Regulation of Community Advisory Boards During Conduct of Clinical Trials in Uganda; a qualitative study involving Stakeholders (preprint)

ABSTRACT

Background: Community advisory structures such as Community Advisory Boards (CABs) play an important role of helping researchers to better understand the community at each phase of the clinical trial. CABs can be a source of accurate information on the community, its perception of proposed research and may identify factors that make community members vulnerable to the problem under investigation. Although CABs help to build mutually beneficial relationships between the researcher(s) and the communities in which the clinical trial is being implemented, meaningful engagement would require ethical guidance and regulatory oversight. The study assessed the stakeholders’ perspectives regarding the regulatory oversight of CABs in Uganda Methods: This was a cross-sectional study employing qualitative methods of data collection and analysis. Key informant interviews (KIIs) with the trial investigators, CAB chairpersons, community liaison officers, regulators and REC chairpersons were conducted. A KII guide was designed and utilized during key informant interviews. The guide included questions on role of investigators and CAB members in clinical trials; challenges of community engagement; facilitation of CABs; regulatory oversight of CABs; work relationships between investigators and CABs; and opinions on how community trials should be conducted among others. All interviews were conducted in English. Qualitative data were transcribed verbatim. A code book was generated based on the transcripts and study objectives. Thematic analysis was used to analyze qualitative data in Atlas ti based on emerging themes and sub-themes and in line with the study objectives. Results: Of the 34 respondents, 29.4% were investigators, 29.4% CAB chairpersons, 29.4% research regulators/REC Chairs and 11.8% community liaison officers. Fifty-nine percent were male and had varying occupations and demographic characteristics. Content analysis identified themes including the current practices for CAB establishment and monitoring; need for regulatory oversight; appropriate training and skills; and challenges faced by CABs. Conclusion: There is need for regulatory oversight of CABs based on contextualized ethical guidelines as well as capacity strengthening in terms of training and skills development.