Capacity Building for CABs

It is essential to increase CAB knowledge about research, TB and CE.

CAB members are not typically TB researchers, and therefore may have limited knowledge about research or clinical management of TB. In addition, CAB members may have limited experience with CE in countries where CE for TB clinical trials is new. However, CAB members do need to be familiar with fundamental concepts about research, TB and CE in order to make meaningful contributions to trial design and implementation. It is therefore incumbent on sponsors and researchers to ensure CAB members have access to the capacity building opportunities required to develop their knowledge of research, TB and CE.

Capacity building activities for STREAM CAB members were multi-faceted, and had both locally- and centrally-led components. Study teams used regular quarterly and general CAB meetings to train CAB members on key trial documents, including the protocol and informed consent. During each CAB’s annual work planning and budgeting process, CABs were encouraged to incorporate local training sessions – for example, training on advocacy or building basic computer skills – to be funded by the sponsor.

The most important aspect of centrally-led CAB capacity building was a cross site webinar series organized by the trial’s CE Technical Advisor/Coordinator to cover topics suggested by STREAM CABs. The series extended over two years and eventually included nine sessions on topics ranging from the WHO guideline development process to the role of community members in ethics committees. Expert presenters from organizations including the WHO, Makerere University and Wits Health Consortium were invited to lead the webinars. The Sponsor also supported CAB participation in international conferences, such as the Union World Conference on Lung Health, and cross site experience sharing visits by CABs to other research sites.

The community representatives did not ha[ve] a positive attitude to research in general and specifically to a clinical trial before they were a member of the CAB and involved in the activities of CE. Attending as a CAB member helps them to have a basic knowledge on what research is, its benefit and risk, who shall attend and the benefit… from [participating] in studies.

STREAM CLO/CEO

In addition to making STREAM CAB members better partners for local study teams, this investment in capacity building translated into excellent community outreach work by the STREAM CABs, where information about the study and TB treatments were shared with communities.

Recommended best practices

Ensure CABs are equipped to make meaningful contributions to trial design and implementation by building capacity through the following measures:

  • Early in the trial, develop and agree on a mandatory training curriculum for CAB members to be delivered by the research team. Modules should include (at a minimum):

    • Study protocol

    • Study informed consent

    • Participant confidentiality

    • Basic principles of Good Clinical Practice

    • GPPs

  • Support locally-led training in CAB work plans and budgets

  • Regularly map CAB training priorities and adjust centrally-led capacity building programs accordingly

  • Establish mechanisms for cross-site learning and experience sharing

  • Create space for CAB members to discuss health policies, local health institutions and international TB guidelines

  • Use lower-cost, virtual meetings to expand centrally-led training opportunities