An evaluation of ethical concerns of an institutional research ethics committee in Ghana, using the Emanuel et al. (2004) principles and benchmarks.

Abstract

Research Ethics Committees (RECs) are mandated to review and approve protocols of all proposed research projects, so as to ensure that all potential ethical risks associated with such projects are addressed appropriately before such projects are executed. This will ensure maximum protection for research participants. The eight-point framework of Emanuel et al. has been provided to be used as a universal tool by RECs for review of research protocols in many settings including developing countries. With the eight-points in place, RECs are encouraged to assess each research protocol to ensure that it has the following: (i) collaborative partnership; (ii) social value; (iii) scientific validity; (iv) fair participant selection; (v) favourable risk–benefit ratio; (vi) undergoes independent ethics review; (vii) informed consent; and (viii) will also demonstrate ongoing respect for participants in the project. What is not known is whether African research ethics committees’ work is compatible or complies with the framework. Additionally, the lack of acceptable norms and critical analyses of the eight principles of the framework means that some RECs may raise diverse ethical concerns frequently than others during review of research protocols. The purpose of this study was to identify and describe the pattern of ethical concerns and issues that were raised by the Ghanaian REC in their review of newly submitted research protocols, and to analyse the ethical issues and concerns in order of merit. The investigator used the eight principles of the Emanuel framework as a guide to assess the two-year minutes of the index REC, coded them, and ranked the most frequent ethical issues which were considered by members of the index REC during review of research protocols for the years 2012 to 2013. The study was based on content analysis of archived minutes of a Ghanaian institutional REC’s review meetings for the period 2012-2013. Minutes of 153 newly submitted protocols were assessed. In this study, scientific validity emerged as the issue that the index REC queried the most, followed (in descending order) by informed consent, respect for participants, favourable risk-benefit ratio, independent review, collaborative partnership, fair participant selection, and social value. Although the REC’s comments conform with and were largely accommodated by the principles of the Emanuel et al. framework, there were some concerns raised by the REC that did not fit into the framework. These included storage and materials transfer agreements (MTA) for transportation of human biological materials, signed agreements between sponsors and investigators, and certificates of Good Clinical Practice (GCP). This study represents one of the first two attempts to analyse a Ghanaian institutional REC’s minutes of review meetings. Applying the principles of the framework in this study helped the researcher to describe and categorise the main business of the index REC during the protocol review.