The Aids Support Organization, Kampala, Uganda.
Makerere University Lung Institute, Kampala, Uganda.
BMC Health Serv Res. 2023 Feb 6;23(1):119. doi: 10.1186/s12913-023-09136-w.
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.
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.
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.
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.
社区咨询委员会（CAB）等社区咨询结构在帮助研究人员更好地了解临床试验各个阶段的社区方面发挥着重要作用。CAB 可以成为社区准确信息的来源，了解社区对拟议研究的看法，并确定使社区成员容易受到研究中问题影响的因素。尽管 CAB 有助于在研究人员和实施临床试验的社区之间建立互利关系，但有效的参与需要道德指导和监管监督。本研究评估了利益攸关方对乌干达 CAB 监管监督的看法。
这是一项采用定性数据收集和分析方法的探索性研究。对试验研究者、CAB 主席、社区联络官、监管机构和研究伦理委员会（REC）主席进行了关键知情人访谈（KII）。设计并在关键知情人访谈中使用了 KII 指南。该指南包括关于研究者和 CAB 成员在临床试验中的作用、社区参与的挑战、CAB 的促进、CAB 的监管监督、研究者和 CAB 之间的工作关系、以及关于如何进行社区试验等问题。所有访谈均以英语进行。对访谈进行了逐字记录。根据记录和研究目标生成了一个代码簿。使用主题分析对数据进行分析并确定主题。使用 Atlas ti 支持数据分析。
在 34 名受访者中，35.3%是研究者，32.3%是 CAB 主席，23.5%是研究监管机构/REC 主席，8.8%是社区联络官。研究结果表明，CAB 由研究机构/研究者任命，在研究者的指导下运作，独立性有限。此外，CAB 提供志愿服务，缺乏指导方针或监管监督。出现了四个主题。
CAB 的运作和活动不受国家监管机构或 REC 的监管。CAB 的监管监督应基于本土化的道德准则。需要进一步培训研究伦理、社区参与以及研究可用伦理准则的宣传。
