Summary Sheet, Proposed Program Regarding Persons Injected with Plutonium During 1945-47

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Sub iect : PROPOSED PROGRAM REGARDING PERSONS INJECTED WITH PLUTONIUM To seek Commission approval of a course of action with respect to eighteen (18) persons injected with plutonium in connection with a Manhattan Engineering District (MED) and Atomic Energy Commission (AEC) research program during As a result of Commission consideration of this matter during recent executive sessions, the following actions, including certain alternatives, have been considered and are now presented for Commission approval (with the exception of previously authorized and now completed action 1, The Director, BER, has informed the directors of institutions, involved in the performance of studies on the above patients, of the need to have future studies on these human subjects reviewed by their institutional review (human use) committees. la. The Atomic Energy Commission will seek to discover all available information regarding the matter. This inquiry will take the form of a search for documentation of events and the interview of interestec Division of Inspection, with assistance from the Division of Biomedical and Environmental Research (BER). All interviews will be conducted on a - regularized basis by a team(s) of BER and Inspection Division representatives. The detailed plans and procedures will be formulated by these two Divisions in consultation with the Office of the General Counsel. This investigation shall be conducted as rapidly and completely as possible. The investigation will be conducted by the

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lb. The AEC will undertake afact finding investigation regarding the matter. The investigation,to be conducted jointly by the Divisions of Biomedical and Environmental Research and of Inspection, shall be sufficiently complete t o provide information the matter, (b) the capability for well informed public disclosure or for public response inthe event of prior external disclosure, and (c) an adequate basis for a report to be submitted toa non-AEC review committee discussed below i n C. i f review by such a committee i s requested. E e necessarily establish the legal culpability of individuals nor meet the needs of the Office of investigation will take the form of asear c&or relevant documentation and the interview of principals as well as persons having contributory background.informatCon. During prefatory remarks t o interviews a s recommended by the Office of the their potential involvement in legal actions. \ required f o r (a) accurate Commission knowledge of\\, .. investigation to be conducted at this time will not , General Counsel inthe event of AEC liability, The , General Counsel, principals will be advised of Under either la.orlb. above, interviews will be conducted i n accordance with one of the following options as selected by the Comission: All interviews will be taped upon consent of the Interviews of non-principals having background information and of AEC contractor personnel will be taped upon their consent. principals, an interview team will prepare a report based upon handwritten notes, return to the inter - viewed person for correction of that report and for hisor her signature on the corrected report. Inthe case of No interviews will be taped, but all will be conducted using handwritten notes and t h e preparation of corrected, signed reports as i n option IT.

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2. If results of the AEC investigation discussed above indicate that au ate disclosure to patient has not been made, representatives of BER and of the contractor will inform attending physicians of the four surviving patients and the family of the exhumed deceased patient of the need for disclosure of the nature of the injections and the subsequent studies conducted on them. Disclosure will be made i n such a manner that it will not interfere with the physiciandetermine the manner of disclosure and the recipient of the information, whether it be the patient,a relative or friend. surviving patients anP,,family of the exhumed The attending physician will 3. The Director, BER, ond the Director, OIS, w i l l assume joint responsibility for the prompt preparation of a response t o be available in the event of public inquiry before the investigation has been completed. C. Later and tentative actions. If results of the above investigation indicate the need for an outside review, a committee of disinterested medical scientists shall be appointed by the President of the Institute of Medicine (or some other appropriate outside party)to review this matter, including the involvement of the Manhattan Engineering District, Atomic Energy Commission and their contractors. shall make available to the committee the BER-Inspection Division report and any material information inits possession. In addition,the committee will be expected t o seek any further information that it may need. comit tees hall prepare a report suitable for public release upon the completion of its deliberations. I n accordance with certain understandings at the April1 Executive Session, D r . Liverman advised Dr. Robert Sproull, President, University of Rochester, and, with a representative of the Office of the General Counsel (OGC) advised Robert W. Berry, Esq., General Counsel of t h e Army and matter. Dr. Sproull stated that "no useful purpose could

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be served t o the patients,the University, o r the Commission by informing (four surviving) patients at this point i n time of an event now thirty years past." Dr. Green expressed a similar view but advised that he would cooperate with AEC i n any appropriate way i n connection with t h i s matter. Mr. Berry expressed the belief that a fact finding inquiry was important i n view of the likelihood of public disclosure of t h i s matter. Recomrnenda t i on : The General Manager recommends that the Comnission: Scheduling: Consideration a t an early Policy Session. Division of Biomedical w d