Ethical Issues Surrounding Human Subjects Research: Past, Present, and Future

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Ethical Issues Surrounding Human Subjects
Research Past, Present, and Future

• Benjamin Sachs, Ph.D.

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Disclaimer

• The views expressed here are my own and do not
  necessarily represent the views of the federal
  government.

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Whats an Inducement?

• Inducement Anything offered to potential study
  subjects that might encourage them to agree to
  participate in the study.
• - Money/Gift Certificate
• - Free medical care
• - Information
• - And much more!

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Undue Inducement

• There are many circumstances that can cause
  undue inducements to participate in clinical
  trials, including offers of medical care not
  otherwise available or offers of money.
  National Bioethics Advisory Commission, 2001

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Undue Inducement

• The payments should not be so largeor the
  medical services so extensive as to induce
  prospective subjects to consent to participate in
  the research against their better judgment
  ("undue inducement"). The Council for
  International Organizations of Medical Sciences,
  2002

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Undue Inducement

• Undue Inducement An inducement that is so
  enticing as to be unethical.

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Why Do We Use Inducements?

• Because the development of generalizable medical
  knowledge enhances the capacity to meet basic
  medical needs, it is desirable for society to
  promote the conduct of clinical research.
  Payment of research subjects encourages
  individuals to participate in clinical studies,
  thereby promoting the timely development of
  medical knowledge.
• - Terrence F. Ackerman

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Why Do We Use Inducements?

• Patient recruitment is now consuming thirty per
  cent of clinical trial time.
• These delays are costing drug companies over
  half a million dollars for specialty products and
  more than 8m (6.7m) for blockbuster brands in
  lost sales.
• An alarming 75 of clinical trials are delayed
  due to slow enrolment.

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Why Might an Inducement Be Undue?
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Why Might an Inducement Be Undue?

• THE NUREMBERG CODE
• The voluntary consent of the human subject is
  absolutely essential.
• - Directive 1

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Why Might an Inducement Be Undue?

• Voluntary Consent
• Uncoerced Autonomous Informed

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Some More Definitions

• Uncoerced Done freely or by choice
• Autonomous Done in light of ones own values

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The Ethical Basis for the Idea of Undue Inducement

• An offer of a large reward can force potential
  subjects to consent. This is coercive.
• An offer of a large reward can cause potential
  subjects to act in a way that is inconsistent
  with their own values. In such cases, their
  consent is not autonomous.
• An offer of a large reward can cause potential
  subject to discount, or fail to appreciate or
  attend to certain facts about the study
  (especially the risks). In such cases, their
  consent is not informed.

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Where Things Stand Today

• The problem with the proposal that monetary
  payments be set at the lowest amount capable of
  drawing a sufficient number of volunteers is that
  it simply fails to guarantee that the payment is
  not an undue inducement

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Where Things Stand Today

• start with a presumption that payments to
  normal, healthy volunteers should be set low,
  rather than high. If the use of this guideline
  yields an insufficient number of subjects for
  particular research projects, it may count as
  evidence that there is something unacceptable
  about the researchBefore raising the cash
  payment, thereby incurring the risk of offering
  an undue inducement, investigators should rethink
  the research design to see if alternative methods
  would be feasible.
• - Ruth Macklin

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Questions for Discussion

• Can an offer be coercive?

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Questions for Discussion

• Do offers of large rewards cause people to
  ignore their values?
• Or do people just value excessive rewards??!!

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Questions for Discussion

• If offers of large rewards can cause
  potential subjects to ignore the risks of a
  study, cant we just try harder to make the risks
  clear to them?

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Food For Thought
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Food For Thought
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Food For Thought

• The Yellow Fever Study
• 100-200 inducement offered
• Medical care inducement offered
• Consent documents signed
• Subjects were subjected to high risk of
  contracting yellow fever
• Some subjects died

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Food For Thought
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Food For Thought
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Food For Thought
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Food For Thought

• The Malaria Study
• 2000 or more paid to subjects as an inducement
• Subjects stay in downtown Seattle hotel for a few
  days
• Subjects receive experimental malaria vaccine
• Subjects bitten by malarial mosquitoes
• Treatment for malaria provided if symptoms
  develop