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Responsible Conduct of Research in the Health Sciences

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Responsible Conduct of Research in the Health Sciences Dr. Peggy Valentine Professor and Associate Dean Division of Allied Health Sciences – PowerPoint PPT presentation

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Title: Responsible Conduct of Research in the Health Sciences


1
Responsible Conduct of Research in the Health
Sciences
  • Dr. Peggy Valentine
  • Professor and Associate Dean
  • Division of Allied Health Sciences

2
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

3
What are examples of misconduct?
  • Fabrication, falsification or plagiarism in
    proposing, performing, or reviewing research, or
    in reporting the results

4
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

5
The focus of this presentation
  • In this presentation, I will use HIV/AIDS as a
    paradigm in highlighting important issues that
    face researchers.

6
The HIV/AIDS Pandemic and Research
(VOA photo - N. Colombant)
7
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

8
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)

9
Informed 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

10
Confidentiality
  • 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.

11
Confidentiality, 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.

12
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?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)

14
Other Considerations
  • Involvement of the community (community
    participatory research)
  • Human rights and discrimination
  • Legal issues

15
Involving 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.

16
Cameroon 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.

17
Respect for vulnerable persons
Dan Heller's Photos, Arusha, Tanzania
18
Vulnerable Persons
  • Diminished decision-making capacity
  • Diminished competency
  • Children
  • Institutionalized
  • Avoid abuse, exploitation, discrimination

19
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)

20
Whistleblower, 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.

21
Inclusion
  • 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

23
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

24
Lawsuit 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

25
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

26
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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