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Archivtr md ROW & OMCO Tnis ciocument esta ulis ii es tne policies and procedures for the protection of human su j ect s uiider projects conducted by tile -awrence berkeley Lau orator - of the University of California. It also serves to hp lune nt tr Le specific requirements of me a s sec forth in trie Federal it egis ter of 14ay 30, 1374, Vol. 39, The policies and procedures set forth here in apply to all act i - vi tie sir resp active of fund source, wiiich involve human subjects for which the Lawrence aerie ley Laboratory is responsible. A . "Subject a t itiak" means any individual who may be exposed to the possibility of injury,including p nys ical, psychological or social injury, as a consequence of participation as a subject i n any research, development, or related activity, which departs from tile application of tnose established and accepted metiiods necessary to meet his needs, o r whicn increases the ordinary risks of daily life,including tile recognized risks inherent in a chosen occupation or field of service. Tiiese may include patients,out - patients, donors of organs , tissues, body fluids, and service,including normal volunteers. Uf particular concern are minors, tile mentally ill or retarded, prisoners, persons subject to military discipline and employees wnose employment relations nip to t ne principal investigator might render t nen subject to coercion. The unborn and tile dead should be considered subjects to the extent tn at they have rights whicn can be exercised by their next of kin or legally autiiorized In addition to physical risks,subjects may be exposed t o psychological risks, through inadequate or inaccurate understanding of tne procedure being conducted, or carelessness about tne maintenance of confidentiality of records. Social risks are related intne main t o procedures tnat may place t ne reputation or status of a social group or institution in jeopardy. 6. "Informed Consent" mdans the knowing consent of an individual o r his legally auriiorized re2resent at ive so situated as to be able to exercise free power of choice without undue inducement o r any element of force,fraud,deceit,duress or any other form of constraint or coercion. 'I'ite basic elements of information necessary t o such consent include: 1. a fair explanation of tne procedures t o be followed, and
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tneir purposes, including identification of any procedures which are experimental; reasonably t o be expected; tnat might be advantageous to the subject ; consent, and t o .discontinue 2art i cig ation in the projector activity at any tine,without prejudice to the subject. 2.a description of any attendant discomforts and risks 3.a description of any benefits reasonably t o be expecti.. an offer to answer any inquiries concerning txe pro6. an instruction ti at t ne person is free to withdraw his a disclosure of any appropriate alternative procedures 1.04 Sl'AT'Ei\Ei?T OF PAIN CI PUS A. The Lawrence Berkeley Laboratory accepts as basic ethical to health orwell being; research,training, development and other activities who are outweighed by the potential benefit to him o r by the imaortance ofthe knowledge t o be gained, and formed consent is to be obtained without duress or deception i n those cases where human beings will Le or are likely to ue B.All persons involved i n planning, approving, conducting, or supervising activities involving human subjects must oe aware of their joint responsibility for tne welfare of tnein - divi dual s who serve as subjects. C. While the authority for approving, modifying o r disapproving the involvement of subjects in a proposed investigation rests with tile Laboratory's Committee for tile Protection of Human Subjects, compliance wit n the DHEW regulations and tale Laboratory ' s policy, is .a basic responsibility of t ne individual investigator. Wnenever he lacks knowledge t o make an informed judgment, it is his obligation to obtain the advice of knowled gable individuals. D. Any possible hazard to health resulting from procedures utilizing numan subjects must be first investigated througn animal research, whenever sucl ~be possible and relevant. E. Administration of medications o r pharmaceutical sw stances, diagnostic or therapeutic procedures, o r exposures t o nazardous environmental conditions,require medical supervision. 1. no human subject is to be exposed t o unreasonable risk 2.the rights and welfare of all subjects involved i n 3. tn at the risks to an individual must be significantly 4 . that adequate and appropriate legally effective in -
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Lowrrnco Bork rly LDbOralOIy F. The nature of the activity, the procedures t o be followed, and the possible risks involved must be carefully and fully explained to t ne subject,parent,or guardian, as appropriate. The explanation must have bean fully understood and legally effective informed consent ob ta he das appropriate. G. The subject ' s personal privacy and the confidentiality of information received from him must be protected. H. Any subject may request termination of n is participation i n an experiment a t any time, and this request will be honored promptly and without prejudice. I. Remuneration may be offered to a subject as recompense for his time or inconvenience, provided that such remuneration i s not so large as to constitute an improper inducement. J. Tlie University will provide, a t no cost to the subject, adequate medical treatment for hospitalization as required during or as a direct result of an experiment. Sucn individual cares n all be provided without the necessity for establishing legal liability on the part of the University. The subject ' s ri grit to compensation for damages must, however, be established on trie basis of legal liability,e.g., negligence o r wrongdoing, on the part of the University. A . Organization of tne Committee The Committee must consist of atleast five members, a t least one of wnom must not be employed by, o r otherwise affiliated with,the Laboratory apart from his membership on the Committee. N embers must possess varying qualifications, backgrounds and experience, which will assure complete and adequate review of projects and activities commonly conducted by the Laboratory. Atleast two members of the Committee shall be medical doctors, and atleast one member shall not be a medical doctor,but shall be competent in other relevant areas. the chairman and members of the Committee shall be made by the Director, Lawrence Berkeley Laboratory, and the term of service shall be a this pleasure.k quorum of the Committee shall consist of a majority of the total membership. mittee membership i s set forth in Appendix "A". a. Functions of t h e Committee The Committee has two responsible functions: 1. t o determine and certify that all Laboratory activities utilizing human subjects conform to the regulations and policies of DHEW, the Laboratory, and the University, concerning the safety,welfare,health,rights and privileges of human subjects ; 2.within these regulations to facilitate accomplishment of project and program objectives by those whose work involves the use of human subjects.
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The Committee and the Laboratory administration desire at all times to be of service to members of the Lauoratory staff, and consultation with the Corn it tee or individual Committee membe rs in project planning is strongly encouraged. The Committee's function is to benefit the Laboratory, the scientific community, and the public through the facilitation of act iv i - ties that will extend the boundaries of human knowledge. C. Procedures f o r Obtaining Committee Review a. General. - Proposed activities involving human subjects may a- one of two basic contexts : element of a specific research proposal being submitted toa funding agency, the conduct of such activity being dependent upon receipt of support from the agency; orasa new element i n one of the Laboratory ' s ongoing research programs conducted under AEC contract W7405-eng-48. b. Projects Submitted for Funding Outside theUC. Procedure. - Eacn sucn project, when submitted for approval t o the Divisional Associate Director,shall be accompanied by an indication of whether or not the proposal will involve the use o f human subjects. This will be inthe form of a memorandum o r such other document as the Associate Director for Administration may proscribe. shall attach a protocol and consent form, as specified in secAll documents pertaining to the involvement of human subjects,or absence tn ere of,shall accompany the proposal when it is transmitted by the Divisional Associate Director through tne administrative channels prescribed for proposal submission, until it reaches the office designated by the Associate Director for Administration to serve as secretariat to the Committee for Protection of Human Subjects. Timely Submission. - I t is the responsibility of the principal investigator to submit proposals sufficiently in advance of agency deadlines to permit review and certification in an orderly manner, with due regard to the Committee's work load. Invest i - gators are advised that some agencies, DHEW included,require certification before the proposal can be transmitted to the Agency. Investigators are encouraged to discuss planned propos als with the Comit tee or individual merbers i n advance of Proposals Lacking Definite Plans for Involvement of Human SubFor certain proposa s,e use 0 iuman sj ect s may bs finitely anticipated at he %e of s%n is sion j lb iut the precise nature of their involvenent will not become known until after work under the proposal has been started. This circumstance I f human subjects are involved, the principal investigator
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Lawrenco Berkeley Laborrlory kchlv0: and moreord, Offlco would occur with a training grant,wrier e the identity of the trainees and the description of tneir projects cannot be determined until after an award is made, or in tne case of indi - vi dual fellowships, wnere research objectives are broadly outlined in the application, and specific protocols are established only after the fellowship has started. It would also occur i n research grants in which the precise eniployment of human subjects i s dependent upon the development of instruments,the completion of animal studies,t ne synthesis of chemical compounds, etc. Proposals lacking definite plans for involvement of iiuman subjects must be accompanied, wherever possible, by a de scrip - tion in general terms ofthe type of involvement anticipated, a certification that the investigator will submit protocols to tne Committee as soon as specific projects are designed, and assurance that he will not start the projects until Committee There may also be situations in which unanticipated developments inthe conduct of a project make appropriate and desir - able the use of human subjects even though their involvement was not foreseen when the application was submitted. Invest i - gators conducting such projects must submit a protocol in accord wit n section 1.05 c3for Committee review, approval, and certification,prior to the use of human subjects. Some agencies require,in addition,tn at the protocol be submitted for tiieir own approval prior to involvement o f human sun jects. W-7405-eng-48. - Investigators desiring to undertake projects involving numan subjects,not previously approved DY tne Committee, must submit a protocol as specified in section 1.05 C3. Such protocols may be submitted a t any time, butin no event may t ne project proceed prior to receipt of Committee approval. c. New Projects Supported by AEC Funds Under Contract All approved projects involving human subjects shall be reviewed by the Committee a t least annually. This review, a s a minimum, will require the investigator to certify tn at the use of human subjects has been, and will continue t o be, conducted i n accord with the approved protocol and special conditions,if any, imposed by the Committee. Any proposed change inthe use of human subjects will require the submission of a new protocol f o r Committee review and approval. jects,particularly those wit na higher than usual degree of risk,at more frequent intervals. It may also utilize oral briefing by the project director before the Committee, review of progress reports,or a project site visit. limb. - Most agencies have established deadlines for receipt oat in u ation or renewal applications. of the principal investigator to transmit his application, along The committee, at its discretion, may review certain proI t is the responsibility
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with the appropriate documents pertaining to involvement of human subjects, sufficiently in advance o f agency deadlines t o permit timely Committee review, approval, and certification. The Committee s ecr atari at will be responsible for requesting from those investigators with projects not swject t o agency application deadlines, the material required by the Committee for its annual review. Within the constraint of reviewing each project involving human subjects atleast annually, the Committee may adjust the schedule for review of projects not related to application deadlines in order to equalize its Each protocol submitted for Committee review must contain information insufficient detail for the Committee t o render an informed judgment. Inadequate protocols will be returned to the investigator, and the consequent delay may cause a propos alto miss an agency application deadline.Protocols must be signed by the principal investigator / project director and by the responsible Associate Director.It is the responsibility of the secretariat t of omar d protocols for Committee action. utilization of human subjects; tne proposed project with respect to the subject and to society emotional, or socially deleterious effects upon the subjects, a description of the means t o be taken t o minimize each such effect(including confidentiality safe qu ard s), and an assessment population and an explanation of the rationale for using i n this population special groups, such as minors, prisoners,the mentally disabled or others whose ability to give voluntary, informed consent may be in question ; f . if the project involves res ear cn on tlie nature and effects of marijuana and ha luc in a tory drugs, drug abuse, o r investigation al new drugs, the protocol must so state : g. analysis of the risk / benefit ratio,if that is not obvious from the foregoing: n. each protocol must be accompanied by a consent form inthe format of Appendix B,or the short form in the format of Appendix C.If the short form is used it must be accompanied by a written script of the oral presentation to be made toths subjects. If a modified procedure is proposed, the protocol Asa minimum, protocols will consist of the following a. an evaluation of the need or desirability fort ne b. the precise way i n which human subjects will be c.a statement of the significance and benefits of d . an analysis of the possible physical, psychological, e. a description of the requirements for a subject
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