An evaluation of ethical concerns raised by a South African research ethics committee using the principles and benchmarks proposed by Emanuel et al. (2004, 2008)

Abstract

"Mission creep”, “closed doors”, “bureaucracy”, “time delays”, “incompetence” are terms used in some of the arguments advanced by researchers who are not in favour of or are critical of the system of independent ethics review of research by Research Ethics Committees (RECs). “Human subjects’ projection”, “public accountability”, “good research governance” are some of the terms used by researchers who embrace the system of independent ethics review of research. Also known and referred to as institutional review boards (IRBs), ethics review boards (ERBs), ethical review committees (ERCs), human research ethics committees (HRECs) evaluate all human research to ensure that proposed studies comply with international and national ethics principles and guidelines for conducting human research. These committees may either approve, reject, or require modifications to submitted protocols and their decision is binding. A key feature of such committees and their members is their independence. Despite being for or against ethics review, there is a growing body of work attempting to describe and understand the functioning and outcomes of RECs in protecting research participants and promoting ethical research. In this area, there is relatively little work describing the actual issues that RECs look for and subsequently raise when reviewing research protocols. The current study therefore assessed minutes of a South African biomedical REC and identified ethical concerns raised during review of protocols submitted between 2015 - 2016. Ten sets of minutes were retrospectively analysed using Emanuel et al.’s (2004, 2008) framework to code, rank and classify the issues raised by the REC. There were 813 queries raised in the two-year period; 86% (697) of the queries were consistent with the framework. Top four most frequently queries were identified with scientific validity (38%) being the most frequently raised concern, followed by informed consent (33%), ongoing respect for participants (11%) and independent ethics review (9%). Of the 813 queries raised, 14% (116) of queries could not be accommodated by the framework and these pertained to administrative issues. The results of this study support the findings of the primary study by Tsoka-Gwegweni and Wassenaar who were the first to propose and establish that the Emanuel et al. framework is a useful tool to categorize concerns raised by one South African REC. In this study, it was found that 99,7% of 1,043 queries raised for the years 2008 to 2012 were compatible with the Emanuel et al. framework with informed consent emerging as the most frequently raised concern. Equally comparable are the results of a subsequent study by Silaigwana and Wassenaar who also reported that 97,7% of the 1,272 queries raised for the years 2009 to 2014 could be categorised using the Emanuel et al. framework. The Emanuel et al. framework of eight principles and benchmarks proves to be a useful and important tool in evaluating ethical queries raised during EC protocol review meetings. Both the current study and these previous studies support use of this framework.