Response to Query: AEC Human Testicular Irradiation Project

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Beginning in 1963, AEC funded a series o f radiation experiments using as subjects inmates at the Oregon State Prison. The inmates were irradiated at varying levels t o determine the effects of such exposures on human feriility. The actual irradiations were completed 'in 1971. AEC continued D o provide support for data analysis, and ERDA is currently providing funds to maintain custody of*various medical specimens which were collecte preparation of scientific reports. fWillamette Week, a small Oregon weekly newspaper, ?rinted a story dealing with the experiments on February 17, 1976. The experiments involved 67 prisoners at the Oregon State Prison at Salem. Dr. Carl C . Heller of the Pacific Northwest Research Foundation, Seattle, was the senior investigator. In December 1972, Dr. Heller scffered an incapacitating stroke; on February 2 2 , 1973, Mavis J. Rowley, his senior research assistant, was named principal investigator and placed in charge of the numerical data and physical specimens which were collected. The total funding for the project, by AEC and ERDA, has amounted to through July 31, 1973, and $22,165 additional f o r August 1, 1973, t o July 31, 1974 -- the terminal year for the contac,t listing both Dr. Heller and Ms. Rowley as investigators. From October 1, 1974, through December 31, 1975, Mavis Rowley, now affiliated with the Swedish Hospital in Seattle, A J X provided $1.064 million from June 1963.

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has received $ 3 4 , 5 5 0 in operathg funds, under a spearate contra <e ;rs./ to assist in publishing parts of the accumulated data, and see the storage and preservation of blqod and semen samples, and material from testicular biopsies. No additional funding h a s been approved 1 In the Oregon study, the prisoner volunteers were given x-ray exposures ' t o the testes in doses ranging from 8 to 600 rads, in order to obtain data on specific male sterility caused by radiation. a single exposure, five received two exposures, and one received three To volunteer and be considered, prisoners were required to be under life sentence. Each inmate agreed to have a vasectomy at the completion of his part of the project; consent of the prisoner's wife was obtained for this procedure. All prisoners involved eventually received a vasectomy. Ages o f the irradiated prisoners ranged from 25 to 5 2 . The consent procedure involved full explanation of the short- and long-term effects, usually in the presence of a chaplain. were required to have a preliminary psychological examination and to sign notices of inforined,consent. It w a s made clear to each subject that he could withdraw from th2 experiment at any time. The justification 2i.ven for the project at the time was thst data - drawn from experiments vith animals could r o t be extrapolated to rnaF-. The study w a s approved only after all appropriate human use committees

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and criteria which weresthen in effect had been satisfied. (A Committee was established in 1966, in response to the Surgeon memorandum of February 8 , 1966.) The procedures and standerds were again reviewed at later stages in the research. At the time the project began, the question of radiation-induced sterility was considered critical, and it was felt that the objectives 'Of this research were valid. All guidelines governing the use of humans in experiments, which had been set forth at that time by the Department Questions will probably be raised concerning ERDA's position on this apecific experiment, and on the general issue of using humans a s subjects in medical-scientific experiments. The Oregon prison study was initiated at a time when the use of prisoners in experiments was much more couimon khan at present. The record suggests that for many of the volunteers a prime incentive to participate in the experiments was the feeling that they were performing an important public service. As to ERDA's current attitude toward such experiments: It is, and will continue to be, ERDA"s policy to try to learn as much as possible frou the experience of humans who have been subjected to radiation through accidental or occupational exposure. However, it is difficult to imagine circumstances under which ERDA's need for information would be so compelling as to warrant experiments involving the irradiation of hL:nar,s for the sole or primary purpose of studying effects.

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If an occasion were to arise in which information on radiat onr effects was desperately needed t o protect national health and sa and there were no other way to obtain such information, it is conIn that event,ceivable that ERDA might consider using human subjects. ERDA would be controlled entirely by HEW or other prevailing national guidelines. It should be emphasized that the possibility for future rERDA irvolvement in such studies is extremely remote. (Although the Willamette newspaper is not expected to discuss it, the AEC supported a similar project beginning at the sane time in Washington State Prison at WalZa Walla. The contract, with Dr. C. Alvin Paulsen, School of Medicine, University of Washington, was terminated in 1970-71, after seven years and a cost of about $5C5,000. prisoners were involved in Washington state, and the same basic criteria Public Affairs Officer Office of Public Affairs