Role Of Research Ethics Committees Research Articles

The Political Life of Research Ethics Committees And What It Means for Ethnographic Research

This review discusses three pieces of work, that is, a conference panel and two books, that deal with the role of research ethics committees (RECs) in regulating biomedical research and medical anthropological research. We summarise the papers and conversations of a panel we convened on this topic during the 2020 European Association for Social Anthropologists (EASA) conference. We review two relatively recent books which discuss the role of RECs in biomedical research: Adam Hedgecoe’s (2020) Trust in the System: Research Ethics Committees and the Regulation of Biomedical Research, and Salla Sariola and Bob Simpson’s (2019) Research as Development: Biomedical Research, Ethics, and Collaboration in Sri Lanka. Finally, we consider how the review that RECs outside academic institutions perform is inadequate for ethnographic research, including that involving prospective participants who may lack capacity to consent. We conclude that undertaking the research ethics review internally (i.e., under university RECs) would be a first step forward in reclaiming ethnographic research ethical conversations.

Research ethics: From principles to practical aspects

Any research conducted on human beings or human biological samples requires a prior ethical assessment to avoid risks and problems for all involved parties. The legislation in this regard is very broad and emphasizes the safeguarding of patient rights in relation to the universal principles of autonomy, beneficence and justice. The present article reviews the regulations applicable to clinical trials, observational studies with drugs, biobank projects or any other type of study that may be conducted in the health care field. It also addresses the role of research ethics committees, data protection and the foundations of scientific integrity.

Ética en investigación: de los principios a los aspectos prácticos

Any research conducted on human beings or human biological samples requires a prior ethical assessment to avoid risks and problems for all involved parties. The legislation in this regard is very broad and emphasizes the safeguarding of patient rights in relation to the universal principles of autonomy, beneficence and justice. The present article reviews the regulations applicable to clinical trials, observational studies with drugs, biobank projects or any other type of study that may be conducted in the health care field. It also addresses the role of research ethics committees, data protection and the foundations of scientific integrity.

The evolving role of research ethics committees in the era of open data

While open science gains prominence in South Africa with the encouragement of open data sharing for research purposes, there are stricter laws and regulations around privacy – and specifically the use, management and transfer of personal information – to consider. The Protection of Personal Information Act No. 4 of 2013 (POPIA), which came into effect in 2021, established stringent requirements for the processing of personal information and has changed the regulatory landscape for the transfer of personal information across South African borders. At the same time, draft national policies on open science encourage wide accessibility to data and open data sharing in line with international best practice. As a result, the operation of research ethics committees (RECs) in South Africa is affected by the conflicting demands of the shift towards open science on the one hand, and the stricter laws protecting participants’ personal information and the transfer thereof, on the other. This article explores the continuing evolving role of RECs in the era of open data and recommends the development of a data transfer agreement (DTA) for the ethical management of personal health information, considering the challenges that RECs encounter, which centres predominantly on privacy, data sharing and access concerns following advances in genetic and genomic research and biobanking.

Research ethics in a changing social sciences landscape

The role of research ethics committees, and research ethics issues more broadly are often not viewed in the context of the development of scientific methods and the academic community. This topic piece seeks to redress this gap. I begin with a brief outline of the changes we experience within the social sciences before exploring in more detail their impact on research ethics and the practices of research ethics committees. I conclude with recommendations for how the existing research ethics processes may be made more future-proof.

Educational Research Ethics Committees as Space for Situated Learning in Higher Education

This paper contributes a different perspective to the debates regarding the role of research ethics committees (RECs) in educational and social sciences research. It identifies limited explicit engagements from such debates about how academics who serve in RECs can learn from these committees towards academic growth and development in and beyond being ethical researchers. We (the authors) follow a duoethnographic method to reflect on our experiences of learning from one committee in a South African university. We argue that, notwithstanding the identified shortcomings in some of the REC committees, they can also be spaces for situated learning. Based on our experience, we identify several ways in which these committees can be resourceful. (1) They can empower the less experienced members through observation and interaction with the experienced. (2) They provide opportunities for the transfer of “knowledge power” to beyond the committee for quality research and postgraduate supervision practices. (3) They can be a solution to the limited research supervision capacity in some institutions. The paper also extends the understanding of the situated learning theory as we add ‘visitors’ as an element of the community of practice.

The Role of Research Ethics Committees: Making a Fair Offer

"In this paper, I engage with the on-going debate about the nature of the task that research ethics committees (RECs) have in coming to assess the ethics of research proposals. Some have argued that the role of RECs is to protect participants from harm in the context of researchers who want to benefit future people. Others have argued that the role of RECs is primarily to ensure that potential participants are provided with full information – enough to make an informed choice. On this later view, RECs protect choice rather than restrict it. I argue that both of these orientations are mistaken and that the role of RECs more akin to a societal overseer who ensures that the research is worthwhile and, most importantly, that it presents a fair offer to potential participants. On this view, the REC’s role is to balance potential harms to participants with the potential benefits of the research in the context of presenting the choice about whether to participate to potential participants. "

Rethinking the role of Research Ethics Committees in the light of Regulation (EU) No 536/2014 on clinical trials and the COVID-19 pandemic.

Research Ethics Committees (RECs)—or Institutional Review Boards (IRBs), as they are known in the US—were created about 50 years ago to independently assess the ethical acceptability of research projects involving human subjects, their fundamental role being the protection of the dignity and rights of research participants. In this paper we develop some critical reflections about the current situation of RECs. Our starting point is the definition of the role they should ideally play, a role that should necessarily include a collaborative approach and the focus on the ethics component of the review. This ideal is unfortunately quite far from reality: inadequacies in the functioning of RECs have been discussed for decades, along with reform proposals. Both in the US and in the European Union (EU), reforms that aim at the centralization of the review process were recently approved. Even though these reforms were needed, they nonetheless raise concerns. We focus on two such concerns, related in particular to Regulation (EU) No 536/2014: the risk of narrowing the scope of the ethics review and that of disregarding the local context. We argue that the COVID‐19 pandemic paved the way for the transition towards the centralized model and that an analysis of its impact on the research review process could provide some interesting insights into possible shortcomings of this new model. We conclude by identifying three objectives that define the role of a REC, objectives that any reform should preserve.

Critiquing the ethics review process in the 2019 Nieuwoudt et al. study on the impact of age and education on cognitive functioning among coloured South African women

In April 2019, Nieuwoudt et al . published an article on the impact of age and education on cognitive functioning among coloured women in the Western Cape Province, South Africa (SA). The study reported that coloured women in SA have increased risk for low cognitive functioning, as a result of limited education and unhealthy lifestyles. The article was widely criticised, and the journal subsequently withdrew the piece. It was argued that the study was unethical as it perpetuated racial stereotypes through its failure to recognise the distinction between race and ethnicity when undertaking biological research on a race group. The study had received ethical approval, which raised pertinent questions about the ethics review process. This article looks at ( i ) the role of research ethics committees (RECs); and ( ii ) the normative framework within which ethics committees operate. It avers that an understanding of the ethical issues of scientific validity, fair subject selection and minimising harms must be viewed in the light of the complex social issues surrounding the construction of coloured identity in SA. The article finds that the REC should have considered this study unapprovable, because its methodology was based on racist assumptions, and its focus on one race or ethnic group posed social risks for that community. The REC ought to have interrogated why researchers were unclear in their distinction between race and ethnicity, and have been mindful of race being a social rather than a biological construct.

The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents

Aim To conduct a descriptive content analysis of normative documents on the role of research ethics committees (RECs) after the approval of clinical trial protocols. The question to be addressed is whether and to what extent normative documents support a monitoring role for RECs in the United States and the European Union. Design A qualitative content analysis of 19 normative documents on clinical research as outlined by the International Compilation of Human Research Standards 2020 edition and other related documents for the EU and USA. Results After the approval of research protocols, RECs’ general role is to receive reports from researchers on the trials’ progress. Additionally, RECs receive notifications of protocol amendments, deviations and, to a lesser extent, violations, which is the remit of the regulatory/competent authorities. RECs are expected to issue opinions on clinical trials’ progress and give supplemental opinions/approval or withdraw/suspend/terminate previous favorable opinions on adverse events or safety concerns that may arise. RECs are to receive an end of the trial report. Conclusion The role of RECs post approval of protocols is to protect human participants through activities such as continuing review of: (a) progress reports, (b) notifications of significant protocol amendments, (c) adverse events, (d) protocol deviations, and (e) protocol violations. Although some international guidelines such as the Declaration of Helsinki emphasize the right to monitor, RECs’ predominant activity is document review. In the USA, RECs are authorized to issue approvals and terminate/suspend previously issued approvals. However, in the EU, the approach is to relegate to member states to decide the extent of legislative power they wish to give to the RECs. The REC’s opinion on the end of trial report is identified as an area for further exploration.

The understanding of research ethics at health sciences schools in Jordan: a cross-sectional study

BackgroundResearch ethics is required for high-quality research that positively influences society. There is limited understanding of research ethics in Middle Eastern countries including Jordan. Here, we aim to investigate the level of understanding of research ethics principles among health sciences faculty members in Jordan.MethodsThis is a cross sectional study where faculty members from the University of Jordan were surveyed for their knowledge and, attitude of research ethics principles. The study was conducted in the period between July 2016 to July 2017 using a customized-design questionnaire involving demographic data and participants’ contributions toward research, and assessment of participants’ knowledge, belief and attitude towards research ethics. Different question-formats have been used including multiple-choice, yes or no, and a four point Likert-type questions. Obtained responses were tabulated according to gender, academic-rank, and knowledge about research ethics principles.ResultsThe study had a response rate of 51%. Among the 137 participants of this study, most (96%) were involved in human and animal research, yet, only 2/3 had prior training in research ethics. Moreover, 91% believed that investigators should have training in research ethics and 87% believed that there should be a mandatory postgraduate course on that. The average correct scores for correct understanding of researchers towards research ethics was 62%. Yet, there were some misconceptions about the major ethical principles as only 43% identified them correctly. Additionally, the role of research ethics committees was not well understood by most of the respondents.ConclusionsAlthough there is acceptable knowledge about research ethics, discrepancies in understanding in research ethics principles seems to exist. There is a large support for further training in responsible conduct of research by faculty in health sciences in Jordan. Thus, such training should be required by universities to address this knowledge gap in order to improve research quality and its impact on society.

The role of research ethics committees in South Africa when human biological materials are transferred between institutions

The role of health research ethics committees (RECs) has evolved dramatically over the past few decades. Novel and specialised research, multicentre trials across borders and commercially sponsored research, coupled with a huge increase in the number and complexity of research protocols, and capacity and resource constraints on the part of RECs, have led to serious breaches regarding the protection of human participants. Research involving the exchange or cross-border transfer of human biological materials (HBMs) requires specialised legal and ethical knowledge relating to multiple governance frameworks. RECs may be required to monitor compliance not only with contractual requirements, but also the national laws and national ethical guidelines and standards of selected jurisdictions, not to mention adherence to international regulatory instruments governing biomedical research generally, and the conditions for the collection and use of HBMs specifically. The South African (SA) legislator’s decision to make RECs signatories to the prescribed material transfer agreement (MTA) template is a first step in the right direction, reinforcing the role and responsibilities of RECs, and their duty of care towards human participants in research. In addition, there has to be a transformation of the general mindset, towards accepting ethical principles within legal documents, particularly legal documents that involve the REC and create binding provisions that have a direct impact on participants. It is time that African views and participant protections are respected and accepted with the same vigour commanded by the Western world. In this article, the role of RECs in general is considered, prior to focusing on their responsibilities with respect to HBM transfer. The ethico-regulatory framework for REC functioning is discussed both from global and national perspectives. Also deliberated is the critical role that RECs play in reviewing health research proposals when HBMs are transferred between institutions, and the REC as a party to the SA national MTA template.

The role of research ethics committees in South Africa when human biological materials are transferred between institutions

The role of health research ethics committees (RECs) has evolved dramatically over the past few decades. Novel and specialised research, multicentre trials across borders and commercially sponsored research, coupled with a huge increase in the number and complexity of research protocols, and capacity and resource constraints on the part of RECs, have led to serious breaches regarding the protection of human participants. Research involving the exchange or cross-border transfer of human biological materials (HBMs) requires specialised legal and ethical knowledge relating to multiple governance frameworks. RECs may be required to monitor compliance not only with contractual requirements, but also the national laws and national ethical guidelines and standards of selected jurisdictions, not to mention adherence to international regulatory instruments governing biomedical research generally, and the conditions for the collection and use of HBMs specifically. The South African (SA) legislator’s decision to make RECs signatories to the prescribed material transfer agreement (MTA) template is a first step in the right direction, reinforcing the role and responsibilities of RECs, and their duty of care towards human participants in research. In addition, there has to be a transformation of the general mindset, towards accepting ethical principles within legal documents, particularly legal documents that involve the REC and create binding provisions that have a direct impact on participants. It is time that African views and participant protections are respected and accepted with the same vigour commanded by the Western world. In this article, the role of RECs in general is considered, prior to focusing on their responsibilities with respect to HBM transfer. The ethico-regulatory framework for REC functioning is discussed both from global and national perspectives. Also deliberated is the critical role that RECs play in reviewing health research proposals when HBMs are transferred between institutions, and the REC as a party to the SA national MTA template.

I. THE ROLE OF RESEARCH ETHICS COMMITTEES IN OBSERVATIONAL STUDIES: EPIDEMIOLOGICAL REGISTRIES, CASE REPORTS, INTERVIEWS, AND RETROSPECTIVE STUDIES.

It is often unclear to the clinical investigator whether observational studies should be submitted to a research ethics committee (REC), mostly because, in general, no active or additional interventions are performed. Moreover, obtaining an informed consent under these circumstances may be challenging, either because these are very large epidemiological registries, or the subject may no longer be alive, is too ill to consent, or is impossible to contact after being discharged. Although observational studies do not involve interventions, they entail ethical concerns, including threats such as breaches in confidentiality and autonomy, and respect for basic rights of the research subjects according to the good clinical practices. In this context, in addition to their main function as evaluators from an ethical, methodological, and regulatory point of view, the RECs serve as mediators between the research subjects, looking after their basic rights, and the investigator or institution, safeguarding them from both legal and unethical perils that the investigation could engage, by ensuring that all procedures are performed following the international standards of care for research. The aim of this manuscript is to provide information on each type of study and its risks, along with actions to prevent such risks, and the function of RECs in each type of study.

The dual use of research ethics committees: why professional self-governance falls short in preserving biosecurity

BackgroundDual Use Research of Concern (DURC) constitutes a major challenge for research practice and oversight on the local, national and international level. The situation in Germany is shaped by two partly competing suggestions of how to regulate security-related research: The German Ethics Council, as an independent political advisory body, recommended a series of measures, including national legislation on DURC. Competing with that, the German National Academy of Sciences and the German Research Foundation, as two major professional bodies, presented a strategy which draws on the self-control of science and, inter alia, suggests expanding the scope of research ethics committees (RECs) to an evaluation of DURC.Main bodyThis situation is taken as an occasion to further discuss the scope and limits of professional self-control with respect to security-related research. The role of RECs as professional bodies of science is particularly analyzed, referring to the theoretical backgrounds of professionalism. Two key sociological features of professionalism – ethical orientation and professional self-control – are discussed with respect to the practice of biomedical science. Both attributes are then analyzed with respect to the assessment of DURC by RECs.ConclusionIn conclusion, it is stated that issues of biosecurity transcend the boundaries of the scientific community and that a more comprehensive strategy should be implemented encompassing both professional self-control and legal oversight.

Bridge the gap: The need for harmonized regulatory and ethical standards for postmarketing observational studies.

Drug safety issues do not respect national borders. Hence, addressing a safety question may necessitate globally coordinated efforts between regulatory authorities and market authorization holders (MAHs) to draw reliable conclusions. Regulatory authorities have shared responsibility with MAHs sponsoring postmarketing nonintervention studies in determining study goals and design. Their shared accountabilities include what will be investigated and how the data will be retrieved to ensure appropriate study quality required for regulatory decision making. The need for a harmonized framework and ethical standards for postmarketing observational studies is well recognized but has been lacking even among the United States, European Union, and Japan, which are so-called International Conference on Harmonisation (ICH) regions. A recent update of the Council for International Organizations of Medical Sciences International Ethical Guidelines for Health-Related Research Involving Humans provides further clarification on provisions for informed consent and the role of research ethics committees. However, without incorporation into legislative structures, the future impact of these guidelines is uncertain. This lack of harmonization leads to a complex and uncertain framework for ethical review and for participant informed consent, resulting in numerous inefficiencies in the regulatory postmarketing observational studies. The regulatory frameworks for postmarketing observational studies conducted under the auspices of regulatory agencies in the 3 regions are reviewed, with a focus on ethical requirements and opportunities for efficiencies.

High risk yet invisible: conflicting narratives on social research involving children and young people, and the role of research ethics committees

Universities have a special status in society because of the position they hold within their communities and their responsibilities for civic leadership. Consequently, there are increasing calls on universities to make their processes, teaching and finances more transparent to the general public in order to promote greater accountability. Guidance from the Association for Research Ethics Committees includes openness as one of the key principles for research ethics governance but little is known about whether universities are making information about these processes available to the public. Additionally, given the central importance of children and young people as stakeholders in education research, there is particular interest in what the available information would reveal about their inclusion in social research. A search of the websites of 33 social science research‐leading institutions in the UK found that only 20 (60%) had publicly accessible information about ethics review and governance. The available information was highly variable in terms of detail, format and procedures and not very easy to locate. Information about the involvement of children and young people in social research was even more limited and variable; tending to emphasise the ‘vulnerable’ status of children as participants and yet providing little or no information about how to effectively support children to provide informed consent. The article concludes with discussion of the potentially concerning impact of this on the involvement of children and young people in research and the need for universities to do more to generate, share and encourage greater innovation in this area.

The role of research ethics committees in making decisions about risk.

Most medical research and a substantial amount of non-medical research, especially that involving human participants, is governed by some kind of research ethics committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants. The role of RECs is usually seen as twofold: firstly, to make some kind of calculation of the risks and benefits of the proposed research, and secondly, to ensure that participants give informed consent. The extent to which the role of the REC includes the former is not uncontroversial. Indeed, the most prevalent debate on the role of RECs sees liberals and strong paternalists arguing over the importance of informed consent given by competent agents versus the significance of making benevolent decisions on behalf of others. On the one hand, liberals argue for the rights of competent adults to decide for themselves the kinds and extents of risks to which they wish to expose themselves. On the other hand, proponents of strong paternalism raise concerns about the likelihood of participants being able to truly understand the complex data involved in research. They support a role for RECs in which they exercise duties of benevolence towards patients and participants by limiting the extent to which they can be exposed to significant, permanent and irreversible harms. In this paper, we will argue that when it comes to decisions about risk it is neither possible nor desirable for RECs to adopt either role.

Current role of research ethics committees in health research in three geopolitical zones in Nigeria: A qualitative study

Background. Ethics are rules or standards governing the conduct of a person or members of a profession. Medical research must be regulated to ensure that fundamental human rights are not breached in the quest for knowledge. Nigeria had no laws or specific guidelines to regulate health research until 2007, when a national regulatory body, the National Health Research Ethics Committee (NHREC), was established. Its function is to ensure ethical conduct in research and to accredit institutional and state health research ethics committees (HRECs). Objective. To document the current role of HRECs in the ethical practice of health research in Nigeria, 4 years after the establishment of the NHREC. Methods. Functioning of the HRECs was evaluated via interviews of 14 members of state and institutional HRECs chosen from selected geopolitical zones of the country. Results. The HRECs surveyed had between nine and 15 members, with more males than females. Review meetings were held only occasionally owing to the competing interests of members, who receive no incentives for participation, and poor funding. Scientific and ethical reviews are conducted together by the same committee, but few members of the HRECs are trained in research ethics. Monitoring of research after approval is poor. Conclusion. Nigeria now has about 30 institutional HRECs, but their functioning is hampered by a shortage of both money and qualified individuals to serve on them.

Deferred Consent in Emergency Care Research

Obtaining informed consent from potential research participants can be fraught with difficulty at the best of times. In emergency care research, consent procedures are particularly controversial as research subjects are usually unable to voice their wishes and unable to consider the material benefits and risks of the medical procedures, treatment and research. And, an added level of difficulty is the unique nature of the emergency situation, where time is of the essence and obtaining proxy consent from a legal representative or family member is not always logistically possible. This article will consider the deferred consent procedures and regulations of emergency care research in South Africa. A comparative overview will then be provided of the relevant procedures and regulations on emergency care research in the UK, continental Europe, and the USA. The important oversight role of Research Ethics Committees and Institutional Review Boards in emergency care research will be emphasized in terms of the difficult ethical and legal concerns that must guide them in their decision-making responsibilities.