Research Ethics Committees’ Oversight of Biomedical Research in South Africa: A Thematic Analysis of Ethical Issues Raised During Ethics Review of Non-Expedited Protocols

Silaigwana, Blessing; Wassenaar, Douglas

doi:10.1177/1556264618824921

Cited by 18 publications

(46 citation statements)

References 40 publications

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“…This was not unexpected, as several reports have suggested that RECs are generally reluctant to be researched, suggesting that more needs to be done to encourage them to accept that their work is a legitimate research focus. [9,11] In REC 1, the chair (after informing REC members about the study during a monthly meeting) granted the first author access to the names and contact details of all REC members. Thereafter, a recruitment email was sent to each member, inviting them to volunteer to participate.…”

Section: Participant Sampling Strategymentioning

confidence: 99%

“…Each member was then provided with graphs showing the aggregated frequency rankings of the ethical issues that had been raised by both their RECs combined. [9] Semi-structured interviews 45 -60 minutes long were conducted face-to-face or by telephone, using an interview guide. Probes, requests for clarification and follow-up questions were used to elicit respondents' views and impressions of the issues revealed.…”

Section: Participant Sampling Strategymentioning

confidence: 99%

“…[3] In a related study, we reported data on aggregated ranked ethical issues raised by the two SA biomedical RECs included in this study, and found that these issues were ranked in the following descending order of frequency: informed consent; respect for participants; scientific validity; administrative queries; collaborative partnership; editorial errors; fair participant selection; favourable risk/benefit ratio; independent ethics review; and social value. [9] The present paper explores REC members' perceptions of and comments on those findings, to see if they align with their own perceptions of what RECs should be highlighting in the ethics review process. We were therefore interested in gaining a better understanding of the views of individual REC members on the aggregated ranked ethical issues from the two RECs combined.…”

mentioning

confidence: 97%

“…We were therefore interested in gaining a better understanding of the views of individual REC members on the aggregated ranked ethical issues from the two RECs combined. [9] Such data are relevant because there is no agreed normative framework for interpreting the ranking or optimal frequency of types of ethical queries. For this reason, we conducted qualitative interviews with REC members to explore their perceptions of the ranked distribution of the ethical issues in the earlier study.…”

mentioning

confidence: 99%

“…For this reason, we conducted qualitative interviews with REC members to explore their perceptions of the ranked distribution of the ethical issues in the earlier study. [9] ARTICLE Methods The present study was approved by RECs at both research sites (no names or ethics clearance reference numbers can be provided, to preserve confidentiality under the conditions of non-disclosure agreements). Gatekeeper permissions were also obtained from the relevant institutional authorities.…”

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confidence: 99%

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Views of South African biomedical research ethics committee members on their own ethics review outcomes

Silaigwana

Wassenaar

2019

S Afr J BL

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Research ethics committees (RECs; known as institutional review boards (IRBs) in the USA) are an integral part of the human research participants' protection system. [1] They have the authority to approve, conditionally approve or reject research proposals, depending on the committee's determination of a study's ethical acceptability, as judged in terms of local and international guidance. [1] Unfortunately, RECs generally operate behind closed doors, meaning that there is little understanding of REC reviews in practice. Two books, Behind Closed Doors: IRBs and the Making of Ethical Research [2] and Ethics Police: The Struggle to Make Human Research Safe, [3] provide important insights into the work of IRBs in the USA. However, research into the operation of RECs is still relatively limited in developing countries such as South Africa (SA). While RECs play an important role in ensuring the protection of research participants, they are often heavily criticised for overstepping their scope, being too bureaucratic, delaying important research and spending too much time rewording informed consent forms. [3,4] Some social science commentators have even called for the abolition of REC reviews, arguing that mandatory ethics review is itself unethical because RECs do not respect researchers or each other, lack merit and integrity and are neither just nor beneficent. [5] Despite such criticism, there have been relatively few empirical studies exploring the work of RECs, although some studies [6-9] have examined REC minutes and decision letters retrospectively to identify the ethical issues raised, both internationally and in SA. These studies This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

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Section: Participant Sampling Strategymentioning

confidence: 99%

Section: Participant Sampling Strategymentioning

confidence: 99%

mentioning

confidence: 97%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Views of South African biomedical research ethics committee members on their own ethics review outcomes

Silaigwana

Wassenaar

2019

S Afr J BL

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Shifts in UNAIDS ethics guidance and implications for ethics review of preventive HIV vaccine trials

et al. 2021

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IntroductionA major change in the ethics framework for preventive HIV vaccine trials worldwide is the release of the UNAIDS 2021 ethical considerations in HIV prevention trials. This new guidance comes at an exciting time when there are multiple HIV vaccine efficacy trials in the field. Research Ethics Committees (RECs) or Institutional Review Boards are a most likely audience for these guidelines. Our objective is to highlight shifts in ethics recommendations from the earlier 2012 UNAIDS guidance.DiscussionWe review recommendations related to four key issues, namely standard of prevention, post‐trial access to safe and effective vaccines, enrolment of adolescents and enrolment of pregnant women. We outline implications and make recommendations for the ethics review process, including suggested lines of inquiry by RECs and responses by applicants.ConclusionsThere have been several shifts in the UNAIDS ethics guidance with implications for HIV vaccine researchers submitting applications for initial ethics review or re‐certification, and for RECs conducting such reviews. This review may assist RECs in a more efficient and consistent application of ethics recommendations. However, additional tools and training may further help stakeholders comply with new UNAIDS ethics recommendations during protocol development and ethics review.

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Evidence-Based Guidelines for Low-Risk Ethics Applicants: A Qualitative Analysis of the Most Frequent Feedback Made by Human Research Ethics Proposal Reviewers

McLinton,

Menz,

Guerin

et al. 2024

J Acad Ethics

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Human Research Ethics Committee (HREC) reviewers often provide similar feedback across applications, which suggests that the problem lies in researcher awareness of key issues rather than novel, unsolvable challenges. If common problems can be addressed before lodgement by applicants referencing clear evidence-based supports (e.g., FAQs on common application shortcomings), it would improve efficiency for HREC members and expedite approvals. We aim to inform such supports by analysing the patterns in the most frequent feedback made by HREC members during review processes. We collected every instance (N = 4,195) of feedback made on N = 197 ‘low-risk’ protocols by all HREC staff (N = 16) at one institution over the course of a full year (2019). Reflexive thematic analysis to identify themes (and content analysis to determine relative frequency) revealed that the top three themes are consistent with existing literature: Consent, Administrative, and Methodological concerns. However, we identified important new themes that are not captured in previous research, including ‘Risk to Researchers’, ‘Commercial benefit, scope and scale’, ‘Diversity’ (covering issues of cultural sensitivity, language and accessibility), as well as fair right to a complaints process. Our thorough exploration of information-rich primary data marks an important methodological improvement over previous studies and offers a theoretical contribution to understanding themes that have heretofore been overlooked in the ethics review process. By identifying the common challenges experienced in HREC review we can better inform tailored supports to applicants (by extension reducing workload burdens on HREC systems) and reduce their perceived barriers to engaging in challenging but meaningful research.

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Research Ethics Committees’ Oversight of Biomedical Research in South Africa: A Thematic Analysis of Ethical Issues Raised During Ethics Review of Non-Expedited Protocols

Cited by 18 publications

References 40 publications

Views of South African biomedical research ethics committee members on their own ethics review outcomes

Views of South African biomedical research ethics committee members on their own ethics review outcomes

Shifts in UNAIDS ethics guidance and implications for ethics review of preventive HIV vaccine trials

Evidence-Based Guidelines for Low-Risk Ethics Applicants: A Qualitative Analysis of the Most Frequent Feedback Made by Human Research Ethics Proposal Reviewers

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