Assessment Of The Standard Operating Procedures Of Selected Research Ethics Committees In Ghana

ABSTRACT

Background: Research involving human participants presents a number of key ethical challenges. In the context of health-related research, it is globally recognized that there is the need to protect human participants from the risks that may be posed by various research activities. These risks may be social, psychological, emotional, and physical. One of the key safeguards to protecting human participants from research-related risks is the role of Institutional Review Boards (IRBs) or research ethics committees (RECs). Aims: This study assessed the Standard Operating Procedures of selected research ethics committees in Ghana by examining the composition and submission requirements of these committees, exploring key stakeholders’ views on Standard Operating Procedures of the Ethics Committees and identifying key challenges in the review process. Methods: The study used an exploratory qualitative research approach to collect primary data from three Research Ethics Committees (REC)/Institutional Review Boards (IRB), namely; Ghana Health Service- Ethics Review Committee (GHS-ERC), the Institutional Review Board of the Kintampo Health Research Center (KHRC-IRB), and that of the Dodowa Health Research Center (DHRC-IRB). Documents including the Standard Operating Procedures (SOP) of these IRB/REC and the World Health Organization’s (WHO) Guidelines on Research Ethics with Human Participants were reviewed for this study. The study also used In-depth Interviews (IDI) to collect qualitative data from 32 respondents which included Heads of Institutions, the IRB/REC Administrators, the Chair, researchers and the members of the research ethics committee for the selected Research Ethics Committees (REC)/Institutional Review Boards (IRB). These respondents were purposively selected from these institutions for the study. Results: From the study, one of the major challenges facing institutions in running the activities of research ethics committees is funding. These activities include, monitoring v approved protocols, proper or adequate motivation for committee members and providing frequent training programmes for committee members. Another important finding is that the institutions do not have a formal system to evaluate the activities of the research ethics committees. Also, committee members are overburdened with an increasing number of protocols despite their busy schedules. Other key challenges identified in this study include requirements for requirements for submitting several copies of the research protocol, delays in the review process and delays in communicating the outcome of the review process to researchers. Most respondents of the study viewed the ethics committees as independent though the Heads of Institution were part of the review process contrary to WHO recommendations. Generally, the research ethics committees have diverse expertise, which makes them capable of reviewing all types of research protocols. Conclusion: The standard operating procedures of the IRBs/RECs are closely aligned with the recommendations in the WHO SOPs. However, there are unique challenges that need to be addressed to improve the efficiency of the IRB/RECs’ operations.