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

Abstract

Research Ethics Committees (RECs) and Institutional Review Boards (IRBs) are critical in biomedical research to ensure protection of human participants. However, increased international collaboration with multi-country, multi-site research projects has increasingly given rise to complex ethical issues with which local RECs may not be readily familiar. Therefore, the important question to ask is what ethical issues do African RECs typically raise when reviewing biomedical or health related social science research proposals? To assist researchers and RECs with review processes, Emanuel, Wendler and Grady (2004, 2008) proposed a universal framework/tool which could be used in many countries or contexts. The framework comprises eight systematic principles and accompanying benchmarks that specify core and practical considerations necessary to justify ethical research in developed and developing country settings. In this study, the ethical framework designed by Emanuel and colleagues was used as a tool to analyse (assess, code and rank) the ethical issues considered by a Ghanaian REC during their ethical review process. This was done through a content analysis of the minutes recorded for the period 2012 to 2013. Out of the 22 protocols assessed and 232 queries that emerged, informed consent (34.05%) and scientific validity (24.57%) were the two ethical issues most frequently considered by the REC. The least frequently considered issue was social value which recorded only 0.86% of queries. Collaborative partnership was not considered at all throughout the two-year review period under study. These results show that the REC has fairly considered most of the eight Emanuel et al. (2004, 2008) principles, suggesting that the work of this REC can be accommodated by the Emanuel framework, and vice-versa, that the framework was compatible with the work of this REC. It can thus be concluded that the framework is useful and applicable, and can be adapted by RECs for training and review processes.