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ADVISORY COMMIlTEE ON HUMAN RADIATION EXPERIMENTS Environmental and Life Sciences Oflice of the Director of Defense Research and Engineering In the course o f reviewing the history ofthc University orCincinnati's involvement with total body irradiation (TBI) as therapy and DOD funding of studies dependent on this underlying clinical practice, the Advisory Committee has raised questions about the potential for R similar cthically problematic situation arising today, As you know, DOD Punded several extramural studies ofthe acute health nnd performance effects of high dosage total body irradiation in thc 1960s and 1970s. These studies were also focused on finding a biological dosimeter of external radiation exposure, Dr. Eugene Saengcr at the University of Cincinnati was the last clinician-researcher to be funded by DOD for work in this area. through contracts awarded between 1960 and 1971 The issues that this past episode raises for current policies concerning human subjects research arc the following. If future opportunities for conducting non-therapeutic research in conjunction with either therapeutic research or innovative standard therapy arose, would l R B s or ethical review in DOD consider the full scope of the subject-paiient's experience with the intcrvention in . Would 1RBs or other DOD reviewers consider the (potentially ddrimental) effect of Federal thnding for the add-on research on patient care decisions. regardless of whether the underlying treatment itself is experimental or standard?
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The Advisory Committee would like to know how DOD human subjects research policy and reviews today can be expected to address complex research scenarios like this one. Do DOD's policy guidelines for IRB review address the question of multiple-purpose research, particulfuly with respect to the underlying care, directly? We would apprcciate your response IO these questions by Ma): 12, understanding that this is a tight deadline. Please contact Wilhelmine Miller (254-9795) if you would like to discuss this requcst further. Thanks for your continued Col. Claud Bailey