DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. TAB D-1 MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: May 25, 1995 RE: New Documents Concerning Early AEC Ethics and Classification Policies We enclose four documents recently located by staff in the Department of Energy (DOE) archives--including a complete copy of the November, 1947 General Manager Wilson letter--that fill in important gaps in our understanding concerning the 1947 Atomic Energy Commission (AEC) ethics and classification policies. Among other things the documents: (l) further suggest that in 1947 the AEC stated a policy requiring therapeutic benefit and "informed consent in writing" in experimentation involving "substances known to be, or suspected of being, poisonous or harmful"; (2) indicate that this standard and the decision to keep secret reports of experimentation that did not conform to it was based on the endorsement by the Advisory Committee on Biology and Medicine (ACBM) of a secret draft recommendation of the Medical Board of Review; and (3) indicate that the Manhattan Project's use of "unwitting subjects" underlay the new AEC's 1947-48 secrecy and ethics policy discussions. The documents are described in chronological order below: Attachment 1: June 5, 1947 Letter from Carroll Wilson to Robert Stone This letter indicates that the decision to classify reports on Manhattan Project human experimentation reflected concern for the use of "unwitting subjects." In the spring of 1947 AEC officials considered public relations implications in classifying reports on human experimentation. The June 5 letter refers to a request by Dr. Stone to declassify research in order that it be published in the public realm. In response, AEC General Manager Wilson stated: With reference to your third paragraph dealing with medical experiments on human subjects, this action was taken upon 1 the advice of the Interim Medical Advisory Committee.1[This group, headed by Stafford Warren, met in January 1947 to formulate a biomedical research agenda for the new AEC. Following the January meeting, the AEC lawyers asked to help formulate legal and financial groundrules for AEC funding of contract research. The result was the April, 1947 letter from General Manager Wilson to Warren, which required documentation from attending doctors that the patient understood the "clinical testing" which he/she was being subjected to.] It is believed that if human beings were the unwitting subjects of experimentation, such experiments might have an adverse effect upon the position of the Commission. Wilson told Stone that he could seek reconsideration of his request for declassification, but should take "into full account the responsibility of the Atomic Energy Commission in the eyes of the American people and the medical profession in general." Attachment 2: August 12, 1947 Letter from Carroll Wilson to Robert Stone This letter confirms that the AEC withheld declassification because some medical reports "involve[d] experimentation on human subjects where the material was not given for therapeutic reasons." Wilson explained that this issue was considered in the June meeting of the Medical Board of Review, the group established by AEC Chairman Lilienthal to advise the new agency on biomedical program and policy. Wilson explains that the Medical Board of Review had deferred a decision, and recommended that "all Project reports on human experimentation, except where the experimenter is the subject, be withheld from declassification until the question of medical and legal policy for the Commission can be determined." "I am sure," Wilson concluded, "you appreciate the questions of medical ethics and legal rights that are involved." Attachment 3: November 5, 1947 Letter from Carroll Wilson to Robert Stone This document, a continuation of the dialogue with Dr. Stone, is the complete text of the November 5, 1947 Wilson letter. As staff has previously reported, a portion of the letter was extracted in a 1951 letter from Shields Warren to Los Alamos, in response to Los Alamos' inquiry on human experimentation policy. The complete text shows that the questions of ethics and declassification policy were linked, and that the policy cited in 1951 reflected the ACBM's affirmation of an "unpublished and restricted draft" of the Medical Board of Review report to the Commission. 2 Wilson told Stone that his declassification concerns had been taken up at the October 11, 1947 meeting of the Advisory Committee on ' Biology and Medicine. The ACBM: reaffirmed the stand of the Medical Board of Review, which met in June, and considers the matter of human experimentation classified where the conditions cited below were not complied with. For your information, the following is quoted from the preliminary unpublished and restricted draft of the report read to the Commissioners: The atmosphere of secrecy and suppression makes one aspect of the medical work of the Commission especially vulnerable to criticism. We therefore wish to record our approval of the position taken by the medical staff of the AEC in point of their studies of the substances dangerous to human life. We believe that no substances known to be, or suspected of being, poisonous or harmful should be given to human beings unless all of the following conditions be fully met: (a) that a reasonable hope exists that the administration of such a substance will improve the condition of patient, (b) that the patient give his complete and informed consent in writing, and (c) that the responsible nearest of kin give in writing a similarly complete and informed consent, revocable at any time during the course of such treatment. Were it not for the extreme value and pressure for securing reliable information on the limits of human tolerance of radioactive substances there would be no need for explicit reference to this subject. We wish to see immediate and steady increase in the gravely important subject of human tolerance of radioactivity, but we believe that since secrecy must of necessity mark much of the medical research supported by the federally-sponsored AEC, particular care must be taken in all matters that under other circumstances would be open to investigation and publicity. It may be recalled that in its public report, the Medical Board of Review spoke strongly of the need for openness in scientific inquiry, declaring that "in so far as is compatible with national 3 security, secrecy in the field of biological and medical research be avoided."2 [See page 11 of the Board's June, 1947 report, which appears in the May Briefing Book.] Attachment 4: November 5, 1947 Letter from Carroll Wilson to Alan Gregg Gregg served on the Medical Board of Review and as the chairman of the ACBM. Following his letter to Stone, Wilson indicated to Gregg that the ACBM should not issue a policy on human experimentation because the policy articulated by the Medical Board of Review in June, 1947, was adequate. 4