically, (5) arguments related to the freedom, identity and autonomy of the individual, and (6) arguments related to social/group effects and dynamics. We discuss each argument separately, and assess the debate as a whole. First, there is little discussion on what distinguishes moral bioenhancement from treatment of pathological deficiencies in morality. Furthermore, remarkably little attention has been paid so far to the safety, risks and side-effects of moral enhancement, including the risk of identity changes. Finally, many authors overestimate the scientific as well as the practical feasibility of the interventions they discuss, rendering the debate too speculative. Summary Based on our discussion of the arguments used in the debate on moral enhancement, and our assessment of this debate, we advocate a shift in focus. Instead of speculating about non-realistic hypothetical scenarios such as the genetic engineering of morality, or morally enhancing ‘the whole of humanity’, we call for a more focused debate on realistic options of biomedical treatment of moral pathologies and the concrete moral questions these treatments raise. PMID:25227512

  2. Review of Instructional Approaches in Ethics Education.

    Science.gov (United States)

    Mulhearn, Tyler J; Steele, Logan M; Watts, Logan L; Medeiros, Kelsey E; Mumford, Michael D; Connelly, Shane

    2017-06-01

    Increased investment in ethics education has prompted a variety of instructional objectives and frameworks. Yet, no systematic procedure to classify these varying instructional approaches has been attempted. In the present study, a quantitative clustering procedure was conducted to derive a typology of instruction in ethics education. In total, 330 ethics training programs were included in the cluster analysis. The training programs were appraised with respect to four instructional categories including instructional content, processes, delivery methods, and activities. Eight instructional approaches were identified through this clustering procedure, and these instructional approaches showed different levels of effectiveness. Instructional effectiveness was assessed based on one of nine commonly used ethics criteria. With respect to specific training types, Professional Decision Processes Training (d = 0.50) and Field-Specific Compliance Training (d = 0.46) appear to be viable approaches to ethics training based on Cohen's d effect size estimates. By contrast, two commonly used approaches, General Discussion Training (d = 0.31) and Norm Adherence Training (d = 0.37), were found to be considerably less effective. The implications for instruction in ethics training are discussed.

  3. 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...

  4. 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...

  5. Ethics Review for a Multi-Site Project Involving Tribal Nations in the Northern Plains.

    Science.gov (United States)

    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.

  6. Ethical issues in action-oriented research in Indonesia.

    Science.gov (United States)

    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

  7. Research ethics and approval process: A guide for new GP researchers.

    Science.gov (United States)

    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.

  8. The 2016 CIOMS guidelines and public-health research ethics

    African Journals Online (AJOL)

    2017-12-01

    Dec 1, 2017 ... CIOMS International Ethical Guidelines for Biomedical Research Involving ... mention of public health in relation to social value. • The new guideline 7, .... reports, can be obtained from conventional media sources such as.

  9. Ethical Issues in Translational Research: From the Bench to Theatre

    African Journals Online (AJOL)

    However, if there is no adequate evidence of benefit to the patient, then ... In fact, international and local ethical guidelines for research involving human participants do not have specific ... they can be applied as and when they are needed at.

  10. Auditing of clinical research ethics in a children's and women's academic hospital.

    Science.gov (United States)

    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

  11. 76 FR 37353 - Federal Acquisition Regulation; Submission for OMB Review; Contractor Business Ethics Compliance...

    Science.gov (United States)

    2011-06-27

    ...; Submission for OMB Review; Contractor Business Ethics Compliance Program and Disclosure Requirements AGENCIES... contractor business ethics compliance program and disclosure requirements. Public comments are particularly... Information Collection 9000- 0164, Contractor Business Ethics Compliance Program and Disclosure Requirements...

  12. Readiness of ethics review systems for a changing public health landscape in the WHO African Region.

    Science.gov (United States)

    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

  13. [Ethics and laws related to human subject research].

    Science.gov (United States)

    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.

  14. Ethics and methods for biological rhythm research on animals and human beings.

    Science.gov (United States)

    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

  15. Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.

    Science.gov (United States)

    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

  16. Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic.

    Science.gov (United States)

    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

  17. Ethical and methodological issues in research with Sami experiencing disability.

    Science.gov (United States)

    Melbøe, Line; Hansen, Ketil Lenert; Johnsen, Bjørn-Eirik; Fedreheim, Gunn Elin; Dinesen, Tone; Minde, Gunn-Tove; Rustad, Marit

    2016-01-01

    A study of disability among the indigenous Sami people in Norway presented a number of ethical and methodological challenges rarely addressed in the literature. The main study was designed to examine and understand the everyday life, transitions between life stages and democratic participation of Norwegian Sami people experiencing disability. Hence, the purpose of this article is to increase the understanding of possible ethical and methodological issues in research within this field. The article describes and discusses ethical and methodological issues that arose when conducting our study and identifies some strategies for addressing issues like these. The ethical and methodological issues addressed in the article are based on a qualitative study among indigenous Norwegian Sami people experiencing disability. The data in this study were collected through 31 semi-structured in-depth interviews with altogether 24 Sami people experiencing disability and 13 next of kin of Sami people experiencing disability (8 mothers, 2 fathers, 2 sister and 1 guardian). The researchers identified 4 main areas of ethical and methodological issues. We present these issues chronologically as they emerged in the research process: 1) concept of knowledge when designing the study, 2) gaining access, 3) data collection and 4) analysis and accountability. The knowledge generated from this study has the potential to benefit future health research, specifically of Norwegian Sami people experiencing disability, as well as health research concerning indigenous people in general, providing scientific-based insight into important ethical and methodological issues in research with indigenous people experiencing disability.

  18. Ethics in family violence research: cross-cultural issues.

    Science.gov (United States)

    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.

  19. Ethical issues in international biomedical research: an overview.

    Science.gov (United States)

    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.

  20. Navigating the ethics of cross-cultural health promotion research.

    Science.gov (United States)

    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.

  1. Research ethics board approval for an international thromboprophylaxis trial.

    Science.gov (United States)

    Lutz, Kristina; Wilton, Kelly; Zytaruk, Nicole; Julien, Lisa; Hall, Richard; Harvey, Johanne; Skrobik, Yoanna; Vlahakis, Nicholas; Meade, Laurie; Matte, Andrea; Meade, Maureen; Burns, Karen; Albert, Martin; Cash, Bronwyn Barlow; Vallance, Shirley; Klinger, James; Heels-Ansdell, Diane; Cook, Deborah

    2012-06-01

    Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards. Copyright © 2012 Elsevier Inc. All rights reserved.

  2. A Systematic Literature Review of US Engineering Ethics Interventions.

    Science.gov (United States)

    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.

  3. Qualitative research in multicultural psychology: philosophical underpinnings, popular approaches, and ethical considerations.

    Science.gov (United States)

    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.

  4. Research Ethics Boards as Spaces of Marginalization: A Canadian Story

    Science.gov (United States)

    Patterson, Donna

    2008-01-01

    This article complicates how Canadian universities are pressured to capitalize on research and how these same pressures affect both the collaborative and community-based research within the academy by privileging one type of research and relationships within community over others. Through examining historical influences on Research Ethics Boards…

  5. Perception, understanding and practice of ethics during research on ...

    African Journals Online (AJOL)

    Background: Scandals have occurred over time involving conduct of research in different parts of the world. This study was aimed at exploring researchers' perception, understanding, appreciation and practice of research ethics during research on human subjects. Methods: A qualitative approach using the exploratory and ...

  6. What Is Right? Ethics in Intellectual Disabilities Research

    Science.gov (United States)

    McDonald, Katherine E.; Kidney, Colleen A.

    2012-01-01

    There are important benefits to including adults with intellectual disabilities in research. Calls for their increased participation in research co-occur with notable discussion about how to conduct ethically strong research with adults with intellectual disabilities, a population widely considered vulnerable in the context of research. The…

  7. Fulfilling an Ethical Obligation: An Educative Research Assistantship

    Science.gov (United States)

    McGinn, Michelle K.; Niemczyk, Ewelina K.; Saudelli, Mary Gene

    2013-01-01

    Scant research evidence is available about the day-to-day workings of research assistantships or the educational possibilities they provide for research assistants and their academic supervisors. This case study documents the equitable, educative, and ethical nature of one research assistantship at a Canadian university. Data sources include audio…

  8. Considerations, clues and challenges: Gaining Ethical and Trust research approval when using the NHS as a research setting

    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.

  9. Considerations, clues and challenges: Gaining Ethical and Trust research approval when using the NHS as a research setting

    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.

  10. Ethical practice in internet research involving vulnerable people: lessons from a self-harm discussion forum study (SharpTalk).

    Science.gov (United States)

    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.

  11. Teaching medical students to discern ethical problems in human clinical research studies.

    Science.gov (United States)

    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.

  12. Human Participants in Engineering Research: Notes from a Fledgling Ethics Committee.

    Science.gov (United States)

    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

  13. Health impacts and research ethics in female trafficking.

    Science.gov (United States)

    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.

  14. Ethics in published brain-computer interface research

    Science.gov (United States)

    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.

  15. Ethical use of social media to facilitate qualitative research.

    Science.gov (United States)

    Lunnay, Belinda; Borlagdan, Joseph; McNaughton, Darlene; Ward, Paul

    2015-01-01

    Increasingly, qualitative health researchers might consider using social media to facilitate communication with participants. Ambiguity surrounding the potential risks intrinsic to social media could hinder ethical conduct and discourage use of this innovative method. We used some core principles of traditional human research ethics, that is, respect, integrity, and beneficence, to design our photo elicitation research that explored the social influences of drinking alcohol among 34 underage women in metropolitan South Australia. Facebook aided our communication with participants, including correspondence ranging from recruitment to feeding back results and sharing research data. This article outlines the ethical issues we encountered when using Facebook to interact with participants and provides guidance to researchers planning to incorporate social media as a tool in their qualitative studies. In particular, we raise the issues of privacy and confidentiality as contemporary risks associated with research using social media. © The Author(s) 2014.

  16. Methodologic and ethical ramifications of sex and gender differences in public health research.

    Science.gov (United States)

    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

  17. Henry Beecher's Contributions to the Ethics of Clinical Research.

    Science.gov (United States)

    Veatch, Robert M

    2016-01-01

    In the 1950s and '60s, Henry Beecher pioneered the discussion of the ethics of clinical research, leading eventually to the publication of the famous New England Journal of Medicine article summarizing 22 research studies that Beecher suggests were unethical. Those studies generally showed a pattern of posing serious risks to subjects without anticipated proportional benefit. Beecher famously claimed that the problem was not that researchers were malicious or evil; rather, he claimed the problem was they manifested thoughtlessness or carelessness. He called for more rigorous self-scrutiny rather than public review.This article argues that Beecher's reliance on conscientious investigators is problematic. In particular, it focuses on benefits and harms to the exclusion of other moral criteria. However, both research subjects and public regulators are also concerned about autonomy and the consent requirement, confidentiality, and fairness in subject selection and research design. The movement in the 1970s toward more public scrutiny was critical, even though Beecher was right in holding that it was not "vicious disregard for subject welfare" that explained unethical protocols.

  18. Social and ethical aspects of forensic genetics: A critical review.

    Science.gov (United States)

    Williams, R; Wienroth, M

    2017-07-01

    This review describes the social and ethical responses to the history of innovations in forensic genetics and their application to criminal investigations. Following an outline of the three recurrent social perspectives that have informed these responses (crime management, due process, and genetic surveillance), it goes on to introduce the repertoire of ethical considerations by describing a series of key reports that have shaped subsequent commentaries on forensic DNA profiling and databasing. Four major ethical concerns form the focus of the remainder of the paper (dignity, privacy, justice, and social solidarity), and key features of forensic genetic practice are examined in the light of these concerns. The paper concludes with a discussion of the concept of "proportionality" as a resource for balancing the social and ethical risks and benefits of the use of forensic genetics in support of criminal justice. Copyright © 2017 Central Police University.

  19. The status of research ethics in social work.

    Science.gov (United States)

    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.

  20. Ethical issues in engineering models: an operations researcher's reflections.

    Science.gov (United States)

    Kleijnen, J

    2011-09-01

    This article starts with an overview of the author's personal involvement--as an Operations Research consultant--in several engineering case-studies that may raise ethical questions; e.g., case-studies on nuclear waste, water management, sustainable ecology, military tactics, and animal welfare. All these case studies employ computer simulation models. In general, models are meant to solve practical problems, which may have ethical implications for the various stakeholders; namely, the modelers, the clients, and the public at large. The article further presents an overview of codes of ethics in a variety of disciples. It discusses the role of mathematical models, focusing on the validation of these models' assumptions. Documentation of these model assumptions needs special attention. Some ethical norms and values may be quantified through the model's multiple performance measures, which might be optimized. The uncertainty about the validity of the model leads to risk or uncertainty analysis and to a search for robust models. Ethical questions may be pressing in military models, including war games. However, computer games and the related experimental economics may also provide a special tool to study ethical issues. Finally, the article briefly discusses whistleblowing. Its many references to publications and websites enable further study of ethical issues in modeling.

  1. The Ethics of Traditional Chinese and Western Herbal Medicine Research: Views of Researchers and Human Ethics Committees in Australia

    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.

  2. Rethinking Research Ethics: The Case of Postmarketing Trials

    Science.gov (United States)

    London, Alex John; Carlisle, Benjamin

    2015-01-01

    Phase IV studies are often criticized for poor scientific standards. Yet they provide an important resource for addressing evidence shortfalls in drug safety, comparative effectiveness, and real-world utility. Current research ethics policies, and contemplated revisions to them, do not provide an adequate framework for preventing social harms that result from poor post-marketing research practice. Rather than focus exclusively on the welfare and interests of human volunteers, research policies and ethics should also safeguard the integrity of the research enterprise as a system for producing reliable medical evidence. We close by briefly describing how an integrity framework might be implemented for phase IV studies. PMID:22556237

  3. Ethical Medical and Biomedical Practice in Health Research in Africa

    International Development Research Centre (IDRC) Digital Library (Canada)

    Ethical Medical and Biomedical Practice in Health Research in Africa. African countries have an urgent need for research to battle the diseases that ravage their populations and hamper their economic and social development. This research entails both benefits and risks for the people involved. Particular effort must be ...

  4. 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

  5. The impact of European research ethics legislation on UK radiology research activity: a bibliometric analysis

    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.

  6. Progress in centralised ethics review processes: Implications for multi-site health evaluations.

    Science.gov (United States)

    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.

  7. Ethics.

    Science.gov (United States)

    Pellegrino, Edmund D

    In this brief annual review of ethical issues in medicine, Pellegrino focuses on two issues, AIDS and surrogate mothers. The AIDS epidemic has generated debate over public health needs vs. individual rights, modification of sexual practices, screening programs to detect infected persons, confidentiality of test results, experimental therapies, and the duty of physicians to care for AIDS patients. Surrogate motherhood arrangements have become one of the more controversial of the new reproductive technologies. The publicity that accompanied the custody battle over New Jersey's "Baby M" intensified debate over the commercialization of childbearing and the regulation of reproduction. Pellegrino concludes that physicians, along with ethicists and policymakers, have an obligation to "lead society in careful and judicious deliberation" of the ethical issues raised by AIDS and by reproductive technologies.

  8. Identifying Ethical Issues in Mental Health Research with Minors Adolescents: Results of a Delphi Study

    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.

  9. Identifying Ethical Issues in Mental Health Research with Minors Adolescents: Results of a Delphi Study.

    Science.gov (United States)

    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.

  10. Identifying Ethical Issues in Mental Health Research with Minors Adolescents: Results of a Delphi Study

    Science.gov (United States)

    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

  11. How to depolarise the ethical debate over human embryonic stem cell research (and other ethical debates too!)

    NARCIS (Netherlands)

    Espinoza, N.; Peterson, M.B.

    2012-01-01

    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

  12. THE ETHICS OF SCIENTIFIC RESEARCH (WITH PARTICULAR EMPHASIS ON EXERCISE AND MOVEMENT SCIENCE (English translated version

    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.

  13. Ethical issues in paleopathological and anthropological research experiences.

    Science.gov (United States)

    Licata, Marta; Monza, Francesca

    2017-10-23

    In recent years, archaeologists and anthropologists involved in the study of human remains have had to take into consideration ethical issues, which have come to the fore. The aim of this study is to illustrate the ethical and religious issues involved in relation to the positions of researchers. Ethical issues involve the different study phases of human remains: archaeological excavation, anthropological analysis and, finally, museum display. Osteoarchaeological remains may find a place in museums. However, in recent years, even the display of human remains museum has had to face new important ethical issue involving previously ignored or neglected aspect. The adoption of Native American Grave Protection Act in 1990 in the United States and the Human Tissue Act in 2004 in England, has created new scenarios relating to the storage of human remains in museum. All this caused a series of changes in the study of human remains, but many issues remain open to debate.

  14. Using the Emanuel et al. framework to assess ethical issues raised by a biomedical research ethics committee in South Africa.

    Science.gov (United States)

    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.

  15. Scientists' Ethical Obligations and Social Responsibility for Nanotechnology Research.

    Science.gov (United States)

    Corley, Elizabeth A; Kim, Youngjae; Scheufele, Dietram A

    2016-02-01

    Scientists' sense of social responsibility is particularly relevant for emerging technologies. Since a regulatory vacuum can sometimes occur in the early stages of these technologies, individual scientists' social responsibility might be one of the most significant checks on the risks and negative consequences of this scientific research. In this article, we analyze data from a 2011 mail survey of leading U.S. nanoscientists to explore their perceptions the regarding social and ethical responsibilities for their nanotechnology research. Our analyses show that leading U.S. nanoscientists express a moderate level of social responsibility about their research. Yet, they have a strong sense of ethical obligation to protect laboratory workers (in both universities and industry) from unhealthy exposure to nanomaterials. We also find that there are significant differences in scientists' sense of social and ethical responsibility depending on their demographic characteristics, job affiliation, attention to media content, risk perceptions and benefit perceptions. We conclude with some implications for future research.

  16. Ethical issues in the qualitative researcher--participant relationship.

    Science.gov (United States)

    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.

  17. PROFESSIONAL CODES OF CONDUCT IN PSYCHOLOGY: DESCRIPTIVE STUDY OF COMPLAINTS REVIEWED BY THE COPC ETHICS COMMITTEE

    Directory of Open Access Journals (Sweden)

    Mila Arch

    2013-09-01

    Full Text Available In recent decades a significant increase has been observed in the number of complaints filed with ethical committees. The possibility of being the subject of a complaint is therefore a growing concern for professionals. However, research on ethics and codes of conduct in psychology is still very limited and real data on the complaints filed with Ethics Committees against psychologists are practically nonexistent. This article describes the results of a descriptive analysis of the complaints reviewed by the COPC Ethics Committee from 1998 to 2011. A total of 324 complaints were filed, but only 20% led to opening disciplinary proceedings, the judicial context being the professional area in which the highest percentage of complaints were filed (85%. Among the most prevalent reasons for complaints were making assessments without prior examination and partiality.

  18. 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

  19. What makes public health studies ethical? Dissolving the boundary between research and practice

    Science.gov (United States)

    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

  20. [Clinical research XXIV. From clinical judgment to ethics in research on humans].

    Science.gov (United States)

    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.

  1. Undocumented Status: Implications for Child Development, Policy, and Ethical Research

    Science.gov (United States)

    Suárez-Orozco, Carola; Yoshikawa, Hirokazu

    2013-01-01

    Nearly 5.5 million children in the United States grow up in the shadows of undocumented status. We review the ecological domains of influence in children's and adolescents' lives and briefly consider health, cognitive, socioemotional, educational, and labor market outcomes ripe for study. We also reflect upon the ethical policy…

  2. IS ETHICAL HACKING ETHICAL?

    OpenAIRE

    MUHAMMAD NUMAN ALI KHAN; DANISH JAMIL,

    2011-01-01

    This paper explores the ethics behind ethical hacking and whether there are problems that lie with this new field of work. Since ethical hacking has been a controversial subject over the past few years, the question remains of the true intentions of ethical hackers. The paper also looks at ways in which future research could be looked intoto help keep ethical hacking, ethical.

  3. The full spectrum of ethical issues in the care of patients with ALS: a systematic qualitative review.

    Science.gov (United States)

    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.

  4. Partnering with patients in translational oncology research: ethical approach.

    Science.gov (United States)

    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

  5. RETHINKING RESEARCH ETHICS FOR MEDIATED SETTINGS

    NARCIS (Netherlands)

    Beaulieu, Anne; Estalella, Adolfo

    2012-01-01

    An important feature of e-research is the increased mediation of research practices, which changes not only the objects and tools of research, but also the relation between researcher and object, between researchers, and between researchers and their constituencies and stakeholders. This article

  6. Ethical Medical and Biomedical Practice in Health Research in Africa

    International Development Research Centre (IDRC) Digital Library (Canada)

    Then, they will propose an ethical framework for health research and put forward the basic elements of a training course for professionals, researchers and decision-makers in the area of bioethics and health and the environment. The work will be carried out in three West African Countries (Bénin, Cameroon and Nigeria), ...

  7. Approaching Ethical Reasoning in Nursing Research through a Communitarian Perspective.

    Science.gov (United States)

    Dresden, Elissa; McElmurry, Beverly J.; McCreary, Linda L.

    2003-01-01

    Case studies depict dilemmas in nursing research involving protection of community rights and community informed consent. Outlines research guidelines derived from communitarian ethical frameworks that consider beneficence, justice, and respect for autonomy in the context of community. (Contains 58 references.) (SK)

  8. Ethical Issues Affecting Human Participants in Community College Research

    Science.gov (United States)

    Wurtz, Keith

    2011-01-01

    The increasing demand of constituents to conduct analyses in order to help inform the decision-making process has led to the need for Institutional Research (IR) guidelines for community college educators. One method of maintaining the quality of research conducted by IR staff is to include professional development about ethics. This article…

  9. Web-Based Research Ethics Training for Gerontologists

    Science.gov (United States)

    Scialfa, Charles T.; Lyndon, Jaci

    2008-01-01

    As part of a Canadian Institutes for Health Research (CIHR)-funded Strategic Training Grant, we have developed and delivered a brief course in research ethics directed toward postgraduate students in experimental gerontology. In this paper, we report on the initial offering, its content and delivery, and student reactions to the course. We…

  10. Philosophy of organ donation: Review of ethical facets.

    Science.gov (United States)

    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.

  11. Future issues in transplantation ethics: ethical and legal controversies in xenotransplantation, stem cell, and cloning research.

    Science.gov (United States)

    Shapiro, Robyn S

    2008-07-01

    With little prospect of developing a sufficient supply of human transplantable organs to meet the large and growing demand, attention has turned to xenotransplantation, as well as stem cell and cloning research, as possible approaches for alleviating this allograft shortage. This article explores ethical and legal issues that surround developments in these fields.

  12. The nature and scope of psychiatric ethics: review article | Radden ...

    African Journals Online (AJOL)

    Both the professional code of conduct required in the practice of psychiatry, and the broader set of moral and ethical problems distinctive to, or at least magnified by, the mental health care setting are reviewed here. Some perennial aspects of mental disorder and its cultural history are introduced, together with problems ...

  13. Teaching ethics to engineers - a research-based perspective

    Science.gov (United States)

    Bowden, Peter

    2010-10-01

    This paper describes research underpinning a course, developed in Australia, on ethics for engineers. The methodology used, that of identifying the principal ethical issues facing the discipline and designing the course around these issues, would be applicable to other disciplines and in other countries. The course was based on the assumption that identifying the major ethical issues in the discipline, and subsequently presenting and analysing them in the classroom, would provide the future professional with knowledge of the ethical problems that they were likely to face on graduation. The student has then to be given the skills and knowledge to combat these concerns, should he/she wish to. These findings feed into several components of the course, such as the development of a code of ethics, the role of a professional society or industry association and the role of ethical theory The sources employed to identify the issues were surveys of the literature and about 30 case studies, in Australia and overseas. The issues thus identified were then put before a sample of engineering managers to assess the relevance to the profession.

  14. ENVRI PLUS project: Developing an ethical framework for Environmental and Earth System Research Infrastructures

    Science.gov (United States)

    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

  15. Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network.

    Science.gov (United States)

    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.

  16. Toward ethical norms and institutions for climate engineering research

    International Nuclear Information System (INIS)

    Morrow, David R; Kopp, Robert E; Oppenheimer, Michael

    2009-01-01

    Climate engineering (CE), the intentional modification of the climate in order to reduce the effects of increasing greenhouse gas concentrations, is sometimes touted as a potential response to climate change. Increasing interest in the topic has led to proposals for empirical tests of hypothesized CE techniques, which raise serious ethical concerns. We propose three ethical guidelines for CE researchers, derived from the ethics literature on research with human and animal subjects, applicable in the event that CE research progresses beyond computer modeling. The Principle of Respect requires that the scientific community secure the global public's consent, voiced through their governmental representatives, before beginning any empirical research. The Principle of Beneficence and Justice requires that researchers strive for a favorable risk-benefit ratio and a fair distribution of risks and anticipated benefits, all while protecting the basic rights of affected individuals. Finally, the Minimization Principle requires that researchers minimize the extent and intensity of each experiment by ensuring that no experiments last longer, cover a greater geographical extent, or have a greater impact on the climate, ecosystem, or human welfare than is necessary to test the specific hypotheses in question. Field experiments that might affect humans or ecosystems in significant ways should not proceed until a full discussion of the ethics of CE research occurs and appropriate institutions for regulating such experiments are established.

  17. Toward ethical norms and institutions for climate engineering research

    Science.gov (United States)

    Morrow, David R.; Kopp, Robert E.; Oppenheimer, Michael

    2009-10-01

    Climate engineering (CE), the intentional modification of the climate in order to reduce the effects of increasing greenhouse gas concentrations, is sometimes touted as a potential response to climate change. Increasing interest in the topic has led to proposals for empirical tests of hypothesized CE techniques, which raise serious ethical concerns. We propose three ethical guidelines for CE researchers, derived from the ethics literature on research with human and animal subjects, applicable in the event that CE research progresses beyond computer modeling. The Principle of Respect requires that the scientific community secure the global public's consent, voiced through their governmental representatives, before beginning any empirical research. The Principle of Beneficence and Justice requires that researchers strive for a favorable risk-benefit ratio and a fair distribution of risks and anticipated benefits, all while protecting the basic rights of affected individuals. Finally, the Minimization Principle requires that researchers minimize the extent and intensity of each experiment by ensuring that no experiments last longer, cover a greater geographical extent, or have a greater impact on the climate, ecosystem, or human welfare than is necessary to test the specific hypotheses in question. Field experiments that might affect humans or ecosystems in significant ways should not proceed until a full discussion of the ethics of CE research occurs and appropriate institutions for regulating such experiments are established.

  18. Retrospective research: What are the ethical and legal requirements?

    Science.gov (United States)

    Junod, V; Elger, B

    2010-07-25

    Retrospective research is conducted on already available data and/or biologic material. Whether such research requires that patients specifically consent to the use of "their" data continues to stir controversy. From a legal and ethical point of view, it depends on several factors. The main criteria to be considered are whether the data or the sample is anonymous, whether the researcher is the one who collected it and whether the patient was told of the possible research use. In Switzerland, several laws delineate the procedure to be followed. The definition of "anonymous" is open to some interpretation. In addition, it is debatable whether consent waivers that are legally admissible for data extend to research involving human biological samples. In a few years, a new Swiss federal law on human research could clarify the regulatory landscape. Meanwhile, hospital-internal guidelines may impose stricter conditions than required by federal or cantonal law. Conversely, Swiss and European ethical texts may suggest greater flexibility and call for a looser interpretation of existing laws. The present article provides an overview of the issues for physicians, scientists, ethics committee members and policy makers involved in retrospective research in Switzerland. It aims at provoking more open discussions of the regulatory problems and possible future legal and ethical solutions.

  19. Stem cell research ethics: consensus statement on emerging issues.

    Science.gov (United States)

    Caulfield, Timothy; Ogbogu, Ubaka; Nelson, Erin; Einsiedel, Edna; Knoppers, Bartha; McDonald, Michael; Brunger, Fern; Downey, Robin; Fernando, Kanchana; Galipeau, Jacques; Geransar, Rose; Griener, Glenn; Grenier, Glenn; Hyun, Insoo; Isasi, Rosario; Kardel, Melanie; Knowles, Lori; Kucic, Terrence; Lotjonen, Salla; Lyall, Drew; Magnus, David; Mathews, Debra J H; Nisbet, Matthew; Nisker, Jeffrey; Pare, Guillaume; Pattinson, Shaun; Pullman, Daryl; Rudnicki, Michael; Williams-Jones, Bryn; Zimmerman, Susan

    2007-10-01

    This article is a consensus statement by an international interdisciplinary group of academic experts and Canadian policy-makers on emerging ethical, legal and social issues in human embryonic stem cells (hESC) research in Canada. The process of researching consensus included consultations with key stakeholders in hESC research (regulations, stem cell researchers, and research ethics experts), preparation and distribution of background papers, and an international workshop held in Montreal in February 2007 to discuss the papers and debate recommendations. The recommendations provided in the consensus statement focus on issues of immediate relevance to Canadian policy-makers, including informed consent to hESC research, the use of fresh embryos in research, management of conflicts of interest, and the relevance of public opinion research to policy-making.

  20. Promoting an ethic of engagement in pediatric palliative care research.

    Science.gov (United States)

    Rahimzadeh, Vasiliki; Bartlett, Gillian; Longo, Cristina; Crimi, Laura; Macdonald, Mary Ellen; Jabado, Nada; Ells, Carolyn

    2015-10-16

    This paper defends the ethical and empirical significance of direct engagement with terminally ill children and adolescents in PPC research on health-related quality of life. Clinical trials and other forms of health research have resulted in tremendous progress for improving clinical outcomes among children and adolescents diagnosed with a life-threatening illness. Less attention has been paid, however, to engaging this patient population directly in studies aimed at optimizing health-related quality of life in PPC. Though not restricted to care at the end of life, PPC--and by extension PPC research--is in part dependent on recognizing the social complexities of death and dying and where health-related quality of life is a fundamental element. To explore these complexities in depth requires partnership with terminally ill children and adolescents, and acknowledgement of their active social and moral agency in research. Principles of pediatric research ethics, theoretical tenets of the "new sociology of the child(hood)," and human rights codified in the United Nations Convention on the Rights of the Child (UNCRC) underpin the position that a more engagement-centered approach is needed in PPC research. The ethics, sociologies and human rights of engagement will each be discussed as they relate to research with terminally ill children and adolescents in PPC. Qualitative method(ologies) presented in this paper, such as deliberative stakeholder consultations and phenomenology of practice can serve as meaningful vehicles for achieving i) participation among terminally ill children and adolescents; ii) evidence-bases for PPC best practices; and iii) fulfillment of research ethics principles. PPC research based on direct engagement with PPC patients better reflects their unique expertise and social epistemologies of terminal illness. Such an approach to research would strengthen both the ethical and methodological soundness of HRQoL inquiry in PPC.

  1. Sexuality in institutionalized elderly persons: a systematic review of argument-based ethics literature.

    Science.gov (United States)

    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.

  2. Researcher Tales and Research Ethics: The Spaces in Which We Find Ourselves

    Science.gov (United States)

    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…

  3. Financial remuneration for clinical and behavioral research participation: ethical and practical considerations.

    Science.gov (United States)

    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.

  4. You Must Participate: Violating Research Ethical Principles through Role-Play

    Science.gov (United States)

    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…

  5. A Critical Review of Theories and Measures of Ethics-Related Leadership.

    Science.gov (United States)

    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.

  6. Research ethics I: Responsible conduct of research (RCR)--historical and contemporary issues pertaining to human and animal experimentation.

    Science.gov (United States)

    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.

  7. 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.

  8. The challenge of developing ethical guidelines for a research infrastructure

    Science.gov (United States)

    Kutsch, Werner Leo

    2016-04-01

    The mission of the Integrated Carbon Observation System (ICOS RI) is to enable research to understand the greenhouse gas (GHG) budgets and perturbations. The ICOS RI provides the long-term observations required to understand the present state and predict future behaviour of the global carbon cycle and GHG emissions. Technological developments and implementations, related to GHGs, will be promoted by the linking of research, education and innovation. In order to provide this data ICOS RI is a distributed research infrastructure. The backbones of ICOS RI are the national measurement stations such as ICOS atmosphere, ecosystem and ocean stations. ICOS Central Facilities are the European level ICOS RI Centres, which have the specific tasks in collecting and processing the data and samples received from the national measurement networks. During the establishment of ICOS RI ethical guidelines were developed. These guidelines describe principles of ethics in the research activities that should be applied within ICOS RI. They should be acknowledged and followed by all researchers affiliated to ICOS RI and should be supported by all participating institutions. The presentation describes (1) the general challenge to develop ethical guidelines in a complex international infrastructure and (2) gives an overview about the content that includes different kinds of conflicts of interests, data ethics and social responsibility.

  9. Culture, context and community: ethical considerations for global nursing research.

    Science.gov (United States)

    Harrowing, J N; Mill, J; Spiers, J; Kulig, J; Kipp, W

    2010-03-01

    High-quality research is essential for the generation of scientific nursing knowledge and the achievement of the Millennium Development Goals. However, the incorporation of Western bioethical principles in the study design may not be suitable, sufficient or relevant to participants in low-income countries and may indeed be harmful and disrespectful. Before engaging in global health studies, nurses must consider carefully the cultural and social context and values of the proposed setting in order to situate the research within the appropriate ethical framework. The purpose of this paper was to examine the ethical principles and considerations that guide health research conducted in international settings using the example of a qualitative study of Ugandan nurses and nurse-midwives by a Canadian researcher. The application of Western bioethical principles with their emphasis on autonomy fails to acknowledge the importance of relevant contextual aspects in the conduct of global research. Because ethics is concerned with how people interact and live together, it is essential that studies conducted across borders be respectful of, and congruent with, the values and needs of the community in which it occurs. The use of a communitarian ethical framework will allow nurse scientists to contribute to the elimination of inequities between those who enjoy prosperity and good health, and those who do not.

  10. Animal models in biological and biomedical research - experimental and ethical concerns.

    Science.gov (United States)

    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.

  11. Evaluating institutional capacity for research ethics in Africa: a case study from Botswana.

    Science.gov (United States)

    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

  12. Evaluating institutional capacity for research ethics in Africa: a case study from Botswana

    Science.gov (United States)

    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

  13. Detecting, preventing, and responding to "fraudsters" in internet research: ethics and tradeoffs.

    Science.gov (United States)

    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