Professional Documents
Culture Documents
Ethics
Ethics
COM
New Prevention
Technologies
Workshop
Module 6:
Ethics
HUMAN RIGHTS AND
ETHICAL CHALLENGES IN
NPT RESEARCH
OUTLINE
Overview of research ethics: origins, guidelines,
principles
Overview of role of various players in
biomedical prevention research
Community engagement: models, challenges,
vulnerability and targeted populations
Dynamics of North-South research
Case study: Cambodia, Cameroon, Thai trials
Standard of prevention and care for trial
participants
Use of ARVs for prevention vs treatment
What is “Ethics”?
Ethics
is a way of understanding and
examining what is “right” and what is
“wrong”
Beneficence/Non-Maleficence
Justice/Non-Exploitation
Respect for Persons
Autonomy
Says that each individual:
Is unique and free;
Has the right and capacity to decide;
Has value and dignity; and
Has the right to informed consent.
Researchers must:
Protect the physical, mental and social well-
being of each research participant;
Minimizes physical and social risks;
Maximize the possible benefits; and
Retain the community perspective.
Beneficence/Non-Maleficence
ON BALANCE:
The research should generate more
good than harm; and
Risks of research should be reasonable
in light of the expected benefits to the
individual and to society.
Justice/Non-Exploitation
Research must:
Ensure a fair distribution of risks and benefits
Research should not be done in a community
that is not likely to benefit from the result
Conduct equitable recruitment of research
participants; and
Provide special protection for vulnerable groups.
RISKS and BENEFITS
DISCUSSION QUESTIONS
What are the potential What are the potential
RISKS of becoming BENEFITS of becoming
involved in a prevention involved in a prevention
trial? trial?
For participants? For participants?
For communities? For communities?
Participant Risks vs. Benefits
RISKS BENEFITS
Benefits
Improved health infrastructure
Training
Community education on HIV/research
Preferential access to product if it proves
effective
Will participating in trials increase
people’s risk of HIV?
Generally, no...
People will become infected during the trial but not because of
the trial
People in both arms should have lower HIV prevalence than
people in the general community
Condoms only
Condom only
Risk ` Condoms +
placebo gel
Condoms +
microbicide
(if it works)
Before trial During Trial
Undue
Inducement
Informed
Consent Therapeutic
Misconception
Equipoise
Length of forms
Degree of technical information imparted
Written versus oral consent
Emphasis on right to withdraw
Informed Consent is a Process
Ethics
Committees and
Review Boards
Ethical Community
Research and Advocates
Researchers
and Sponsors
Who Decides?
Decisions have to be made about what the
acceptable balance is between risks and benefits
CABs and ethics committees can help judge
acceptability of risk:benefit ratio overall
The informed consent process helps an individual
make his/her own judgment about the risks and
benefits
The health and well-being of the participant can
never be sacrificed for “research’s sake” or the
“greater global good”
Who are the Players in HIV NPT
Research?
Academic researchers and universities
Community members and organizations,
pharmaceutical
companies
investing?
Perceived low
profitability
Liability concerns
Lack of in-house
expertise
Uncertain regulatory
environment
Government Funders and
Regulators
provide funding for NPT research programs,
academic researchers, conferences
coordinate domestic and global efforts
ensure that adequate clinical research facilities
exist
ensure availability of properly trained staff
help build public awareness and support for
research and development
achieve speedy and appropriate access once a
NPT becomes available
Health Care Providers
refers to the
individuals directly
participating in the
trial, in some
instances their
partner(s), and study
staff working at the
trial site.
“Host Community”
refers to non-profit,
organized, citizen-led
movements or groups
interested in the goals,
process, and outcomes of
microbicide research, and/or
in the rights of communities
or research participants.
• What do you
do with the
left over
blood?
• Are the
needles
safe/clean?
“No one wins when a trial is stopped for non-scientific
reasons. But the only way to prevent this is to invest
the time and resources needed to build the kind of
mutual trust on which collaborative partnerships can
be based.”
-
Anna Forbes & Sanushka Mudaliar
Preventing Prevention Trial Failures: A Case Study and Lessons for Future
Trials from the 2004 Tenofovir Trial in Cambodia
“We will not let Cambodians be
used as guinea pigs…”
Cambodian prime minister
Case Study: Cambodia Tenofovir Study
Partnership and
Mobilization
Advisory Collaborative Research
Historical implementation exists
No involvement Community Community
representatives representatives alongside specific
of community process goals that
except as pool provide input and research
into specific strengthen the role
from which to team cooperate and capacity of
draw research areas of the in developing community to
participants study as and articulate and address
requested by the implementing its own development
research team needs including future
the research
research priorities.