Transcript Community Involvement in Clinical Trials

Good Participatory
Practice
UNAIDS & AVAC Document
Pauline Irungu
Global Campaign for Microbicides
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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.
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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.
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The GPP Audience
• 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
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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.
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GPP Essential Issues and Activities
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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
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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.
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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.
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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.
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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.
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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.
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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)
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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)?
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