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Machine-read from the scan, so expect some errors. Lines that couldn’t be read are left out.
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Minirnal risk exposures vs high risk exposures: NASA deals with minimal risk exposures (studies conducted by AEC at Oak Ridge were exception) Special populations vs general populations: NASA deals with astronaut employees who are a special population in terms of their potential subjugation as research scrbjects -- Numerous ethical issues are involved in the use of astronauts as experimental subjects in biomedical research, particularly around the issue of consent and balancing of (1) need for understanding of biomedical effects of space flight, (2) large investment in astronaut training, and (3) c7strotiaiits1autonomy regarding participation as subjects in biomedical radiation. This category does not include common and routine clinical practices, such as established diagnosis and treatment methods, involving incidental exposure to ionizing radiation. (2) (irrelevant to NASA -- no intentional environmental releases designed to test human exposure) + Concerns with definition (intent) and needs for clarification: radiation in an experimental context or does it mean intentional exposure to ioriizing radiation for the purpose of studying radiation effects? A retrospective study could not involve "intentional exposure to ionizing radiation" from the point of view of the retrospective study, even if the initial exposure was intentional. ( 1 ) Experiments on individuals involving intentional exposure to ionizing 1. Does definition (1) mean any intentional exposure to ionizing 2. Does definition (1) include retrospective studies of radiation effects? Included in definition (intent): Early human dose-response studies conducted by AEC at Oak Ridge. Development of techniques to measure total-body calcium using wholebody neutron exposures. , Development of techniques for determining bone and soft tissue composition using radionuclide absorptornetry. Probably not included in definition (intent), but NASA including in review: experimental context, not given for the direct benefit of the patient (subject) -- studies on astronauts (special population) , bed-rest studies to determine effects of reduced gravity on human physiology (not special population -- minimal exposure, low radiation risk), etc. Any retrospective study of radiation effects involving intentional exposure to ionizing radiation, even i f that exposure resulted from "established ...treatment methods" for the patient's benefit -- Radiation Health NASA Specialized Center of Research and Technology (NSCORT) study of cataract development in patients exposed to high energy helium ions for treatment of uveal melanomas. Any use of X-rays, radioisotopes or other clinical exposures given in an
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Not included in definition (intent): Occupational exposures in routine ground-based activities (loading radioactive sources aboard spacecraft, work with and routine clinical monitoring using X-rays and radioisotopes, etc.) -- monitored as part of routine occupational health program which is not research. Occupational exposures of astronauts (space flight, routine clinical monitoring using X-rays and radioisotopes) -- monitored as part of Longitudinal Study of Astronaut Health, but not "intentional exposure to ionizing radiation" for the purpose of studying radiation effects.