= - OPTIONAL FORM NO 10 MAY 1982 EQITION AOse 3010-107 GSA GEN. REG. NO. 27 UNITED STATES GOVERNMENT Z D Memorandum TO Dr. Charles L. Dunham, Director Division of Biology and Medicine pate: MAY 13 1966 (.-— FROM Bertram H. Sch Associate Generar’ SUBJECT: USE OF HUMAN VOLUNTEERS IN BIOMEDICAL RESEARCH Counsel Tis is in reference to a proposed memorandum to bring to the attention of the General Manager the contemplated new AEC biomedical research project involving the use of human volunteers. As we understand it, convicts, college students, and other individuals, twenty one years of age or older, will be invited to volunteer, and monetary consideration will be paid for their services. These individuals will ingest or be injected with promethium-147 or plutonium-237. This program will be conducted for AEC by the Hanford Occupational Health Foundation. You have asked for our views. From the legal standpoint, there are two areas of potential risk which should be considered in the use of human volunteers in experiments: 1. Risk of adverse effects from the radiation experiments properly carried out; for example, the risk that the intended dosage of 0.1 roentgens might cause some pathological condition in certain individuals, 2. Risk of injury from negligent conduct in the course of the experiment; for example, the risk that an experimenter might be negligent in the operation of the radiation source and give dosage of 1.0 rather than 0.1 roentgens causing injury to the volunteer. It 1s our opinion that each volunteer should sign a written, witnessed agreement in which he or she states that he or she is in sound mental and physical condition and is participating in the experiment on his or her own volition, that he or she understands that what is being done is for experimental purposes and not for the treatment or diagnosis of the individual, and that he or she understands the nature, procedures, and prob- able effects of the experiment. In addition, the agreement should set forth the nature and purpose of the experiment, the procedure to be used (including a description of the individual volunteer's participation or use in the experiment), the known possible risks, if any, and the arrange- ments, if necessary, for possible termination of the experiment or research (e.g. if the volunteer later desires to withdraw from the experiment). It would be advisable if the agreement also negated any inference that the paid volunteers are employees of the contractor for purposes of the experiment. The agreement should be signed only after the volunteer has had an Buy US. Savings Bonds Regularly on the Payroll Savings Plan B88;