Transcript Slide 1

Ethics and community
participation in
clinical trials
Anandi Yuvaraj
PATH
January 2007
National Working Group
on Microbicides
Community and ethics
• International guidelines for ethical research articulate
principles
• In the real world, these principles may be in tension with each
other
• The PROCESS of balancing these tensions is as important as
the outcome
• IMPLEMENTATION of an ethical protocol is as important as
developing it.
National Working Group
on Microbicides
Issues around research ethics
• Informed consent is a process, not a single action or
moment in time
• Community consultation provides basis for
communication
• Confidentiality is utterly essential
• Ensuring understanding
National Working Group
on Microbicides
Experience of a phase III /
effectiveness trial participant
Family
Planning
Informed
consent for
screening
Recruitment:
Participant
receives
information
about the trial
Informed
consent
to enroll.
Screening Visit 1:
Education about the
trial, HIV and
pregnancy test, STI
tests and treatment,
baseline data
collected
National Working Group
on Microbicides
Condoms +
experimental
gel
Condoms
+ placebo
Screening Visit 2:
Results of tests,
counseling,
reinforce education
about trial
Randomization:
Participant
assigned by
chance to a group.
Community involvement
Trials
Research and
Development
Process
Involvement
Participation
Preparedness
Partnership
National Working Group
on Microbicides
Access and
Introduction
Partnership continuum
Advisory
Community
representatives
provide input into
specific areas of the
study as requested by
the research team.
National Working Group
on Microbicides
Collaborative
Community
representatives and
research team
cooperate in
developing and
implementing research
process.
Mobilization
Engagement in the
research process
strengthens community capacity to
analyze and address
its own health and
development priorities.
Obligations of a HIV trial site &
positive people
• Protect health & confidentiality of participants
• Counter perceptions that women are excluded from
participation because she is sero-positive
• Provide access to comprehensive care to those who seroconvert during trial
• Work with community stakeholders to define prevention &
health care services for participants
National Working Group
on Microbicides
History of community involvement in
HIV research
• AIDS activists in the US pushed for a role in early days of HIV
treatment research.
• The institution of Community Advisory Boards (CABs) emerged.
• Recognition of “Community involvement” as a part of ethical clinical
trials, especially trials with vulnerable populations.
– Importation of CAB model to international research sites
– Invoking community involvement as a response to ethical
dilemmas
National Working Group
on Microbicides
Operationalizing community
involvement
Community Involvement  CAB
Community Involvement
=
Activities and mechanisms that promote partnership between
communities and research teams in decision-making,
problem-solving and implementation
National Working Group
on Microbicides
Global Campaign for Microbicides
initiative on community involvement
Goal: to support researchers and communities in building effective
partnerships
– Advance the dialogue and debate
– Provide tools and capacity-building for researchers and
communities
– Advocate for new approaches that view research as an
opportunity for development and empowerment
National Working Group
on Microbicides
Thank you
National Working Group
on Microbicides