Consent to Act as a Human Subject; Experimental Subject's Bill of Rights

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Lawrence Livermore National Laboratory UNIVERSITY OF CALIFORNIA LA'ARENCE LIVERMORE NATIONAL LABORATORY Consent t o Act as a Human Subject LLNL Human Subjects Committee Approval Date: June 13, 1980, December 15, 1981, October 11, 1984 Air Tagged w i t h Radioisotopes 1 3 ~and 4 1 ~ r 1.I hereby consent toact as atest subject in the joint Naval Medical Research and Development Command - Lawrence Livermore National Laboratory study titled Human Subject Experiments With Air Tagged 2. I understand that the procedures for conducting this test will Breathing 13N and 41Ar labeled air for up to 120 minutes. 3. I understand that any possible risks and discomfort that may result from the procedures are considered unlikely but include: a. The discomfort from breathing through a mouthpiece for up to b. Any exposure t o ionizing radiation carries a risk of causing cancer--in this case potentially of the lung o r upper air passages where the most significant part of the radiation dose i s delivlered. The best estimate of the risk of lung cancer from this procedure lies between one chance i n 100,000 and one chance i n 10,000. The radiation exposure tothe lung and air passages in this procedure will be less than 0.4 rem. This amount is slightly below the Federal exposure limit for annual exposure of the general population; i s one tenth of the permissible annual exposure of radiation workers; andis approximately three to four times the radiation received by the public in most geographical areas ofthe United States from natural sources and average usage for medical an dental

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Air Tagged W i t h Radioisotopes 1 3 ~and 4 1 ~ r Approval Date: June 13, 1980, December 15, 1981, October 11 , 1984 4. Since this activity does not involve medical treatment, there is n o alternative procedure which might be advantageous t o me. 5.Atthe conclusion of this procedure itis expected that I will be able t o function normally immediately. 6. I further understand that this study may result in no direct benefit t o me butit ma.y contribute to the understanding of nitrogen uptake and elimination in the body and may therefore, aid in the understanding olf decompression sickness. significant benefit to the diving profession in the future,and will be made available as soon as the studies are completed. The findings will be of 7. I understand that and/or such assistants as may be se1ec:ted will answer any inquiries I may have a t any time concerning t h e procedures and/or investigation. 8. Any publication arising from this study will be made without specific reference t o my name. 9. I recognize that my participation in this experiment is entirely voluntary and I: may refuse to participate or may withdraw a t any time without jeopardy. the investigator may in his absolute discretion terminate the procedures and/or investigations at any time. Owing to the scientific nature of the study, 10. I understand thatI am entitled to a copy of this consent form and the Experimental Subject ’ sBill of Rights. 11. Paul Meyer, an eniployee of the University of California, Lawrence Livermore National Laboratory, i s responsible for the conduct of the research i n wh.ich I am to participate. This research i s sponsored by t h e NavaL Medical Research and Development Command and Lawrence Liv ermor e Nation a1 L a bor a t ory .

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LLNL Human Subjects Committee Air Tagged With Radioisotopes 1 3 ~and 4 1 ~ r Approval Date: June 13, 1980, December 15, 1981, October 1 1 , 1984 12. I understand that if I have any complaints o r concerns about the procedures, I may address them t o Vivian L . Shepherd, Secretary of the Human Subjects Committee, i n person, by telephone, or in writing. Ms. Shepherd can be reached a t (415) 423-2887, L-319, Lawrence Livermore National Laboratory, P.O. Box 808, Livermore, CAY T o be completed i f !Subject isa minor o r otherwise unable t o sign: Subject isa minor (age-) o r otherwise unable t o sign because: Father Legal Guardian

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Lawrence Livermore National Laboratory EXPERIMENTAL SUBJECT'S BILL OF RIGHTS The management and !staff of the University of California, Lawrence Livermore National Laboratory, wish you t o know: Any person who i s requested t o consent to participate as a subject in a research study involving a medical experiment, o r who i s requested t o consent on behalf of another, has the right to : 1. Be informed ofthe nature and purpose of the experiment. 2. Be given an explanation of the procedures t o be followed i n the medical experiment, and any drug or device t o be utilized. 3 . Be given a description of any attendant discomforts and risks reasonably t o be expected from the experiment, i f applicable. 4. Be given an explanation of any benefits to the subject reasonably t o be expected from the experiment, i f applicable. 5. Be given a disclosure of any appropriate alternative procedures, drugs o r devices that might be advantageous to the subject, and their relative risks and benefits. 6. Be informed o f the avenues of medical treatment, i f any, available to the subject after the experiment, i f complications 7. Be given the opportunity t o ask any questions concerning t h e experiment or t h e procedures involved. 8. Be instructed that consent to participate in the medical experiment may b e withdrawn a t any time and the subject may discontinue participation in the medical experiment without 9. Be given a copy ofthe signed and dated written consent form. 10. Be given the opportunity t o decide t o consent or not t o consent toa medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, o r undue influence on the subject ' s decision. I f a t any time you have any questions regarding a research study, the researcher or his / her assistant will be glad t o answer them. You may also seek assistance from the Human Subjects Committee which was established for the protection of volunteers i n research projects. The Secretary of that Committee, Vivian L. Shepherd, may be reached by Friday,or writing tothe Human Subjects Committee, L-319, Lawrence Liverinore National Laboratory, P.O. box 808, Livermore, CN 94550.