Ethical Considerations in Human Subjects Research

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Ethical Considerations in Human Subjects Research

• Marisue Cody, PhD, Director
• ACOS/R Meeting, January 2004

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Belmont report
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Respect for Persons

• Opportunity to choose what shall and shall not
  happen to oneself
• Have sufficient information to make an
  enlightened decision
• Must understand risks and benefits and freely
  choose to accept those risks
• Satisfy standards of informed consent

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Beneficence

• Maximize benefits
• Minimize risks
• Acceptable risk/benefit ratio
• Qualifications of researcher and staff

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Justice

• Equitable selection, recruitment, and fair
  treatment
• Subjects not selected because of easy
  availability or vulnerability
• Subjects included/excluded for scientific reasons

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Living in the Gray Zone
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Conflicts among principles

• Justice Physician-investigator
• Respect for persons Informed consent
• Beneficence Financial conflicts of interest

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Recruitment of subjects

• Inter-role conflict of Physician-Investigator
• Therapeutic misconception
• Potential for undue influence
• Breach of confidentiality

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Managing inter-role conflict

• When a physician has treated or continues to
  treat a patient who is eligible to enroll as a
  subject in a clinical trial that physician is
  conducting, the informed consent process must
  differentiate between the physicians roles as
  clinician and investigator.

- AMA 2000
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Research on informed consent

• Knowledge varied widely and important
  misunderstandings
• Unaware of non-standard treatment
• Potential for incremental increase in risk
• Unproven nature of treatment
• Uncertainty of benefits to self

Joffe et al., Lancet 2001
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Financial conflict of interest

• Conflict occurs when fiduciary relationships
  compromise or appear to compromise an
  investigators professional judgment and
  independence in the design, conduct, or
  publication of research.

- GAO report 2001
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Identification VHA 1200.3

• Compensation to investigator if amount could
  affect study outcome
• Non-VA salary (e.g. consulting fees)
• Equity interests
• Intellectual property rights
• Bonuses or milestone payments
• Fiduciary role for company with financial
  interests in study

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Disclosure

• The nature and source of funding and financial
  incentives offered to the investigators must be
  disclosed to a potential participant as part of
  the informed consent process.

- AMA 2000
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New model
Old model
Director
RD
QA/QI
Patient Advocates
ACOS/Education
IRB
Chief of Staff
ACOS/R
RCO
RD Committee
AO
Medical Records
HPA
Clinical managers
Public Affairs
IRB
Fiscal Office
Pharmacy
Investigators
DSMB
Radiation Safety
Study Coordinators
Subjects
Conflict of Interest Committee
Grants Contracts
Source Joan Porter, ORO
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Culture of Compliance

• Attentive and creative institutional leadership
  creates a culture in which both IRBs themselves
  and the function of protecting human subjects are
  held in high regard.

Gary Ellis JAMA, 1999