COMMUNITY CONSULTATION:

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COMMUNITY CONSULTATION LESSONS LEARNED IN HIV
COMMUNITY-BASED RESEARCH Ronald P. Strauss,
D.M.D., Ph.D. University of North Carolina at
Chapel Hill
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The realms of biomedical research ethics have
been a central societal concern during the past
70 years.  2 main historical events  1. Nazi
Medial Experimentation  2. Tuskegee Syphilis
Study
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Linking Communities and Scientists Project LinCS
was launched to investigate the social and
ethical issues in linking scientists and
communities. Funded jointly by CDC and NIAID 3
Universities
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Goal 1 To understand how communities perceive
biomedical research and what can be done to
improve community trust in science, scientific
institutions and scientists.
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Goal 2 To identify factors that facilitate
collaboration between biomedical research
establishments and the communities they seek to
work with.
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Focus How Communities Can be Meaningfully
Involved in HIV Clinical Efficacy Trials
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Community Involvement  Community-based research
design in partnership with Community Advisory
Boards (CAB)  Explicitly incorporate subjects of
research into the design and conduct of the
inquiry.
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Larger Questions How do you construct
university-community partnerships?  How do you
define community?  Who speaks for the
community?  What is the role of CABs?  Who
controls the research?
The methodology? The results?  How do
you build trust?  What promises need to be made
to assure ethical, sensitive research?
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Major questions were raised in the process 1. Is
biomedical research always positive? 2. How
should poor outcomes
of research be
managed? 3. Should biomedical research
be controlled?
How? Codes? 4. How can truly informed consent be
achieved? 5. What values guide the ethical
choices of scientists? Situational? Principles?
Religious? 6. Do scientists utilize and respect
community input?
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Lessons Learned Getting the Community Involved
in Research.
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Community Comes First

• Before the research begins, researchers must
  build trust and communication with the community.
• Scientists should think about community
  consultation before writing their grant.

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  Conflicts of interest for investigators should
be declared and made evident to the community and
review boards Health and other risk factor
education must be part of all HIV-related
research  Careful that participants dont act
risky because of a study  Careful about the
therapeutic misconception
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Concerns Perceptions of placebos in clinical
trials Informed consent, literacy,
understanding, cultural competency, time to
think  Marginalized and disenfranchised
communities  Distrust of government and public
health researchers  Control of the research/
role of the CAB
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  HIV Specific Issues  Stigma and Fear  HIV
transmission during research  HIV testing
Privacy
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• Community Advisors Can
• facilitate informed consent
• advise researchers
• pretest forms/questionnaires
• guide recruitment
• monitor conduct of research
• analyze findings
• disseminate results

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• Community Advisor Issues
• autonomy and authority
• window-dressing
• resources/time
• leadership
• organization
•  payment and incentives
  

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 Community Advisor Goals  Clarify the
similarity and difference between Doctor/Patient
relationships and Investigator/Subject
relationships.  Assure treatment for people who
seroconvert during the
research.  Determine future use of research
products and community access to products after
the research concludes.  Promise full-disclosure
to participants
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Community Advisor Goals (continued)   Clarify
conflicts of Interest/funding corporate,
government, university  Improve the local
standard of care and health care
infrastructure.  Become educated about
Randomized Clinical Trials early efficacy, Data
Safety Management, trial completion
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PROJECT LINCS CAB Developed WHAT QUESTIONS
SHOULD YOU ASK ABOUT RESEARCH STUDIES? You could
ask the following questions of anyone who wants
you or members of your
family or community to be part
of a
research study
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What is the study about? 1.   Why are you doing
this study? 2.   Why do you want to study me or
people like me? Who else is being
studied? 3.   What do you want to get out of this
study? What will you do with the results? 4.  
Have you or others done this type of study ever
before? Around here? What did you learn?
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Who put this study together? 1.   Who is
running or in charge of this study? 2.   Whose
idea was this study? 3.   How were people like me
part of putting it together? 4.   Who are the
researchers? Are they
doctors or scientists? Who do they work
for? 5.   Have they done studies like this
before? 6.   Is the government part of this
study? Who
else is a part of this study? 7.   Who is paying
for this study? 8.   Who will make money from the
results of this study?
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How can people like me share their ideas as you
do this study? 1. How will the study be
explained in my community? 2. Who of people like
me will look at this study before it starts?
3. Who of people like me are you talking to as
you do this study? A Community Advisory
Board? 4. Who from the study can I go to
with ideas, questions
or complaints? 5. How will people like me find
out about how
the study is going?
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Who is going to be in this study? 1.   What
kinds of people are you looking for? Why? 2.  
Are you trying to get minorities in this
study? 3.   Are you including people less than 18
years old? 4.   How are you finding people for
this study? 5.   Is transportation and/or daycare
provided for
people in this study? 6.   Do I need to sign to
participate? 7.   Will you answer all of my
questions
before I sign the consent form? 8.   Can I quit
the study after signing the consent form? If I
quit the study, will anything happen to me?
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What will I get out of this study? 1.   What
are the benefits? 2.   Is payment involved? How
will I be paid? 3.   Will I get free health care
or other services if I participate? For how
long? 4.   Will I get general health care and/or

psychological care if I participate? For how
long?
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How will I be protected from harm? 1. How do I
stand a chance of being harmed in this study? In
the future? 2. Does the study protect
me from all types of
harm? 3. If I get harmed, who will
take care of me? Who is
responsible? 4. If I get harmed in any way will I
get all needed treatment? Who pays for treatment?
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How will my privacy be protected? 1. Who is
going to see the information I give? 2. Will my
name be used with the information? 3. What
happens to the
information I gave if I
quit the study? 4. Is there a
written guarantee
of privacy?
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What do I have to do in this study? 1. When did
you start this
study? How long will it last? 2. How much of
this study
have you already done? 3. Have there been any
problems so far? 4. Will I get treated the same
as everyone else? 5. What kinds of different
treatments are offered in this study? Is there a
real and a fake treatment?
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What will be left behind after the study is
over? 1. What will happen to the information
people give? How will it be kept? 2. What are you
going to do with the results of the study? 3.
How will the public learn about the results? Will
results be in places where the public can see
them? 4. Are you going to send me a
copy of the
results? When? 5. What other studies are
you
planning to do here?
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Questions