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

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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

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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.

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

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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)

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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

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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.

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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.

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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

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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)

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Other Considerations

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

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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.

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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.

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Respect for vulnerable persons
Dan Heller's Photos, Arusha, Tanzania
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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)

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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.

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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

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"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

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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
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

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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

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Concluding Remarks

• Respect human dignity
• Follow guiding ethical principles
• Avoid careless and negligent research practices
• Involve the community you are studying