An evaluation of the ethical concerns of a South African Research Ethics Committee using the principles and benchmarks proposed by Emanuel, Wendler, Killen and Grady (2004): Evaluating 2017–2018 minutes.

Abstract

Historical ethical transgressions in research with human participants led to the development of ethical principles and guidelines to protect research participants. Research Ethics Committees (RECs) then emerged to further protect the rights of research participants and alert the researcher to the need to ensure compliance with legal requirements for research. (Silaigwana & Wassenaar, 2015). This study aimed to identify ethical issues raised during ethics review of research protocols and assess their relative weight using the Emanuel et al. (2004) recommended principles for ethical review of clinical research. The 2017–2018 meeting minutes of a South African Social Science Research Ethics committee were identified, accessed and coded using the eight principles and benchmarks of the Emanuel et al. (2004) framework. This allowed observable patterns in ethical concerns raised during ethics review of research protocols to be recorded. A total of 20 REC meeting minutes entailing 176 submitted protocols in 2017 and 2018 were purposively included in the study sample. Content analysis was used to analyse the data in terms of the Emanuel et al. (2004) framework. The data obtained during content analysis was captured using Microsoft Excel and analysed using frequency counts and simple descriptive analysis. The study found that the most frequently raised ethical issues were around informed consent (n=300; 35%). The remaining principles were ranked as follows: scientific validity (n=159; 18%), fair selection of participants (n=122; 14%), independent reviews (n=76; 9%), ongoing respect of participants (n=71; 8%), risk-benefit ratio (n=41; 5%), collaborative partnership (n=35; 4%) and social value (n=31; 4%). The study further revealed that the Emanuel et al. (2004) framework was useful in identifying and categorising the questions and concerns typically raised by the study REC during protocol review, with only a small number of queries not fitting into the framework. The framework provides a method and logical process to conduct further comparative analyses of RECs’ concerns and can be used as a standard tool for REC members when reviewing protocols (Emanuel et al., 2004).