NDLI: Regulation of community advisory boards during conduct of clinical trials in Uganda: a qualitative study involving stakeholders

Content Provider	Springer Nature : BioMed Central
Author	Mijumbi, Andrew Ojok Mugenyi, Levicatus Nanfuka, Mastula Agaba, Collins Ochieng, Joseph
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, effective 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 an exploratory study employing qualitative methods of data collection and analysis. Key informant interviews (KIIs) with the trial investigators, CAB chairpersons, community liaison officers, regulators and Research Ethics Committee (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 data and identify themes. Atlas ti was used to support data analysis. Results Of the 34 respondents, 35.3% were investigators, 32.3% CAB chairpersons, 23.5% research regulators/REC Chairs and 8.8% community liaison officers. The findings of the study revealed that CABs are appointed by the research institution/researcher, operate under the guidance of the researcher with limited independence. Additionally, the CABs provide voluntary service and lack guidelines or regulatory oversight. Four themes emerged. Conclusion The operations and activities of CABs are not regulated by the national regulators or RECs. The regulatory oversight of CABs should be based on contextualized ethical guidelines. Need for additional training in research ethics, community engagement and sensitization on available ethics guidelines for research.
Related Links	https://bmchealthservres.biomedcentral.com/counter/pdf/10.1186/s12913-023-09136-w.pdf
Ending Page	14
Page Count	14
Starting Page	1
File Format	HTM / HTML
ISSN	14726963
DOI	10.1186/s12913-023-09136-w
Journal	BMC Health Services Research
Issue Number	1
Volume Number	23
Language	English
Publisher	BioMed Central
Publisher Date	2023-02-06
Access Restriction	Open
Subject Keyword	Public Health Health Administration Health Informatics Nursing Research Regulation Community advisory boards Clinical trials Stakeholders Uganda
Content Type	Text
Resource Type	Article
Subject	Health Policy

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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