| dc.description.abstract | Background: The increasing growth of research involving humans in Uganda has been paralleled with the establishment of research ethics committees. These committees conduct ethical review of research protocols to ensure protection of the rights and wellbeing of human research participants. Research Ethics Committee members’ secondary interest (such as professional, academic and financial interests) can interfere with the primary goal of the ethical review process, hence affecting objectivity and independence of reviews. This study explored the perceptions and experiences of members on conflicts of interest identification and management, with a rationale of protecting research integrity.
Objective: To explore the perceptions and experiences of research ethics committee members, on the identification and management of conflict of interest during the ethical review process.
Methods: The study used a cross-sectional design, and employed qualitative methods of data collection. The study involved document reviews and conducting in-depth interviews with members of the seven research ethics committees on Mulago Hill. Majority of the participants for the in-depth interviews were male with experience of over one year as members on research ethics committees. Document reviews involved extraction of data from minutes of review meetings, standard operating procedures, and local and international guidelines regarding conflicts of interest. Qualitative data obtained from in-depth interviews was analysed thematically. The researcher analysed the content of the transcribed texts to identify key points that were marked with a series of codes. Subsequently, these codes were grouped into similar concepts or categories, which became the basis for the creation of themes. The data was coded using NVIVO version 12 software. A write up was done, and the analysed data was thematically presented in line with the specific objectives.
Results: Participants expressed various views on conflicts of interest identification and management. They perceived conflicts of interest a natural phenomenon, which was unethical to conceal. Conflicts of interest involved two or more competing interests such as finances, academics, family, research, institutions, friends or peers. The main form of conflicts of interest experienced by most participants was a researcher-reviewer conflict due to members’ involvement in a research team. Most participants declared conflicts of interest and as a result the conflicted members refrained from participating in protocol deliberation. Honesty and integrity, setting up institutional policy tools and guidelines for handling conflicts of interest, as well as encouragement of individuals to declare COI were suggested by participants as ways of management and mitigation of reviewers’ conflicts of interest. UNCST, CIOMS and ICH GCP guidelines had specific provisions on conflicts of interest. Unlike the UNCST and ICH GCP, the CIOMS guidelines provide detailed explanation on the different forms of conflicts of interest, their identification and management.
Conclusion: The study suggests that RECs face several forms of conflicts of interest, involving themselves, investigators and institutions, and respond varyingly. Every member of the ethics committee had a role of ensuring that COI was addressed majorly through disclosure. However, ddisclosure was not fully feasible in identifying and managing conflicts of interest, since it relied majorly on the integrity of the conflicted individual. Most of the guidelines offered a generic guidance on reviewers’ conflicts of interest and only the CIOMS, ICH-GCP and UNCST guidelines had specific provisions on conflicts of interest. The standard operating procedures for the RECs had almost similar provisions for identification and management of conflicts of interests. | en_US |
