Final report of the Advisory Committee on Human Radiation Experiments.

  • United States. Advisory Committee on Human Radiation Experiments
Date:
1996
Catalogue details

Licence: Public Domain Mark

Credit: Final report of the Advisory Committee on Human Radiation Experiments. Source: Wellcome Collection.

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    Redman’s characterization of the American Medical Association’s guidelines, as we shall see in chapter 2, is partly incorrect. The requirement of a therapeutic intent is absent from the AMA guidelines. The possibility of direct therapeutic benefit for the patient was, however, a condition of research according to both of General Man- ager Wilson’s 1947 letters. Shields Warren, the DBM chief, responded to Redman by citing Wilson’s November 5, 1947, letter to Stone and by excerpting the con- ditions quoted above.7° But Warren did not term these conditions “standards” or “require- ments.” Rather, Warren’s response to Los Alamos “urges” compliance with these “guiding principles.”?7 Though Los Alamos was provided with the criteria stated by Wilson in November 1947, General Manager Wilson’s statements were not routinely communicated in response to requests for guidance from non-AEC researchers. In an April 1948 letter to the DBM, a university re- searcher explained that the Isotopes Division had approved his request to use phosphorus 32 for “experimental procedures in the human... sim- ply for investigational purposes and not for treat- ment of disease.” What, the researcher wanted to know, should be done about “medical-legal aspects” and “permission forms”??8 The request could have been answered by referring to Wilson’s 1947 statements about consent. In- stead, the DBM simply referred the researcher to the Isotopes Division at Oak Ridge.”? In its response, the Isotopes Division did not indicate that consent should be solicited, as Wilson had stipulated. The Isotopes Division, stating it could be “of little assistance,” declined to pro- vide “legal advice,” save to note that “we under- stand that most hospitals do require patients to sign general releases before entering into treat- ment. ”3° From 1947 onward, the AEC had ample op- portunity to disseminate a research policy. The AEC routinely provided educational and admin- istrative materials to applicants for AEC fund- ing and to the far greater number of applicants for AEC-produced radioisotopes. The isotopes distribution program, in particular, included a sophisticated structure of regulation, replete with review committees, training courses, and informational brochures (see chapter 6). At the federal level, this included the Subcommittee on Human Applications of the Committee on Iso- tope Distribution, whose very purpose was “to review all initial requests for radioisotopes to be used experimentally or otherwise in human be- ings [emphasis added].”*! The AEC Subcom- mittee on Human Applications was supple- mented by similar committees at the research institutions where the work was conducted. In principle, there does not seem to be any reason these local committees could not have been instructed by the Isotopes Division on con- sent requirements.** Some evidence suggests that in March 1948 the Subcommittee on Human Applications discussed consent requirements for healthy subjects and patient-subjects. In a docu- ment dated March 29, 1948, the Subcommit- tee on Human Applications appeared to resolve that 1. Radioactive materials should be used in experi- ments involving human subjects when infor- mation obtained will have diagnostic value, therapeutic significance, or will contribute to knowledge on radiation protection. 2. Radioactive materials may be used in normal human subjects provided a. The subject has full knowledge of the act and has given his consent to the procedure. b. Animal studies have established the assimi- lation, distribution, selective localization and excretion of the radioisotope or derivative in question. 3. Radioactive materials may be used in patients suffering from diseased conditions of such na- ture that there is no reasonable probability of the radioactivity employed producing manifest injury provided: a. Animal studies have established the assimi- lation, distribution, selective localization and excretion of the radioisotope or derivative in question. b. The subject is of sound mind, has full knowl- edge of the act and has given his consent to the procedure... . 4. Investigations are approved (1) by medical di- rector or his equivalent at the installation responsible for the investigation, (2) by the Director, Division of Biology and Medicine, and (3) full written descriptions of experimen-
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