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United States Government Department of Energy Action Hemorandum on Protection of Human Subjects c. ' Per our conversation of April 23, 1986, I am providing a summary of t h e etat us of the subject action memorandum. on animal subjects is still being discussed with GC and is not yet ready subject memorandum will require a considerable expenditure of time and effort from a number of people. obtain for us from XA for the expeditious writing of what promises t o be a lengthy new DOE Order, as well as in the revisions to the current 10 CFR At this time the parallel action As you are well aware, carrying out the recommended actions of We would be most appreciative of any help you can At the present time,a draft revision of DOE 4300.U, Non-Department of Energy Funded Work is being circulated. ORER as the Office to review and concur in all research involving human or concurrence with DOE requirements for the protection of such subjects. respect to the subject action memo, concurrences have been received from PEP PE, RW, NE, and CE. Concurrences with comment have been received from have no problem vith this request. in the action memo. We will be addressing this shortly. DP requests a change from "concurrence*t t o "coordinate" on action item #2. opinion, "coordinate" i s not strong enough and we will maintain "concurrence" 88 t h e language of choice. subject research at DOE eites. This revision explicitly identifies This will 80 a long way toward establishing formal With GC requests to review all informed consent forms. We MA requests that a timetable be included Lastly, nonconcurrence has been received from El3 has requested that they concur, as well as OHER, on all human This issue is currently being reviewed. When the above items are resolved,the action memo will be redone and completed. You will be BO advised. Deputy Aseociate Director for Health Office of Energy Research and Environmental Research
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' DI'JiS1CN INITIALS 1 DIVISION I INITIALS i DIVISION f INITIALS 1