Transcript Community Involvement in Clinical Trials

Emerging Approaches to
Community Engagement with
Microbicides Clinical Trials
Paramita Kundu
Global Campaign for Microbicides in India
Regional Meeting On Regulatory Issues In
Microbicides Research
28-31 October 2007
New Delhi, India
www.global-campaign.org
Why Community Involvement?
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Improve ethical and scientific integrity of trials
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Make research more accurate, acceptable and ethical
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Increase transparency and accountability of the
research to the community
Maximize benefits and minimize risks for the community
Provide additional benefits to the community beyond
research
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History of Community
Involvement in HIV Research
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US AIDS activists pushed for a role in early days of HIV
treatment research
Institution of Community Advisory Board (CAB) emerged
Recognition of the importance of community in
implementing ethical and scientifically rigorous clinical trials
“Institutionalization” of community involvement and
importation of CAB model to international research sites
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But…
“It may be difficult to meet the diverse and complex
challenges of community involvement through a
single mechanism like CAB.
Sites have begun to use other mechanisms to help
educate, respond to, protect, collaborate with
and seek ongoing input from communities.”
(Mobilization for Community Involvement in Microbicide
Trials, SAMRI and GCM,’03)
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Expectations and Challenges
CABs Face
Expectations
•Represent community viewpoints
Challenges
•Representing or representative? Do CABs
run the risk of becoming the vehicle for one
group / individual agenda?
•Channel for communication between
•Mechanisms for information gathering and
researchers and community
dissemination?
•Independent advice to researchers
•Ability to challenge the institution
supporting the structure?
•Voluntary commitment of members over
•Overburdened with responsibilities: dropout
time
rates high
•Provide input on trial design and protocol •Competing priorities in resource-limited
settings?
•Oversight/watchdog for the research
•Power to influence research agenda?
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“Community Mobilization: Moving
Towards CAB +”
Advisory
Community
representatives
provide input as
requested by the
research team.
Collaborative
Community
representatives and
research team
cooperate in
developing and
implementing the
research.
Mobilization
Strengthening community capacity to
analyze and address
its own health and
development priorities
Ownership?
Community
defines the
research
agenda, then
implements it
in partnership
with research
institutions
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What is Meaningful and
Comprehensive Community
Involvement? What Does it
Involve?
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Good Participatory Practice (GPP)
Guidelines in HIV Prevention Trials
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Outcome of 2005 Global Consultation: “Creating Effective Partnerships for
HIV Prevention Trials”
Developed by UNAIDS and AVAC
Objectives
 Establish clear, global standards for community participation and input in
HIV prevention trials
 Publish guideline on good participatory practice for biomedical HIV
prevention trial
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Interdisciplinary, international working group convened
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Draft reviewed based on inputs from researchers, trial sponsors, community
members, advocates, and the public,
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GPP Core Principles
1. Scientific and ethical integrity
6. Autonomy
2. Respect
7. Transparency
3. Clarity in roles and responsibilities
8. Standard of prevention
4. Shared responsibility
9. Access to care
5. Participatory management
10. Building research literacy
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GPP Essential Issues and Activities
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Community involvement runs through research life cycle: from site
selection to technology access
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
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Mechanisms for Meaningful
Community Involvement
•Participatory action research: needs
assessment, community asset mapping,
situational analysis, priority setting
•Feedback mechanisms: formal mechanisms
for soliciting and providing input between
community and research team
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Mechanisms for Meaningful
Community Involvement (cont’d)
•Multiple advisory groups: participant advisory
groups, research advocacy groups, multiple trial
CABs
•Participant advocates: individuals hired and
trained by local NGO to accompany participants
during informed consent process, ensure
comprehension and voluntary participation
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Mechanisms for Meaningful
Community Involvement (cont’d)
•Social mobilization: Strengthens the
community’s ability to analyze and address their
own needs and priorities
•Advocacy: building advocacy skills of community,
local orgs, supporting community to participate at
different levels, networking, funding, protocol
development, ethics review, agenda setting,
access and introduction
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Ongoing Work on Ethics and
Community Involvement
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Adoption of GPP document as standards by UNAIDS
Standard of care assessment by GCM
Community involvement toolkit by GCM
CD-ROM/Web-based course on research literacy and
microbicide science
MDS Civil Society Working Group spearheaded by GCM
Community Involvement in HIV Vaccine Research:
Making It Work
(http://www.hvtn.org/community/resources.html)
Microbicides Media Communication Initiative (MMCI)
MTN’s Community Working Group
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