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

ABSTRACT

Background. Current research ethics guidelines and legislation provide research ethics committees (RECs) with the prerogative to review and approve the ethical acceptability of human research before commencement. However, individual REC members' views on the ethical issues identified behind closed doors remain largely empirically unexplored. Objective. To investigate the views and perceptions of South African biomedical REC members on their own aggregated ethics review outcomes. Methods. Semi-structured interviews were conducted with nine REC members from two different institutions in South Africa. Results. All respondents concurred with the prioritisation of informed consent in the review outcomes, emphasising the importance of the use of simple and understandable language for participants. Respondents also discussed lack of scientific validity as a common problem when reviewing proposals. Interestingly, while the majority of respondents reiterated the common view that scientifically invalid research is unethical, some REC members believed that there was an overemphasis on evaluation of scientific validity, and that it was not within the remit of RECs to review the scientific quality of proposed studies. The REC members felt that HIV and tuberculosis research had high social value, because it addresses national and regional public health priorities. For this reason, there was no concern expressed that a high proportion of research proposals involved HIV and TB. Conclusion. Although most respondents found the aggregated results unsurprising, there was some disagreement with the ranked review outcomes, with a minority of respondents arguing that scientific validity was overemphasised. These findings have potential training and practice implications for RECs and researchers. The study findings call for further studies to validate such findings in other RECs