Transcript Community involvement in research

Teaching Skills in
International Health
Research Ethics (TaSkR)
February 19-21st 2013,
Sirikwa Hotel, Eldoret.
Violet Naanyu-Ayah, PhD.
Senior Lecturer, Moi University School of Medicine,
Co-Field Director of Research, AMPATH
Reviewer, IREC
Member, National Bioethics Committee
Email: [email protected]
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Community Engagement &
Consent Issues
*Adapted from Markkula Center for Applied Ethics; Mutsambi, J.M. (n.d); Uzo Anucha (2009) ; Wasunna A.A . The
Hastings Center (n.d); Interagency Coalition on AIDS & Development (n.d); HIV/AIDS Network (HANC) (n.d); Eng , E. & ,
Viswanathan M. (2004); Global Campaign for Microbicides (n.d); Mullinix. B.B. (2000); Winer & Ray (2000); Moran, J.C.
(2007). Leo S. Morales, L.S (2012) Global Health Research Institute
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What we WONT do in TaSkR VI …
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Magically solve major bio-banking ethical dilemmas
Give you quick and easy solutions
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What is communityengaged research?
It is a framework or approach for conducting research
that entails involving users of the research and other
stakeholders in the formulation as well as the
application of the research.
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What is a community?
A group of people with diverse characteristics who are
linked by social ties, shared perspectives, and engage in
joint action in geographical locations or settings.
Therefore a community may share common:
 Geography
 Racial or ethnic makeup
 Values, culture, beliefs, and interests
MacQueen KM, McLellan E, Metzger DS, Kegeles S, Strauss RP, Scotti R, Blanchard L, Trotter RT. What Is
Community? An Evidence-Based Definition for Participatory Public Health. American Journal of Public
Health. 2001; 91(12): 1929-1938.
Understanding the Clinical Research Process and Principles of Clinical Research. HIV/AIDS Network
(HANC)
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Examples:
-Bodaboda riders
-Street vendors
-Patients
-Bus park
-Rally drivers
-Sex workers
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- MSM
-BB Team
-Taxi drivers
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Principles of community
engagement
Have a clear statement of the purpose/ goals of the
engagement effort
 Define the community/population you wish to engage
 Become knowledgeable about the community
 Visit, establish relationships, build trust, & seek
commitments from community organizations & leaders
 Be humble & respectful, recognizing the expertise &
resources locals bring to any project
 Recognize community diversity
 Identify & mobilize community assets and develop a
community’s capacity to make decisions & take action
 Be prepared to adapt your methods to meet community
needs
 Be prepared to make long-term commitments to
community partners

Adapted from: Principles of Community Engagement, 2nd Edition,
JuneTaSkr.
2011 2014
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Common areas of community involvement
Type of Community Involvement
Percent of Studies
0% 25% 50% 75% 100%
Selection of Research Question
Proposal Development
Financial Responsibility for Grant
Funds
Study Design
Recruitment and Retention
Instruments & Data Collection
Intervention Development,
Implementation
Interpretation of Findings
Dissemination of Findings
Application of Findings to Health
Concern Identified
* Viswanathan M , Ammerman A, Eng E, Gartlehner G, Lohr KN, Griffith D, Rhodes S, Webb L, Sutton SF, Swinson T, Jackman A, &
Whitener L. (January 16, 2004). Community-Based Participatory Research. Agency for Healthcare Research and Quality, U.S.
Department of Health and Human Services (Final Evidence Report).
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For our
research to
be ethical, all
relevant
players must
do their part
Ethics
Committees and
Review Boards
Ethical
Research
Community
and Advocates
Researchers
and Sponsors
Interagency Coalition on AIDS & Devpt.
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The nature of ethics

Ethics
◦ The inner-guiding moral principles, values, and beliefs
that people use to analyze or interpret
a situation and then
decide what is the
“right” or appropriate
way to behave
◦ Bioethics is a way of
understanding & examining
what is “right” & what is “wrong”
in biomedical research & practice.
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Clearly, ethics is not …
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Ethics is not the same as feelings
Ethics is not religion
Ethics is not following the law
Ethics is not following culturally accepted norms
Ethics is not science
So…Two fundamental questions:
1. On what do we base our ethical standards?
2. How do those standards get applied to specific situations
we face? E.g. to bio-banking?
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Do the ends ever justify the
means?
Morally acceptable ‘ends’
Morally acceptable means to those ‘ends’
◦How do we intend to carry out bio-banking?
Translation:
You need a good reason to do research, and while you are
doing it – you need to be ethical... So you can’t use the
excuse that ‘the ends justify the means’
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Making ethical decisions begins
with recognition of an ethical
concern
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Is there something wrong personally,
interpersonally, or socially? Could the conflict, the
situation, or the decision be damaging to people or
to the community?
Does the issue go beyond legal or institutional
concerns? What does it do to people, who have
dignity, rights, and hopes for a better life together?
Apply these questions to bio-banking
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Get the bio-banking facts…
Remember: Good ethics begin with good facts
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What are the relevant facts of the case? What facts
are unknown?
What individuals & groups have an important stake
in the outcome? Do some have a greater stake
because they have a special need or because we
have special obligations to them?
What are the options for acting? Have all the
relevant persons & groups been consulted? If you
showed your list of options to someone you respect,
what would that person say?
Are there alternative options to what the proposed
bio-banking project proposes?
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Care & protection of research
participants…things to consider:
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Suitability of the investigator(s) - qualifications & experience
Plans to withhold standard therapies & justification
Medical care to be provided during & after the research
Adequacy of medical supervision & psychosocial support for
participants
A description of any financial costs to research participants
Rewards and compensations for research participants ($?
Services? Gifts?)
Criteria for extended access to, the emergency use of, and/or the
compassionate use of study products
Provisions for compensation/treatment in case of
injury/disability/death of a research participant attributable to
participation in the research
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Protection of research participants’
confidentiality

A description of the persons who will have access to
personal data of the research participants, including
medical records and biological samples
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The measures taken to ensure the confidentiality and
security of personal information concerning research
participants
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Community considerations
• Impact & relevance of the research on the local community & on
communities from which participants are drawn
• Steps taken to consult with the concerned communities during
the course of designing the research
• Influence of the community on the consent of individuals
• Community consultation during the course of the research
• Research contribution to capacity building e.g. enhancement of
local healthcare, research, & ability to respond to PH needs
• Description of the availability & affordability of any successful
study product to the concerned communities following the
completion of research
• The manner in which the results of the research will be made
available to the research participants concerned communities
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The “Informed consent” is the
golden tool…
Informed consent should clearly inform on:
 WHAT
 WHY
 BY WHOM
 TO WHOM
 HOW
 WHEN
 WHERE
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Comprehension of informed
consent
Informed consent is not valid unless the consentor
comprehends the information upon which consent is
based
 The language used therefore must be easy and
understandable by the consentor
 Grammar & punctuation must be used appropriately
to enhance comprehension
 The consent document must be revised until the ERC
is fully satisfied before approval
 ERC should play the role of educator to investigators
and sponsors to develop quality consent documents
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BUT… what is “real” Consent?
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After the process of informing, assurance of comprehension
and assurance of autonomy have been completed to a
mutually satisfactory extent, the prospective participant
signifies willingness to participate by consenting
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This may involve signing of a consent form - a contract or
commitment is thereby established
NB: The investigator is obligated ethically and legally to renegotiate this
agreement from time to time incase of any changes in the conduct of
the research
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Barriers to community participation
in research projects
History of poor relationships with academic researchers
◦ Topics of research not of interest
◦ Results of research not shared with community
◦ Community members subjects of experimentation
 Limited time and resources for research
 Limited experience proposing or conducting research
 Lack of tangible benefits to community
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Do/would these barriers apply to bio-banking projects in
Kenya?
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‘Subject’ vs. ‘Participant’
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Being the subject of research is different from being a
participant in research. With a community-engaged
approach communities are seen as partners.
◦ Collaborators and community members are viewed as research
participants, not as research subjects.
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Community members who have not worked on the planning
of the research or been involved in any way, but who
volunteer to enroll in the research, are still called
participants rather than subjects.
Carlson, ED. 2004; Corbie-Smith, G. 1999; Freimuth, VS. et al. 2001; Lasker RD, Weiss ES. 2003; Minkler M. 2005
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Community Advisory Groups
(CAGs)
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Also called Community Advisory Boards (CABs)
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A CAG is a group of volunteers from the general public and
from the diverse communities affected by a condition e.g.
HIV/AIDS
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A CAG is organized to assist and advise researchers within a
given research site.
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Unfortunately, we don’t find institutionalized CAG-like
structures in all communities.
◦ So how would we deal with bio-banking in such set-ups?
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E.g.1 Dealing with trial rumors/ concerns in Mwanza*
• Why is so
much blood
taken?
• What do you
do with the
left over
blood?
• Are the
needles
safe/clean?
The trial personnel invited community members to visit
the lab/ clinic to understand exactly what is done with the
blood samples
*Interagency Coalition on AIDS & Devpt.
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E.g.2 Naanyu’s MSM project
mmmmm
mmmmm
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E.g. Tell us about your projects…

Share your past/current/planned activities:
◦ What is it about?
◦ Where?
◦ What community involvement strategies are you
using?
 Elaborate on how you are informing locals about it
 Elaborate on processes of seeking approvals/permissions
to carry out your work
 Elaborate on compensations (individual/community level)
◦ Challenges faced?
◦ Advantages of fully engaging local communities?
◦ Is there something you would do differently?
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Remember: Our work & research ethics
Respect for Persons
Beneficence
Justice
People have a right to make
their own choices
Researchers do everything
possible to make sure the
research does not harm
participants
There are more
benefits for the
participant than risks
All facts about the research
are presented to potential
participants
The risks of the study will be
kept as low as possible
Participants are fairly
recruited as research
participants
Volunteers must not be
pressured to choose research
over other options for care
The benefits of participating in
the research study should be
greater than the risks
The community where
research is being conducted is
respected
It is more important to protect
participants than to achieve
benefits
The community has a voice in
what is done during the
research (CABs can help)
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The missing 4th ethical principle?
“Respect for communities”

The Belmont principles are:
◦ Focused on rights of individuals
◦ Use a biomedical framework
◦ They lack ethical precepts for:
 Community collaboration & consideration of
culture
 Ethical conduct of research with community
partners
 Community level risks
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We cannot ignore ubuntu…
Humans are social beings & live in communities
 Humans are linked by culture & associated social
institutions
 Public & private life are interwoven
 The welfare of a society should be considered (as a
whole): common good
 Democratic community discussions are key when making
community level decisions

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Current bio-banking ‘hot’
questions bothering us…
-Should we store left-over specimens at the end of defined
research activities?
-What if we did not tell research participants that their
samples would be stored?
-Where shall we store the specimens?
-Who would later on be allowed to use the specimens?
-For what type of research?
-Who will be the ‘watch-dog’ for such samples?
-What are the potential RISKS of becoming involved in a biobanking endeavor?
For participants? For communities?
-What are the potential BENEFITS of becoming involved in a
bio-banking endeavor?
For participants? For communities?
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AMPATH’S research strategic priority 4: To
enhance AMPATH engagement with the community
Objective:
Improve AMPATH research program’s relationship with the
community
 Activities:
◦ Communicate findings/benefits of research to the
community
◦ Receive community feedback
◦ Find ways to address problems identified

Critique: Main focus is the end period of projects.
Bio-banking requires engagement from the beginning
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TaSkR is about teaching skills…
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Public health cannot compromise on value systems
Students learn a professional value system as it is
portrayed by the institution they attend and by the faculty
attitudes towards each other and towards their profession.
Do we lack knowledge? Skills?
◦ Socrates: “Ethics consists of knowing what we ought to
do, and such knowledge can be taught.”
Remember:
"Sow an act...reap a habit; Sow a habit...reap a character; Sow
a character...reap a destiny." George Dana Boardman
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Everyday ethics: 5 Questions
Did I practice any virtues today?
2. Did I do more harm than good today?
3. Did I treat people with dignity and respect today?
4. Was I fair and just today?
5. Was my community better because I was in it?
1.
“Many people say that it is the intellect which makes a great
scientist.
They are wrong: it is character.” Albert Einstein
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“…because I trust doctors [health
workers]…”
When I asked AIDS
trial research
participants why
they consented,
they said that they
have faith is us –
that we can never
invite them to
participate in a
harmful project
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Finally…
Make a conscious
choice to carry out
“Community-engaged”
Projects
 Where are our
watchdogs? Are they
asleep? 
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Asante…and remember:
"Our character is what we
do when we think no one is
looking.” Jackson Browne
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