Document text
Machine-read from the scan, so expect some errors. Lines that couldn’t be read are left out.
Page 1
Divisi o ii of Biology aid Medicine Research Projects Involving Testicular Radiation of Volunteer Subjects : PACIFIC NORTITWEST RESEAP,CH FOUXDATION, AT(45-1)1780, Seattle, Washington, I. NEED FOR THE STUDY: Sufficient data had been accumulated at this point in time (1963) t o of the most radio sensitive tissues of the body, demonstrable effects resulting from doses of about8rads, and (2) the kinetics of spermatogenesis in man differs from that of other mammalian species to the extent that extrapolation of data obtained from laboratory animals to man would be hazardous if not impossible. The primary differences in spermatogenesis of man include : 8 # (1) the germinal epithelium of mammalian testes i s one (a) The stages of cellular as soci.ation within these mini fe rous tubules are random i n man and sequential in other mammals. (b) There are fewer cell generations between the stem cell and the primary sperm a to cyte in man, Germinal cell recovery kinetics following germ cell damage i s different in man which results in a longer recovery period following irradiation than extrapolation from bull and rodent data would indicate. Spermatogonia that survive irradiation in the rodent will repopulate these mini fe rous tubule prior to maturation division that begins the spermatogonia in these mini fe rous tubules of man will remain "dormant" for a prolonged period,then begin maturation into subsequent generations without first re populating the tubule. of the surviving germ cells before this process is checked and repo pula - tion finally begins. The mechanism of this " maturation depletion " i s not yet understood. This results in further depletion ' In summary, due to the extreme radio sensitivity of these mini fe rous epithelium and because we did not know the dose - effect relationship and dose - recovery relationship of ra iii iLl oll on tile human testes, two studies
Page 2
The purpose of parallel studies provides important confirmatory information and adds more credence to the final results. project was planned to include the effects of neutron irradiation on 11. APPROVAL OF THE STUDIES: Initial scientific approval was given by the Division of Biology and Medicine Research Committee i n May 1963. Special consideration was given to the legal and ethical aspects of the projects, ' Penitentiary were to be used in Dr. Heller's studies and volunteers at Washington State Penitentiary were t o be used in Dr.Paulsen ' s studies. Approval was obtained for each project from the respective penitentiary Superintendent, Warden and Chief Medical Officer,the legal consultant of the State Board of Medical Examiners for the State of Oregon and the State of Washington, the Assistant Attorney General for the State of Washington and Institutional officials. Counsel, AEC, was made aware of the studies. Inmate volunteers at the Oregon State A single advisory committee was established by both investigators and became In response to the HEW Surgeoil General ' s memorandum of February8, 1966, concerning clinical investigations involving human beings,the Pacific Northwest Research Foundation established a "Human Use Committee" t o review research applications involving human subjects. The committee convened on May 9,1966,to review the methods involved to assure the rights and welfare of human subjects involved in Dr.Heller ' s research project. The program has since been reviewed by this committee on an annual basis.Alist of members are attached. (Attachment 1). Dr.Paulsen ' s program was reviewed by five Washington University committees concerned with the use of human subjects in experimentation s. (Attachment 2). I11 e SELECTION OF PRISONER VOLUNTEERS