Good Participatory Practice UNAIDS & AVAC Document

1. Good Participatory PracticeUNAIDS & AVAC Document Pauline Irungu Global Campaign for Microbicides

2. Goals of the GPP • “These Good Participatory Practice guidelines aim to provide systematic guidance on the roles and responsibilities of entities funding and conducting biomedical HIV prevention trials towards participants and their communities” • And to elevate the GPP process to the same level as other normative guidance documents (GCP, etc.) • The GPP document has the potential to be the basis for and/or a tool in community advocacy around HIV prevention research.

3. Overview of the Process Follow-up to recommendations of the 2005 UNAIDS global consultation Creating Effective Partnerships for HIV Prevention Trials: • An interdisciplinary, international working group was convened. • Guidelines were drafted to provide minimum standards, common principles to guide HIV prevention trials, and systematic ways of evaluating engagement of community before, during, and after trials are completed. • AVAC, UNAIDS and other collaborators worked to develop the current pre-publication version of GPP over the past 12 months. • The draft was systematically reviewed based on input from researchers, trial sponsors, community members, advocates, and the public, through e-mail comments, interviews, and listserve postings for a wide range of stakeholders.

4. Those involved in designing, financing and executing clinical trials research, including: Investigators Research staff Pharmaceutical industry sponsors Foundations Government-supported research networks NGO research sponsors The GPP Audience

5. What the GPP Document Does • Outlines ten core principles, describes essential issues and activities and illustrates these throughout the research life-cycle. • Provides guidance to researchers, funders, and communities on the conduct of prevention trials. • Defines minimum standards and common principles to enhance existing research programmes and assist in the development of new HIV prevention trials globally. • Describes systematic ways of evaluating engagement of the community before, during, and after a trial is completed. • Lays a foundation for locally-driven processes which could address critical questions and issues.

6. GPP Essential Issues and Activities • Formative research with community • Protocol development and review • Institutional review boards, ethics committees, and other regulatory mechanisms • Informed consent • Standard of prevention and access to care • Policy on coverage for research-related harm • Community engagement/involvement/education plan • Communications plan • Monitoring and issues management plan • Community advisory mechanisms Community involvement runs through research life cycle: from site selection to technology access

7. What the GPP Doesn’t Do • The GPP aims to provide guidelines on laying the framework for participatory practice and what should be considered. It does not tell you HOW to do community engagement.

8. Critique of the GPP • Does not explicitly recognize the limitations of the values framework it advances. • Does not acknowledge that research is taking place in the context of inequality. • Needs to be realistic about the fact that power imbalances between North & South, researchers & participants, and study staff & CABs exists and will remain. • Must include need for country adaptation. • GPP is too aspirational and needs to acknowledge these imbalances that exist in the field and accept incremental progress.

9. The Future of the GPP • UNAIDS and AVAC are collecting comments on the GPP including feedback from 40 interviews with civil society members and leaders. • The GPP will be released as a living document. • AVAC is committed to putting together a civil society response to the document and to advocate for changes based on that response. • As part of this process they will hold a moderated listserv discussion on the GPP and plan to put out a Request for Proposals, giving small grants to capture further input.

10. The AVAC RFP on GPP • In December 2007, AVAC will launch a Request for Proposals (“RFP”) for community feedback on and engagement with the GPP document • The RFP is a first step in attempting to generate community feedback and identify the ways in which the document can become a useful tool.

11. Who is Eligible? • The CC-GPP Awards will be made to non-profit groups and organizations (NGO) who engage in community-based work. Community advisory mechanisms which are independent or which have been established in collaboration with research entities are also eligible for funding.

12. What Kind of Activities Will the RFP Support? • One-day or half-day stakeholder consultations on some or all sections of the existing GPP document • Local meetings with key stakeholders to get input into the GPP document as a guidance tool • Pilot use in relation to an ongoing or planned trial in a community • Retrospective analyses of past trial-related advocacy or scenarios (how the document would or would not have helped in the situation)

13. Discussion Points • One of the goals of the GPP is to be institutionalized as a normative document (similar to GCP, GLP, etc.). Is that what we want? Is it time well spent? • AVAC is considering next steps (RFP). Do we have thoughts about how the RFP could be better contoured? Would it be more useful to have some money available for other activities related to the GPP? • Looking back at the unmet needs we mapped, which of these needs does the GPP address? Which does it not address (remain as a gap)?