Good Participatory Practice Guidelines for TB Vaccine Research (GPP-TB VACC)

"A primary goal of the GPP-TB VACC is to ensure that community stakeholders are empowered to actively participate in and advocate for TB vaccine research. These guidelines enable research teams to obtain greater community support, enhance their communication and messaging, and gain useful ideas about different aspects of their research."

Aeras, a nonprofit organisation developing tuberculosis (TB) vaccines, has developed this resource (GPP-TB VACC) to support research teams, particularly those team members who lead, implement, and support stakeholder engagement programmes and/or activities in the pursuit of a new TB vaccine. It is meant to be a user-friendly framework that defines specific standards and key elements needed for creating effective partnerships with stakeholders throughout the entire research process, including trial design, conduct, results analysis, and dissemination. GPP-TB VACC was made possible through funding provided by the Bill and Melinda Gates Foundation and the United States Agency for International Development (USAID).

GPP-TB VACC outlines and promotes minimum standards for research teams to follow in order to ensure the early, sustained and effective participation of stakeholders in all stages of the TB vaccine research process.

• Section 1: Engaging Stakeholders in TB Vaccine Research
  • Defines the terms "stakeholder" and "stakeholder engagement".
  • Describes the underlying determinants of TB.
  • Offers a rationale for why a participatory approach is critical for the successful design and development of a new TB vaccine.
• Section 2: Guiding Principles for Good Participatory Practice summarises the core principles that form the foundation of relationships between research teams and stakeholders in biomedical trials. Effective and ethical stakeholder engagement is anchored around 6 guiding principles: respect, mutual understanding, integrity, transparency, accountability, and community stakeholder autonomy.
• Section 3: GPP for TB Vaccine Research introduces a process model for good participatory practice and describes 13 topic areas that correspond to different parts of the TB vaccine research life cycle (e.g., stakeholder education plan), with each topic area divided into the following sub-sections:
  • Definition of the topic area
  • Relevance and benefits of stakeholder input into this aspect of TB vaccine research
  • Special considerations for stakeholder engagement in this area of TB vaccine research
  • An outline of the key participatory practices or "minimum standards" to be followed by research teams that is designed to help ensure meaningful contributions from and involvement of stakeholders throughout the entire research process
  Section 3 also lists key questions for each topic area to assist research teams in the design and implementation of their engagement strategies.
• Appendices consist of acronyms, a glossary, and guidance documents relevant to biomedical and TB vaccine research.

A participatory development process was implemented to draft these guidelines, with contributions from international TB vaccine and HIV researchers, advocates, community and global advisory groups, funders, and sponsors. GPP-TB VACC is a dynamic document that may change over time. Furthermore, it is assumed that no single set of practices will work equally well in all contexts. Therefore, the guidelines have been developed for a global audience, and it is expected that research teams will adapt them to their local context.

Going forward, Aeras is committed to implementing GPP at all TB vaccine clinical trial sites and establishing a TB Vaccine Community Engagement Network that will be used as a resource for stakeholders in these trials.