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Xenotransplantation Science, Ethics, and Public Policy (1996) / Chapter Skim
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Executive Summary
Pages 1-5

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From page 1...
... Council on Health Care Technology, and with sponsorship from a number of federal agencies and two foundations, the IOM convened a committee in October 1994 to plan a workshop to consider the scientific and medical feasibility of xenotransplantation and to explore the ethical and public policy issues applicable to the possibility of renewed clinical trials of xenotransplantation. Another area of focus was added in response to increasing concern about the potential risk of animal-to-human disease transmission through xenotransplantation.
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From page 2...
... continued surveillance throughout their lifetimes of patients and periodic surveillance of their contacts (families, health care workers, and others) for evidence of infectious diseases; (39 establishment of tissue banks containing tissue and blood samples from source animals and patients; and 64)
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From page 3...
... To assist local IRBs, IACUCs, and society at large to address such questions, the committee recommends further investigation into the special ethical issues that are raised by xenotransplantation' particularly those related to informed consent in light of the requirement for lifetime surveillance of patients and those related to fairness and justice in allocating organs, as well as research into the psychological and social impact of receiving animal organs on recipients, their families, and members of the society as a whole. RECOMMENDATION 4 The committee is aware of and commends the efforts of the Food and Drug Administration and the Centers for Disease Control and Prevention in developing the first set of guidelines for xenotransplantation, which were not final before this report was complete but developed from discussions with other federal agencies and representatives from stakeholder groups.
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From page 4...
... After considerable- discussion of this view and consideration of the issues listed above that will be required to assess the risk of infection, the committee concluded that the potential benefits of xenotransplants are great enough to justify this risk. Hence, the committee recommends that, when the science base for specific types of xenotransplants is judged sufficient and the appropriate safeguards are in place, well-chosen human xenotransplantation trials using animal cells, tissues, and organs would be justified and should proceed.
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From page 5...
... EXECUTIVE SUMMARY 5 is great enough to justify funding, by federal agencies, private industry, and other sources, of research and other programs (e.g., tissue banks and patient registries) necessary to minimize the risk of disease transmission.
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Key Terms

  • disease transmission
  • xenotransplantation trials
  • infectious disease
  • science base
  • infectious agents

  • tissue banks
  • patient registries
  • human xenotransplantation
  • special issues
  • informed consent

  • address special
  • source animals
  • continued surveillance
  • animal care
  • national guidelines

  • local irbs
  • receiving xenotransplants
  • suggest modifications
  • maintain patient
  • adequate resources

  • animal cells
  • human trials
  • sample collections
  • irb level
  • cellular xenotransplants

  • specific national
  • care technology
  • allocating organs
  • human transplant
  • institutional review


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