Autonomous CABs

CE processes must empower CABs to act autonomously and share community views.

The ultimate objective of CE is to foster independent input into the research process by the community where it is conducted. However, CAB autonomy can be hard to achieve because reliance on the sponsor for funding and on researchers for information and training can contribute to a significant imbalance of power that is difficult for CABs to overcome. This is especially true in locations with no or limited experience with CE in clinical trials and/or a hierarchical social structure where civil society participation is not a regular practice.

Of the 13 STREAM sites, 11 had no or limited experience with CE in a TB trial and no pre-existing CAB. As a consequence, Sponsor involvement in CAB formation, CAB work planning and budgeting, and CAB capacity building was necessarily significant. This involvement likely reduced CAB independence and autonomy; however, the Sponsor concluded this was necessary to ensure CE activities were implemented, given the inexperience of some trial sites. In addition, in all but one case, funding for CE activities was funneled to CABs via the trial site, increasing CAB reliance on the study team. This was necessary because most CABs/CAB members were not separate legal entities or able to manage external donor funding.

A strategic starting point for [our CAB] was transcending the institutional subjection of the project [becoming autonomous from the research institute]. Starting with 2018, we can undoubtedly call [our CAB] a community initiative, independent from the Research Team and [Research] Institute.

STREAM CAB Member

To mitigate the impact of significant Sponsor involvement, an intensive CAB capacity building program was implemented, and CABs had significant freedom to choose and implement CE activities that responded to their local priorities and conditions. In addition, during the last year of CE activities, the Sponsor held a cross-site training series focused on longer-term CAB sustainability covering topics such as CAB integration into existing research structures and post-trial funding opportunities. Therefore, we are hopeful that STREAM’s investment in capacity and institution building will benefit future TB trials.

Recommended best practices

Foster autonomous CABs through the following measures:

  • The sponsor should always empower CAB members to communicate openly and honestly with the study team (even if their views are unpopular)

  • The sponsor should ensure CAB representatives participate in key trial stakeholder events and given “space” to present the community’s perspective

  • In addition to capacity building related to research, TB and CE, the sponsor should invest in capacity building related to finance, program management and other topics to strengthen long-term sustainability

  • Where possible, the sponsor should make CE grants directly to CABs (or CAB members), rather than to research sites. This will enhance CAB independence from the trial site

  • The sponsor and researchers should invest in long-term CAB sustainability