An evaluation of the ethical concerns of Zimbabwean Research Ethics Committees (RECs), using the Emanuel et al. (2004) principles and benchmarks.

Abstract

The nature of concerns and issues raised by research ethics committees (RECs) during protocol review meetings can be informative about the principles which they apply in protocol review, yet little is known about the actual concerns they raise. This study sought to examine these local concerns in light of the internationally acclaimed Emanuel et al. (2004) framework and also describe the pattern of the ethical issues raised. Protocol review meetings’ minutes can provide a rich source of information and insight into the concerns that RECs raise during protocol review meetings. These concerns are central to the practice of research ethics: they shape the nature of research and sometimes even alter the knowledge it produces, and by doing so, contour what comprises ethical research and how this can be pursued. Nevertheless, these concerns have seldom been subject to scrutiny. Accordingly, this study carried out a qualitative analysis of minutes written during the review of protocols by a Zimbabwean REC overseeing biomedical, health and behavioural research. It sought to offer a description and analysis of the REC’s concerns, using the Emanuel et al. framework. It is hoped that this study will provide a useful window into the REC’s concerns. Key findings were that 65% of concerns raised during REC review fitted into the Emanuel et al. (2004) framework. Of these, the most frequently raised concerns revolved around the principle of informed consent. The principle with the least number of concerns was social value. The study also noted a significant number of concerns which did not necessarily fit into the Emanuel et al. (2004) framework which seems to suggest the REC’s preoccupation with routine, procedural concerns.