WHY RESEARCH BECAME REGULATED

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WHY RESEARCH BECAME REGULATED

• Harold Y. Vanderpool, Ph.D., Th.M.
• Institute for the Medical Humanities
• University of Texas Medical Branch

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• The principle of medical and surgical morality
  consists in never performing on man an experiment
  which might be harmful to him to any extent, even
  though the result might be highly advantageous to
  science, i.e., the health of others. Claude
  Bernard, 1865

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Walter Reeds Research Contract with American
Servicemen Who Would Become Yellow Fever
Experimental Subjects

• The undersigned understands perfectly well that
  in the case of the development of yellow fever in
  him, that he endangers his life to a certain
  extent. But it being entirely impossible for him
  to avoid the infection during his stay on this
  island, he prefers to take the chance of
  contracting it intentionally in the belief that
  he will receivethe greatest care and most
  skillful medical service.

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• For all volunteers 100 in gold
• For volunteers who contracted yellow fever an
  additional 100 in gold, which, in the event of
  the subjects death could be given to heirs

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Regulations on New Therapy and Human
Experimentation-Reich Minister of the Interior,
1931

• 1. The freedom to be granted to the physician
  to do research accordingly shall be weighed
  against his special duty to remain aware at all
  times of his major responsibility for the life
  and health of any persons on whom he undertakes
  innovative therapy or perform an experiment.
• 2. Innovative therapy may be carried out only if
  it has been nested in advance in animal trials
  where these are possible).

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• 5. Innovative therapy may be carried out only
  after the subject or his legal representative has
  unambiguously consented to the procedure in the
  light of relevant information provided in
  advance.
• Exploitation of social hardship in order to
  undertake innovative therapy is incompatible with
  the principles of medical ethics.
• 14. Academic training courses should take every
  suitable opportunity to stress the physicians
  special duties when carrying out a new form of
  therapy or a scientific experiment, as well as
  when publishing his results.

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SIMILARITIES AND DIFFERENCES BETWEEN WWII
MEDICAL RESEARCH IN THE THIRD REICH AND THE
UNITED STATES

• SIMILARITIES
• Organized and funded at the national level
• Defended as benefit to armed forces
• Often performed on vulnerable and
  institutionalized subjects usually prisoners
• Often little attention to informed consent
  (excepting gonorrhea in U.S.)

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• DIFFERENCES
• Medical personnel usually highly trained in the
  U.S.
• Research usually predicated on prior animal
  studies in U.S.
• U.S. studies not predicated on serious injury or
  death as end points.

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• Evidence is at hand that many of the patients in
  the examples to follow never had the risks
  satisfactorily explained to them, and it seems
  obvious that further hundreds have not known that
  they were the subjects of an experiment although
  grave consequences have been suffered as a direct
  result of experiments described here.

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• I am aware that these are troubling charges.
  They have grown out of troubling practices. They
  can be documented, as I propose to do, by
  examples from leading medical schools, university
  hospitals, private hospitals governmental
  institutes and industry.??--Henry K. Beecher,
  M.D., Ethics and Clinical Research, The New
  England Journal of Medicine 274 (16 June 1966)
  1345-1360, quotation from p. 1354.

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DISCOVERIES OF THE ADVISORY COMMITTEE ON HUMAN
RADIATION EXPERIMENTS

• Several thousands of government-sponsored
  experiments and hundreds of intentional releases
  of radiation between 1944 and 1974
• Over 100 prisoners submitted to non-therapeutic
  testicular irradiation
• 3,000 military personnel served as research
  subjects in atomic bomb tests, sometimes
  unknowingly
• 2,000 cancer patients subjects to non-therapeutic
  total body irradiation
• Serious concerns over informed consent in present
  1990s medical research
• --ACHRE,
  Final Report, 1996

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QUOTATIONS FROM GREG KOSKI, M.D.Director-Designat
e of the Office for Human Research Protections
(OHRP)

• On the question of the eight major
  universities and hospitals whose research has
  been shut down for ethics violations, including
  failure to fully disclose to the experiments
  subjects the risks they faced, Dr. Koski said
  that anyone who did not comply with ethics rules
  was showing a lack of regard for patients.
• Compliance, he said, is one way we
  demonstrate our respect for the subjects. And
  failure to comply is a symptom of an
  institutions unwillingness to accept
  responsibility in its work.

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• I want to make it unmistakably clear, he
  said, that institutions and individuals who fail
  to accept this responsibility should not be
  permitted to engage in human experimentation.
• --Philip J. Hilts, Medical-Research Official
  Cites Ethics Woes, New York Times (17 August
  2000)

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• Adopting the recommendations of this report will
  lead to better protection of human participants
  while also promoting ethically sound research and
  reducing unnecessary bureaucratic burdens.
  Achieving these goals will, in turn, support the
  publics trust in research, enhance enthusiasm
  for all research involving human beings, and
  restore the respect of investigators for the
  oversight system.
• (National Bioethics Advisory Commission, Ethical
  and Policy Issues in Research Involving Human
  Participants, 2001, p. 131)