Transcript Responsible Conduct of Research in the Health Sciences

Responsible Conduct
of Research in the
Health Sciences
Dr. Peggy Valentine
Professor and Associate Dean
Division of Allied Health
Sciences
What is meant by responsible
conduct of research?
It involves the ethical responsibilities of
those engaged in research
 It ensures protection of the rights and
interests of study participants
 Researchers are obligated to avoid
misconduct
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What are examples of
misconduct?
Fabrication, falsification or plagiarism in
proposing, performing, or reviewing
research, or in reporting the results
Why is research important in the
health sciences?
To reduce human suffering
 To validate social or scientific theories
 To dispel ignorance
 To improve understanding of human
behavior
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The focus of this presentation
In this presentation, I will use HIV/AIDS as
a paradigm in highlighting important issues
that face researchers.
The HIV/AIDS Pandemic and
Research
(VOA photo - N. Colombant)
Guiding Ethical Principles
Respect for human dignity
 Respect for informed consent
 Respect for vulnerable persons
 Respect for privacy and confidentiality
 Respect for inclusion
 Minimize harm
 Maximize benefit

Human Dignity
….What makes a person a person, rather
more than merely an individual, is a
spiritual capacity: the capacity to reflect
and choose, to be imaginative and
creative, to be an originating source of
action (Michael Novak, 1999)
Informed Consent
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Official statement developed by the researcher
that informs study participants of the purpose
and scope of the study
Basic elements: purpose, description of
procedures, disclosure of risks or discomforts,
how confidentiality will be ensured, right of
refusal, benefits, signatures, name of institution
and telephone number of investigator
Confidentiality
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The need to take utmost care with patient
confidentiality is a paramount consideration in
HIV-related research. There is a potential for
discrimination and stigmatization.
Mail should not be sent to an individual's
address or phone calls made that could identify
them as possibly being HIV-positive. Family or
friends may not be aware of the health status.
Confidentiality, cont’d.
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In cases where identifying information on
research participants needs to be kept for
research purposes (for example, longitudinal
studies) it should be stored separately from
collected data
Participants should be informed of confidentiality
procedures and also the risks, however remote,
that there are some circumstances where
researchers may be required to report on data,
for example if subpoenaed in court.
Be Careful
A person's HIV status may be illegally
revealed to pharmacists, police officers,
doctors, school officials, or other authority
figures. Most states already protect
medical privacy, and a new federal law
provides more protection
http://www.aclu.org/HIVAIDS/HIVAIDSlist.cfm?c=88
Issue: HIV names reporting
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Researchers should be aware of the
potential of being placed in situations
where mandatory reporting of behaviors to
authorities is required (i.e.. Illegal drug
use, child abuse)
Other Considerations
Involvement of the community (community
participatory research)
 Human rights and discrimination
 Legal issues

Involving the Community
Researchers wishing to recruit HIVpositive people to their studies should
consult the affected communities before
starting the project. This may involve
discussions with People Living with
HIV/AIDS organizations or AIDS Councils
about the nature of the research.
Cameroon AIDS Research Sparks
Controversy
By Nico Colombant, Abidjan, 26 January 2005
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A Yaounde-based activist for a nongovernmental organization dealing with
ethics and AIDS, Calice Talom, says
everything started badly when participants
were rushed to sign a consent form in
English most of them probably didn't
understand.
Respect for vulnerable persons
Dan Heller's Photos, Arusha, Tanzania
Vulnerable Persons
Diminished decision-making capacity
 Diminished competency
 Children
 Institutionalized
 Avoid abuse, exploitation, discrimination
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Whistleblower Says U.S. Bungled AIDS
Study
Tuesday, January 04, 2005
Federal officials involved in a U.S.funded study in Uganda endangered
the lives of hundreds of patients testing
an AIDS drug because of careless and
negligent research practices, a
government whistleblower said
Tuesday. (WebMD)
Whistleblower, cont’d.
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Fishbein told NIH's AIDS research chief in 2003
that the Uganda study should not be resumed.
The agency had stopped the research for 15
months after auditors, medical experts and
others disclosed problems with the project.
(Problem with liver failure in the study
participants) The concerns were dismissed, and
the clinics reopened.
Inclusion
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Fairness and equity
Fair methods, standards and procedures for
reviewing research protocols
No segment of the population should be unfairly
burdened with the harms of research
Do not neglect nor discriminate against those
who may benefit from research advances
"Women Don't Get AIDS, They Just Die
From It . .”
http://fubini.swarthmore.edu/~WS30/WS30F1998/moriah3-intro.html
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Women have not been involved in the clinical trials which test the
safety and efficacy of HIV/AIDS drugs.
Latest advances are denied to women because harm to their
potential offspring is feared (but unstudied).
Drugs tested only on men are more dangerous for women, the
dosages may need to be different
HIV/AIDS research that has been done on women has almost
exclusively focused on vertical or perinatal (i.e., during birth)
transmission
Barrier to women participating in studies include the location, gender
of study primary investigator, the availability of child/family care, and
transportation to the site
Balancing Harm and Benefit
Remember the rights of participants in a
study
 Duty to avoid, prevent or minimize harm
 Maximize the benefits for participants,
society and the advancement of
knowledge
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Lawsuit Filed Over Woman Who
Died in AIDS Drug Trial
Wednesday, December 29, 2004
The family of a pregnant woman who
died while taking experimental AIDS
drugs to protect her baby from getting
the disease is suing the doctors, drug
makers and hospitals involved in the
study for $10 million. http://www.foxnews.com/story
Flawed AIDS Drug Study Exposes
NIH Misconduct
Thursday, February 03, 2005; By Jonathan M. Fishbein
“Scientists are pressured to produce
results at the expense of regulations
whose purpose is to protect the safety,
rights and welfare of study subjects, not to
mention the preservation of scientific
integrity”
Concluding Remarks
Respect human dignity
 Follow guiding ethical principles
 Avoid careless and negligent research
practices
 Involve the community you are studying
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