Multi-disciplinary research ethics review: is it feasible?

This paper reviews the currently rapid changes in research ethics governance affecting many kinds of social research. Arguments for and against single‐discipline and multidisciplinary research ethics committees will be considered, with examples of how medical and social research ethics can inform one another. We conclude that the use of multidisciplinary research ethics committees, guidance and governance can be an effective and necessary part of social research methodology

NHS research ethics committees : still need more common sense and less bureaucracy

National Health Service research ethics committees exist to ensure that research performed within the NHS complies with recognised ethical standards and to protect the rights, safety, and dignity of all actual or potential participants. In the past decade the operation of research ethics committees has come under, and continues to come under, close scrutiny. Researchers now consider the process of acquiring ethical approval to be so onerous that it is compromising clinical research. Medical educators also think that the process is too unwieldy to allow undergraduate students to acquire research experience, an essential learning outcome required by the General Medical Council

Ethics review of research projects involving human subjects

Maltreatment of subjects has led to the introduction of an ethics review process for research involving humans. There is a feeling that the bureaucratization of the process is too restrictive and that it may be hampering research. The function, duties, and effectiveness of ethics committees are examined, and it is contended that there are problems with the way that committees operate. The remit of committees needs to be clarified, and the paper presents guidelines for making decisions on ethical matters, with deontological considerations taking precedence over consequentialist ones. It is concluded that the functions and processes of ethics committees need to be modified

An eight-year follow-up national study of medical school and general hospital ethics committees in Japan

<p>Abstract</p> <p>Background</p> <p>Ethics committees and their system of research protocol peer-review are currently used worldwide. To ensure an international standard for research ethics and safety, however, data is needed on the quality and function of each nation's ethics committees. The purpose of this study was to describe the characteristics and developments of ethics committees established at medical schools and general hospitals in Japan.</p> <p>Methods</p> <p>This study consisted of four national surveys sent twice over a period of eight years to two separate samples. The first target was the ethics committees of all 80 medical schools and the second target was all general hospitals with over 300 beds in Japan (n = 1457 in 1996 and n = 1491 in 2002). Instruments contained four sections: (1) committee structure, (2) frequency of annual meetings, (3) committee function, and (4) existence of a set of guidelines for the refusal of blood transfusion by Jehovah's Witnesses.</p> <p>Results</p> <p>Committee structure was overall interdisciplinary. Frequency of annual meetings increased significantly for both medical school and hospital ethics committees over the eight years. The primary activities for medical school and hospital ethics committees were research protocol reviews and policy making. Results also showed a significant increase in the use of ethical guidelines, particularly those related to the refusal of blood transfusion by Jehovah's Witnesses, among both medical school and hospital ethics committees.</p> <p>Conclusion</p> <p>Overall findings indicated a greater recognized degree of responsibilities and an increase in workload for Japanese ethics committees.</p

Organizational Ethics Committees

EssayThe first official healthcare ethics committee convened in 1971. But the origin of such committees came years earlier in response to a rising tide of moral concern in health care. “Committees for the Discussion of Morals in Medicine” were formed by U.S. Catholic Hospitals in the 1960s in response to increasing social awareness of personal rights and the new dilemmas created by evolving life saving medical technology

The role of research ethics committees: Friend or foe in educational research?

Ethics committees have an important role to play in ensuring ethical standards (e.g. BERA, ESRC, RCUK recommendations) are met by educational researchers. Balancing obligations to participants, society, institutions and the researchers themselves is not, however, easy. Researchers often experience the Ethics committee as unsympathetic to their research endeavour, whilst Ethics committees find some research approaches do not make ethical implications sufficiently explicit. This potential for misunderstanding is evident in the literature; but studies investigating how participants perceive this relationship is missing. This study comprises a novel empirical study which explores researcher perceptions of research ethics committees. Fifty-five participants in Higher Education departments of Education responded to an online survey. Open and closed ended questions were used to collect data on roles, methodological stance, experiences of the research ethics committee, perceived tensions and examples of good practice. The results indicated that contemporary educational researchers regard research ethics committees as friends when researcher and reviewer are transparently engaged in a shared endeavour. When this shared endeavour breaks down, for a variety of reasons including apparently unreasonable demands or mutual misunderstanding, the research ethics committees can become foe. The difference between foe and friend lies in the quality of communication, clear systems and a culture of respectful mutual learning. The contributions of this study have practical implications for the ways that education researchers and research ethics committees relate to one another within university settings, both to alleviate areas of tension and to arrive at shared understanding which will enable best ethical research practice

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

<p>Abstract</p> <p>Background</p> <p>Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.</p> <p>Discussion</p> <p>Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.</p> <p>The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.</p> <p>Conclusion</p> <p>Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed?</p

Revising the legislation of Ethics Committees to ease biomedical research in humans across the world: lessons from the COVID-19 emergency

: As a legislative domain that considerably influences implementation of biomedical research, the need to improve the legal rules surrounding the organization and functioning of Ethics Committees in public health, toxicology, and clinical medicine is widely recognized within and outside the European Union. Given the often-heard complaints by researchers about the complexity and length of both the application and the review process by Ethics Committees in the authorization of new studies, adjustments to their legislation appears to be warranted. Within the European Union this seems also all the timelier, given the upcoming new regulation of clinical trials to become effective in early 2022. For this process, valuable lessons can be gleaned from the COVID-19 pandemic and the changes in the functioning of Ethics Committees that were adopted to cope with the exceptional circumstances imposed by the health emergency. The pandemic experience clearly indicates that a more responsive and practical system of applications' review by the Ethics Committees can be squared with acceptable levels of transparency and reliability in ethical accountability. For this reason, countries like Italy should consider undertaking a significant revision of the public law rules that govern the review processes of Ethics Committees in light of the pandemic experience. (www.actabiomedica.it)