Commitment to Key Principles

Key stakeholders must understand and commit to the principles underlying CE to achieve its benefits.

The Good Participatory Practice (GPP) guidelines for TB Drug Trials 2012 represent an important set of CE principles developed by a working group whose members included the World Health Organization, the United States Food and Drug Administration and the National Institutes of Health. As such, they are an excellent, agreed starting point for defining the minimum standards required for effective CE. The GPPs confirm that the benefits of CE – mutual understanding, complementarity and efficiency – require a genuine commitment to six guiding principles – respect, fairness, integrity, transparency, accountability, and autonomy.

STREAM’s commitment to these principles yielded important and long-term successes, including the development of highly productive working relationships between STREAM CABs and study teams, as well as creative stakeholder collaborations on complementary activities – for example, STREAM CABs supporting national TB programs with community outreach. Careful implementation by the Sponsor also ensured CABs had the freedom to act independently as the voice of the community throughout the trial.

Nevertheless, the STREAM experience highlighted areas of focus for future trials. Although the GPPs indicate their intended audience includes trial funders, sponsors, and research teams, many STREAM study teams were unaware of the GPPs at the start of the trial, and study team buy-in to the GPP principles was quite variable. Awareness and understanding of the GPPs by CAB members was also variable. This highlights the need, at the start of every trial, to discuss and agree with both the study team and CAB members the incorporation of the underlying GPP principles into an agreed CE plan.

[Our biggest CE successes were d]evelopment of an effective Community Engagement structure in a new site where there was no prior research and forming a regional and even international CE structure that addresses the needs of all communities involved.

STREAM Study Team Member

At some sites, the study team’s commitment to information sharing – a key prerequisite to transparency – required development over time. In addition, cultural norms sometimes led CAB and community members to be reticent about sharing their views, and study team members being less likely to acknowledge and respond to CAB and community feedback. Overcoming these barriers required a structured program of study team/CAB member interactions, active intervention from the Sponsor/CE technical advisor/coordinator where stakeholder expectations did not align, and a targeted training program for CAB members aimed at increasing their capacity for meaningful participation in trials.

Recommended best practices

Build in understanding and adherence to GPP principles as a requirement of the trial through the following measures:

  • Donors should require researchers to build-in CE and to fund CE/CABs meaningfully from the beginning of trial planning and design, through to dissemination of results

  • Particularly where there is limited experience with CE, the sponsor should arrange for appropriate technical assistance for CABs

  • The GPP guidelines should be clearly referenced in the trial protocol

  • The choice of sites should, in part, be based on experience with and support for CE

  • Sponsors should plan to fund a significant FTE for a Community Liaison Officer/Community Engagement Officer (CLO/CEO) in the study team to support CE

  • All trial sites should appoint a CLO/CEO that fully commits to CE

  • The CLO/CEO should be empowered to work independently with the trial CAB (or other established CE mechanism)

  • Site initiation should include training in GPPs for study team members and ongoing GPP training should be offered throughout the trial