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December 20, 1985

Informed Consent and Baby Fae

JAMA. 1985;254(23):3359-3360. doi:10.1001/jama.1985.03360230091032

Ever since Dr Leonard Bailey transplanted the heart of a young baboon into a human newborn with fatal hypoplastic left heart syndrome, there has been great public concern about the ethical issues involved in the highly experimental surgery. Among the many questions asked were: How much was known about this procedure? How much did the parents understand and how was their permission obtained? In the particular area of informed consent, the report by the investigative team of the National Institutes of Health (NIH) answers some questions but raises new ones.1

In December 1984 members of the NIH's Office of Protection From Research Risks, an NIH legal adviser, and two nongovernmental consultants accepted Loma Linda University's (LLU) invitation to examine the university's decision to attempt the xenograft. After two days of discussions, the site visitors concluded that the review of the proposed procedure— which had included participation by the hospital