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During th.e three - t o six-month control period, plasma samples were collected six times, seminal fluid was collected once weekly and one testicular biopsy scheduled. Prior to any collections,a consent form was explained and signed. If during the control biopsy procedure the volunteer created any disturbance or if any problems arose following the procedure, the investigating physician discussed the problems with him and decided whether he should be dropped from t h e program. Atthe end of the control period (about six months), all available data were examined for normalcy (testicular biopsy, hormone analysis, sperm count and morphology, physical condition) and the man's attitude and reliability evaluated. If all were favorable, he was considered for a specific project. The exact procedures and potential risks of that project were explained to him i n great detail and he was allowed t o decide i f he wanted to participate in that projector would rather be i n another specific program. Once a man selected the projects in which he wanted to participate, t h e proper consent forms were discussed and signed. During the actual experimental program, the man could discontinue taking a drug a t any time without notice. He could also refuse a testicular biopsy a t any time. If a biopsy were refused late in the project,the man would be allowed to continue collecting semen be dropped, although .he was observed medically to in sure no untoward reactions from the agent admini ste red. If it.were refused early in the project,the man wuld b)Did any test subject fail to have a vasectomy? None ofthe 67 Oregon prisoners refused vasectomy. Washington prisoners did not have a vasectomy prior to termination of the program for the following reasons: Declined and released from prison2 Declined and still in prison1 Vasectomy prior to prison sentence 1 Released earlier than scheduled vasectomy Mutual agreement (myocardial in farc t and Not requi red because of Sert ol i- cell - only Not required for sham ir radi tion procedure 3 Agreement with prison physician for
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c ) Were any of the test subjects subsequently released from incarceration ? As of the termination of the prisoner irradiation s in 1972, it i s documented that three prisoners without vasectomies were released. From the reports, it is clear that some prisoners with vasectomies were also released, but, we were unable to find a documented number. d)Did any of the test subjects subsequently father any children ? With what The experimental design was such that released prisoners did not continue t o participate in the experiment; therefore, no follow - u p data is available to answer this question. The attached letter from W . E. Johnson t o John R. Totter indicates that the AEC suggested follow - up in the form of periodic medical examinations. This was, however, opposed by the prisoners and by the prison officials and was not put into effect. Some prisoners did return voluntarily for exarninations,but data on them was not entered into the study.
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e ) Were any subjects tested for subsequent genetic or somatic damage? The prisoners ' reproductive normalcy was determined prior to irradiation by physical examination, examination of testicular biopsy specimens, sperm concentration and sperm morpho1ow. Level s of urinary total gonadotropins, estrogen and/or plasma LH, FSH, and testosterone were also determined. irradiation observations were made on each parameter mentioned above. Exploratory investigations on the mapping of mei o tic (pachytene) chromosomes were conducted in order to establish a basis for the evaluation of irradiation effects. Not sufficient precision nor quantitative data resulted. Observing the usual parameters o f chromosomal breaks, bridging,translocation and other gross chromosomal defects confirmed that,in man, as in other species, radiation at dose levels of 10r and above caused damage. The recovery time was longer for the higher doses than for the lower doses. participant of these studies who is,oris thought t o be, still living. Please identify the health status, names and addresses o f each See cover letter.