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/

Ethics Committee or Community? Examining the identity of Czech Ethics Committees in the period of transition.

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Simek, Jiri; Zamykalova, Lenka; Mesanyova, Marie

2010-09-01

Reflecting on a three year long exploratory research of ethics committees in the Czech Republic authors discuss the current role and identity of research ethics committees. The research of Czech ethics committees focused on both self-presentation and self-understanding of ECs members, and how other stakeholders (representatives of the pharmaceutical industry) view them. The exploratory research was based on formal and informal communication with the members of the ethics committees. Members of the research team took part at six regular voluntary meetings of the ethics committees' members, organised by the Forum of Czech Ethics Committees, and at three summer schools of medical ethics. There were realised twenty-five semi-structured interviews as well as six focus group sessions and a participant observation of several regular meetings of three ethics committees. On the grounds of experience from the interviews a simple questionnaire survey was realised among the members of the ethics committees. The ethics committees comprise a community of members working voluntarily, without claims to remuneration or prestige; the unifying goal is protection of subjects of research. The principal working methods are dialogue and agreement. The members of the ethics committees thus, among other things, create an informal community, which can be to a certain extent seen as a Kantian ethical community in a weak sense. The phenomenon of ethics committees can also be described by terms of an epistemic community and a community of practice. These concepts, which are borrowed from other authors and areas, are used as a way how to think of ECs role and identity a bit differently and are meant as a contribution to the current international debate on the topic.

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

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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

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

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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

Ethics committees in India: Facing the challenges!

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Kadam, Rashmi; Karandikar, Shashikant

2012-04-01

The past few years have seen a tremendous rise in the number of clinical trials conducted in India. This is been attributed to the huge patient population, genetic diversity, and rich technical pool in our country. However, the economical upsurge in the clinical trial industry has also caused concerns pertaining to the efficiency of the Regulatory Agencies and Ethics Committees (EC). The EC plays an important role in the regulation of clinical research at the local level. However, it is seen that many ECs are oblivious to their roles and responsibilities. It is reported that ECs lack standard operating procedures, do not have a proper composition or adequate representation, thus affecting their functions in regulating clinical research. Moreover, ECs seem to function in isolation, as self-sufficient bodies, having no communication with the regulatory agency or other ECs. This brings forth the need for ECs to come together and share their experiences and observations, with the aim of updating themselves and refining their functions. Efforts also need to be focused on capacity building, centralized registration of ECs, and bringing an oversight mechanism in place. The Ethics Committees in India need to work in close association with forums such as the Forum for Ethics Review Committees in India and the Forum for Ethical Review Committees in Asia Pacific, in an effort towards empowering themselves.

Ethics committees in India: Facing the challenges!

Directory of Open Access Journals (Sweden)

Rashmi Kadam

2012-01-01

Full Text Available The past few years have seen a tremendous rise in the number of clinical trials conducted in India. This is been attributed to the huge patient population, genetic diversity, and rich technical pool in our country. However, the economical upsurge in the clinical trial industry has also caused concerns pertaining to the efficiency of the Regulatory Agencies and Ethics Committees (EC. The EC plays an important role in the regulation of clinical research at the local level. However, it is seen that many ECs are oblivious to their roles and responsibilities. It is reported that ECs lack standard operating procedures, do not have a proper composition or adequate representation, thus affecting their functions in regulating clinical research. Moreover, ECs seem to function in isolation, as self-sufficient bodies, having no communication with the regulatory agency or other ECs. This brings forth the need for ECs to come together and share their experiences and observations, with the aim of updating themselves and refining their functions. Efforts also need to be focused on capacity building, centralized registration of ECs, and bringing an oversight mechanism in place. The Ethics Committees in India need to work in close association with forums such as the Forum for Ethics Review Committees in India and the Forum for Ethical Review Committees in Asia Pacific, in an effort towards empowering themselves.

Hospital ethics committees in Israel: structure, function and heterogeneity in the setting of statutory ethics committees

OpenAIRE

Wenger, N; Golan, O; Shalev, C; Glick, S

2002-01-01

Objectives: Hospital ethics committees increasingly affect medical care worldwide, yet there has been little evaluation of these bodies. Israel has the distinction of having ethics committees legally required by a Patients' Rights Act. We studied the development of ethics committees in this legal environment.

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

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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

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...

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...

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

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Yanagawa, Hiroaki; Katashima, Rumi; Takeda, Noriaki

2015-01-01

The first Japanese ethics committee for biomedical research involving human subjects was established at Tokushima University in 1982. Although this committee was not formed as a response to national directives, the government eventually developed ethical guidelines, such as the Ethical Guidelines for Clinical Studies that were established in 2003. The practical impact of such guidelines was a rapid increase in the number of protocols seeking ethics committee approval and, accordingly, an increase in the workload of ethics committees. This review describes the activity of the ethics committee at Tokushima University during the last thirty years and discusses the infrastructure that best supports the activities of this committee. In addition, we address the issues that ethics committees now face and discuss future directions. J. Med. Invest. 62: 114-118, August, 2015.

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

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Essack, Zaynab; Wassenaar, Douglas R

2018-04-01

HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prevention research. For this reason, it is critical to study the implementation of relevant ethical-legal frameworks for such research in South Africa. This qualitative study used in-depth interviews to explore the practices and perspectives of eight members of South African research ethics committees (RECs) who have reviewed protocols for HIV vaccine trials. Their practices and perspectives are compared with ethics guideline requirements for standards of prevention.

Ethics review in compassionate use.

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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.

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

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Piasecki, Jan; Waligora, Marcin; Dranseika, Vilius

2017-06-01

Epidemiological research is subject to an ethics review. The aim of this qualitative review is to compare existing ethical guidelines in English for epidemiological research and public health practice in regard to the scope and matter of an ethics review. Authors systematically searched PubMed, Google Scholar and Google Search for ethical guidelines. Qualitative analysis (constant comparative method) was applied to categorize important aspects of the an ethics review process. Eight ethical guidelines in English for epidemiological research were retrieved. Five main categories that are relevant to the review of epidemiological research by Institutional Review Boards/Research Ethics Committees were distinguished. Within the scope of main categories, fifty-nine subcategories were analyzed. There are important differences between the guidelines in terms of the scope and matter of an ethics review. Not all guidelines encompass all identified ethically important issues, and some do not define precisely the scope and matter of an ethics review, leaving much to the ethics of the individual researchers and the discretion of IRBs/RECs.

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

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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.

\\How Can Clinical Ethics Committees Take on Organizational Ethics? Some Practical Suggestions.

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Sabin, James E

2016-01-01

Although leaders in the field of ethics have for many years pointed to the crucial role that organizations play in shaping healthcare ethics, organizational ethics remains a relatively undeveloped area of ethics activity. Clinical ethics committees are an important source of potential expertise, but new skills will be required. Clinical ethics committees seeking to extend their purview to organizational issues will have to respond to three challenges-how to gain sanction and support for addressing controversial and sensitive issues, how to develop an acceptable process, and how to make a difference on the ground. The article presents practical suggestions for how clinical ethics committees meet these challenges. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

Education of ethics committee members: experiences from Croatia.

NARCIS (Netherlands)

Borovecki, A.; Have, H.A.M.J. ten; Oreskovic, S.

2006-01-01

OBJECTIVES: To study knowledge and attitudes of hospital ethics committee members at the first workshop for ethics committees in Croatia. DESIGN: Before/after cross-sectional study using a self administered questionnaire. SETTING: Educational workshop for members of hospital ethics committees,

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

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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.

Different views on ethics: how animal ethics is situated in a committee culture.

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Ideland, M

2009-04-01

Research that includes non-human animal experimentation is fundamentally a dilemmatic enterprise. Humans use other animals in research to improve life for their own species. Ethical principles are established to deal with this dilemma. But despite this ethical apparatus, people who in one way or another work with animal experimentation have to interpret and understand the principles from their individual points of view. In interviews with members of Swedish animal ethics committees, different views on what the term ethics really means were articulated. For one member, the difficult ethical dilemma of animal experimentation is the lack of enriched cages for mice. For another, the ethical problem lies in regulations restraining research. A third member talks about animals' right not to be used for human interests. These different views on "ethics" intersect once a month in the animal ethics committee meetings. There is no consensus on what constitutes the ethical problem that the members should be discussing. Therefore, personal views on what ethics means, and hierarchies among committee members, characterise the meetings. But committee traditions and priorities of interpretation as well are important to the decisions. The author discusses how "ethics" becomes situated and what implications this may have for committees' decisions.

Taking on organizational ethics. To do so, ethics committees must first prepare themselves.

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Weber, L J

1997-01-01

Healthcare ethics committees which have focused almost entirely on clinical ethics, now need to prepare to deal with organizational ethics, a field that is attracting increasing attention. As they did with clinical ethics, ethics committees members must educate themselves in the demands of the newer field. As before, they must respect the perspectives of the actual decision makers while maintaining an independent framework for analyzing the issues at stake. They must ensure that management is properly represented on the committee if they need guidance from a professional ethicist they should seek one with a strong background in business ethics and social justice. Healthcare organizations are likely to need help with a wide range of ethical issues involving patient services (rationing of resources, for example), business and service plans (mergers and joint ventures, for example), business and professional integrity (conflicts of interest, for example), employee rights and responsibilities (downsizing, for example), and the organization's role in in the community (advocacy and lobbying, for example). To be helpful to the organization, the ethics committee must be prepared to say when cost factors trump other considerations and when they do not. An ethics committee will often be asked to give advice on specific occasions-a proposed new policy, for instance. The most important part of its response is its analysis of the issue. Finally, an ethics committee should view its organization as part of the larger social context.

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

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2012-01-01

Background Many studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies. Methods The data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004–2009 (n = 688). These included a total of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning. Results The researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research. Conclusion The written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies. PMID:22873761

Education of ethics committee members: experiences from Croatia.

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Borovecki, A; ten Have, H; Oresković, S

2006-03-01

To study knowledge and attitudes of hospital ethics committee members at the first workshop for ethics committees in Croatia. Before/after cross-sectional study using a self administered questionnaire. Educational workshop for members of hospital ethics committees, Zagreb, 2003. Knowledge and attitudes of participants before and after the workshop; everyday functioning of hospital ethics committees. The majority of the respondents came from committees with at least five members. The majority of ethics committees were appointed by the governing bodies of their hospitals. Most committees were founded after the implementation of the law on health protection in 1997. Membership structure (three physicians and two members from other fields) and functions were established on the basis of that law. Analysis of research protocols was the main part of their work. Other important functions-education, case analysis, guidelines formation-were neglected. Members' level of knowledge was not sufficient for the complicated tasks they were supposed to perform. However, it was significantly higher after the workshop. Most respondents felt their knowledge should be improved by additional education. Their views on certain issues and bioethical dilemmas displayed a high level of paternalism and over protectiveness, which did not change after the workshop. The committees developed according to bureaucratic requirements. Furthermore, there are concerns about members' knowledge levels. More efforts need to be made to use education to improve the quality of the work. Additional research is necessary to explore ethics committees' work in Croatia especially in the hospital setting.

Report of the Ethics Committee, 2008

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American Psychologist, 2009

2009-01-01

In accordance with the bylaws of the American Psychological Association (APA), the Ethics Committee reports regularly to the membership regarding the number and types of ethics complaints investigated and the major programs undertaken. In 2008, ethics adjudication, ethics education and consultation, convention programs, ethics publications,…

Barriers and challenges in clinical ethics consultations: the experiences of nine clinical ethics committees.

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Pedersen, Reidar; Akre, Victoria; Førde, Reidun

2009-10-01

Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They also reported, however, that tendencies to evade moral disagreement, conflict, and 'outsiders' are common in the hospitals. Sometimes even the committees comply with some of these tendencies. The committees agree that there is a need to improve their routines and procedures, clarify the committees' profile and field of responsibility, to make the committees well-known, to secure adequate operating conditions, and to develop organizational integration and support. Various strategies to meet these challenges on a local, regional or national level are also explored in this paper.

Informed consent in Sri Lanka: a survey among ethics committee members.

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Sumathipala, Athula; Siribaddana, Sisira; Hewage, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin

2008-05-20

Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. Twenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. The number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed

Rebuilding a Research Ethics Committee

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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,…

[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.

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

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Gorman, Susanna M

2011-09-01

Australian Human Research Ethics Committees (HRECs) have to contend with ever-increasing workloads and responsibilities which go well beyond questions of mere ethics. In this article, I shall examine how the roles of HRECs have changed, and show how this is reflected in the iterations of the National Statement on Ethical Conduct in Human Research 2007 (NS). In particular I suggest that the focus of the National Statement has shifted to concentrate on matters of research governance at the expense of research ethics, compounded by its linkage to the Australian Code for the Responsible Conduct of Research (2007) in its most recent iteration. I shall explore some of the challenges this poses for HRECs and institutions and the risks it poses to ensuring that Australian researchers receive clear ethical guidance and review.

Report of the Ethics Committee, 2010

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American Psychologist, 2011

2011-01-01

In accordance with the bylaws of the American Psychological Association (APA), the Ethics Committee reports regularly to the membership regarding the number and types of ethics matters investigated and the major programs undertaken. In 2010, ethics adjudication, ethics education and consultation, and special projects were activities of the Ethics…

Research governance: new hope for ethics committees?

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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.

Report of the Ethics Committee, 2009

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American Psychologist, 2010

2010-01-01

In accordance with the bylaws of the American Psychological Association (APA), the Ethics Committee reports regularly to the membership regarding the number and types of ethics complaints investigated and the major programs undertaken. This article is a summary of the talks and workshops of 2009, ethics adjudication, ethics education and…

Ethical aspects in clinical trials in the CIS, in particular the setting up of ethical committees.

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Kubar, Olga

2005-01-01

The ethical aspects of clinical trials in the CIS are based on the development of systematic ethical review and ethical insight and responsibility on the part of researchers, sponsors, and government agencies and society. This is the main purpose of the Forum for Ethics Committees in the Commonwealth of Independent States (FECCIS) whose establishment and activities are focused on the integration of the CIS into the world system of biomedical research with regard to safeguarding ethical standards of human rights protection and harmonization of regulative and methodological space to safeguard protection of human rights and the dignity of biomedical research participants in the CIS.

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

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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.

Informed consent in Sri Lanka: A survey among ethics committee members

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Siriwardhana Chesmal

2008-05-01

Full Text Available Abstract Background Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research. However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. Methods We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. Results Twenty-nine members from ethics committees participated. Majority of participants (23, believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%, believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52% believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. Conclusion The number of themes generated for the consent form (N = 18 is as many as for the information leaflet (N = 19 and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and

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

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Mondragón Barrios, Liliana; Guarneros García, Tonatiuh; Jiménez Tapia, Alberto

2017-07-01

The objective of this article is to compare various ethical issues considered by social scientists and research ethics committees in the evaluation of mental health social research protocols. We contacted 47 social scientists and 10 members of ethics committees in Mexico with two electronic national surveys that requested information from both groups related to the application of ethical principles in mental health social research. The results showed no significant difference between these groups in the value placed on the ethical issues explored. Based on this finding, we make proposals to strengthen the collaboration between the two groups.

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

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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.

Public titles of clinical trials should have ethics review.

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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.

Ethical challenges within Veterans Administration healthcare facilities: perspectives of managers, clinicians, patients, and ethics committee chairpersons.

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Foglia, Mary Beth; Pearlman, Robert A; Bottrell, Melissa; Altemose, Jane K; Fox, Ellen

2009-04-01

To promote ethical practices, healthcare managers must understand the ethical challenges encountered by key stakeholders. To characterize ethical challenges in Veterans Administration (VA) facilities from the perspectives of managers, clinicians, patients, and ethics consultants. We conducted focus groups with patients (n = 32) and managers (n = 38); semi-structured interviews with managers (n = 31), clinicians (n = 55), and ethics committee chairpersons (n = 21). Data were analyzed using content analysis. Managers reported that the greatest ethical challenge was fairly distributing resources across programs and services, whereas clinicians identified the effect of resource constraints on patient care. Ethics committee chairpersons identified end-of-life care as the greatest ethical challenge, whereas patients identified obtaining fair, respectful, and caring treatment. Perspectives on ethical challenges varied depending on the respondent's role. Understanding these differences can help managers take practical steps to address these challenges. Further, ethics committees seemingly, are not addressing the range of ethical challenges within their institutions.

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

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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…

Communicating Qualitative Research Study Designs to Research Ethics Review Boards

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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…

ETHICAL AND LEGAL ASPECTS OF FUNCTIONING OF ETHIC COMMITTEES IN BULGARIA

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Mariela Deliverska

2017-06-01

Full Text Available Scientific research has to be based on ethical standards that promote the protection of human rights. On a national level, the domestic legislation of the Republic of Bulgaria foresees a procedure for obtaining an opinion from the Ethics Committee for Multicentre Trials in order to introduce a substantial change in a clinical trial and non-interventional study. The procedure aims to evaluate the compliance of the planned clinical trial with the norms of good clinical practice, the requirements of the Medicinal Products in Human Medicine Act. On European Union level, standards have been set down in Regulation (EC No. 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use. The licensing regime that has been introduced on a national level requires the performance of documentation evaluation that addresses a major change in a clinical trial and non-interventional research. Legal definitions of the terms "principal investigator" and "coordinating investigator" have been introduced. The "principal investigator" is the medical doctor or the dentist, designated by the sponsor, who leads the overall execution of the clinical trial in accordance with the approved protocol and good clinical practice guidelines and is responsible for the researchers. The "coordinating researcher" is a researcher appointed to coordinate researchers from different centres participating in a multicentre trial. Ethic committees performing review have to provide independent advice on the extent to which a biomedical research proposal complies with recognized ethical standards. Scientific research must necessarily conform to commonly accepted scientific principles and be based on thorough knowledge of scientific literature and other relevant sources of information.

Ethical Competence Training for Members on Clinical Ethics Committees (CEC)

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Knox, Jeanette Bresson Ladegaard

2017-01-01

To address the moral questions in patient care and medical practice, Danish hospitals are starting to solicit clinical ethics committees (CEC). As in other places around the world, CECs in Denmark is an interdisciplinary group that includes physicians, nurses, social workers, psychologists, lawyers...... lingering moral quandaries. Thus, the creation of CECs in Denmark has raised the question of qualifications for those who serve on a committee. When the Danish Society of Clinical Ethics was formed in 2012, it was therefore at the forefront of its agenda to establish a training program that would offer...... valuable contributions to the ethical aspect of medical decision making and to serve as an important resource for health care providers, patients and their families. This article describes the history, development and preliminary results of the current training program as well as reflects on future ideas...

Clinical ethics and the role of clinical ethics committees: proposals for a revival. Commentary.

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Petrini, Carlo; Ricciardi, Walter

2017-01-01

The issue addressed in the paper published by the Italian National Bioethics Committee (NBC) entitled "Clinical ethics committees", is highly significant for many reasons. One of these is the fact that the ethics committees charged with assessing clinical trials have so much responsibility and such a heavy work-load that they have little time available for other tasks such as engaging directly with patients "at the bedside", as a result of which the role of committees responsible for assessing clinical cases is especially important. According to the NBC, the opinions of clinical ethics committees should be formulated jointly and are non-binding. The NBC offers practical proposals not only for the Italian context. While the Italian National Institute of Health (Istituto Superiore di Sanità - ISS) is not involved directly in treating patients, its role in providing guidance is crucial to the national health service and it has always paid special attention to these issues.

Bridging problems and models in medical ethics: four images of local ethics committees.

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Incorvati, G

In the context of the continuing debate about how ethics committees in Italy should be structured (see Bulletin 160) Professor Incorvati, from the Comitato Nazionale per la Bioetica in Rome, considers four theoretical models of how such committees may be arranged, and why one in particular looks better placed to face the growing ethical problems that are emerging as a result of current developments in medicine.

Can non-regulators audit Independent Ethic Committees (IEC), and if so, how?

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Dent, N J; Sweatman, W J

A number of guidelines and directives have reinforced the need for a more formalised approach to Independent Ethic Committees (IECs) and support the need to audit IECs. The key elements of an audit of an IEC are reviewed within the context of the European Guidelines for Auditing Independent Ethics Committees published by the European Forum for Good Clinical Practice (EFGCP). Auditing requirements in these recent guidelines and the EU Clinical Trial Directive are discussed as well as the methodology and type of documentation and SOPs that should be present at an audit. It is argued that both inspectorates and independent auditors need to conduct such audits to improve the overall global standard.

Human Research Ethics Committees in Technical Universities

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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

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

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

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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.

A cross-sectional survey to investigate community understanding of medical research ethics committees.

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Fritschi, Lin; Kelsall, Helen L; Loff, Bebe; Slegers, Claudia; Zion, Deborah; Glass, Deborah C

2015-07-01

Study explanatory forms often state that an ethics committee has approved a research project. To determine whether the lay community understand the roles of ethics committees in research, we took a cross-sectional national sample from three sampling frames: the general population (n=1532); cohort study participants (n=397); and case-control study participants (n=151). About half (51.3%) of the participants had heard of ethics committees. Those who had were more likely to be those who had participated in previous surveys, older participants, those born in Australia and those with higher education. Almost all participants agreed that the roles of an ethics committee were to protect participants' privacy and ensure no harm came to study participants and most agreed that the committee's role was to ensure that the research was capable of providing answers. Case-control and cohort participants were more likely than the general population to consider that the role of an ethics committee was to design the research and obtain research funding. Overall, we found that about half of the population are aware of ethics committees and that most could correctly identify that ethics committees are there to protect the welfare and rights of research participants, although a substantial minority had some incorrect beliefs about the committees' roles. Increased education, particularly for migrants and older people, might improve understanding of the role of ethics committees in 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.

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

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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.

Doing the right thing! A model for building a successful hospital-based ethics committee in Nunavut

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Madeleine Cole

2013-08-01

Iqaluit in September 2011, we are working to develop a model for the QGH ethics committee that incorporates multi-level perspectives, from that of community to that of front-line worker. Conclusion . Ideally, the scope of the QGH Ethics Committee will grow over time to include ethics education, facilitation of clinical ethical consults, ethical review of policy, advice on governance issues and involvement and support of an external northern Health REB.

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

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Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara

2018-01-11

Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of clinical trials (chapters II and IV in 'Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants' in Lebanon?' This was a quantitative and descriptive questionnaire-based study conducted among RECs of university hospitals in Lebanon. The questionnaire had to be completed online and included general questions in addition to items reflecting the different aspects of a REC performance and effectiveness. All the questionnaire was assigned a total score of 175 points. General information and questions assigned point values/scores were analysed using descriptive statistics: frequency and percentage, mean score ± standard deviation. Ten RECs participated in the study (52 persons: four chairs, one vice-president, 47 ordinary members). Forty-seven (90.4%) had previous experience with clinical research and 30 (57.7%) had a diploma or had done a training in research ethics. Forty-one percent confirmed that they were required to have a training in research ethics. All RECs had a policy for disclosing and managing potential conflicts of interest for its members, but 71.8% of participants reported the existence of such a policy for researchers. Thirty-three point three percent reported that the RECs had an anti-bribery policy. The questionnaire mean score was 129.6 ± 22.3/175 points reflecting thus an excellent adherence to international standards. Inadequate training of REC members and the lack of anti-bribery policies should be resolved to

Do ethics committees need a legal framework?

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Byk, Christian

2007-01-01

The question "do ethics committees need a legal framework" may then raise fundamental discussion in the case of developing countries: will an ethical framework bring them a better capacity to assume their task? And what should this task be if we consider the particularities of clinical research conducted in developing countries?

[Independent ethics committees for clinical research in Argentina. An evaluation and a system to guarantee their independence].

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Gonorazky, Sergio E

2008-01-01

The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT) requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the assumed autonomy of the former can be reduced to merely a relationship of "service provider-customer". The Institutional Review Board of the Mar del Plata s Community Hospital has evaluated, between 2005 and 2006, thirty three research protocols (with their corresponding information sheets for patients and informed consent forms) previously approved by a non-institutional Independent Ethics Committee. The median number of objections made by the Institutional Review Board, which prompted the previously mentioned protocols to be modified in order to be approved, was of three per protocol. In other words, the accreditation of an Independent Ethics Committee requires a system that guarantees actual independence from the sponsors and/or researchers, as well as management control mechanisms that may lead them into an eventual loss of accreditation. Several measures are proposed in order to correct the deficiencies of the present system.

Qualitative analysis of healthcare professionals' viewpoints on the role of ethics committees and hospitals in the resolution of clinical ethical dilemmas.

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Marcus, Brian S; Shank, Gary; Carlson, Jestin N; Venkat, Arvind

2015-03-01

Ethics consultation is a commonly applied mechanism to address clinical ethical dilemmas. However, there is little information on the viewpoints of health care providers towards the relevance of ethics committees and appropriate application of ethics consultation in clinical practice. We sought to use qualitative methodology to evaluate free-text responses to a case-based survey to identify thematically the views of health care professionals towards the role of ethics committees in resolving clinical ethical dilemmas. Using an iterative and reflexive model we identified themes that health care providers support a role for ethics committees and hospitals in resolving clinical ethical dilemmas, that the role should be one of mediation, rather than prescription, but that ultimately legal exposure was dispositive compared to ethical theory. The identified theme of legal fears suggests that the mediation role of ethics committees is viewed by health care professionals primarily as a practical means to avoid more worrisome medico-legal conflict.

Novel Paths to Relevance: How Clinical Ethics Committees Promote Ethical Reflection.

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Magelssen, Morten; Pedersen, Reidar; Førde, Reidun

2016-09-01

How may clinical ethics committees (CECs) inspire ethical reflection among healthcare professionals? How may they deal with organizational ethics issues? In recent years, Norwegian CECs have attempted different activites that stretch or go beyond the standard trio of education, consultation, and policy work. We studied the novel activities of Norwegian CECs by examining annual reports and interviewing CEC members. Through qualitative analysis we identified nine categories of novel CEC activities, which we describe by way of examples. In light of the findings, we argue that some novel working methods may be well suited to promote ethical reflection among clinicians, and that the CEC may be a suitable venue for discussing issues of organizational ethics.

A New Ethical Challenge for Institutional Review Boards (IRBs/Ethics Committees (ECs in the Assessment of Pediatric Clinical Trials

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Klaus Rose

2015-05-01

Full Text Available Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA’s Pediatric Committee (PDCO may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs/ethics committees (ECs and that clinical trials resulting from negotiations with EMA’s PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.

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).

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Sacarlal, Jahit; Muchanga, Vasco; Mabutana, Carlos; Mabui, Matilde; Mariamo, Arlete; Cuamba, Assa Júlio; Fumo, Leida Artur; Silveira, Jacinta; Heitman, Elizabeth; Moon, Troy D

2018-05-23

Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique (CNBS) encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine (FM) of University Eduardo Mondlane (UEM) and the Maputo Central Hospital (MCH) established a joint Institutional Committee on Bioethics for Health (CIBS FM & MCH). This study examines the experience of the first 4 years of the CIBS FM & MCH. This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee's respective reviews and actions. A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master's degree research (42%). Descriptive cross-sectional studies were the most frequently reviewed research (61%). The majority were prospective (71%) and used quantitative methodologies (51%). The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS's average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS. Our results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training

Committees for Ethics in Research involving human subjects.

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Hossne, William Saad; Vieira, Sonia; De Freitas, Corina Bontempo Duca

2008-01-01

In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.

[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.

Ethics committees and the changed clinical research environment in India in 2016: A perspective!

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Davis, Sanish; Sule, Poonam; Bughediwala, Murtuza; Pandya, Vrunda; Sinha, Shilpi

2017-01-01

Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs Standard Control Organization has in the period 2013-2016 introduced several new regulations and amendments to existing regulations overseeing the conduct of Research in India. Several of these have direct effect on the functioning of the EC from a review, approval, and oversight mechanism. The Ethics Council of Indian Society for Clinical Research conducted a questionnaire survey among EC members to understand the impact of these changes in their functioning. The domains surveyed included awareness about recent changes/amendments and impacts, serious adverse events (SAEs) and compensation, informed consent and audio-video recording, monitoring and auditing of research, and future working of ECs. Seventy-nine percent of ECs are of the opinion that the new regulations/guidelines will add to their existing burden in the process of review and approval, providing subject protection and research oversight. Even though 68% of ECs stated that they are comfortable with SAE assessment and compensation determination, they state that there is variability in calculation of compensation amount using the formulae. An overwhelming majority (80%) of ECs stated that they were not in favor of centralized EC for providing review, approval, and oversight of clinical studies. Ethics Committees act as local regulator for clinical trials at sites providing Human Subject protection. The survey captures the contemporary issues faced by the ECs and also raises important questions on the ease of doing research, oversight of approved research, and administrative burden on the EC. Recent changes in regulations have on the one hand empowered Ethics committees but brought in challenges in the way that they provide oversight and monitor research carried out at the site.

Protecting vulnerable research participants: a Foucault-inspired analysis of ethics committees.

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Juritzen, Truls I; Grimen, Harald; Heggen, Kristin

2011-09-01

History has demonstrated the necessity of protecting research participants. Research ethics are based on a concept of asymmetry of power, viewing the researcher as powerful and potentially dangerous and establishing ethics committees as external agencies in the field of research. We argue in favour of expanding this perspective on relationships of power to encompass the ethics committees as one among several actors that exert power and that act in a relational interplay with researchers and participants. We employ Michel Foucault's ideas of power as an omnipresent force which is dynamic and unstable, as well as the notion that knowledge and power are inextricably intertwined. The article discusses how research ethics committees may affect academic freedom. In addition it is pointed out that research participants could be harmed - not only by unfortunate research practices, but also by being subjected to the protective efforts of ethics monitoring bodies.

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

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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

An ethics for the living world: operation methods of Animal Ethics Committees in Italy

Directory of Open Access Journals (Sweden)

Mariano Martini

2015-09-01

Full Text Available INTRODUCTION AND OBJECTIVES. Coinciding with the recent implementation in Italy of the "Directive 2010/63/EU, regarding the protection of animals used for scientific purposes", the Authors would like to analyse the topic of the introduction of ethical committees for animal experimentation in Italy. This paper furthermore aims to underline some critical aspects concerning the actions taken by Italian institutions to comply with the provisions of EU. RESULTS AND DISCUSSION. The implementation of the recent Italian law (Decreto Legislativo n. 26 on 4 March 2014 Implementation of the Directive 2010/63/EU on the protection of animals used for scientific purposes leans towards a restrictive interpretation of the European provisions about composition and responsibilities of "Ethical Committee for Animal Experimentation". In the composition of the bodies mentioned, we note a tendency to restrict the composition to few professional figures contemplated by Italian law, without guaranteeing the independence of each committee; also, an absence of hierarchical relationship between a research institution and his committee is apparent. Moreover, a critical aspect is the lack of decision-making powers of these new organisms in terms of ethical evaluation of protocols and research projects. CONCLUSIONS. What EU legislation imposes on the member states is to set up an animal-welfare body (art. 26. This represents a strong incentive for Italy to follow the steps of many other European Countries, where ad hoc ethical committees have been working for a long time. The proper functioning of these bodies may contribute to guarantee the safety and welfare of the animals inside the laboratories, and to balance the protection of animal life and the interests of research.

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.

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Smith, T; Moore, E J; Tunstall-Pedoe, H

1997-05-31

To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace. Tayside, Scotland (mixed rural and urban population). 30 research projects approved by Tayside local medical research ethics committee. Adherence to the agreed protocol, particularly for recruitment (obtaining and recording informed consent) and for specific requirements of the ethics committee, including notification of changes to the protocol and of adverse events. In one project only oral consent had been obtained, and in a quarter of the studies one or more consent forms were incorrectly completed. Inadequate filing of case notes in five studies and of consent forms in six made them unavailable for scrutiny. Adverse events were reported, but there was a general failure to report the abandoning or non-starting of projects in two studies the investigators failed to notify a change in the responsible researcher. Monitoring of medical research by local medical research ethics committees promotes and preserves ethical standards, protects subjects and researchers, discourages fraud, and has the support of investigators. We recommend that 10% of projects should undergo on-site review, with all others monitored by questionnaire. This would require about six person hours of time and a salary bill of 120 pounds per study monitored.

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

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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

[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.

A "next generation" ethics committee. St. Joseph Health system has integrated performance-improvement features into its ethics work.

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Murphy, Kevin

2006-01-01

Understanding the limitations that accompany the traditional model of ethics committees, St. Joseph Health System (SJHS), Orange, CA, has been working to integrate ethics expertise and quality-improvement methodology into its "Next Generation Model" (NG Model) for such committees. However, moving from a traditional structure to the NG Model (introduced to SJHS facilities in 1999) brought some challenges, not the least of which was a deep-rooted culture of resistance to change. Following a 2004 audit of how the NG model was working, some common challenges were identified. To deal with those challenges, SJHS developed some tools and techniques that have helped ease the ongoing transition. These tools have helped the system's ethics committees address such issues as collaboration for the sake of organizational integration, setting goals, and measuring performance of various ethics roles.

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

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Taljaard, Monica; Hemming, Karla; Shah, Lena; Giraudeau, Bruno; Grimshaw, Jeremy M; Weijer, Charles

2017-08-01

Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants-yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28

How not to argue against mandatory ethics review.

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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.

78 FR 48438 - Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting

Science.gov (United States)

2013-08-08

...] Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug... of Subcommittee: Pediatric Ethics Subcommittee of the Pediatric Advisory Committee. General Function... pediatric ethical issues. Date and Time: The meeting will be held on September 9, 2013, from 8 a.m. to 5:30...

Stating the Case for Nursing Research Ethics Committees: A Discussion Paper.

Science.gov (United States)

Mitchell, Theresa; Fletcher, Ian

1998-01-01

Nurse-led research ethics committees are generally more tolerant of diversity in research proposals than are medical committees steeped in empirical traditions. However, national trends in nursing in Britain may influence a preference for multidisciplinary over nurse-led committees. (SK)

Spotlight on Ethics: Institutional Review Boards as Systemic Bullies

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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…

International variation in ethics committee requirements: comparisons across five Westernised nations

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Nachson Israel

2002-04-01

Full Text Available Abstract Background Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications. Discussion The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel to considerable amendments designed to minimise participant harm in New Zealand. Assessment of minimal risk is a complex and unreliable estimation further compounded by insufficient information on probabilities of particular individuals suffering harm. Estimating potential benefits/ risks ratio and protecting participants' autonomy similarly are not straightforward exercises. Summary Safeguarding moral/humane principles should be balanced with promotion of ethical research which does not impede research posing minimal risk to participants. In ensuring that ethical standards are met and research has scientific merit, ethics committees have obligations to participants (to meet their rights and protect them from harm; to society (to ensure good quality research is conducted; and to researchers (to treat their proposals with just consideration and respect. To facilitate meeting all these obligations, the preferable focus should be promotion of ethical research, rather than the prevention of unethical research, which inevitably results in the impediment of researchers from doing their work. How the ethical principles should be applied and balanced requires further consideration.

[Disability, inability and vulnerability: on ableism or the pre-eminence of ableist and biomedical approaches of the Human Subjects Ethics Committee of UFSC].

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Mello, Anahi Guedes de

2016-10-01

Anthropology has increasingly questioned the hegemony of biomedical knowledge in ethical review processes of social research projects prevailing in Brazil, which was governed until 2012 by the Human Research Ethics Committee of each institution under the auspices of the National Research Ethics Commission (CONEP). This was mandated through Resolution No. 196/1996 prevailing in 2012 when this field research was conducted. The scope of this study is to recount and reflect upon the barriers to obtaining approval in 2012 for my master's research project from the Human Research Ethics Committee of the Federal University of Santa Catarina (CEP/UFSC) in Florianopolis. In this ethnographic experience, in the light of Crip theory, I observed how the "disability," "vulnerability" and "inability" categories are articulated to reveal the ableism and the primacy of the biomedical model in the case of an ethics review at UFSC regarding the participation and legal capacity of persons with disabilities as subjects of research.

Can UK NHS research ethics committees effectively monitor publication and outcome reporting bias?

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Begum, Rasheda; Kolstoe, Simon

2015-07-25

Publication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service (NHS) research ethics committee to monitor both types of reporting bias. As part of an internal audit we accessed research ethics database records for studies submitting an end of study declaration to the Hampshire A research ethics committee (formerly Southampton A) between 1st January 2010 and 31st December 2011. A literature search was used to establish the publication status of studies. Primary and secondary outcomes stated in application forms were compared with outcomes reported in publications. Out of 116 studies the literature search identified 57 publications for 37 studies giving a publication rate of 32%. Original Research Ethics Committee (REC) applications could be obtained for 28 of the published studies. Outcome inconsistencies were found in 16 (57%) of the published studies. This study showed that the problem of publication and outcome reporting bias is still significant in the UK. The method described here demonstrates that UK NHS research ethics committees are in a good position to detect such bias due to their unique access to original research protocols. Data gathered in this way could be used by the Health Research Authority to encourage higher levels of transparency in UK research.

Publication Ethics: A Case Series with Recommendations According to Committee on Publication Ethics (COPE).

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Fazly Bazzaz, Bibi Seddigheh; Sadeghi, Ramin

2012-09-01

Ethical misconduct is not a new issue in the history of science and literature. However, ethical misconducts in science have grown considerably in the modern era which is due to emphasis on the scientific proliferation in research institutes and gauging scientists according to their publications. In the current case series, several misconducts occurring over the previous years in Mashhad University of Medical Sciences (Mashhad, Iran) either for Journals or Faculty members were gathered and specific recommendations were provided to avoid similar events in the future. All recommendations are according to Committee on Publication Ethics (COPE).

AWARENESS OF MEDICAL SPECIALISTS AND PATIENTS IN BULGARIA OF ETHICS COMMITTEES AND THE BENEFITS OF THEIR WORK

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Neli Gradinarova

2018-02-01

Full Text Available In today’s healthcare, the role of morality emerges to the forefront as a result of the high degree of uncertainty in our modern environment. Ethically responsible behaviour is therefore perceived as a prerequisite for preventing and counteracting a number of moral risks in society. With regard to moral hazard and responsibility, ethical codes represent a rational control mechanism, lowering the extent of the probability of moral peril. Ethics committees are also founded based on such ethical codes, the purpose of such committees being the proclamation and observation of the principles and norms set forth. At the healthcare institutions of the Republic of Bulgaria, ethics committees are established that are based on the principles of medical ethics and medical law. The significance with which ethics committees are charged regarding the sustainable development of the healthcare system consists of protecting the patients, the medical professionals and the institution itself. Awareness of the significance, functions and benefits of ethics committees and their impact on the medical practice and patients in Bulgaria is, however, insufficiently low. In a questionnaire survey conducted among 149 medical specialists employed at three medical establishments for hospital care in the country, and 269 patients under treatment at them, at being asked “Do you think that ethics committees contribute to protecting and respecting patients’ rights?”, 26.2% of the respondents among the medical professionals replied that they are not sure, while 25.7% of did not provide an answer to the question thus asked due to being unfamiliar with ethics committees as an institutionalized body and their functions. The analysis of the results of the abovementioned survey among medical professionals and patients evidences a low level of awareness of the ethics committees and their work on the territory of the Republic of Bulgaria. It is essential for healthcare

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.

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

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De Smit, Elisabeth; Kearns, Lisa S; Clarke, Linda; Dick, Jonathan; Hill, Catherine L; Hewitt, Alex W

2016-01-01

Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs) and Research Governance Offices (RGOs) across Australia. In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA), for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a "National Ethics Application Form" and three a "Low Negligible Risk" form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22) and panel review turnaround time (range nine to 136 days). We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently.

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

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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

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

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Farajkhoda, Tahmineh

2017-01-01

Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs) research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies), appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights) in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening legislation systems

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

Ethics committees in Italy--a time for change?

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Wray, E

2000-01-01

The Comitato Nazionale per la Bioetica (CNB) in Italy has recently produced an unprecedented discussion document on the state of ethics committees in Italy, with an invitation to interested parties to comment on proposed changes to their fundamental structure. After this consultation, and taking note of relevant official publications and the most recent national and international literature on the subject, the CNB proposes to produce a final, definitive document that will consider options for the future development of such committees.

Mock Hospital Ethics Committee: An Innovative Simulation to Teach Prelicensure Nursing Students the Complexities of Ethics in Practice.

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Hagedorn Wonder, Amy

Limited opportunities exist for prelicensure nursing students to observe the interprofessional process required to resolve complex ethical cases in practice. Therefore, a mock hospital ethics committee (MHEC) was assembled to teach the application of ethics in practice through simulation. The MHEC meeting is an example of how nursing education and practice can partner to create meaningful learning experiences.

The Role of Ethics Committees and Ethics Consultation in Allocation Decisions

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Strech, Daniel; Hurst, Samia; Danis, Marion

2013-01-01

Background Decisions about the allocation and rationing of medical interventions likely occur in all health care systems worldwide. So far very little attention has been given to the question of what role ethics consultation and ethics committees could or should play in questions of allocation at the hospital level. Objectives and Methods This article argues for the need for ethics consultation in rationing decisions using empirical data about the status quo and the inherent nature of bedside rationing. Subsequently, it introduces a 4-stage process for establishing and conducting ethics consultation in rationing questions with systematic reference to core elements of procedural justice. Results Qualitative and quantitative findings show a significant demand for ethics consultation expressed directly by doctors, as well as additional indirect evidence of such a need as indicated by ethically challenging circumstances of inconsistent and structurally disadvantaging rationing decisions. To address this need, we suggest 4 stages for establishing and conducting ethics consultation in rationing questions we recommend: (1) training, (2) identifying actual scarcity-related problems at clinics, (3) supporting decision-making, and (4) evaluation. Conclusion This process of ethics consultation regarding rationing decisions would facilitate the achievement of several practical goals: (i) encouragement of an awareness and understanding of ethical problems in bedside rationing, (ii) encouragement of achieving efficiency along with rationing, (iii) reinforcement of consistency in inter- and intraindvidual decision-making, (iv) encouragement of explicit reflection and justification of the prioritization criteria taken into consideration, (v) improvement in internal (in-house) and external transparency, and (vi) prevention of the misuse of the corresponding consulting structures. PMID:20706163

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

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Tansey, Catherine M; Anderson, James; Boulanger, Renaud F; Eckenwiler, Lisa; Pringle, John; Schwartz, Lisa; Hunt, Matthew

2017-06-28

The conduct of research in settings affected by disasters such as hurricanes, floods and earthquakes is challenging, particularly when infrastructures and resources were already limited pre-disaster. However, since post-disaster research is essential to the improvement of the humanitarian response, it is important that adequate research ethics oversight be available. We aim to answer the following questions: 1) what do research ethics committee (REC) members who have reviewed research protocols to be conducted following disasters in low- and middle-income countries (LMICs) perceive as the key ethical concerns associated with disaster research?, and 2) in what ways do REC members understand these concerns to be distinct from those arising in research conducted in non-crisis situations? This qualitative study was developed using interpretative description methodology; 15 interviews were conducted with REC members. Four key ethical issues were identified as presenting distinctive considerations for disaster research to be implemented in LMICs, and were described by participants as familiar research ethics issues that were amplified in these contexts. First, REC members viewed disaster research as having strong social value due to its potential for improving disaster response, but also as requiring a higher level of justification compared to other research settings. Second, they identified vulnerability as an overarching concern for disaster research ethics, and a feature that required careful and critical appraisal when assessing protocols. They noted that research participants' vulnerabilities frequently change in the aftermath of a disaster and often in unpredictable ways. Third, they identified concerns related to promoting and maintaining safety, confidentiality and data security in insecure or austere environments. Lastly, though REC members endorsed the need and usefulness of community engagement, they noted that there are significant challenges in a disaster

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.

Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

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Siriwardhana Chesmal

2008-02-01

Full Text Available Abstract Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka. Methods We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized. Results Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent. Conclusion Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal.

Co-design and implementation research: challenges and solutions for ethics committees.

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Goodyear-Smith, Felicity; Jackson, Claire; Greenhalgh, Trisha

2015-11-16

Implementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised controlled trials. Implementation science commonly involves the partnership of researchers and stakeholders, attempting to understand and encourage uptake of completed or piloted research. A co-creation approach involves collaboration between researchers and end users from the onset, in question framing, research design and delivery, and influencing strategy, with implementation and broader dissemination strategies part of its design from gestation. A defining feature of co-creation is its emergent and adaptive nature, making detailed pre-specification of interventions and outcome measures impossible. This methodology sits oddly with ethics committee protocols that require precise pre-definition of interventions, mode of delivery, outcome measurements, and the role of study participants. But the strict (and, some would say, inflexible) requirements of ethics committees were developed for a purpose - to protect participants from harm and help ensure the rigour and transparency of studies. We propose some guiding principles to help square this circle. First, ethics committees should acknowledge and celebrate the diversity of research approaches, both formally (through training) and informally (by promoting debate and discussion); without active support, their members may not understand or value participatory designs. Second, ground rules should be established for co-design applications (e.g. how to judge when 'consultation' or 'engagement' becomes research) and communicated to committee members and stakeholders. Third, the benefits of power-sharing should be recognised and credit given to measures likely to support this important goal, especially in research with

Pharmaceuticalisation and ethical review in South Asia: issues of scope and authority for practitioners and policy makers.

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Simpson, Bob; Khatri, Rekha; Ravindran, Deapica; Udalagama, Tharindi

2015-04-01

Ethical review by expert committee continues to be the first line of defence when it comes to protecting human subjects recruited into clinical trials. Drawing on a large scale study of biomedical experimentation across South Asia, and specifically on interviews with 24 ethical review committee [ERC] members across India, Sri Lanka and Nepal, this article identifies some of the tensions that emerge for ERC members as the capacity to conduct credible ethical review of clinical trials is developed across the region. The article draws attention to fundamental issues of scope and authority in the operation of ethical review. On the one hand, ERC members experience a powerful pull towards harmonisation and a strong alignment with international standards deemed necessary for the global pharmaceutical assemblage to consolidate and extend. On the other hand, they must deal with what is in effect the double jeopardy of ethical review in developing world contexts. ERC members must undertake review but are frequently made aware of their responsibility to protect interests that go beyond the 'human subject' and into the realms of development and national interest [for example, in relation to literacy and informed consent]. These dilemmas are indicative of broader questions about where ethical review sits in institutional terms and how it might develop to best ensure improved human subject protection given growth of industry-led research. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

A Study on the Directed Living Non-Related Donor Kidney Transplantation Submitted to the Hospital Transplant Ethics Committee at the National Kidney and Transplant Institute.

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Suguitan, G; Arakama, M-H I; Danguilan, R

2017-03-01

In the latter part of 2009, the Department of Health of the Philippines prohibited kidney transplantation with non-related kidney donors. Hence, the National Kidney and Transplant Institute created a Hospital Transplant Ethics Committee. This study describes directed non-related kidney donation at the National Kidney and Transplant Institute. This retrospective study reviewed the profiles of recipients and directed living non-related kidney transplant donors submitted to the Hospital Transplant Ethics Committee. A total 74 recipients and donors were reviewed by the Hospital Transplant Ethics Committee in 2014. Donors initiated the talks about being a donor (75%) to repay the good deeds that were done by the recipient for them or their families; examples of which are: sometime in their lives they needed financial assistance for hospitalization for their relatives and it was the patient who paid the hospital bill; or because they pitied the recipient, whom they found to be a good person, thus they would want to give one of their kidneys. Seventy-four (100%) said that they were not expecting anything in return for this act but wanted to be of help to the recipient. Of these 74 cases, 70 cases (95%) were approved and the others were disapproved. With a Hospital Transplant Ethics Committee in place, directed kidney donation is a valuable tool as an additional source of kidney donor without violating any ethical issues. Copyright © 2016. Published by Elsevier Inc.

Ethics support in institutional elderly care: a review of the literature.

Science.gov (United States)

van der Dam, Sandra; Molewijk, Bert; Widdershoven, Guy A M; Abma, Tineke A

2014-09-01

Clinical ethics support mechanisms in healthcare are increasing but little is known about the specific developments in elderly care. The aim of this paper is to present a systematic literature review on the characteristics of existing ethics support mechanisms in institutional elderly care. A review was performed in three electronic databases (Pubmed, CINAHL/PsycINFO, Ethxweb). Sixty papers were included in the review. The ethics support mechanisms are classified in four categories: 'institutional bodies' (ethics committee and consultation team); 'frameworks' (analytical tools to assist care professionals); 'educational programmes and moral case deliberation'; and 'written documents and policies'. For each category the goals, methods and ways of organising are described. Ethics support often serves several goals and can be targeted at various levels: case, professional or organisation. Over the past decades a number of changes have taken place in the development of ethics support in elderly care. Considering the goals, ethics support has become more outreaching and proactive, aiming to qualify professionals to integrate ethics in daily care processes. The approaches in clinical ethics support have become more diverse, more focused on everyday ethical issues and better adapted to the concrete learning style of the nursing staff. Ethics support has become less centrally organised and more connected to local contexts and primary process within the organisation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Ethical review in Pakistan: the credibility gap.

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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.

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.

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.

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

Health Research Ethics Committees in South Africa 12 years into democracy

Directory of Open Access Journals (Sweden)

Myer Landon

2007-01-01

Full Text Available Abstract Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. Results Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56% are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity.

Evaluation of the work of hospital districts' research ethics committees in Finland.

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Halila, Ritva

2014-12-01

The main task of research ethics committees (RECs) is to assess research studies before their start. In this study, 24 RECs that evaluate medical research were sent questionnaires about their structure and functions. The RECs were divided into two separate groups: those working in university hospital districts (uRECs) and those in central hospital districts (non-uRECs). The two groups were different in many respects: the uRECs were bigger in size, covered a wider range of disciplines (both medical and non-medical), had better resources and more frequent and regular meetings. After the survey was performed and analysed, the Medical Research Act was amended so that only hospital districts with a medical faculty in their region had a duty to establish ethics committees. After the amendment, the number of RECs evaluating medical research in Finland decreased from 25 to 9. The ethics committees that remained had wider expertise and were better equipped already by the time of this survey. Only one non-uREC was continuing its work, and this was being done under the governance of a university hospital district. Simple measures were used for qualitative analysis of the work of RECs that evaluate medical research. These showed differences between RECs. This may be helpful in establishing an ethics committee network in a research field or administrational area. 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.

A Hospital-Based Committee of Moral Philosophy to Revive Ethics.

Science.gov (United States)

Illy, Margaux; Le Coz, Pierre; Mege, Jean-Louis

2017-08-15

The Méditerranée Infection Foundation's primary goal is supporting a research hospital for the treatment of infectious diseases in Marseille. The main objective of this innovative center is to understand the mechanisms of contagion and face them. The Foundation will include a committee on moral philosophy that will accompany and supervise biomedical research. This is not a conventional ethics committee, frequently giving rise to a board's bureaucratic excesses, which might slow down creative biomedical clinical research without necessarily restricting abuses. Moral philosophy, however, can handle contemporary biomedical issues. In all its diversity, this discipline is able to enrich the debate on medical issues, thanks to many philosophical currents such as deontological ethics and consequentialism. The purpose of this committee is therefore to advance reflection on the bioethical issues encountered in biomedical research in infectious diseases, while respecting the precepts of moral philosophy. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

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.

Evaluation in health promotion: thoughts from inside a human research ethics committee.

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Allen, Judy; Flack, Felicity

2015-12-01

Health promotion research, quality improvement and evaluation are all activities that raise ethical issues. In this paper, the Chair and a member of human resear ch ethics committees provide an insiders' point of view on how to demonstrate ethical conduct in health promotion research and quality improvement. Several common issues raised by health promotion research and evaluation are discussed including researcher integrity, conflicts of interest, use of information, consent and privacy.

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

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.

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.

Early Childhood Special Educators and the Hospital Ethics Committee.

Science.gov (United States)

Lowenthal, Barbara

1989-01-01

The paper discusses issues of concern to early childhood special educators serving on hospital ethics committees to assist families with seriously ill and handicapped infants in neonatal intensive care units. Issues include infant euthanasia and the right to life, child abuse legislation, and possible effects on families. (Author/JDD)

Patients come from populations and populations contain patients. A two-stage scientific and ethics review: The next adaptation for single institutional review boards.

Science.gov (United States)

Knopman, David; Alford, Eli; Tate, Kaitlin; Long, Mark; Khachaturian, Ara S

2017-08-01

For nearly 50 years, institutional review boards (IRB) and independent ethics committees have featured local oversight as a core function of research ethics reviews. However growing complexity in Alzheimer's clinical research suggests current approaches to research volunteer safety is hampering development of new therapeutics. As a partial response to this challenge, the NIH has mandated that all NIH-funded multi-site studies will use a single Institutional Review Board. The perspective describes a joint program to provide a single IRB of record (sIRB) for phases of multi-site studies. The approach follows two steps. One, an expert Scientific Review Committee (SRC) of senior researchers in the field will conduct the review principally of scientific merit, significance, feasibility, and the likelihood of meaningful results. The second step will be the IRB's regulatory and ethics review. The IRB will apply appropriate regulatory criteria for approval including minimization of risks to subjects and risks reasonable in relation to anticipated benefits, equitable subject selection, informed consent, protections for vulnerable populations, and application of local context considerations, among others. There is a steady demand for scientific, ethical and regulatory review of planned Alzheimer's studies. As of January 15, 2017, there are nearly 400 open studies, Phase II and III, industry and NIH sponsored trials on disease indications affecting memory, movement and mood in the US. The effort will initially accept protocols for studies of Alzheimer's disease, dementia, and related disorders effecting memory, movement and mood. Future aims will be to provide scientific review and, where applicable, regulatory and ethical review in an international context outside North America with sites possibly in Asia, Europe and Australia. Copyright © 2017 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

An evaluation of a data linkage training workshop for research ethics committees.

Science.gov (United States)

Tan, Kate M; Flack, Felicity S; Bear, Natasha L; Allen, Judy A

2015-03-04

In Australia research projects proposing the use of linked data require approval by a Human Research Ethics Committee (HREC). A sound evaluation of the ethical issues involved requires understanding of the basic mechanics of data linkage, the associated benefits and risks, and the legal context in which it occurs. The rapidly increasing number of research projects utilising linked data in Australia has led to an urgent need for enhanced capacity of HRECs to review research applications involving this emerging research methodology. The training described in this article was designed to respond to an identified need among the data linkage units in the Australian Population Health Research Network (PHRN) and HREC members in Australia. Five one-day face to face workshops were delivered in the study period to a total of 98 participants. Participants in the workshops represented all six categories of HREC membership composition listed in the National Health and Medical Research Centres' (NHMRC) National Statement on Ethical Conduct in Human Research. Participants were assessed at three time points, prior to the training (T1), immediately after the training (T2) and 8 to 17 months after the training (T3). Ninety participants completed the pre and post questionnaires; 58 of them completed the deferred questionnaire. Participants reported significant improvements in levels of knowledge, understanding and skills in each of the eight areas evaluated. The training was beneficial for those with prior experience in the area of ethics and data linkage as well as those with no prior exposure. Our preliminary work in this area demonstrates that the provision of intensive face to face ethics training in data linkage is feasible and has a significant impact on participant's confidence in reviewing HREC applications.

Members of research ethics committees accepted a modification of the randomized consent design

NARCIS (Netherlands)

Schellings, Ron; Kessels, Alfons G.; ter Riet, Gerben; Kleijnen, Jos; Leffers, Pieter; Knottnerus, J. André; Sturmans, Ferd

2005-01-01

Background and Objective: The use of randomized consent designs has been subject of methodologic and ethical controversy. In most Western countries, research ethics committees make the decision as to whether a randomized consent design can be applied. The purpose of the study is to assess to what

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...

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

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…

Evaluation of Viewpoints of Health Care Professionals on the Role of Ethics Committees and Hospitals in the Resolution of Clinical Ethical Dilemmas Based on Practice Environment.

Science.gov (United States)

Marcus, Brian S; Carlson, Jestin N; Hegde, Gajanan G; Shang, Jennifer; Venkat, Arvind

2016-03-01

We sought to evaluate whether health care professionals' viewpoints differed on the role of ethics committees and hospitals in the resolution of clinical ethical dilemmas based on practice location. We conducted a survey study from December 21, 2013 to March 15, 2014 of health care professionals at six hospitals (one tertiary care academic medical center, three large community hospitals and two small community hospitals). The survey consisted of eight clinical ethics cases followed by statements on whether there was a role for the ethics committee or hospital in their resolution, what that role might be and case specific queries. Respondents used a 5-point Likert scale to express their degree of agreement with the premises posed. We used the ANOVA test to evaluate whether respondent views significantly varied based on practice location. 240 health care professionals (108-tertiary care center, 92-large community hospitals, 40-small community hospitals) completed the survey (response rate: 63.6 %). Only three individual queries of 32 showed any significant response variations across practice locations. Overall, viewpoints did not vary across practice locations within question categories on whether the ethics committee or hospital had a role in case resolution, what that role might be and case specific queries. In this multicenter survey study, the viewpoints of health care professionals on the role of ethics committees or hospitals in the resolution of clinical ethics cases varied little based on practice location.

Italian ethical committee intervention in a case of embryo-fetal medicine.

Science.gov (United States)

Cannovo, Nunzia; Buccelli, Paola; Bryce, Jane

2011-06-01

Embryo-fetal experimentation is intuitively associated with a therapeutic intent, according to a consolidated line of thought on the international and national levels. We report on a researcher's request for Ethics Committee approval to perform intrauterine transplantation of stem cells via cordocentesis on a fetus diagnosed with dystrophic epidermolysis bullosa, using stem cells obtained from a sibling's umbilical cord blood. The Ethics Committee rejected the request because of deontological issues and clinical judgments about the potential good to be derived from the procedure. In particular, in this case there was no preclinical or animal research on the procedure, the risk factors for mother and fetus were unknown, there was no way to guarantee compliance with Italian laws regarding safety and quality of the donor cells, and there was lack of clear informed consent.

77 FR 34046 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2012-06-08

... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... ACD, CDC, regarding a broad range of public health ethics questions and issues arising from programs... ethics standards to the accreditation process for public health departments; ethical considerations...

Making Room for Ethics

DEFF Research Database (Denmark)

Douglas-Jones, Rachel

2017-01-01

This article examines the work that goes in to ‘making room’ for ethics, literally and figuratively. It follows the activities of a capacity building Asia-Pacific NGO in training and recognising ethics review committees, using multi-sited field materials collected over 12 months between 2009...

77 FR 58397 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-Ethics...

Science.gov (United States)

2012-09-20

... Committee to the Director (ACD), Centers for Disease Control and Prevention--Ethics Subcommittee (ES) In..., regarding a broad range of public health ethics questions and issues arising from programs, scientists and practitioners. Matters To Be Discussed: Agenda items will include the following topics: Ethical considerations...

Locating Ethics

DEFF Research Database (Denmark)

Douglas-Jones, Rachel

2013-01-01

Research ethics has become integrated into what it means to conduct good science. This thesis is about the nature of that integration, which I argue is not neutral, carrying with it ideas of duty, moral obligations, organisational mechanisms, and processes of monitoring. For developing countries...... to participate in global research, the pre-requisite of ethical review has necessitated a growth in capacity building exercises. The chapters aim to elucidate ethnographically the activities and implications of 'capacity building' activities in biomedical research ethics, through following the trainings......, assessments and networking of the Forum of Ethics Review Committees of Asia and the Pacific (FERCAP), a Non-Governmental Organisation. The work provides a critical reflection on the spread and uptake of ethics, contributing particularly to literatures in medical anthropology, organisational studies...

75 FR 30409 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-Ethics...

Science.gov (United States)

2010-06-01

... Committee to the Director (ACD), Centers for Disease Control and Prevention--Ethics Subcommittee (ES) In... to the ACD, CDC, regarding a broad range of public health ethics questions and issues arising from... address public health ethics issues and coordination of these efforts with the CDC Office of State, Tribal...

76 FR 29755 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2011-05-23

... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... of public health ethics questions and issues arising from programs, scientists and practitioners... April 28, 2011, ACD, CDC meeting; discussion of next steps on addressing potential public health ethical...

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

77 FR 2549 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2012-01-18

... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... will provide counsel to the ACD, CDC, regarding a broad range of public health ethics questions and... territorial health departments in their efforts to address public health ethics challenges, approaches for...

75 FR 57044 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2010-09-17

... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... will provide counsel to the ACD, CDC, regarding a broad range of public health ethics questions and...; efforts to support state, tribal, local and territorial health departments address ethical issues in the...

76 FR 3909 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2011-01-21

... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES..., regarding a broad range of public health ethics questions and issues arising from programs, scientists and... submitted on the ethical considerations document for the allocation of ventilators during a severe pandemic...

Decisions by Finnish Medical Research Ethics Committees: A Nationwide Study of Process and Outcomes.

Science.gov (United States)

Hemminki, Elina; Virtanen, Jorma I; Regushevskaya, Elena

2015-10-01

Review by research ethics committees (RECs) is the key in medical research regulation. Data from meeting notes and project summaries were abstracted from all projects submitted in 2002 (n = 1,004) and 2007 (n = 1,045) to the official medical RECs in Finland. Data from consecutive submissions were combined per project. When comparing RECs, logistic regression was used to adjust for application characteristics. The number of projects handled varied notably by REC. In the first handling, 85% of applications in 2002 and 77% in 2007 were approved, while 13% and 20% were tabled. For 61% of the projects, the review time was 89 days, and 6% had 6 months or longer. The variation by REC in approval rates, number of handlings, or long review times was not explained by project characteristics. In the last handling, 94% of the projects in both years were approved or concluded not to need a statement from that REC. The most common reason for tabling or not approving an application was patient autonomy, usually centered on the patient leaflet. The next most common reasons were requests for further information and dissatisfaction with the scientific aspects of the project. The reasons classified as "ethics" in the narrow sense were rare. The REC focus was to assure that researchers follow the various rules on medical research and to improve the quality of research and project documents. REC considerations could be divided into decisions based on ethics and recommendations covering other aspects. © The Author(s) 2015.

Ethics policy review: a case study in quality improvement.

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Frolic, Andrea Nadine; Drolet, Katherine

2013-02-01

Policy work is often cited as one of the primary functions of Hospital Ethics Committees (HECs), along with consultation and education. Hospital policies can have far reaching effects on a wide array of stakeholders including, care providers, patients, families, the culture of the organisation and the community at large. In comparison with the wealth of information available about the emerging practice of ethics consultation, relatively little attention has been paid to the policy work of HECs. In this paper, we hope to advance the development of best practices in HEC policy work by describing the quality improvement process that we undertook at Hamilton Health Sciences, Hamilton, Ontario, Canada. In the first section of the paper we describe the context of our HEC policy work, and the shortcomings of our historical review process. In subsequent sections, we detail the quality improvement project we undertook in 2010, the results of the project and the specific tools we developed to enhance the quality of HEC policy work. Our goal in sharing this organisational case study is to prompt other HECs to publish qualitative descriptions of their policy work, in order to generate a body of knowledge that can inform the development of best practices for ethics policy review.

The Virtues of National Ethics Committees.

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Montgomery, Jonathan

2017-05-01

The United Kingdom has many bodies that play their part in carrying out the work of national ethics committees, but its nearest equivalent of a U.S. presidential bioethics commission is the Nuffield Council on Bioethics, established in 1991. The Council is charged with examining ethical questions raised by developments in biological and medical research, publishing reports, and making representations to appropriate bodies in order to respond to or anticipate public concern. It is a nongovernment organization with no defined or guaranteed channels of influence. It has no authority merely by virtue of the position it holds. Rather, it has established relational authority based on its reputation. Unlike the U.S. bioethics commission, it is not part of executive government, nor is it constituted to contribute to the legislative branch, as does the French Comité Consultatif National d'Ethique. Its nongovernmental status notwithstanding, the Nuffield Council's work affects the U.K. government and the British public, and the Council has achieved international recognition for its reports. I was the chairperson from 2012 to 2017 and draw on my experience in this piece to consider three key audiences: governments, publics, and the international community. © 2017 The Hastings Center.

76 FR 55678 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2011-09-08

... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... provide counsel to the ACD, CDC, regarding a broad range of public health ethics questions and issues... in their efforts to address public health ethics challenges. The agenda is subject to change as...

Young people's views about the purpose and composition of research ethics committees: findings from the PEARL qualitative study.

Science.gov (United States)

Audrey, Suzanne; Brown, Lindsey; Campbell, Rona; Boyd, Andy; Macleod, John

2016-09-02

Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study within which the Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. PEARL incorporated qualitative research to seek the views of young people about data linkage, including their opinions about appropriate safeguards and research governance. In this paper we focus on views expressed about the purpose and composition of research ethics committees. Digitally recorded interviews were conducted with 48 participants aged 17-19 years. Participants were asked about whether medical research should be monitored and controlled, their knowledge of research ethics committees, who should sit on these committees and what their role should be. Interview recordings were fully transcribed and anonymised. Thematic analysis was undertaken, assisted by the Framework approach to data management. The majority of interviewees had little or no specific knowledge of ethics committees. Once given basic information about research ethics committees, only three respondents suggested there was no need for such bodies to scrutinise research. The key tasks of ethics committees were identified as monitoring the research process and protecting research participants. The difficulty of balancing the potential to inhibit research against the need to protect research participants was acknowledged. The importance of relevant research and professional expertise was identified but it was also considered important to represent wider public opinion, and to counter the bias potentially associated with self-selection possibly through a selection process similar to 'jury duty'. There is a need for more education and public awareness about the role and composition of research ethics committees. Despite an initial lack of knowledge, interviewees were able to contribute their ideas and balance

75 FR 72831 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2010-11-26

... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... counsel to the ACD, CDC, regarding a broad range of public health ethics questions and issues arising from... strategy for addressing its charge to provide a preliminary overview to the ACD on ethical issues related...

Overall Assessment of Human Research and Ethics Committees in the United Arab Emirates.

Science.gov (United States)

Abdulrahman, Mahera; Nair, Satish Chandrasekhar

2017-04-01

Growing demand for human health research in the United Arab Emirates (UAE) has prompted the need to develop a robust research ethics oversight. Examination of the structure, function, and practices of the human research ethics committees (HRECs), followed by evaluation of standards for measuring research output, was conducted. Results indicate that among the HRECs, 90% followed International Council for Harmonization-Good Clinical Practice guidelines, 66.6% have been in operation for more than 5 years, 95% reviewed proposals within 8 weeks, and 56% reviewed for scientific merit apart from ethics. However, systems to recognize accomplishments of researchers, funding transparency, and adverse event reporting were deployed in less than 30% of all HRECs. Research was incorporated into the vision and mission statements of many (65%) organizations. Research publications, collaborations, and recognitions were used to measure research output and report key performance indicators. In spite, resources to generate research output such as dedicated budget (20%), support staff (20%), and continuous training and mentoring program for medical residents (15%) and HREC members (25%) were somehow lacking. HREC structure and operations in the UAE are similar to other regions of the world. Systems to conduct research and report outcomes are defined in the UAE. Regulatory legislation and allocation of resources to support the clinical research enterprise will not only help to meet growing demand for clinical trials but also transform the quality of patient care in the UAE. It is anticipated that the results of this study will benefit investigators, regulators, pharmaceutical sponsors, and the policy makers in the region.

Implications of the ethical-legal framework for adolescent HIV ...

African Journals Online (AJOL)

Nicky

Fourthly, the institutional framework for establishing research priorities and regulation of ethical review is being strengthened with the establishment of new institutions such as the National. Health Research Ethics Committee. The South African ethical-legal framework and its implications for adolescent HIV vaccine trials ...

Human somatic cell nuclear transfer and reproductive cloning: an Ethics Committee opinion.

Science.gov (United States)

2016-04-01

This document presents arguments that conclude that it is unethical to use somatic cell nuclear transfer (SCNT) for infertility treatment due to concerns about safety; the unknown impact of SCNT on children, families, and society; and the availability of other ethically acceptable means of assisted reproduction. This document replaces the ASRM Ethics Committee report titled, "Human somatic cell nuclear transfer and cloning," last published in Fertil Steril 2012;98:804-7. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

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

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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.

75 FR 4830 - Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention-Ethics...

Science.gov (United States)

2010-01-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention--Ethics Subcommittee (ES..., CDC, regarding a broad range of public health ethics questions and issues arising from programs...

From "a Fair Game" to "a Form of Covert Research": Research Ethics Committee Members' Differing Notions of Consent and Potential Risk to Participants Within Social Media Research.

Science.gov (United States)

Hibbin, R A; Samuel, G; Derrick, G E

2018-04-01

Social media (SM) research presents new challenges for research ethics committees (RECs) who must balance familiar ethical principles with new notions of public availability. This article qualitatively examines how U.K. REC members view this balance in terms of risk and consent. While it found significant variance overall, there were discernible experience-based trends. REC members with less experience of reviewing SM held inflexible notions of consent and risk that could be categorized as either relying on traditional notions of requiring direct consent, or viewing publicly available data as "fair game." More experienced REC members took a more nuanced approach to data use and consent. We conclude that the more nuanced approach should be best practice during ethical review of SM research.

Ethical issues in using data from quality management programs.

Science.gov (United States)

Nerenz, David R

2009-08-01

Since the advent of formal, data-driven quality improvement programs in health care in the late 1980s and early 1990s, there are have been questions raised about requirements for ethical committee review of quality improvement activities. A form of consensus emerged through a series of articles published between 1996 and 2007, but there is still significant variation among ethics review committees and individual project leaders in applying broad policies on requirements for committee review and/or written informed consent by participants. Recent developments in quality management, particularly the creation and use of multi-site disease registries, have raised new questions about requirements for review and consent, since the activities often have simultaneous research and quality improvement goals. This article discusses ways in which policies designed for local quality improvement projects and data bases may be adapted to apply to multi-site registries and research projects related to them.

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.

Nurses serving on clinical ethics committees: A qualitative exploration of a competency profile

NARCIS (Netherlands)

dr. Bart Cusveller

2014-01-01

The competency profile underlying higher nursing education in the Netherlands states that bachelor-prepared nurses are expected to be able to participate in ethics committees. What knowledge, skills and attitudes are involved in this participation is unclear. In five consecutive years, groups of two

Monitoring 'monitoring' and evaluating 'evaluation': an ethical framework for monitoring and evaluation in public health.

Science.gov (United States)

Gopichandran, Vijayaprasad; Indira Krishna, Anil Kumar

2013-01-01

Monitoring and evaluation (M&E) is an essential part of public health programmes. Since M&E is the backbone of public health programmes, ethical considerations are important in their conduct. Some of the key ethical considerations are avoiding conflicts of interest, maintaining independence of judgement, maintaining fairness, transparency, full disclosure, privacy and confidentiality, respect, responsibility, accountability, empowerment and sustainability. There are several ethical frameworks in public health, but none focusing on the monitoring and evaluation process. There is a need to institutionalise the ethical review of M&E proposals. A theoretical framework for ethical considerations is proposed in this paper. This proposed theoretical framework can act as the blueprint for building the capacity of ethics committees to review M&E proposals. A case study is discussed in this context. After thorough field testing, this practical and field-based ethical framework can be widely used by donor agencies, M&E teams, institutional review boards and ethics committees.

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

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Iedema, Rick A M; Allen, Suellen; Britton, Kate; Hor, Suyin

2013-05-01

This paper describes the ethics approval processes for two multicentre, nationwide, qualitative health service research projects. The paper explains that the advent of the National Ethics Application Form has brought many improvements, but that attendant processes put in place at local health network and Human Research Ethics Committee levels may have become significantly more complicated, particularly for innovative qualitative research projects. The paper raises several questions based on its analysis of ethics application processes currently in place. WHAT IS KNOWN ABOUT THE TOPIC? The complexity of multicentre research ethics applications for research in health services has been addressed by the introduction of the National Ethics Application Form. Uptake of the form across the country's human research ethics committees has been uneven. WHAT DOES THIS PAPER ADD? This paper adds detailed insight into the ethics application process as it is currently enacted across the country. The paper details this process with reference to difficulties faced by multisite and qualitative studies in negotiating access to research sites, ethics committees' relative unfamiliarity with qualitative research , and apparent tensions between harmonisation and local sites' autonomy in approving research. WHAT ARE THE IMPLICATIONS FOR PRACTITIONERS? Practitioners aiming to engage in research need to be aware that ethics approval takes place in an uneven procedural landscape, made up of variable levels of ethics approval harmonization and intricate governance or site-specific assessment processes.

Under the shelter of ethics.

Science.gov (United States)

Lichterman, Boleslav L

2005-01-01

Problems of ethics committees in post-communist Russia are briefly discussed. The first ethics committees were established in 1980s upon the initiative of international pharmaceutical companies involved in clinical trials. Generally, such committees exist at hospitals conducting these trials and at research institutions dealing with human experimentation. They are bureaucratic structures heavily dependent on hospital or institution administration. Publication of research results in international periodicals is the main reason for their existence. An officially recognized National Ethics Committee is non-existent although there are several competing ethics committees at a national level (at the Ministry of Health, Academy of Sciences, Academy of Medical Sciences, Russian Medical association etc.). There is no federal legislation on the structure and status of ethics committees.

Professional ethics in nursing: an integrative review.

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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.

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

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Stevenson, Fiona A; Gibson, William; Pelletier, Caroline; Chrysikou, Vasiliki; Park, Sophie

2015-05-08

UK-based research conducted within a healthcare setting generally requires approval from the National Research Ethics Service. Research ethics committees are required to assess a vast range of proposals, differing in both their topic and methodology. We argue the methodological benchmarks with which research ethics committees are generally familiar and which form the basis of assessments of quality do not fit with the aims and objectives of many forms of qualitative inquiry and their more iterative goals of describing social processes/mechanisms and making visible the complexities of social practices. We review current debates in the literature related to ethical review and social research, and illustrate the importance of re-visiting the notion of ethics in healthcare research. We present an analysis of two contrasting paradigms of ethics. We argue that the first of these is characteristic of the ways that NHS ethics boards currently tend to operate, and the second is an alternative paradigm, that we have labelled the 'iterative' paradigm, which draws explicitly on methodological issues in qualitative research to produce an alternative vision of ethics. We suggest that there is an urgent need to re-think the ways that ethical issues are conceptualised in NHS ethical procedures. In particular, we argue that embedded in the current paradigm is a restricted notion of 'quality', which frames how ethics are developed and worked through. Specific, pre-defined outcome measures are generally seen as the traditional marker of quality, which means that research questions that focus on processes rather than on 'outcomes' may be regarded as problematic. We show that the alternative 'iterative' paradigm offers a useful starting point for moving beyond these limited views. We conclude that a 'one size fits all' standardisation of ethical procedures and approach to ethical review acts against the production of knowledge about healthcare and dramatically restricts what can be

49 CFR 8.9 - Information Security Review Committee.

Science.gov (United States)

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false Information Security Review Committee. 8.9 Section.../DECLASSIFICATION/ACCESS Classification/Declassification of Information § 8.9 Information Security Review Committee. (a) There is hereby established a Department of Transportation Information Security Review Committee...

Ethics, big data and computing in epidemiology and public health.

Science.gov (United States)

Salerno, Jennifer; Knoppers, Bartha M; Lee, Lisa M; Hlaing, WayWay M; Goodman, Kenneth W

2017-05-01

This article reflects on the activities of the Ethics Committee of the American College of Epidemiology (ACE). Members of the Ethics Committee identified an opportunity to elaborate on knowledge gained since the inception of the original Ethics Guidelines published by the ACE Ethics and Standards of Practice Committee in 2000. The ACE Ethics Committee presented a symposium session at the 2016 Epidemiology Congress of the Americas in Miami on the evolving complexities of ethics and epidemiology as it pertains to "big data." This article presents a summary and further discussion of that symposium session. Three topic areas were presented: the policy implications of big data and computing, the fallacy of "secondary" data sources, and the duty of citizens to contribute to big data. A balanced perspective is needed that provides safeguards for individuals but also furthers research to improve population health. Our in-depth review offers next steps for teaching of ethics and epidemiology, as well as for epidemiological research, public health practice, and health policy. To address contemporary topics in the area of ethics and epidemiology, the Ethics Committee hosted a symposium session on the timely topic of big data. Technological advancements in clinical medicine and genetic epidemiology research coupled with rapid advancements in data networks, storage, and computation at a lower cost are resulting in the growth of huge data repositories. Big data increases concerns about data integrity; informed consent; protection of individual privacy, confidentiality, and harm; data reidentification; and the reporting of faulty inferences. Copyright © 2017 Elsevier Inc. All rights reserved.

A Proposal for a UK Ethics Council for Animal Policy: The Case for Putting Ethics Back into Policy Making

Directory of Open Access Journals (Sweden)

Steven P. McCulloch

2018-06-01

Full Text Available Substantial controversy is a consistent feature of UK animal health and welfare policy. BSE,~foot and mouth disease, bovine TB and badger culling, large indoor dairies, and wild animals in circuses are examples. Such policy issues are inherently normative; they include a substantial moral dimension. This paper reviews UK animal welfare advisory bodies such as the Animal Health and Welfare Board of England, the Farm Animal Welfare Committee and the Animals in Science Committee. These bodies play a key advisory role, but do not have adequate expertise in ethics to inform the moral dimension of policy. We propose an “Ethics Council for Animal Policy” to inform the UK government on policy that significantly impacts sentient species. We review existing Councils (e.g., the Nuffield Council on Bioethics and The Netherlands Council on Animal Affairs and examine some widely used ethical frameworks (e.g., Banner’s principles and the ethical matrix. The Ethics Council for Animal Policy should be independent from government and members should have substantial expertise in ethics and related disciplines. A pluralistic six-stage ethical framework is proposed: (i Problematisation of the policy issue, (ii utilitarian analysis, (iii animal rights analysis, (iv virtue-based analysis, (v animal welfare ethic analysis, and (vi integrated ethical analysis. The~paper concludes that an Ethics Council for Animal Policy is necessary for just and democratic policy making in all societies that use sentient nonhuman species.

Patient decision-making: medical ethics and mediation.

OpenAIRE

Craig, Y J

1996-01-01

A review of medical ethics literature relating to the importance of the participation of patients in decision-making introduces the role of rights-based mediation as a voluntary process now being developed innovatively in America. This is discussed in relation to the theory of communicative ethics and moral personhood. References are then made to the work of medical ethics committees and the role of mediation within these. Finally it is suggested that mediation is part of an eirenic ethic alr...

A Systematic Review of Ebola Treatment Trials to Assess the Extent to Which They Adhere to Ethical Guidelines.

Directory of Open Access Journals (Sweden)

Thomas Richardson

Full Text Available Objective: To determine to what extent each trial met criteria specified in three research frameworks for ethical trial conduct. Design: Systematic review and narrative analysis.Data sources: MEDBASE and EMBASE databases were searched using a specific search strategy. The Cochrane database for systematic reviews, the PROSPERO database and trial registries were examined. A grey literature search and citation search were also carried out. Eligibility criteria for selecting studies: Studies were included where the intervention was being used to treat Ebola in human subjects regardless of study design, comparator or outcome measured. Studies were eligible if they had taken place after the 21st March 2014. Unpublished as well as published studies were included. Included studies: Sixteen studies were included in the data synthesis. Data was extracted on study characteristics as well as any information relating to ten ethical areas of interest specified in the three research frameworks for ethical trial conduct and an additional criterion of whether the study received ethics approval from a research ethics committee. Synthesis of results: Eight studies were judged to fully comply with all eleven criteria. The other eight studies all had at least one criteria where there was not enough information available to draw any conclusions. In two studies there were ethical concerns regarding the information provided in relation to at least one ethical criteria. Description of the effect: One study did not receive ethical approval as the authors argued that treating approximately one hundred patients consecutively for compassionate reasons did not constitute a clinical trial. Furthermore, after the patients were treated, physicians in Sierra Leone did not release reports of treatment results and so study conclusions had to be made based on unpublished observations. In another study the risk-benefit ratio of the trial drug does not appear to be favourable and the

Consensus, contracts, and committees.

Science.gov (United States)

Moreno, J D

1991-08-01

Following a brief account of the puzzle that ethics committees present for the Western Philosophical tradition, I will examine the possibility that social contract theory can contribute to a philosophical account of these committees. Passing through classical as well as contemporary theories, particularly Rawls' recent constructivist approach, I will argue that social contract theory places severe constraints on the authority that may legitimately be granted to ethics committees. This, I conclude, speaks more about the suitability of the theory to this level of analysis than about the ethics committee phenomenon itself.

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.

[Presumptive organ donations for transplants agreement of the Ethics Committee of the University of Chile Medical School].

Science.gov (United States)

Roa, A; Rosselot, E

1995-04-01

The ethics committee of the Faculty of Medicine, University of Chile was consulted about the ethical aspects of presumptive organ donation for transplantation. After analyzing the problem, the committee concluded that every human being has the right to make use of his organs freely, voluntarily and according to his own discernment. The society has no right to make obligatory this donation, even after death. The foundations of this agreement were laid in a series of reasons. In fact, the corpse is not a juridical but a ethical asset and deserves respect for whom it was. It cannot be commercialized and is the only non-religious object susceptible of profanation. It is also object of popular affective and religious manifestations. Beliefs and affects must be respected. Organ donation is an act of charity and cannot be compulsory. The organ donation consent must be explicit, voluntary and solemn.

A Case-Study of the Resources and Functioning of Two Research Ethics Committees in Western India.

Science.gov (United States)

Chenneville, Tiffany; Menezes, Lynette; Kosambiya, Jayendrakumar; Baxi, Rajendra

2016-12-01

Assessing the resources and functioning of research ethics committees (RECs) in low-resource settings poses many challenges. We conducted a case study of two medical college RECs (A and B) in Western India utilizing the Research Ethics Committee Quality Assurance Self-Assessment Tool (RECQASAT) as well as in-depth interviews with representative members to evaluate REC effectiveness. REC A and B obtained 62% and 67% of allowable points on the RECQASAT. These scores together with findings from the in-depth interviews suggest the need for significant improvement in REC effectiveness particularly in the areas of membership and educational training, organizational aspects, recording minutes, communicating decisions, and REC resources. Developing evidence-based best practices and strengthening infrastructure are essential to enhancing REC efficacy in low-resource countries.

Financial "risk-sharing" or refund programs in assisted reproduction: an Ethics Committee opinion.

Science.gov (United States)

2016-10-01

Financial "risk-sharing" fee structures in assisted reproduction programs charge patients a higher initial fee but provide reduced fees for subsequent cycles and often a partial or complete refund if treatment fails. This opinion of the ASRM Ethics Committee analyzes the ethical issues raised by these fee structures, including patient selection criteria, conflicts of interest, success rate transparency, and patient informed consent. This document replaces the document of the same name, last published in 2013 (Fertil Steril 2013;100:334-6). Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Ethics committees in Croatia in the healthcare institutions: the first study about their structure and functions, and some reflections on the major issues and problems.

NARCIS (Netherlands)

Borovecki, A.; Have, H.A.M.J. ten; Oreskovic, S.

2006-01-01

OBJECTIVES: In Croatia, ethics committees are legally required in all healthcare institutions by the Law on the Health Protection. This paper explores for the first time the structure and function of ethics committees in the healthcare institutions in Croatia. DESIGN: Cross-sectional survey of the

Payment of research participants: current practice and policies of Irish research ethics committees.

Science.gov (United States)

Roche, Eric; King, Romaine; Mohan, Helen M; Gavin, Blanaid; McNicholas, Fiona

2013-09-01

Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking. Our aim was to examine REC policies, experiences and concerns with respect to the payment of participants in research projects in Ireland. Postal survey of all RECs in Ireland. Response rate was 62.5% (n=50). 80% of RECs reported not to have any established policy on the payment of research subjects while 20% had refused ethics approval to studies because the investigators proposed to pay research participants. The most commonly cited concerns were the potential for inducement and undermining of voluntary consent. There is considerable variability among RECs on the payment of research participants and a lack of clear consensus guidelines on the subject. The development of standardised guidelines on the payment of research subjects may enhance recruitment of research participants.

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

"The Project Cannot Be Approved in Its Current Form": Feminist Visual Research Meets the Human Research Ethics Committee

Science.gov (United States)

Pitt, Penelope

2014-01-01

This article reflects on a university human research ethics committee's unease regarding a feminist visual pilot study within the field of education. The small exploratory study proposed to explore a migrant mother's production of her son's identity through her family photograph collection. The committee requested substantial…

International Perspectives of Ethical Approval: The New Zealand scene

Directory of Open Access Journals (Sweden)

Antoinette McCallin Ph.D.

2010-12-01

Full Text Available The paper “Navigating the process of ethical approval” (Carey, 2010 raises many issues about the influence Institutional Ethics Committees have on research methodology and what can or cannot take place in research. Carey draws attention to the ethical challenges classic grounded theory researchers face when an ethical proposal that follows the principles of the methodology is presented to an Ethics Committee, whose main responsibility is the protection of participants. Ethics committees not only guide researchers on acceptable ethical practice, but are charged with monitoring ethical standards and ensuring researchers act in accordance with professional expectations for researchers within the jurisdiction. These committees aim to ensure consistency of ethical practice in research. While there is generally some flexibility in the review process researchers often find ethical requirements constraining, as guidelines are primarily prescriptive and are designed to ensure consistency in the application of universal ethical principles in research. In New Zealand, consistency includes paying attention to broader socio-cultural responsibilities to society that includes promoting awareness of the Code of Health and Disability Services Consumer Rights 1996, the Health Information Privacy Code 1994, and promoting ethical practices which involve Maori (the local indigenous people in research proposals as much as possible (Ministry of Health, 2006. So while researchers in training assume that their prime interest concerns the management of a research topic and methodology, they quickly find out that ethical guidelines influence research design. Even though there is an international code of ethics (Universal Declaration of Human Rights, 2005 that defines ethical standards for researchers around the world, each country has its own specific requirements depending on the context. In this paper, ethical drivers in the New Zealand context are outlined and

The ethics of peer review in bioethics

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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

EsPRit: ethics committee proposals for Long Term Medical Data Registries in rapidly evolving research fields - a future-proof best practice approach.

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Oberbichler, S; Hackl, W O; Hörbst, A

2017-10-18

Long-term data collection is a challenging task in the domain of medical research. Many effects in medicine require long periods of time to become traceable e.g. the development of secondary malignancies based on a given radiotherapeutic treatment of the primary disease. Nevertheless, long-term studies often suffer from an initial lack of available information, thus disallowing a standardized approach for their approval by the ethics committee. This is due to several factors, such as the lack of existing case report forms or an explorative research approach in which data elements may change over time. In connection with current medical research and the ongoing digitalization in medicine, Long Term Medical Data Registries (MDR-LT) have become an important means of collecting and analyzing study data. As with any clinical study, ethical aspects must be taken into account when setting up such registries. This work addresses the problem of creating a valid, high-quality ethics committee proposal for medical registries by suggesting groups of tasks (building blocks), information sources and appropriate methods for collecting and analyzing the information, as well as a process model to compile an ethics committee proposal (EsPRit). To derive the building blocks and associated methods software and requirements engineering approaches were utilized. Furthermore, a process-oriented approach was chosen, as information required in the creating process of ethics committee proposals remain unknown in the beginning of planning an MDR-LT. Here, we derived the needed steps from medical product certification. This was done as the medical product certification itself also communicates a process-oriented approach rather than merely focusing on content. A proposal was created for validation and inspection of applicability by using the proposed building blocks. The proposed best practice was tested and refined within SEMPER (Secondary Malignoma - Prospective Evaluation of the

影响医务人员医学伦理审查认知的因素分析%Analysis of the Influential Factors of Medical Staff's Cognition on Medical Ethics Review

Institute of Scientific and Technical Information of China (English)

黄娟; 孙昌林; 张静; 程雨蒙; 左玉玲

2017-01-01

Objective:To analyze the influential factors of medical staff's cognition on medical ethics review in Wuhan municipal medical institutions,and thus to provide suggestions for strengthening the ethical construction.Methods:Aquestionnaire survey was conducted among medical staff.Chi-square test and Logistic regression method were performed to analyze the influential factors of medical staff's cognition on medical ethics review.Results:The results showed that medical staff's cognition on medical ethics review was affected by the technical tide,education background,whether had received ethical education,the cognition on ethics committees and whether the medical institution had established ethics committee.With higher technical titles,they thought more necessity to establish ethics committees and conduct ethical review of the clinical applications of new technology and new business.Those with higher technical titles and had read the ethical propaganda materials thought it more necessary to conduct ethical review of the clinical application of new technology and new business and the ethical review of biomedical research involved human beings.Conclusions:The medical institution should embody the establishment and standardization of ethical committees into the hospital assessment management system,as a necessary condition for the application of research projects and achievement awards.Also,it should conduct medical ethics training for all medical staff.Only those passed the examination can enter into the research and clinical operation with certificates,which can protect the medical ethics education into practice.It should strengthen the medical staff's cognition on ethical review,constantly innovate the operation rules and management system based on following the basic ethical review principles,and constantly improve the medical ethical review mechanism.%目的 �

Surgical innovation: the ethical agenda: A systematic review.

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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

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

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Guta, Adrian; Nixon, Stephanie A; Wilson, Michael G

2013-12-01

In this paper we examine "ethics creep", a concept developed by Haggerty (2004) to account for the increasing bureaucratization of research ethics boards and institutional review boards (REB/IRBs) and the expanding reach of ethics review. We start with an overview of the recent surge of academic interest in ethics creep and similar arguments about the prohibitive effect of ethics review. We then introduce elements of Michel Foucault's theoretical framework which are used to inform our analysis of empirical data drawn from a multi-phase study exploring the accessibility of community-engaged research within existing ethics review structures in Canada. First, we present how ethics creep emerged both explicitly and implicitly in our data. We then present data that demonstrate how REB/IRBs are experiencing their own form of regulation. Finally, we present data that situate ethics review alongside other trends affecting the academy. Our results show that ethics review is growing in some ways while simultaneously being constrained in others. Drawing on Foucauldian theory we reframe ethics creep as a repressive hypothesis which belies the complexity of the phenomenon it purports to explain. Our discussion complicates ethics creep by proposing an understanding of REB/IRBs that locates them at the intersection of various neoliberal discourses about the role of science, ethics, and knowledge production. Copyright © 2012 Elsevier Ltd. All rights reserved.

Organizational ethics: a literature review.

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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

A role for research ethics committees in exchanges of human biospecimens through material transfer agreements.

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Chalmers, Donald; Nicol, Dianne; Nicolás, Pilar; Zeps, Nikolajs

2014-09-01

International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs involving exchange of biospecimens and data and in monitoring compliance.

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

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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.

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...

Applying for ethical approval for research: the main issues.

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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.

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

The ethics of peer review in bioethics.

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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.

A Scoping Study on the Ethics of Health Systems Research.

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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.

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.

[Ethical issue in animal experimentation].

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Parodi, André-Laurent

2009-11-01

In the 1970s, under pressure from certain sections of society and thanks to initiatives by several scientific research teams, committees charged with improving the conditions of laboratory animals started to be created, first in the United States and subsequently in Europe. This led to the development of an ethical approach to animal experimentation, taking into account new scientific advances. In addition to the legislation designed to provide a legal framework for animal experimentation and to avoid abuses, this ethical approach, based on the concept that animals are sentient beings, encourages greater respect of laboratory animals and the implementation of measures designed to reduce their suffering. Now, all animal experiments must first receive ethical approval--from in-house committees in the private sector and from regional committees for public institutions. Very recently, under the impetus of the French ministries of research and agriculture, the National committee for ethical animal experimentation published a national ethical charter on animal experimentation, setting the basis for responsible use of animals for scientific research and providing guidelines for the composition and functioning of ethics committees. Inspired by the scientific community itself this ethical standardization should help to assuage--but not eliminate--the reticence and hostility expressed by several sections of society.

Nurses' ethical conflicts in performance of utilization reviews.

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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.

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

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McKenzie, Joanne E; Herbison, G Peter; Roth, Paul; Paul, Charlotte

2010-03-21

Recent cohort studies of randomised controlled trials have provided evidence of within-study selective reporting bias; where statistically significant outcomes are more likely to be more completely reported compared to non-significant outcomes. Bias resulting from selective reporting can impact on meta-analyses, influencing the conclusions of systematic reviews, and in turn, evidence based clinical practice guidelines.In 2006 we received funding to investigate if there was evidence of within-study selective reporting in a cohort of RCTs submitted to New Zealand Regional Ethics Committees in 1998/99. This research involved accessing ethics applications, their amendments and annual reports, and comparing these with corresponding publications. We did not plan to obtain informed consent from trialists to view their ethics applications for practical and scientific reasons. In November 2006 we sought ethical approval to undertake the research from our institutional ethics committee. The Committee declined our application on the grounds that we were not obtaining informed consent from the trialists to view their ethics application. This initiated a seventeen month process to obtain ethical approval. This publication outlines what we planned to do, the issues we encountered, discusses the legal and ethical issues, and presents some potential solutions. Methodological research such as this has the potential for public benefit and there is little or no harm for the participants (trialists) in undertaking it. Further, in New Zealand, there is freedom of information legislation, which in this circumstance, unambiguously provided rights of access and use of the information in the ethics applications. The decision of our institutional ethics committee defeated this right and did not recognise the nature of this observational research. Methodological research, such as this, can be used to develop processes to improve quality in research reporting. Recognition of the potential

7 CFR 929.125 - Committee review procedures.

Science.gov (United States)

2010-01-01

... MASSACHUSETTS, RHODE ISLAND, CONNECTICUT, NEW JERSEY, WISCONSIN, MICHIGAN, MINNESOTA, OREGON, WASHINGTON, AND LONG ISLAND IN THE STATE OF NEW YORK Rules and Regulations § 929.125 Committee review procedures... Committee within 30 days after receipt of the Committee's determination of sales history, a request for a...

Getting the justification for research ethics review right.

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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.

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

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.

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

E-survey with researchers, members of ethics committees and sponsors of clinical research in Brazil: an emerging methodology for scientific research.

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Dainesi, Sonia Mansoldo; Goldbaum, Moisés

2012-12-01

The growth of Internet users enables epidemiological studies to be conducted electronically, representing a promising methodology for data collection. Members of Ethics Committees, Clinical Researchers and Sponsors were interviewed using questionnaires sent over the Internet. Along with the questionnaire, participants received a message explaining the survey and also the informed consent. Returning the questionnaire meant the consent of the participant was given. No incentive was offered; two reminders were sent. The response rate was 21% (124/599), 20% (58/290) and 45% (24/53) respectively for Ethics Committees, Researchers and Sponsors. The percentage of return before the two reminders was about 62%. Reasons for non-response: participant not found, refusal to participate, lack of experience in clinical research or in the therapeutic field. Characteristics of participants: 45% of Ethics Committee participants, 64% of Researchers and 63% of Sponsors were male; mean age (range), respectively: 47 (28-74), 53 (24-72) and 40 (29-65) years. Among Researchers and Sponsors, all respondents had at least a university degree and, in the Ethics Committees group, only two (1.7%) did not have one. Most of the questionnaires in all groups came from the Southeast Region of Brazil, probably reflecting the highest number of clinical trials and research professionals in this region. Despite the potential limitations of a survey done through the Internet, this study led to a response rate similar to what has been observed with other models, efficiency in obtaining responses (speed and quality), convenience for respondents and low cost.

Activities of an ethics consultation service in a Tertiary Military Medical Center.

Science.gov (United States)

Waisel, D B; Vanscoy, S E; Tice, L H; Bulger, K L; Schmelz, J O; Perucca, P J

2000-07-01

The Joint Commission on Accreditation of Healthcare Organizations requires hospitals to have a mechanism to address issues of medical ethics. Most hospitals, especially those in the military, have an ethics committee composed solely of members who serve as an additional duty. To enhance the ethics consultation service, the 59th Medical Wing created a position under the chief of the medical staff for a full-time, fellowship-trained, medical ethicist. After establishment of this position, the number of consultations increased, a systematic program for caregiver education was developed and delivered, and an organizational presence was achieved by instituting positions on the institutional review board, the executive committee of the medical staff, and the credentials committee. Issues in medical care are becoming increasingly complicated, due in large part to financial stresses and technological advancements. Ethics consultation can help prevent and resolve many of these problems. This report discusses the activities of the first year of a full-time ethicist in a tertiary military medical center.

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.

Opening the black box of ethics policy work: evaluating a covert practice.

Science.gov (United States)

Frolic, Andrea; Drolet, Katherine; Bryanton, Kim; Caron, Carole; Cupido, Cynthia; Flaherty, Barb; Fung, Sylvia; McCall, Lori

2012-01-01

Hospital ethics committees (HECs) and ethicists generally describe themselves as engaged in four domains of practice: case consultation, research, education, and policy work. Despite the increasing attention to quality indicators, practice standards, and evaluation methods for the other domains, comparatively little is known or published about the policy work of HECs or ethicists. This article attempts to open the "black box" of this health care ethics practice by providing two detailed case examples of ethics policy reviews. We also describe the development and application of an evaluation strategy to assess the quality of ethics policy review work, and to enable continuous improvement of ethics policy review processes. Given the potential for policy work to impact entire patient populations and organizational systems, it is imperative that HECs and ethicists develop clearer roles, responsibilities, procedural standards, and evaluation methods to ensure the delivery of consistent, relevant, and high-quality ethics policy reviews.

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.

Integer Linear Programming for Constrained Multi-Aspect Committee Review Assignment

Science.gov (United States)

Karimzadehgan, Maryam; Zhai, ChengXiang

2011-01-01

Automatic review assignment can significantly improve the productivity of many people such as conference organizers, journal editors and grant administrators. A general setup of the review assignment problem involves assigning a set of reviewers on a committee to a set of documents to be reviewed under the constraint of review quota so that the reviewers assigned to a document can collectively cover multiple topic aspects of the document. No previous work has addressed such a setup of committee review assignments while also considering matching multiple aspects of topics and expertise. In this paper, we tackle the problem of committee review assignment with multi-aspect expertise matching by casting it as an integer linear programming problem. The proposed algorithm can naturally accommodate any probabilistic or deterministic method for modeling multiple aspects to automate committee review assignments. Evaluation using a multi-aspect review assignment test set constructed using ACM SIGIR publications shows that the proposed algorithm is effective and efficient for committee review assignments based on multi-aspect expertise matching. PMID:22711970

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.

Ethical considerations for field research on fishes

Directory of Open Access Journals (Sweden)

Rhett H. Bennett

2016-12-01

field research to minimise impacts on fish populations. It is envisaged that this review will be a useful resource for journal editorial committees intending to introduce ethical requirements for publication and for researchers, managers, conservation practitioners and research organisations when designing field studies on fishes, applying for ethical clearance and developing institutional ethical guidelines.

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.

75 FR 7483 - Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention-Ethics...

Science.gov (United States)

2010-02-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention--Ethics Subcommittee (ES); Correction AGENCY: Centers for Disease Control and Prevention (CDC), HHS. ACTION: Notice of meeting; meeting...

Ethical Concerns of and Risk Mitigation Strategies for Crowdsourcing Contests and Innovation Challenges: Scoping Review

Science.gov (United States)

Pan, Stephen W; Mathews, Allison; Stein, Gabriella; Bayus, Barry; Rennie, Stuart

2018-01-01

Background Crowdsourcing contests (also called innovation challenges, innovation contests, and inducement prize contests) can be used to solicit multisectoral feedback on health programs and design public health campaigns. They consist of organizing a steering committee, soliciting contributions, engaging the community, judging contributions, recognizing a subset of contributors, and sharing with the community. Objective This scoping review describes crowdsourcing contests by stage, examines ethical problems at each stage, and proposes potential ways of mitigating risk. Methods Our analysis was anchored in the specific example of a crowdsourcing contest that our team organized to solicit videos promoting condom use in China. The purpose of this contest was to create compelling 1-min videos to promote condom use. We used a scoping review to examine the existing ethical literature on crowdsourcing to help identify and frame ethical concerns at each stage. Results Crowdsourcing has a group of individuals solve a problem and then share the solution with the public. Crowdsourcing contests provide an opportunity for community engagement at each stage: organizing, soliciting, promoting, judging, recognizing, and sharing. Crowdsourcing poses several ethical concerns: organizing—potential for excluding community voices; soliciting—potential for overly narrow participation; promoting—potential for divulging confidential information; judging—potential for biased evaluation; recognizing—potential for insufficient recognition of the finalist; and sharing—potential for the solution to not be implemented or widely disseminated. Conclusions Crowdsourcing contests can be effective and engaging public health tools but also introduce potential ethical problems. We present methods for the responsible conduct of crowdsourcing contests. PMID:29523500

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.

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.

Joint Integration Office Independent Review Committee annual report, 1985

International Nuclear Information System (INIS)

1986-08-01

Comprised of seven persons with extensive experience in the issues of nuclear waste, the Independent Review Committee (IRC) provides independent and objective review of Defense Transuranic Waste Program (DTWP) activities managed by the Joint Integration Office (JIO), formerly the Defense Transuranic Waste Lead Organization (TLO). The Committee is ensured a broad, interdisciplinary perspective since its membership includes representatives from the fields of nuclear engineering, nuclear waste transportation, industrial quality control, systems and environmental engineering and state and local government. The scope of IRC activities includes overall review of specific TLO plans, projects and activities, and technical review of particular research and development projects. The Committee makes specific suggestions and recommendations based upon expertise in the field of TRU Waste Management. The IRC operates as a consulting group, under an independent charter providing objective review of program activities. This report summarizes the 12 major topics reviewed by the committee during 1985

76 FR 57744 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

Science.gov (United States)

2011-09-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES) Correction: This notice was published in the Federal Register on September 8, 2011, Volume 76, Number 174...

Research Ethics Committees and Participatory Action Research With Young People: The Politics of Voice.

Science.gov (United States)

Yanar, Zeynep M; Fazli, Mehria; Rahman, Jahanara; Farthing, Rys

2016-04-01

Participatory action research (PAR) is a methodological approach that seeks to maximize the participation of people whose lives it researches. It is underpinned by an ethical concern to research "with" people, rather than "on" people. However, this ethical approach to research is often, paradoxically, problematized by universities' research ethics committees (RECs). This article explores one site of tension between PAR and RECs-the requirement for anonymity for below 18-year-olds. It explores this tension by exploring a case study of a peer-to-peer research project undertaken by young women in East London, and using our own experiences and perspectives, it argues that anonymity can be unjust, disempowering, and unnecessary, and can reduce "pride." Without wanting to develop specific recommendations, given the limited scope of our case study, this article uses firsthand experiences to add weight to the broader discussions calling for a critical rethink of REC guidelines. © The Author(s) 2016.

A deviation from standard design? Clinical trials, research ethics committees, and the regulatory co-construction of organizational deviance.

Science.gov (United States)

Hedgecoe, Adam

2014-02-01

Focusing on the high-profile drug disaster at London's Northwick Park Hospital in 2006, this article explores how such an event can be seen as an example of organizational deviance co-constructed between the company running the research and the research ethics committee which approved the trial. This deviance was the result of the normalization of a specific dosing practice in the broader regulatory field, allowing the researchers and regulators to take a risky dosing strategy for granted as best practice. Drawing on the work of Diane Vaughan, this article uses interview data with researchers and members of the research ethics committee concerned as well as documentary material, to show how work group cultures between regulators and those they are intended to oversee are maintained, and how the culturally embedded assumptions of such work groups can result in organizational and regulatory deviance.

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.

Activity of Ethics Committees in Europe on issues related to clinical trials in paediatrics: Results of a survey

Czech Academy of Sciences Publication Activity Database

Altavilla, A.; Giaquinto, C.; Giocanti, D.; Manfredi, C.; Aboulker, J.-P.; Bartoloni, F.; Cattani, E.; Giudice, M. L.; Mellado Peňa, M.J.; Nagler, R.; Peterson, C.; Vajnerová, Olga; Bonifazi, F.; Ceci, A.

2009-01-01

Roč. 11, 1-2 (2009), s. 79-87 ISSN 1389-2827 Grant - others:EC(XE) LSHBCT-2005-005126 Institutional research plan: CEZ:AV0Z50110509 Keywords : ethic committees * clinical trials * pediatrics Subject RIV: FP - Other Medical Disciplines

Phronesis: Beyond the Research Ethics Committee-A Crucial Decision-Making Skill for Health Researchers During Community Research.

Science.gov (United States)

Greeff, Minrie; Rennie, Stuart

2016-04-01

Health researchers conducting research in the community are often faced with unanticipated ethical issues that arise in the course of their research and that go beyond the scope of ethical approval by the research ethics committee. Eight expert researchers were selected through extreme intensity purposive sampling, because they are representative of unusual manifestations of the phenomenon related to their research in the community. They were selected to take part in a semi-structured focus group discussion on whether practical wisdom (phronesis) is used as a decision-making skill to solve unanticipated ethical issues during research in the community. Although the researchers were not familiar with the concept phronesis, it became obvious that it formed an integral part of their everyday existence and decision making during intervention research. They could balance research ethics with practical considerations. The capacity of practical wisdom as a crucial decision-making skill should be assimilated into a researcher's everyday reality, and also into the process of mentoring young researchers to become phronimos. Researchers should be taught this skill to handle unanticipated ethical issues. © The Author(s) 2016.

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.

Nuclear Safety Research Review Committee

International Nuclear Information System (INIS)

Todreas, N.E.

1990-01-01

The Nuclear Safety Research Review Committee has had a fundamental difficulty because of the atmosphere that has existed since it was created. It came into existence at a time of decreasing budgets. For any Committee the easiest thing is to tell the Director what additional to do. That does not really help him a lot in this atmosphere of reduced budgets which he reviewed for you on Monday. Concurrently the research arm of Nuclear Regulatory Commission has recognized that the scope of its activity needed to be increased rather than decreased. In the last two-and-a-half-year period, human factors work was reinstated, radiation and health effects investigations were reinvigorated, research in the waste area was given significant acceleration. Further, accident management came into being, and the NRC finally got back into the TMI-2 area. So with all of those activities being added to the program at the same time that the research budget was going down, the situation has become very strained. What that leads to regarding Committee membership is a need for technically competent generalists who will be able to sit as the Division Directors come in, as the contractors come in, and sort the wheat from the chaff. The Committee needs people who are interested in and have a broad perspective on what regulatory needs are and specifically how safety research activities can contribute to them. The author summarizes the history of the Committee, the current status, and plans for the future

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.

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.

When reviews attack: ethics, free speech, and the peer review process.

Science.gov (United States)

Hadjistavropoulos, T; Bieling, P J

2000-08-01

The peer review process, whether formally applied in publication and grant review, or informally, such as exchange of ideas in scientific and professional newsgroups, has sparked controversy. Writers in this area agree that scholarly reviews that are inappropriate in tone are not uncommon. Indeed, commentators have suggested rules and guidelines that can be used to improve the review process and to make reviewers more accountable. In this paper, we examine the relevance and impact of ethical codes on the conduct of peer review. It is our contention that the peer review process can be improved, not by a new set of rules but through closer attention to the ethical principles to which we, as psychologists, already subscribe.

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

Perspectives of Egyptian research ethics committees regarding their effective functioning.

Science.gov (United States)

Matar, Amal; Silverman, Henry

2013-02-01

The recent increase in research in the Middle East has been associated with the establishment of research ethics committees (RECs). Our aim was to obtain perspectives of RECs regarding the challenges that impede their effective functioning. We conducted in-depth interviews using a semi-structured interview guide. We transcribed and analyzed the interviews to uncover major themes and subthemes. We identified the following themes: membership composition; training needs of members; availability of human and capital resources; role of the national government; concerns with the informed consent process; government scrutiny of research; investigator-related issues; and concerns with transfer of biological samples to other countries. Our interview study revealed several barriers that need to be considered by appropriate stakeholders to enhance adequate functioning of RECs.

Evidence and Ethics (Editorial

Directory of Open Access Journals (Sweden)

Alison Brettle

2012-12-01

discipline the research takes place in, and should be something that we are aware of as consumers of evidence. Within LIS in the UK, ethical principles have been put to the fore within a new professional framework (CILIP Chartered Institute of Library and Information Professionals, 2012a. The framework outlines the broad range of skills required by workers across the LIS profession, placing these on a wheel with ethics and values in the centre, as they underpin the profession. Placing ethics and values at the core in this way helps us set our knowledge into a wider context and, I believe, is one of the ways that we can make a difference as LIS professionals. At the same time, our ethical values and principles help to differentiate us from other professions and help to define what we do as LIS professionals. These ethical principles are outlined in a code (CILIP Chartered Institute of Library and Information Professionals, 2012b, which sets out professional responsibilities in relation to users, colleagues, and the information community and society. The elements which are particularly relevant to EBLIP, and which are espoused in the scope and mission of the journal, include maintaining and enhancing professional knowledge and competence, sharing results of research and development, encouraging best practice, and promoting equitable access to information. There are also ethical codes of practice for journal editors, these include one for LIS editors (Library and Information Science Editorial Committee, 2010 and a more general one which originated in the medical and health domain (Committee on Publication Ethics: COPE, 2011. Both of these guide journal editors in relating to readers, authors, reviewers, and publishers, and both seek to establish best practice for journal publishing. For the EBLIP journal, these codes of practice provide a useful framework for ensuring the journal operates in a professional and ethical way. A recent example where the codes have been used in

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.

e-Government Ethics : a Synergy of Computer Ethics, Information Ethics, and Cyber Ethics

OpenAIRE

Arief Ramadhan; Dana Indra Sensuse; Aniati Murni Arymurthy

2011-01-01

Ethics has become an important part in the interaction among humans being. This paper specifically discusses applied ethics as one type of ethics. There are three applied ethics that will be reviewed in this paper, i.e. computer ethics, information ethics, and cyber ethics. There are two aspects of the three applied ethics that were reviewed, i.e. their definition and the issues associated with them. The reviewing results of the three applied ethics are then used for defining e-Government eth...

When to consult the institutional bioethics committee? The deliberative method for resolving possible dilemmas

Directory of Open Access Journals (Sweden)

Alejandra T Rabadán

2017-12-01

Full Text Available In healthcare, an ethical concern that arises during the decision making process is considered to be a bioethical dilemma. It is often the case that in the absence of proper deliberation, the problem is transferred to a bioethics committee, not even representing precisely a dilemma. Bioethics emerged as a discipline in the mid-20th century. It is defined as a support to decision-making in ethical dilemmas centered on two aspects: ethics of clinical investigation, focused on protecting the rights of research subjects, and bioethics in medical practice, of an advisory nature. To recognize the difference among difficult or complex clinical circumstances and ethical dilemmas could allow knowing when it is necessary to request for advice of a committee. It is not so much a question of deciding what is right or wrong, but which is the most advisable solution to a problem. We review the history of Bioethics Committees in Argentina that are facing today the challenge of promoting social responsibility and opening deliberations to community and health professionals. In the 20th century two historical moments are recognized: a pioneering and slow first period, and a second one of legal regulatory framework. Considering deliberation as a method of ethics, this article proposes a case analysis procedure and the deliberative method to elucidate dilemmas, with or without the help of a Committee.

[When to consult the institutional bioethics committee? The deliberative method for resolving possible dilemmas].

Science.gov (United States)

Rabadán, Alejandra T; Tripodoro, Vilma A

2017-01-01

In healthcare, an ethical concern that arises during the decision making process is considered to be a bioethical dilemma. It is often the case that in the absence of proper deliberation, the problem is transferred to a bioethics committee, not even representing precisely a dilemma. Bioethics emerged as a discipline in the mid-20th century. It is defined as a support to decision-making in ethical dilemmas centered on two aspects: ethics of clinical investigation, focused on protecting the rights of research subjects, and bioethics in medical practice, of an advisory nature. To recognize the difference among difficult or complex clinical circumstances and ethical dilemmas could allow knowing when it is necessary to request for advice of a committee. It is not so much a question of deciding what is right or wrong, but which is the most advisable solution to a problem. We review the history of Bioethics Committees in Argentina that are facing today the challenge of promoting social responsibility and opening deliberations to community and health professionals. In the 20th century two historical moments are recognized: a pioneering and slow first period, and a second one of legal regulatory framework. Considering deliberation as a method of ethics, this article proposes a case analysis procedure and the deliberative method to elucidate dilemmas, with or without the help of a Committee.

Pulsed Power Peer Review Committee Report

International Nuclear Information System (INIS)

BLOOMQUIST, DOUGLAS D.

2002-01-01

In 1993, the Government Performance and Results Act (GPRA, PL 103-62) was enacted. GPRA, which applies to all federal programs, has three components: strategic plans, annual performance plans, and metrics to show how well annual plans are being followed. As part of meeting the GRPA requirement in FY2002, a 15-member external review committee chaired by Dr. Alvin Trivelpiece (the Trivelpiece Committee) was convened by Sandia National Laboratories (SNL) on May 7-9, 2002 to review Sandia National Laboratories' Pulsed Power Programs as a component of the Performance Appraisal Process negotiated with the National Nuclear Security Administration of the Department of Energy (NNSA/DOE). The scope of the review included activities in high energy density physics (HEDP), inertial confinement fusion (ICF), radiation/weapon physics, the petawatt laser initiative (PW) and fast ignition, equation-of-state studies, radiation effects science and lethality, x-ray radiography, ZR development, basic research and pulsed power technology research and development, as well as electromagnetics and work for others. In his charge to the Committee, Dr. Jeffrey P. Quintenz, Director of Pulsed Power Sciences (Org. 1600) asked that the evaluation and feedback be based on three criteria: (1) quality of technical activities in science, technology, and engineering, (2) programmatic performance, management, and planning, and (3) relevance to national needs and agency missions. In addition, the director posed specific programmatic questions. The accompanying report, produced as a SAND document, is the report of the Committee's finding

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.

Ethical Delphi Manual

NARCIS (Netherlands)

Millar, K.; Tomkins, S.; Thorstensen, E.; Mepham, B.; Kaiser, M.

2006-01-01

An ethical Delphi is an iterative participatory process between experts for exchanging views and arguments on ethical issues. The method is structured around the notion of a virtual committee where the exchange of ideas is conducted remotely through a series of opinion exchanges. The ethical Delphi

[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.

Regulatory Review Committee update

Energy Technology Data Exchange (ETDEWEB)

Steele, T. [Polishuk, Camman and Steele, London ON (Canada)

2001-07-01

The Committee's objectives, current membership and current issues are reviewed. Each current issue, notably the consultation process with the Ministry of Natural Resources, appeal of Ministry actions, orphan wells/security deposits, oilfield fluid disposal and labour code practices review are discussed in some detail. Dissatisfaction with the current appeals process to the Ministry is highlighted, along with a search for an all encompassing solution. The orphan well problem also received considerable attention, with similar demands for a comprehensive solution.

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

Pulsed Power Peer Review Committee Report

International Nuclear Information System (INIS)

Bloomquist, Douglas D.

2000-01-01

In 1993, the Government Performance and Results Act (GPRA, PL 103-62) was enacted. GPRA, which applies to all federal programs, has three components: strategic plans, annual performance plans, and metrics to show how well annual plans are being followed. As part of meeting the GRPA requirement in FY2000, a 14-member external peer review panel (the Garwin Committee) was convened on May 17-19, 2000 to review Sandia National Laboratories' Pulsed Power Programs as a component of the Performance Appraisal Process negotiated with the Department of Energy (DOE). The scope of the review included activities in inertial confinement fission (ICF), weapon physics, development of radiation sources for weapons effects simulation, x-ray radiography, basic research in high energy density physics (HEDP), and pulsed power technology research and development. In his charge to the committee, Jeffrey Quintenz, Director of Pulsed Power Sciences (1600) asked that the review be based on four criteria (1) quality of science, technology, and engineering, (2) programmatic performance, management, and planning, (3) relevance to national needs and agency missions, and (4) performance in the operation and construction of major research facilities. In addition, specific programmatic questions were posed by the director and by the DOE-Defense Programs (DP). The accompanying report, produced as a SAND document, is the report of the committee's findings

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.

Ethical issues in personality assessment in forensic psychology.

Science.gov (United States)

Knapp, S; VandeCreek, L

2001-10-01

In this article we address several ethical issues of concern for psychologists who are engaged in personality assessment in forensic settings such as for courts or attorneys. The ethical issues reviewed include the role of the psychologist as an expert witness, matters of competence, informed consent, confidentiality, multiple relationships, and special issues related to billing. Emphasis is placed on how psychologists can provide useful information to the courts in a manner consistent with the American Psychological Association's Ethical Principles of Psychologists and Code of Conduct, the Committee on Ethical Guidelines for Forensic Psychologist's Specialty Guidelines for Forensic Psychologists, and the APA's Guidelines for Child Custody Evaluations in Divorce Proceedings. The practical recommendations made in this article are consistent with the APA's Ethical Principles of Psychologists and Code of Conduct.

Four Roles of Ethical Theory in Clinical Ethics Consultation.

Science.gov (United States)

Magelssen, Morten; Pedersen, Reidar; Førde, Reidun

2016-09-01

When clinical ethics committee members discuss a complex ethical dilemma, what use do they have for normative ethical theories? Members without training in ethical theory may still contribute to a pointed and nuanced analysis. Nonetheless, the knowledge and use of ethical theories can play four important roles: aiding in the initial awareness and identification of the moral challenges, assisting in the analysis and argumentation, contributing to a sound process and dialogue, and inspiring an attitude of reflexivity. These four roles of ethical theory in clinical ethics consultation are described and their significance highlighted, while an example case is used as an illustration throughout.

Navigating the Process of Ethical Approval: A methodological note

Directory of Open Access Journals (Sweden)

Eileen Carey, RNID, BSc. (hons, MSc.

2010-12-01

Full Text Available Classic grounded theory (CGT methodology is a general methodology whereby the researcher aims to develop an emergent conceptual theory from empirical data collected by the researcher during the research study. Gaining ethical approval from relevant ethics committees to access such data is the starting point for processing a CGT study. The adoption of the Universal Declaration on Bioethics and Human Rights (UNESCO, 2005 is an indication of global consensus on the importance of research ethics. There is, however, a wide variation of health research systems across countries and disciplines (Hearnshaw 2004. Institutional Research Boards (IRB or Research Ethics Committees (REC have been established in many countries to regulate ethical research ensuring that researchers agree to, and adhere to, specific ethical and methodological conditions prior to ethical approval being granted. Interestingly, both the processes and outcomes through which the methodological aspects pertinent to CGT studies are agreed between the researcher and ethics committee remain largely ambiguous and vague. Therefore, meeting the requirements for ethical approval from ethics committees, while enlisting the CGT methodology as a chosen research approach, can be daunting for novice researchers embarking upon their first CGT study.

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

Nurses' knowledge, attitudes and willingness to participate officially in workplace Healthcare Ethics Committees (HEC).

Science.gov (United States)

Rubinstein, Dorit; Tabak, Nili

2012-03-01

This research was designed to assess nurses' perceptions, knowledge, attitudes and intentions in relation to nurse participation in Healthcare Ethics Committees (HECs). A convenience sample of 87 nurses from five Israeli hospitals completed a self-administered questionnaire, whose data were then analyzed by quantitative statistics. The main findings were that large percentages of nurses were totally ignorant of the existence and functioning of the HEC in their workplaces. Nurses in managerial roles were (a) much more knowledgeable on these matters than staff nurses and (b) regarded more positively the idea that nurses had an obligation to sit on such committees. Workplace role and rank in the organizational hierarchy had a stronger impact on nurse attitudes to HEC work than level of education. Overall, nurse willingness to sit on an HEC and to take special training in preparation for such a role were high.

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.

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.

The Ethics and Politics of Ethics Approval

Science.gov (United States)

Battin, Tim; Riley, Dan; Avery, Alan

2014-01-01

The regulatory scope of Human Research Ethics Committees can be problematic for a variety of reasons. Some scholars have argued the ethics approval process, for example, is antithetical to certain disciplines in the humanities and social sciences, while others are willing to give it qualified support. This article uses a case study to cast the…

Ethical Issues Surrounding the Use of Modern Human Remains for Research in South Africa.

Science.gov (United States)

Briers, N; Dempers, J J

2017-02-01

Chapter 8 of the South African National Health Act 61 of 2003 (NHA) that deals with the donation of human tissue was promulgated in 2012. The new Act is perceived to impose restrictions on low-risk research involving human remains. This study aimed to identify the issues raised by a research ethics committee (REC) when reviewing protocols where human remains are used as data source. REC minutes from 2009 to 2014 were reviewed, and issues raised by the committee were categorized. In total, 127 protocols submitted to the committee over 6 years involved human remains. Queries relating to science (22.2%) and administration (18.9%) were the most common, whereas queries relating to legal issues constituted only 10.2%. Ethical issues centered on informed consent regarding sensitive topics such as HIV, DNA, and deceased children. The change in legislation did not change the number or type of legal issues identified by the REC.

[Continuing education in ethics: from clinical ethics to institutional ethics].

Science.gov (United States)

Brazeau-Lamontagne, Lucie

2012-01-01

The mandate of the Ethics Committee of the Conseil de médecins, dentistes et pharmaciens (CMDP) at the Centre hospitalier universitaire de Sherbrooke (CHUS), Sherbrooke, Quebec is three-fold: to guide the clinical decision; to address the institutional ethical function; to create the program for continuing education in ethics (Formation éthique continue or FEC). Might FEC be the means of bridging from individual ethics to institutional ethics at a hospital? To take the FEC perspectives considered appropriate for doctors and consider them for validation or disproving in the context of those of other professionals. Situate the proposed FEC mandate in a reference framework to evaluate (or triangulate) the clinical decision and the institutional ethic. CONVICTION: Sustainable professional development for doctors (DPD) includes ethics; it cannot be ignored. Without constant attention to upgrading one's abilities in professional ethics, these suffer the same fate as other professional aptitudes and competences (for example, techniques and scientific knowledge): decay.

Report of the US Nuclear Regulatory Commission Piping Review Committee. Volume 5. Summary - Piping Review Committee conclusions and recommendations

International Nuclear Information System (INIS)

1985-04-01

This document summarizes a comprehensive review of NRC requirements for Nuclear Piping by the US NRC Piping Review Committee. Four topical areas, addressed in greater detail in Volumes 1 through 4 of this report, are included: (1) Stress Corrosion Cracking in Piping of Boiling Water Reactor Plants; (2) Evaluation of Seismic Design; (3) Evaluation of Potential for Pipe Breaks; and (4) Evaluation of Other Dynamic Loads and Load Combinations. This volume summarizes the major issues, reviews the interfaces, and presents the Committee's conclusions and recommendations for updating NRC requirements on these issues. This report also suggests research or other work that may be required to respond to issues not amenable to resolution at this time

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.

Ethical considerations for peer review in forensic neuropsychology.

Science.gov (United States)

Johnson-Greene, Doug; Bechtold, Kathleen T

2002-02-01

The role of an expert is to assist the trier of fact in weighing evidence and reaching conclusions. Critical evaluation of opposing experts is an integral part of this process. In more recent times, cross-examination has given way to critical evaluation of opposing experts outside of the courtroom, a tactic we refer to as peer review in this paper. Though neuropsychologists frequently review the work of their colleagues, we are concerned here primarily with commentary that is at best misleading, and occasionally malicious, unethical, and unprofessional. Despite a growing trend to use experts as peer reviewers in the medicolegal arena, expectations concerning ethical and professional conduct of neuropsychologists have been absent. Enforcement of appropriate conduct is further complicated by the ambiguity of existing ethical standards and state statutes, and their limited applicability to all neuropsychologists who provide forensic services. This article provides an overview of ethical and professional issues pertaining to forensic peer review and concludes with recommendations for appropriate professional conduct.

Impact of three years training on operations capacities of research ethics committees in Nigeria.

Science.gov (United States)

Folayan, Morenike Oluwatoyin; Adaranijo, Aisha; Durueke, Florita; Ajuwon, Ademola; Adejumo, Adebayo; Ezechi, Oliver; Oyedeji, Kola; Akanni, Olayide

2014-04-01

This paper describes a three-year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross-section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research. Following the training, technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants' knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically. © 2012 John Wiley & Sons Ltd.

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…

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.

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.

Ongoing ethical issues concerning authorship in biomedical journals: an integrative review.

Science.gov (United States)

Kornhaber, Rachel Anne; McLean, Loyola M; Baber, Rodney J

2015-01-01

Health professionals publishing within the field of health sciences continue to experience issues concerning appropriate authorship, which have clinical, ethical, and academic implications. This integrative review sought to explore the key issues concerning authorship from a bioethical standpoint, aiming to explore the key features of the authorship debate. Studies were identified through an electronic search, using the PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Scopus databases of peer-reviewed research, published between 2009 and 2014, limited to English language research, with search terms developed to reflect the current issues of authorship. From among the 279 papers identified, 20 research papers met the inclusion criteria. Findings were compiled and then arranged to identify themes and relationships. The review incorporated a wide range of authorship issues encompassing equal-credited authors, honorary (guest/gift) and ghost authorship, perception/experiences of authorship, and guidelines/policies. This review suggests that the International Committee of Medical Journal Editors' (ICMJE) recommended guidelines for authorship are not reflected in current authorship practices within the domain of health sciences in both low-and high-impact-factor journals. This devaluing of the true importance of authorship has the potential to affect the validity of authorship, diminish the real contributions of the true authors, and negatively affect patient care.

Ongoing ethical issues concerning authorship in biomedical journals: an integrative review

Science.gov (United States)

Kornhaber, Rachel Anne; McLean, Loyola M; Baber, Rodney J

2015-01-01

Health professionals publishing within the field of health sciences continue to experience issues concerning appropriate authorship, which have clinical, ethical, and academic implications. This integrative review sought to explore the key issues concerning authorship from a bioethical standpoint, aiming to explore the key features of the authorship debate. Studies were identified through an electronic search, using the PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Scopus databases of peer-reviewed research, published between 2009 and 2014, limited to English language research, with search terms developed to reflect the current issues of authorship. From among the 279 papers identified, 20 research papers met the inclusion criteria. Findings were compiled and then arranged to identify themes and relationships. The review incorporated a wide range of authorship issues encompassing equal-credited authors, honorary (guest/gift) and ghost authorship, perception/experiences of authorship, and guidelines/policies. This review suggests that the International Committee of Medical Journal Editors’ (ICMJE) recommended guidelines for authorship are not reflected in current authorship practices within the domain of health sciences in both low-and high-impact-factor journals. This devaluing of the true importance of authorship has the potential to affect the validity of authorship, diminish the real contributions of the true authors, and negatively affect patient care. PMID:26257520

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

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,…

A Proposal for a UK Ethics Council for Animal Policy: The Case for Putting Ethics Back into Policy Making.

Science.gov (United States)

McCulloch, Steven P; Reiss, Michael J

2018-06-07

Substantial controversy is a consistent feature of UK animal health and welfare policy. BSE, foot and mouth disease, bovine TB and badger culling, large indoor dairies, and wild animals in circuses are examples. Such policy issues are inherently normative; they include a substantial moral dimension. This paper reviews UK animal welfare advisory bodies such as the Animal Health and Welfare Board of England, the Farm Animal Welfare Council and the Animals in Science Committee. These bodies play a key advisory role, but do not have adequate expertise in ethics to inform the moral dimension of policy. We propose an "Ethics Council for Animal Policy" to inform the UK government on policy that significantly impacts sentient species. We review existing Councils (e.g., the Nuffield Council on Bioethics and The Netherlands Council on Animal Affairs) and examine some widely used ethical frameworks (e.g., Banner's principles and the ethical matrix). The Ethics Council for Animal Policy should be independent from government and members should have substantial expertise in ethics and related disciplines. A pluralistic six-stage ethical framework is proposed: (i) Problematisation of the policy issue, (ii) utilitarian analysis, (iii) animal rights analysis, (iv) virtue-based analysis, (v) animal welfare ethic analysis, and (vi) integrated ethical analysis. The paper concludes that an Ethics Council for Animal Policy is necessary for just and democratic policy making in all societies that use sentient nonhuman species.

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.

Seeking ethical approval for an international study in primary care patient safety

NARCIS (Netherlands)

Dovey, S.; Hall, K.; Makeham, M.; Rosser, W.; Kuzel, A.; Weel, C. van; Esmail, A.; Phillips, R.

2011-01-01

Seeking ethics committee approval for research can be challenging even for relatively simple studies occurring in single settings. Complicating factors such as multicentre studies and/or contentious research issues can challenge review processes, and conducting such studies internationally adds a

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.

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.

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

42 CFR 61.15 - Moral character or loyalty; reference to Special Review Committee; review and recommendation.

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Moral character or loyalty; reference to Special... § 61.15 Moral character or loyalty; reference to Special Review Committee; review and recommendation. (a) Moral character or loyalty; reference to Special Review Committee. Whenever the Surgeon General...

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…

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

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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.

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

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Dean, Peter J.

1993-01-01

Provides a review of the key ethical theories and relevant empirical research relating to the practice of human performance technology. Topics addressed include ethics, morals, business ethics, ethics officers, empiricism versus normative ethical theory, consequentialism, utilitarianism, nonconsequentialism, Kohlberg model of cognitive moral…

Human rights, politics, and reviews of research ethics.

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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.

Improving the Level and Quality of Ethics Review in Chinese Medicine and Integrative Medicine.

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Zhang, Cheng-Bin; Li, En-Chang

2018-04-01

Three features of ethics review in Chinese medicine (CM) and integrative medicine (IM) were put forward in this paper. It is consistent with the principles of ethical review in Western medicine; it has to be compliant with the laws of CM and IM; emphasis should be laid on the review of clinical practice facts and experience. Three problems were pointed out. The characteristics of CM and IM are not distinctive enough, operation procedures need to be refined and effectiveness remains to be improved. Based on the mentioned above, seven measures were proposed to improve the level and quality of ethics review in CM and IM, including better brand awareness, considerable tolerance, treatment based on disease differentiation and syndrome differentiation, scientific review and toxicity and side effects of CM, perfection of the ethics review system, reasonable procedures of ethics review and more specialized ethics review workers.

Council Adopts New AERA Code of Ethics: Ethics Committee to Emphasize Ethics Education

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Herrington, Carolyn D.

2011-01-01

At its February 2011 meeting, the AERA Council adopted unanimously a new Code of Ethics. The Code articulates a set of standards for education researchers in education and provides principles and guidance by which they can build ethical practices in professional, scholarly, and scientific activities. The Code reflects the Association's strong…

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.

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

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Nicholls, Stuart G.; Hayes, Tavis P.; Brehaut, Jamie C.; McDonald, Michael; Weijer, Charles; Saginur, Raphael; Fergusson, Dean

2015-01-01

Background To date there is no established consensus of assessment criteria for evaluating research ethics review. Methods We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction. Results Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial - randomised or otherwise – of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review. Discussion Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review. PMID:26225553

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...

Report of the Review Committee of the R and D subjects on Computational Science and Engineering

International Nuclear Information System (INIS)

1999-08-01

The Ad Hoc Review Committee composed of seven experts was set up under the Research Evaluation Committee of JAERI in order to review the R and D subjects to be implemented for five years starting in a 2000 fiscal year at the Center for promotion of Computational Science and Engineering. The review meeting took place on April 26, 1999. According to the review methods consisting of review items, points of review and review criteria given by the Research Evaluation Committee, the review was conducted based on the materials submitted in advance and presentations of CCSE. The Research Evaluation Committee received the review report and its explanations from the Review Committee on July 5. The Research Evaluation Committee has acknowledged appropriateness of the review results. This report describes the review results. (author)

Confessions of an Ethics Committee Chair

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Halse, Christine

2011-01-01

This essay examines the possibilities of being/becoming an ethical researcher in the academy. It tackles this task through the lens of an ethics application by Mary [pseudonym], a PhD student in sociology whose research thesis was investigating the reasons why married men with children use prostitutes. Two analyses are offered of Mary's story. The…

[Reporting ethics board approval in German medical theses and journals].

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Zenz, Michael; Zenz, Julia; Grieger, Maximilian

2018-06-05

Since 1975, the Declaration of Helsinki of the World Medical Association (WMA) has clearly required ethics committee approval for research into humans. Nevertheless, this Declaration is violated quite often. As many English-language publications have addressed the theme of ethics board approval in theses and other published works, it is now to be investigated in Germany for the first time.From 2013 to 2014, a total of 1,482 medical theses at four selected universities in addition to three German-language scientific journals were reviewed. In 543 theses, reference to ethics approval would have been required according to the criteria of the Declaration of Helsinki.However, ethics approval was stated in only 58.7% of cases, and even less frequently if the prevailing doctoral regulations or instructions did not refer to the necessity of obtaining ethics approval. Theses on pediatrics mentioned ethics approval most frequently (78.6%), whereas the proportion of surgical papers was the lowest (34.9%). Among the journals, Der Nervenarzt mentioned ethics approval most frequently (59.4%) and Der Chirurg least frequently (30%).Our results point to significant deficits in mentioning ethics approval in medical theses and publications. These deficits could easily be compensated for by a thorough approach of the referees of doctoral regulations and by journal reviewers and editors.

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).

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Luk, Hsiang-Ning; Ennever, John F; Day, Yuan-Ji; Wong, Chih-Shung; Sun, Wei-Zen

2015-03-01

For this guidance article, the Ethics Review Task Force (ERTF) of the Journal reviewed and discussed the ethics issues related to publication of human research in the field of anesthesia. ERTF first introduced international ethics principles and minimal requirements of reporting of ethics practices, followed by discussing the universal problems of publication ethics. ERTF then compared the accountability and methodology of several medical journals in assuring authors' ethics compliance. Using the Taiwan Institutional Review Board system as an example, ERTF expressed the importance of institutional review board registration and accreditation to assure human participant protection. ERTF presented four major human research misconducts in the field of anesthesia in recent years. ERTF finally proposed a flow-chart to guide journal peer reviewers and editors in ethics review during the editorial process in publishing. Examples of template languages applied in the Ethics statement section in the manuscript are expected to strengthen the ethics compliance of the authors and to set an ethical culture for all the stakeholders involved in human research. Copyright © 2015. Published by Elsevier B.V.

Methods of legitimation: how ethics committees decide which reasons count in public policy decision-making.

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Edwards, Kyle T

2014-07-01

In recent years, liberal democratic societies have struggled with the question of how best to balance expertise and democratic participation in the regulation of emerging technologies. This study aims to explain how national deliberative ethics committees handle the practical tension between scientific expertise, ethical expertise, expert patient input, and lay public input by explaining two institutions' processes for determining the legitimacy or illegitimacy of reasons in public policy decision-making: that of the United Kingdom's Human Fertilisation and Embryology Authority (HFEA) and the United States' American Society for Reproductive Medicine (ASRM). The articulation of these 'methods of legitimation' draws on 13 in-depth interviews with HFEA and ASRM members and staff conducted in January and February 2012 in London and over Skype, as well as observation of an HFEA deliberation. This study finds that these two institutions employ different methods in rendering certain arguments legitimate and others illegitimate: while the HFEA attempts to 'balance' competing reasons but ultimately legitimizes arguments based on health and welfare concerns, the ASRM seeks to 'filter' out arguments that challenge reproductive autonomy. The notably different structures and missions of each institution may explain these divergent approaches, as may what Sheila Jasanoff (2005) terms the distinctive 'civic epistemologies' of the US and the UK. Significantly for policy makers designing such deliberative committees, each method differs substantially from that explicitly or implicitly endorsed by the institution. Copyright © 2014 Elsevier Ltd. All rights reserved.

Why Are There So Few Ethics Consults in Children's Hospitals?

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Carter, Brian; Brockman, Manuel; Garrett, Jeremy; Knackstedt, Angie; Lantos, John

2017-10-03

In most children's hospitals, there are very few ethics consultations, even though there are many ethically complex cases. We hypothesize that the reason for this may be that hospitals develop different mechanisms to address ethical issues and that many of these mechanisms are closer in spirit to the goals of the pioneers of clinical ethics than is the mechanism of a formal ethics consultation. To show how this is true, we first review the history of collaboration between philosophers and physicians about clinical dilemmas. Then, as a case-study, we describe the different venues that have developed at one children's hospital to address ethical issues. At our hospital, there are nine different venues in which ethical issues are regularly and explicitly addressed. They are (1) ethics committee meetings, (2) Nursing Ethics Forum, (3) ethics Brown Bag workshops, (4) PICU ethics rounds, (5) Grand Rounds, (6) NICU Comprehensive Care Rounds, (7) Palliative Care Team (PaCT) case conferences, (8) multidisciplinary consults in Fetal Health Center, and (9) ethics consultations. In our hospital, ethics consults account for only a tiny percentage of ethics discussions. We suspect that most hospitals have multiple and varied venues for ethics discussions. We hope this case study will stimulate research in other hospitals analyzing the various ways in which ethicists and ethics committees can build an ethical environment in hospitals. Such research might suggest that ethicists need to develop a different set of "core competencies" than the ones that are needed to do ethics consultations. Instead, they should focus on their skills in creating multiple "moral spaces" in which regular and ongoing discussion of ethical issues would take place. A successful ethicist would empower everyone in the hospital to speak up about the values that they believe are central to respectful, collaborative practice and patient care. Such a role is closer to what the first hospital philosophers set

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.

Regional Infant and Child Mortality Review Committee--2011 final report.

Science.gov (United States)

Wilson, Ann L; Sideras, James

2012-12-01

The 2011 annual report of the Regional Infant and Child Mortality Review Committee (RICMRC) is presented. Since 1997, the committee has reviewed 224 deaths to achieve its mission to "review infant and child deaths so that information can be transformed into action to protect young lives." In 2011, the committee reviewed 21 deaths (22 met the committee's criteria) of infants and children who were residents of Minnehaha, Turner, Lincoln, Hanson and Brookings counties in South Dakota. The manner of 12 of the reviewed deaths was natural with eight of these the result of progressive neurological diseases or conditions. In 2011 there were no deaths attributed to Sudden Infant Death Syndrome (SIDS), though there were two deaths of infants during sleep. One of these infants was ruled accidental as the baby died of aspiration and the other death occurred in an unsafe environment with its manner determined to be undecided. Six deaths were accidental, one of which occurred as a result of a fire in a home without functional smoke alarms. One motor vehicle death occurred, through no fault of the teen age driver. Another death resulted from tubing over a low head dam on the Big Sioux River. One youth suicide occurred to a resident of the region.

Philosophy of organ donation: Review of ethical facets.

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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.

From reactive to proactive: developing a valid clinical ethics needs assessment survey to support ethics program strategic planning (part 1 of 2).

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Frolic, Andrea; Jennings, Barb; Seidlitz, Wendy; Andreychuk, Sandy; Djuric-Paulin, Angela; Flaherty, Barb; Peace, Donna

2013-03-01

As ethics committees and programs become integrated into the "usual business" of healthcare organizations, they are likely to face the predicament of responding to greater demands for service and higher expectations, without an influx of additional resources. This situation demands that ethics committees and programs allocate their scarce resources (including their time, skills and funds) strategically, rather than lurching from one ad hoc request to another; finding ways to maximize the effectiveness, efficiency, impact and quality of ethics services is essential in today's competitive environment. How can Hospital Ethics Committees (HECs) begin the process of strategic priority-setting to ensure they are delivering services where and how they are most needed? This paper describes the creation of the Clinical Ethics Needs Assessment Survey (CENAS) as a tool to understand interprofessional staff perceptions of the organization's ethical climate, challenging ethical issues and educational priorities. The CENAS was designed to support informed resource allocation and advocacy by HECs. By sharing our process of developing and validating this ethics needs assessment survey we hope to enable strategic priority-setting in other resource-strapped ethics programs, and to empower HECs to shift their focus to more proactive, quality-focused initiatives.

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.

Ethics Education and Adjudication within Psychology.

Science.gov (United States)

Mills, David H.

1984-01-01

Provides an overview of the formal ethics system within psychology. Describes the structure of the American Psychological Association (APA) and state ethics systems, functions of APA's Committee on Scientific and Professional Ethics and Conduct, and its procedures for handling complaints. (Author/CMG)

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.

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

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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.

The role of religious beliefs in ethics committee consultations for conflict over life-sustaining treatment.

Science.gov (United States)

Bandini, Julia I; Courtwright, Andrew; Zollfrank, Angelika A; Robinson, Ellen M; Cadge, Wendy

2017-06-01

Previous research has suggested that individuals who identify as being more religious request more aggressive medical treatment at end of life. These requests may generate disagreement over life-sustaining treatment (LST). Outside of anecdotal observation, however, the actual role of religion in conflict over LST has been underexplored. Because ethics committees are often consulted to help mediate these conflicts, the ethics consultation experience provides a unique context in which to investigate this question. The purpose of this paper was to examine the ways religion was present in cases involving conflict around LST. Using medical records from ethics consultation cases for conflict over LST in one large academic medical centre, we found that religion can be central to conflict over LST but was also present in two additional ways through (1) religious coping, including a belief in miracles and support from a higher power, and (2) chaplaincy visits. In-hospital mortality was not different between patients with religiously versus non-religiously centred conflict. In our retrospective cohort study, religion played a variety of roles and did not lead to increased treatment intensity or prolong time to death. Ethics consultants and healthcare professionals involved in these cases should be cognisant of the complex ways that religion can manifest in conflict over LST. 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/.

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.

Impact of the economic crisis on the activity of a clinical research ethics committee

Directory of Open Access Journals (Sweden)

Paula Arcenillas

2014-11-01

Full Text Available Purpose: Analyze the impact of economic and social crisis in volume and funding of clinical trials (CT and observational studies (ES from the activity of an Research Ethics Committee (REC. Method: REC memories 2003-2012 were reviewed. Financing of evaluated projects, CT and OS were analyzed classifying them into four groups: 1 promoted by pharmaceutical industry, 2 by scientific societies with industry support, 3 by scientific societies with government support and 4 unfunding.Two periods were compared: pre-crisis (2003-2007 and crisis (2008-2012. Results: During 10 studied years, 744 protocols were evaluated: a 71% of group 1, a 9% of group 2, a 3% of group 3 and a 17% was no funding. Regarding OS, 40%, 5,4%, 8,6% and 46% were the groups 1, 2, 3 and 4 respectively. Analyzing crisis versus pre-crisis period, statistically significant differences were observed in the decreasing of number of CT phase 2 and 3 and in the rising EO. Comparing crisis related to the pre-crisis period, the Group 4 increased statistically significantly. Conclusions: Evolution of total number of studies evaluated by REC tends to be maintained and even increased over time. REC maintains its activity and even increased at the expense of financing and unfunded OS.

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.

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

NARCIS (Netherlands)

Hem, M.H.; Pedersen, R.; Norvoll, R.; Molewijk, A.C.

2015-01-01

A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five

Implications of the ethical-legal framework for adolescent HIV vaccine trials--report of a consultative forum.

Science.gov (United States)

Slack, Catherine; Strode, Ann; Grant, Catherine; Milford, Cecilia

2005-09-01

The ethical-legal framework in South Africa is in a period of transition, with a number of new developments changing the substantive principles and procedures for health research in the country. Some of the changing dynamics include both law reform and the review of ethical guidelines. This changing environment poses many complexities for researchers, research ethics committees and participating communities involved in planning, implementing and reviewing research with child participants, including HIV vaccine trials. This paper presents the major themes and outcomes of a consultative meeting convened by the HIV AIDS Vaccines Ethics Group in July 2004 for key stakeholder groups. At this forum participants discussed the complexities posed by a transitional and sometimes contradictory ethical-legal framework and how the framework could be improved to simultaneously promote critical research and the welfare of child participants.

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.

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.

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.

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…

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.

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.

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.

Report of the Parliamentary Standing Committee on the Surrogacy (Regulation) Bill, 2016: A commentary.

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Timms, Olinda

2018-01-01

Soon after the Surrogacy (Regulation) Bill, 2016 was approved by the Cabinet for introduction into Parliament in 2016, it was submitted for review to a Parliamentary Standing Committee on Health and Family Welfare. The report of this committee, The 102nd Report on the Surrogacy (Regulation) Bill, 2016 was laid on the table of the Lok Sabha and presented to the Rajya Sabha on August 10, 2017. It contains hearings with stakeholders and witnesses and a review of relevant documents and related legislation. The comments of the Parliamentary Standing Committee are wide ranging and pertinent, seeking to fill the gaps and explain and rationalise the statute and includes responses from the Department of Health Research. This commentary seeks to analyse the recommendations of the Committee, exploring some of the ethical, legal, and social implications of surrogacy arrangements in our country, where diverse viewpoints and strong sentiments can encounter difficult ground realities.

The Ethics of Sharing Plastic Surgery Videos on Social Media: Systematic Literature Review, Ethical Analysis, and Proposed Guidelines.

Science.gov (United States)

Dorfman, Robert G; Vaca, Elbert E; Fine, Neil A; Schierle, Clark F

2017-10-01

Recent videos shared by plastic surgeons on social media applications such as Snapchat, Instagram, and YouTube, among others, have blurred the line between entertainment and patient care. This has left many in the plastic surgery community calling for the development of more structured oversight and guidance regarding video sharing on social media. To date, no official guidelines exist for plastic surgeons to follow. Little is known about the ethical implications of social media use by plastic surgeons, especially with regard to video sharing. A systematic review of the literature on social media use in plastic surgery was performed on October 31, 2016, with an emphasis on ethics and professionalism. An ethical analysis was conducted using the four principles of medical ethics. The initial search yielded 87 articles. Thirty-four articles were included for analyses that were found to be relevant to the use of social media in plastic surgery. No peer-reviewed articles were found that mentioned Snapchat or addressed the ethical implications of sharing live videos of plastic surgery on social media. Using the four principles of medical ethics, it was determined that significant ethical concerns exist with broadcasting these videos. This analysis fills an important gap in the plastic surgery literature by addressing the ethical issues concerning live surgery broadcasts on social media. Plastic surgeons may use the guidelines proposed here to avoid potential pitfalls.

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.

Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research.

Science.gov (United States)

Newcombe, J P; Kerridge, I H

2007-01-01

Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. We conducted a survey of HREC chairpersons in New South Wales. HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.

Development and oversight of ethical health promotion quality assurance and evaluation activities involving human participants.

Science.gov (United States)

Sainsbury, Peter

2015-12-01

This paper considers the role of ethics and ethics review processes in the development of health promotion quality assurance and evaluation activities involving human participants. The Australian National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research and associated documents provide the framework for the ethical conduct and independent review of research (including quality assurance and evaluation) involving humans in Australia. Identifying the level of risk to which participants may be exposed by participation in quality assurance and evaluation activities is essential for health promotion workers undertaking such activities. Organisations can establish processes other than review by a Human Research Ethics Committee for negligible and low risk research activities. Health promotion quality assurance and evaluation activities often involve negligible and low risk to participants. Seven triggers that indicate the need for ethics review of quality assurance and evaluation activities and a procedural checklist for developing ethical quality assurance and evaluation activities are provided. Health promotion workers should be familiar with the NHMRC's National Statement on Ethical Conduct in Human Research. When ethical considerations underpin the planning and conduct of all quality assurance and evaluation from the very beginning, the activity is the better for it, independent 'ethics approval' can mostly be secured without much trouble and workers' frustration levels are reduced. So what? Health promotion quality assurance and evaluation activities must be ethically justified. Health promotion workers should be familiar with the NHMRC's National Statement on Ethical Conduct in Human Research and should use it when developing health promotion quality assurance and evaluation activities.

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

[Posthumous sperm procurement and use--ethical and legal dilemmas].

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Crha, I; Dostál, J; Ventruba, P; Kudela, M; Záková, J

2004-07-01

To present a review of bioethical discussion and recommendations concerning posthumous sperm procurement and postmortem parenthood. Review article. Department of Obstetrics and Gynecology, Masaryk University, Brno, Department of Obstetrics and Gynecology, Palacky University, Olomouc. Literature search in Database of Abstracts of Reviews of the Evidence (DARE) and MEDLINEplus. Posthumous sperm procurement and cryopreservation must be performed within 36 hours after death. To established appropriate medical practice, it is important to consider all stakeholders in the decision-making process: the deceased, the requesting party, the child, the physician and the society. There are only few legislative measures concerning postmortem parenthood and posthumous sperm procurement. The essential elements for postmortem reproduction are: judicial order, ethics committee approval, bereavement period of at least 6 month before use. Posthumous sperm procurement is fraught with ethical and legal implications. All stakeholder should be considered. Society for reproductive medicine should prepare acceptable standard protocol.

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

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

24 CFR 4.34 - Review of Inspector General's report by the Ethics Law Division.

Science.gov (United States)

2010-04-01

... report by the Ethics Law Division. 4.34 Section 4.34 Housing and Urban Development Office of the... Funding Decisions § 4.34 Review of Inspector General's report by the Ethics Law Division. After receipt of the Inspector General's report, the Ethics Law Division shall review the facts and circumstances of...

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

Ethical responsibilities of pharmacists when selling complementary medicines: a systematic review.

Science.gov (United States)

Salman Popattia, Amber; Winch, Sarah; La Caze, Adam

2018-04-01

The widespread sale of complementary medicines in community pharmacy raises important questions regarding the responsibilities of pharmacists when selling complementary medicines. This study reviews the academic literature that explores a pharmacist's responsibilities when selling complementary medicines. International Pharmaceutical Abstracts, Embase, PubMed, Cinahl, PsycINFO and Philosopher's index databases were searched for articles written in English and published between 1995 and 2017. Empirical studies discussing pharmacists' practices or perceptions, consumers' expectations and normative studies discussing ethical perspectives or proposing ethical frameworks related to pharmacists' responsibilities in selling complementary medicines were included in the review. Fifty-eight studies met the inclusion criteria. The majority of the studies discussing the responsibilities of pharmacists selling complementary medicines had an empirical focus. Pharmacists and consumers identified counselling and ensuring safe use of complementary medicines as the primary responsibilities of pharmacists. No formal ethical framework is explicitly employed to describe the responsibilities of pharmacists selling complementary medicines. To the degree any ethical framework is employed, a number of papers implicitly rely on principlism. The studies discussing the ethical perspectives of selling complementary medicines mainly describe the ethical conflict between a pharmacist's business and health professional role. No attempt is made to provide guidance on appropriate ways to resolve the conflict. There is a lack of explicit normative advice in the existing literature regarding the responsibilities of pharmacists selling complementary medicines. This review identifies the need to develop a detailed practice-specific ethical framework to guide pharmacists regarding their responsibilities when selling complementary medicines. © 2018 Royal Pharmaceutical Society.

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.

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.

The Frequency of Reporting Ethical Issues in Human Subject Articles Published in Iranian Medical Journals: 2009-2013.

Science.gov (United States)

Astaneh, Behrooz; Khani, Parisa

2017-11-10

Researchers should strictly consider the participants' rights. They are required to document such protections as an ethical approval of the study proposal, the obtaining "informed consent", the authors' "conflict of interests", and the source of "financial support" in the published articles. The purpose of this study was to assess the frequency of reporting ethical issues in human subject articles published in Iranian medical journals during 2009-2013. In this cross-sectional study, we randomly reviewed 1460 human subject articles published in Iranian medical journals during 2009-2013 in two Persian and English language groups. Data collection was carried out by assessing articles, focusing on the documentation "ethics committee approval", patients' "informed consent", "financial support", "confidentiality", and "conflict of interest". Of 1460 evaluated articles, 443 (30.3%) reported "ethics committee approval", 686 (47.0%) reported "informed consent", 594 (40.7%) reported "financial support", and 341 (23.4%) reported "conflict of interest". 13% of the articles referred to patients' confidentiality in their text. There was a significant association between these ethical documentations and the year of publication. Articles published in English language journals reported "ethics committee approval", "financial support", and "conflict of interest" significantly more than Persian language journals, but the frequency of "informed consent" was similar. Ethical documentation rate in Iranian medical journals is not up to the expected standards of reputable journals which might be related to a lack of awareness and the education of the authors and the journal's editors. Precise reporting of ethical considerations in medical articles by authors are recommended. It is suggested journals and policymakers pay more attention to reporting this issue while providing standard guidelines in this regard.

[Impact of the economic crisis on the activity of a clinical research ethics committee].

Science.gov (United States)

Redondo Capafons, S; Arcenillas, Paula; Giménez, Nuria; March López, Pablo; Soriano, Laura; Pla, Ramon; Quintana, Salvador

2014-11-03

Analyze the impact of economic and social crisis in volume and funding of clinical trials (CT) and observational studies (ES) from the activity of an Research Ethics Committee (REC). REC memories 2003-2012 were reviewed. Financing of evaluated projects, CT and OS were analyzed classifying them into four groups: 1) promoted by pharmaceutical industry, 2) by scientific societies with industry support, 3) by scientific societies with government support and 4) unfunding.Two periods were compared: pre-crisis (2003-2007) and crisis (2008-2012). During 10 studied years, 744 protocols were evaluated: a 71% of group 1, a 9% of group 2, a 3% of group 3 and a 17% was no funding. Regarding OS, 40%, 5,4%, 8,6% and 46% were the groups 1, 2, 3 and 4 respectively. Analyzing crisis versus pre-crisis period, statistically significant differences were observed in the decreasing of number of CT phase 2 and 3 and in the rising EO. Comparing crisis related to the pre-crisis period, the Group 4 increased statistically significantly. Evolution of total number of studies evaluated by REC tends to be maintained and even increased over time. REC maintains its activity and even increased at the expense of financing and unfunded OS. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Ethical issues in obesity prevention for school children: a systematic qualitative review.

Science.gov (United States)

Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

2017-12-01

Planning and conducting preventive measures against obesity for school children is beset with ethical issues which should be known to make well-informed decisions. The goal of this study was to provide a comprehensive spectrum of these ethical issues by means of a systematic review. In this context, the study also assesses the value of different search strategies for ethical literature in public health. Literature was searched in Medline, EBSCO and others. Three different search strategies with varied scopes were applied and their output was compared. Qualitative content analysis was used for extracting and categorizing ethical issues. 109 publications (published from 1995 to 2015) were finally included. The qualitative analysis resulted in 60 potentially relevant ethical issues. The three search strategies showed substantial differences regarding their search results. The presented spectrum provides an initial evidence base for dealing with ethical issues adequately. The findings of the study further suggest that a broader scope is more fruitful for systematic reviews on ethical issues in the field of public health.

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 ...

Report of the Review Committee on valuation of the research subjects in the fields of advanced science research

International Nuclear Information System (INIS)

2000-07-01

On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods, etc. the Ad Hoc Review Committee composed of eight experts was set up under the Research Evaluation Committee of the JAERI in order to review the research theme completed in FY1998 and those planned for five years starting in FY2000 in the Advanced Science Research Center. The Ad Hoc Review Committee meeting was held on September 17, 1999. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research results/plan documents submitted in advance and presentations by the Research Group Leaders. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on March 14, 2000. As a result, the Research Evaluation Committee acknowledged appropriateness of the review results. This report describes the review results. (author)

The "Ethics Committee": A Practical Approach to Introducing Bioethics and Ethical Thinking

Science.gov (United States)

Goodwin, Mark; Kramer, Cas; Cashmore, Annette

2012-01-01

Bioethics is an increasingly important part of the biosciences curriculum at school and in higher education, but few science teachers have much experience of teaching the subject in an engaging or interactive manner. This article sets out a session that allows students to practise the skills of ethical thinking and ethical debate in a relevant…

A systematic review of ethical issues in vaccine studies involving pregnant women.

Science.gov (United States)

Beeler, Jennifer A; Lambach, Philipp; Fulton, T Roice; Narayanan, Divya; Ortiz, Justin R; Omer, Saad B

2016-08-02

Immunization during pregnancy can provide protection for mother and child. However, there have been only a limited number of studies documenting the efficacy and safety of this strategy. To determine the extent and nature of subject matter related to ethics in maternal immunization by systematically documenting the spectrum of ethical issues in vaccine studies involving pregnant women. We conducted a systematic literature review of published works pertaining to vaccine and therapeutic studies involving pregnant women through searches of PubMed, EMBASE, Web of Science, the Cochrane Database, and ClinicalTrials.gov. We selected literature meeting the inclusion criteria published between 1988 and June 2014. We systematically abstracted subject matter pertaining to ethical issues in immunization studies during pregnancy. Immunization-specific ethical issues were matched and grouped into major categories and subcategories. Seventy-seven published articles met the inclusion criteria. Published articles reported findings on data that had been collected in 26 countries, the majority of which were classified as high-income or upper-middle-income nations according to World Bank criteria. Review of these publications produced 60 immunization-specific ethical issues, grouped into six major categories. Notably, many studies demonstrated limited acknowledgment of key ethical issues including the rights and welfare of participants. Additionally, there was no discussion pertaining to the ethics of program implementation, including integration of maternal immunization programs into existing routine immunization programs. This review of ethical issues in immunization studies of pregnant women can be used to help inform future vaccine trials in this important population. Consistent documentation of these ethical issues by investigators will facilitate a broader and more nuanced discussion of ethics in immunization of pregnant women - offering new and valuable insights for programs

Supporting ethical competence of nurses during recruitment and performance reviews - the role of the nurse leader.

Science.gov (United States)

Poikkeus, Tarja; Leino-Kilpi, Helena; Katajisto, Jouko

2014-09-01

The aim of this study was to analyse how nurse leaders support the ethical competence of nurses during recruitment and performance reviews. Ethical competence of nurses refers to ethical behaviour and action requiring ethical knowledge and reflection. Nurse leaders have a key role in supporting the ethical competence of nurses, but little is known about just how this should be done. The data were collected using a structured questionnaire and analysed statistically. The target sample consisted of nurse leaders (n = 198) from two university hospitals in two healthcare districts in Finland. Nurse leaders support the ethical competence of nurses more often during performance reviews than during recruitment. During recruitment, nurse leaders ensure the ethical behaviour and knowledge of nurses to varying degrees. During performance reviews, nurse leaders ensure that nurses meet the requirements for collegiality and comply with ethical guidelines and that they do so according to nursing values and principles. There seems to be a need to examine and improve support for the ethical competence of nurses, both during recruitment and performance reviews. Future priorities should include a focus on supporting the ethical knowledge, reflection and behaviour of nurses. An important aspect in terms of supporting the ethical competence of nurses has to do with the ethical knowledge and education of nurse leaders and organisational policies or recommendations for ethical support. © 2013 John Wiley & Sons Ltd.

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...

An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study

Directory of Open Access Journals (Sweden)

Subhrojyoti Bhowmick

2014-01-01

Full Text Available Purpose of study: The vital responsibility of Institutional Ethics Committee (IEC members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. Materials and Methods: A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals in Kolkata conducting active clinical research and having functional Ethics Committees (ECs in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to all EC members through telephone/e-mail for completion and returning of the forms. The filled in forms were returned to their respective Member Secretaries, from whom authors′ collected the forms. Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Categorical data were analyzed using Chi-square test and a P < 0.05 was considered statistically significant. Results: Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly. Overall awareness regarding different pharmacovigilance terminologies and activities among EC members from nonmedical background (71.43% was found to be more than that of the medical members (68.75%, though the figure was not statistically significant. Majority of the members (75% felt that EC should decide compensation in case of a serious adverse event. Conclusion: The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding

Resolving the ethical dilemma of nurse managers over chemically-dependent colleagues.

Science.gov (United States)

Chiu, W; Wilson, D

1996-12-01

This paper addresses the nurse manager's role regarding chemically-dependent nurses in the workplace. The manager may intervene by: terminating the contract of the impaired colleague; notifying a disciplinary committee; consulting with a counselling committee; or referring the impaired nurse to an employee assistance programme. A dilemma may arise about which of these interventions is ethically the best. The ethical theories relevant to nursing involve ethical relativism, utilitarianism, Kantian ethics, Kohlberg's justice, and Gilligan's ethic of care. Nurse managers first need to understand these theories in order to clarify their own perceptions and attitudes towards chemical dependency, and then satisfactorily resolve this ethical dilemma. Education and social learning are routes to a better understanding of chemical dependency and to broadening the ethical dimensions of nurse managers.

15 CFR 2008.19 - Classification Review Committee.

Science.gov (United States)

2010-01-01

... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Classification Review Committee. 2008.19 Section 2008.19 Commerce and Foreign Trade Regulations Relating to Foreign Trade Agreements OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE REGULATIONS TO IMPLEMENT E.O. 12065; OFFICE OF THE UNITED...

76 FR 28237 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-05-16

... commercial property such as patentable material, and personal information concerning individuals associated... Committee: Center for Scientific Review Special Emphasis Panel, Societal and Ethical Issues in Research...

A narrative review of undergraduate peer-based healthcare ethics teaching.

Science.gov (United States)

Hindmarch, Thomas; Allikmets, Silvia; Knights, Felicity

2015-12-12

This study explores the literature in establishing the value of undergraduate peer-based healthcare ethics teaching as an educational methodology. A narrative review of the literature concerning peer-based ethics teaching was conducted. MEDLINE, EMBASE, CINAHL, SCOPUS databases, and the Cochrane Library, were systematically searched for studies of peer-based ethics or professionalism teaching. Selected studies related peer-based teaching to ethics education outcomes. Ten publications were identified. Selected studies were varied in their chosen intervention methodology and analysis. Collectively, the identified studies suggest peer-based ethics education is an effective and valued educational methodology in training healthcare professionals. One paper suggests peer-based ethics teaching has advantages over traditional didactic methods. Peer-based ethics teaching also receives positive feedback from student participants. However, the limited literature base demonstrates a clear need for more evaluation of this pedagogy. The current literature base suggests that undergraduate peer based healthcare ethics teaching is valuable in terms of efficacy and student satisfaction. We conclude that the medical community should invest in further study in order to capitalise upon the potential of peer-based ethics teaching in undergraduate healthcare education.

[Perception and satisfaction of main researchers on the management of a Clinical Research Ethics Committee].

Science.gov (United States)

Vilardell Navarro, N; Redondo-Capafons, S; Giménez, N; Quintana, S

2013-01-01

To analyze the main researchers (MR) perception and satisfaction associated to face-to-face project presentation as well as Clinical Research Ethics Committee (CREC) functions related to administrative and advisement aspects. Descriptive study performed during nine months (January to September 2011) through voluntary participation questionnaire given to MR who assisted to CREC meetings. The questionnaire contained a numeric range (1-10) and open issues to evaluate the presentation process, the satisfaction of CREC functions considering bureaucratic aspects, ethics, scientific-methodological, legal recommendations and its global function. Descriptive statistics and Student test were performed. The questionnaire was answered by 36 (95%) of total MR. Average score obtained in the evaluation of face-to-face study presentation was 9.2 (SD 0.9). In reference to legal issues an average punctuation of 7.1 (DE 0.4) was obtained, whereas ethics and scientific-methodological aspects scored 8.2 (DE 0.2 and 0.4). Global average evaluation about CREC tasks was 8.6 (SD 1.0). A positive assessment related to attend to the project presentation was made for 22 (61%) of the MR. The study showed a high satisfaction of CREC operation and a high evaluation of face-to-face project presentation. There were detected further improvement aspects to optimize CREC meetings, taking into account the effort developed by MR and CREC members. Copyright © 2013 SEFH. Published by AULA MEDICA. All rights reserved.

The science of ethics: Deception, the resilient self, and the APA code of ethics, 1966-1973.

Science.gov (United States)

Stark, Laura

2010-01-01

This paper has two aims. The first is to shed light on a remarkable archival source, namely survey responses from thousands of American psychologists during the 1960s in which they described their contemporary research practices and discussed whether the practices were "ethical." The second aim is to examine the process through which the American Psychological Association (APA) used these survey responses to create principles on how psychologists should treat human subjects. The paper focuses on debates over whether "deception" research was acceptable. It documents how members of the committee that wrote the principles refereed what was, in fact, a disagreement between two contemporary research orientations. The paper argues that the ethics committee ultimately built the model of "the resilient self" into the APA's 1973 ethics code. At the broadest level, the paper explores how prevailing understandings of human nature are written into seemingly universal and timeless codes of ethics. © 2010 Wiley Periodicals, Inc.

Physician-Rating Web Sites: Ethical Implications.

Science.gov (United States)

Samora, Julie Balch; Lifchez, Scott D; Blazar, Philip E

2016-01-01

To understand the ethical and professional implications of physician behavior changes secondary to online physician-rating Web sites (PRWs). The American Society for Surgery of the Hand (ASSH) Ethics and Professionalism Committee surveyed the ASSH membership regarding PRWs. We sent a 14-item questionnaire to 2,664 active ASSH members who practice in both private and academic settings in the United States. We received 312 responses, a 12% response incidence. More than 65% of the respondents had a slightly or highly unfavorable impression of these Web sites. Only 34% of respondents had ever updated or created a profile for PRWs, although 62% had observed inaccuracies in their profile. Almost 90% of respondents had not made any changes in their practice owing to comments or reviews. One-third of respondents had solicited favorable reviews from patients, and 3% of respondents have paid to improve their ratings. PRWs are going to become more prevalent, and more research is needed to fully understand the implications. There are several ethical implications that PRWs pose to practicing physicians. We contend that it is morally unsound to pay for good reviews. The recourse for physicians when an inaccurate and potentially libelous review has been written is unclear. Some physicians have required patients to sign a waiver preventing them from posting negative comments online. We propose the development of a task force to assess the professional, ethical, and legal implications of PRWs, including working with companies to improve accuracy of information, oversight, and feedback opportunities. It is expected that PRWs will play an increasing role in the future; it is unclear whether there will be a uniform reporting system, or whether these online ratings will influence referral patterns and/or quality improvement. Copyright © 2016 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

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.

药物临床试验伦理委员会运作实践%The Operation of Ethics Committees in Drug Clinical Trials

Institute of Scientific and Technical Information of China (English)

鲁瑞萍; 单志桂; 申洁

2013-01-01

在药物临床试验的过程中,必须对受试者的个人权益给予充分的保障,并确保试验的科学性和可靠性.伦理委员会与知情同意书是保障受试者权益的主要措施.为确保临床试验中受试者的权益,须成立独立的伦理委员会,并向国家食品药品监督管理局备案.介绍了某医院药物临床试验伦理委员会的组成及备案、规范伦理委员会运作、存在的问题以及解决的对策与方法.%In the process of drug clinical trials,it is necessary to give full guarantee of personal rights of the subjects,and ensure the scientific nature and reliability of the test.Ethics committee and informed consent are the main measures to safeguard the rights and interests of the subjects.In order to protect the clinical trial subjects'rights and interests,it should set up an independent ethics committee,and put on records in the State Food and Drug Administration.In this paper,the authors also introduced the construction and records,standard business,existing problems and solving countermeasures in a hospital ethics committee.

Committee on Scientific Values | Initiatives | Indian Academy of ...

Indian Academy of Sciences (India)

Academy Committee on Scientific Values. The Council of the Academy had in 2003 constituted a Committee to consider and submit a report on ethical guidelines which the fellowship of the Academy should follow. The Committee submitted its report to the Council, which at its meeting in December 2005 approved this report ...

Listening to professional voices: draft 2 of the ACM code of ethics and professional conduct

OpenAIRE

Flick, Catherine; Brinkman, Bo; Gotterbarn, D. W.; Miller, Keith; Vazansky, Kate; Wolf, Marty J.

2017-01-01

The file attached to this record is the author's final peer reviewed version. The Publisher's final version can be found by following the DOI link. For the first time since 1992, the ACM Code of Ethics and Professional Conduct (the Code) is being updated. The Code Update Task Force in conjunction with the Committee on Professional Ethics is seeking advice from ACM members on the update. We indicated many of the motivations for changing the Code when we shared Draft 1 of Code 2018 with the ...

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.

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.

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.

The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

Science.gov (United States)

Homedes, Núria; Ugalde, Antonio

2015-06-01

To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries. Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries. Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols. 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.

Ethics in Online Publications.

Science.gov (United States)

Vervaart, Peter

2014-10-01

Journals have been publishing the results of scientific investigations since the founding of Philosophical Transactions in 1665. Since then we have witnessed a massive expansion in the number of journals to the point that there are now approximately 28,000 active, peer reviewed journals collectively publishing more than 1.8 million articles per year. Before the mid-1990s, these journals were only available on paper but by the end of the 20th century, most journals had moved to online platforms. Online publication has also served as the impetus for the move to 'open-access' to the information contained in journals. The fact that a publication is 'on-line' and 'open-access' does not negate the responsibility of the author and the publisher to publish in an ethical way. [1] The document produced by the IFCC Ethics Task Force (TF-E) on publication ethics states that 'Ethics in Science at its broadest level encompasses research ethics, medical ethics, publication ethics, conflicts of interest, ethical responsibilities as educator, plus many other areas.' Thus publication ethics is a continuum from the first step of research design through to the information being read by the reader. In general terms 'publication ethics' includes the ethical behaviour of the authors in writing and submitting a scientific manuscript to a publisher for the purpose of publication, thus any discussion of publication ethics must include the role of the authors, referees, publisher and reader and the issues of authorship (and the use of 'ghosts'), plagiarism, duplicate publication (including in different languages), image manipulation (particularly in the era of digitisation), and conflict of interest [2]. To aid the authors, and others involved in the process of publication, a number of resources are now available particularly those from the Committee on Publication Ethics (COPE) [3] and the World Association of Medical Editors (WAME) [4]. More recently the issue of 'publisher ethics' has

Ethics in Early Childhood Special Education.

Science.gov (United States)

Bowe, Frank G.

1995-01-01

This article discusses ethical questions in providing prenatal services, including testing and genetic engineering, and medical interventions with neonates and other very young children who have severe disabilities. It explores ways to enhance ethical decision making, including recruitment for multidisciplinary teams or other committees of adults…

Report of the review committee on evaluation of the R and D subjects in the field of nuclear fusion research

International Nuclear Information System (INIS)

2000-10-01

On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods and the Practices Manuals of the Institution Evaluation Committee, the Ad Hoc Review Committee composed of 12 experts was set up under the Research Evaluation Committee of the JAERI in order to review the whole R and D subjects in fusion research, including post-review for those completed in FY1998, intermediate-review for those started in FY1999, and pre-review for those to be implemented in FY2001. The Ad Hoc Review Committee meeting was held on March 9, 2000. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research result/plan documents submitted in advance and presentations by the Department Directors. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on August 31, 2000. The Research Evaluation Committee recognized the review results as appropriate. This report describes the review results. (author)

What methods do reviews of normative ethics literature use for search, selection, analysis, and synthesis? In-depth results from a systematic review of reviews.

Science.gov (United States)

Mertz, Marcel; Strech, Daniel; Kahrass, Hannes

2017-12-19

(Semi-)systematic approaches to finding, analysing, and synthesising ethics literature on medical topics are still in their infancy. However, our recent systematic review showed that the rate of publication of such (semi-)systematic reviews has increased in the last two decades. This is not only true for reviews of empirical ethics literature, but also for reviews of normative ethics literature. In the latter case, there is currently little in the way of standards and guidance available. Therefore, the methods and reporting strategies of such reviews vary greatly. The purpose of the follow-up study we present was to obtain deeper methodological insight into the ways reviews of normative literature are actually conducted and to analyse the methods used. Our search in the PubMed, PhilPapers, and Google Scholar databases led to the identification of 183 reviews of ethics literature published between 1997 and 2015, of which 84 were identified as reviews of normative and mixed literature. Qualitative content analysis was used to extract and synthesise descriptions of search, selection, quality appraisal, analysis, and synthesis methods. We further assessed quantitatively how often certain methods (e.g. search strategies, data analysis procedures) were used by the reviews. The overall reporting quality varies among the analysed reviews and was generally poor even for major criteria regarding the search and selection of literature. For example, only 24 (29%) used a PRISMA flowchart. Also, only 55 (66%) reviews mentioned the information unit they sought to extract, and 12 (14%) stated an ethical approach as the theoretical basis for the analysis. Interpretable information on the synthesis method was given by 47 (60%); the most common methods applied were qualitative methods commonly used in social science research (83%). Reviews which fail to provide sufficient relevant information to readers have reduced methodological transparency regardless of actual methodological

Safety Review Committee - Annual Report 1991-1992

International Nuclear Information System (INIS)

1993-01-01

During the year under review. The Safety Review Committee (SRC) assessed the safety of ANSTO's operations. This was done by site visits, examination of documentation and briefing by ANSTO officers responsible for particular operations, and includes HIFAR and Moata reactors, radioisotope production, packing and dispatch, radioactive waste management practices, occupational health and safety activities and ANSTO's arrangements for public health and safety beyond the site. This report describes the activities and findings of the SRC during the year ending 30 June 1992. 8 figs., ills

Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.

Science.gov (United States)

Driscoll, Andrea; Currey, Judy; Worrall-Carter, Linda; Stewart, Simon

2008-08-01

To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects. The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC. Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study. Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services. The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits

Report of the review committee on evaluation of the R and D subjects in the field of nuclear safety research

International Nuclear Information System (INIS)

2000-09-01

On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods and the Practices Manuals of the Institution Evaluation Committee and Research Evaluation Committee, the Ad Hoc Review Committee on Nuclear Safety Research composed of twelve experts was set up under the Research Evaluation Committee of the JAERI in order to review the R and D subjects to be implemented for five years starting in FY2000 in the Nuclear Safety Research Center (Department of Reactor Safety Research, Department of Fuel Cycle Safety Research and Department of Safety Research Technical Support). The Ad Hoc Review Committee meeting was held on January 20, 2000. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research plan documents submitted in advance and presentations by the Department Directors. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on August 31, 2000. The Research Evaluation Committee recognized the review results as appropriate. This report describes the review results. (author)

75 FR 57475 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-09-21

... evaluate grant applications. Place: InterContinental Mark Hopkins Hotel, 999 California Street, San....m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Melrose Hotel, [email protected] . Name of Committee: Genes, Genomes, and Genetics Integrated Review Group; Ethical, Legal...

[International regulation of ethics committees on biomedical research as protection mechanisms for people: analysis of the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research of the Council of Europe].

Science.gov (United States)

de Lecuona, Itziar

2013-01-01

The article explores and analyses the content of the Council of Europe's Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research regarding the standard legal instrument in biomedical research, issued by an international organization with leadership in bioethics. This implies ethics committees are mechanisms of protection of humans in biomedical research and not mere bureaucratic agencies and that a sound inescapable international regulatory framework exists for States to regulate biomedical research. The methodology used focuses on the analysis of the background, the context in which it is made and the nature and scope of the Protocol. It also identifies and analyses the characteristics and functions of ethics committees in biomedical research and, in particular, the information that should be provided to this bodies to develop their functions previously, during and at the end of research projects. This analysis will provide guidelines, suggestions and conclusions for the awareness and training of members of these committees in order to influence the daily practice. This paper may also be of interest to legal practitioners who work in different areas of biomedical research. From this practical perspective, the article examines the legal treatment of the Protocol to meet new challenges and classic issues in research: the treatment of human biological samples, the use of placebos, avoiding double standards, human vulnerability, undue influence and conflicts of interest, among others. Also, from a critical view, this work links the legal responses to develop work procedures that are required for an effective performance of the functions assigned of ethics committees in biomedical research. An existing international legal response that lacks doctrinal standards and provides little support should, however, serve as a guide and standard to develop actions that allow ethics committees -as key bodies for States- to advance in

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...

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.

Report of the review committee on evaluation of the research subjects in the field of advanced science research (FY2000)

International Nuclear Information System (INIS)

2000-10-01

On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods and the Practices Manuals of the Institution Evaluation Committee, the Ad Hoc Review Committee composed of eight experts was set up under the Research Evaluation Committee of the JAERI in order to review the research themes completed in FY1999, those to be ended through FY2000, and those planned for five years starting in FY2001 in the Advanced Science Research Center. The Ad Hoc Review Committee meeting was held on July 17, 2000. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research result/plan documents submitted in advance and presentations by the Research Group Leaders. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on August 31, 2000. The Research Evaluation Committee recognized the review results as appropriate. This report describes the review results. (author)

Do committees ru(i)n the bio-political culture? On the democratic legitimacy of bioethics committees.

Science.gov (United States)

Friele, Minou Bernadette

2003-08-01

Bioethical and bio-political questions are increasingly tackled by committees, councils, and other advisory boards that work on different and often interrelated levels. Research ethics committees work on an institutional or clinical level; local advisory boards deal with biomedical topics on the level of particular political regions; national and international political advisory boards try to answer questions about morally problematic political decisions in medical research and practice. In accordance with the increasing number and importance of committees, the quality of their work and their functional status are being subjected to more and more scrutiny. Besides overall criticism regarding the quality of their work, particular committees giving political advice are often suspected of being incompatible with democratic values, such as respect for affected parties, representation of diverse values and transparency in the decision-making processes. Based on the example of the German National Ethics Council, whose inauguration caused a still ongoing debate on the aims and scopes of committees in general, this paper discusses: (1) the requirements of modern democratic societies in dealing with complex scientific-technical problems; (2) the composition and organisation of committees working as political advisory boards; and (3) the appointment procedures and roles of laymen and experts, and here in particular of ethicists, who may legitimately be taken on by a committee. I will argue that bioethics committees do not necessarily endanger democratic values, but can considerably improve their realisation in democratic decision-making procedures--if, and only if, they do not act as substitutes for parliamentarian processes, but help prepare parliamentarian processes to be organised as rationally as possible.

Report of the marketing science editorial review committee

NARCIS (Netherlands)

Fader, Peter S.; Bronnenberg, B.J.J.A.M.; Lyer, Ganesh; Neslin, Scott A.; Netzer, Oded; Srinivasan, Kannan

2014-01-01

This is an abridged version of an evaluation report for Marketing Science, which was commissioned by the INFORMS Publications Committee as part of its periodic review of every INFORMS journal. The coauthors listed here comprised the task force that conducted the research project and strategic

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...

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 ...

The role of national ethics commissions in Finland.

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