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the oversight agencies<

A summary of these agencies' guidelines to date (March 2001) on xenotransplantation and the U.S. regulatory bodies which have been created to foster public discussion on the issues surrounding xenotransplantation


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federal guidelines

U.S. federal government agencies have issued several sets of guidelines on xenotransplantation:

Although these guidelines will likely be closely followed by those proposing xeno experiments, they are voluntary and may not be binding for privately funded experiments. Responsibility for ensuring that a researcher follows the proper protocol often falls to the regulatory bodies of the local institution where the research is being carried out, known as Institutional Review Boards (IRBs). The proposal may have to be reviewed additionally by the location's Institutional Animal Care and Use Committee (IACUC), as well as the Institutional Biosafety Committee (IBC).

federal regulatory bodies for  fostering public discussion

U.S. federal agencies have set up two bodies to facilitate public discussion of the issues surrounding xenotransplantation:

  • In 1997, the FDA's Biological Response Modifiers Advisory Committee created a Subcommittee on Xenotransplantation, which holds open public meetings to discuss the scientific, medical, social, ethical, and public health concerns surrounding xenotransplantation.

  • The Department of Health and Human Services created the Secretary's Advisory Committee on Xenotransplantation (SACX) in July 1999. The SACX is comprised of 18 voting members from fields including xenotransplantation, epidemiology, virology, microbiology, infectious diseases, veterinary medicine, immunology, law, bioethics, patient advocacy, and animal welfare. It also holds open public meetings to discuss xenotransplantation's public health implications.


informed consent WIDTH=

The process of educating a subject before a clinical research procedure is known as informed consent. It is important for the patient to fully understand the risks as well as the potential benefits before agreeing to undertake any experimental procedure.

  • The Department of Health and Human Services has issued General Guidelines for Informed Consent, which outline the information the subject must be provided, including any potential risks and/or benefits, as well as any alternative procedures that could benefit the patient. Signing an informed consent document does not mean that the subject has relinquished his legal rights or released the sponsor from liability.

  • The Declaration of Helsinki describes the World Medical Association's guidelines for biomedical research involving human subjects. While it acknowledges "Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects" the document also states "The subjects must be volunteers and informed participants in the research project."


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