Title: Responsible Conduct of Research in the Health Sciences
1Responsible Conduct of Research in the Health
Sciences
- Dr. Peggy Valentine
- Professor and Associate Dean
- Division of Allied Health Sciences
2What 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
3What are examples of misconduct?
- Fabrication, falsification or plagiarism in
proposing, performing, or reviewing research, or
in reporting the results
4Why 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
5The focus of this presentation
- In this presentation, I will use HIV/AIDS as a
paradigm in highlighting important issues that
face researchers.
6The HIV/AIDS Pandemic and Research
(VOA photo - N. Colombant)
7Guiding 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
8Human 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)
9Informed Consent
- 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
10Confidentiality
- 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.
11Confidentiality, contd.
- 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.
12Be 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?c88 - Issue HIV names reporting
13- 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)
14Other Considerations
- Involvement of the community (community
participatory research) - Human rights and discrimination
- Legal issues
15Involving the Community
- Researchers wishing to recruit HIV-positive
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.
16Cameroon AIDS Research Sparks Controversy By
Nico Colombant, Abidjan, 26 January 2005
- A Yaounde-based activist for a non-governmental
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.
17Respect for vulnerable persons
Dan Heller's Photos, Arusha, Tanzania
18Vulnerable Persons
- Diminished decision-making capacity
- Diminished competency
- Children
- Institutionalized
- Avoid abuse, exploitation, discrimination
19Whistleblower 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)
20Whistleblower, contd.
- 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.
21Inclusion
- 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
22"Women Don't Get AIDS, They Just Die From It . .
http//fubini.swarthmore.edu/WS30/WS30F1998/moria
h3-intro.html
- 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
23Balancing 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
24Lawsuit Filed Over Woman Who Died in AIDS Drug
TrialWednesday, 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
25Flawed 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
26Concluding Remarks
- Respect human dignity
- Follow guiding ethical principles
- Avoid careless and negligent research practices
- Involve the community you are studying