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- I. In biological research it eventually becomes desirable that the results Of laboratory experimentation be app lie a to huinan subjects, the aims being the furthering of scientific knowledge, and the relief of human.ills.A basic distinction must be drawn betweell research projects whose aim is essentially therapeutic, and clinical research,whosa object is purely scion ti fic and without potential va he ts the research subject. clinical research projects who is not legally competent and in such mental and physical state as t o be able to exercise fully his power of choice to participate in the research project. Committee is unable to anticipate the necessity of the use of: minor children or adults wh:, for one reason or another are unable . to provide informed consent for the procedures to be carried out, In this Laboratory, no human subject will be used i n Written consent for the research procedures will always be secured prfor to the actual investigative activities. - The subject is free t o withdraw from participation inthe project a t any time, without stated cause, The investigator must terminate the expe?iment if findings indicate the probability of injury tothe research subjects. Research projects involving human subjects will always be non-trivial, in some way relevant to humanitarian ends, and lsa ding t o results not available by other means. knowledge of results of animal experimentation a n d scientif Lc evaluation of the problem under study so that the anticipated results justify the performance of t h e experiment. They .will be based upon It is not anticipated that infliction of pain and suffering, o r the production of demonstrable injury or disability in the research subject can ever be condoned. Research involving human subjects can be carried out only by scientifically qualified persons and under competent medical Committee consists of the following : The Los ALomos Scientific Laboratory Human Studies Review Henry Keyman, Attorney, Legal Liaison, L4SL David Law, h1.D. Chief, bledical Services, Alb quer que VA Hospital ; Professor of hledicice, L?iS! Biomedical Kesearch Group, LASL
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Leader of Industrial Hygiene Grou ? , LASL LASL, and forrnsrly Staff Physician, USFDA and Alternate Health Division Leader, LASL Research will be given institutional review and approval pri to the submission of research proposals. If necessary, subsequent reviews will b e carried out by the Committee if this is warr a a ted : delays in instituting research, or if a rapidly changing scientific area requires reassessment of risks. The Review Committee w i l l independently examine the research plan to assess all possible hazards, and t o see that all appropriat safeguards are provided. It recognizes that in any medical .emergencies that might arise, even from supposedly routine procedures, the physicians of the Industrial i.Iedicine Group of LASL or the facilities of the Los Alanos Xedical Center are close by and immediately available. The Committee will require written informed consent from the research subject himself. Ne cannot consider circumstances which - would require use of a research subject who is a minor, or who for other physical or legal reason is incapable of giving informed consent. The Committee will review the adequacy of the consen;., . in light of the risks to the subject and the circumstances of research, and asto whether ths information given the subject is afair statement of the procedure, its possible benefits, and its In all cases, The Committee will carefully consider the relative weights of risks and benefits of the procedures to the subjects, and the motivation of the subjects in submitting to them. it may still prescribe conditions or'restrictions on the conduct of the proposed research,indicate areas of possible change which nllst be brought t o its attention, and establish the nature and frcquency of interim review procedures. Although the Committee may give ii favorable overall re com end a Favorable review and reconmendat ion by the LASL Review Committee is subject to further appropriate review or rejectim by the Committee as further information is developed. Administration mayl of course, subject the project to further appropriate reviev or rejection in spite of r'avorable action by the Review Committee.
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Unfavorable review, restrictions, or conditions can b e rcmvec only by the LASL Review Committee itself. The Committee will attempt to deal promptly crith propos3ls . brought before it, and will advise the scientist proposing the research fully and frankly of the reasons for its actions.