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December 2000

Bad Science and the Role of Institutional Review Boards

Arch Pediatr Adolesc Med. 2000;154(12):1183-1184. doi:10.1001/archpedi.154.12.1183

IN 1963, A PRESTIGIOUS cancer researcher in New York, NY, injected live cancer cells underneath the skin of unsuspecting, elderly, debilitated patients to study the immunological effects of this nontherapeutic exploration. No attempt was made to inform the patients or to obtain their permission.1 Following the uproar precipitated by this outrageous incident, James Shannon, Director of the National Institutes of Health (NIH), appointed an internal committee to review the issues involved in this disturbing episode. "In the setting in which the patient is involved in an experimental effort," the committee concluded, "the judgment of the investigator is not sufficient as a basis for reaching a conclusion concerning the ethical and moral set of questions in that relationship."

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