Letter to H M Agnew from C O Mccorkle, Subject: Policy on the Protection of Human Subjects and Attachments

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Gent la en : Policy on The Protection of Hwnan Subject8 Subsequent to the issuance of a U . S . Publi health Service policy titled President Hitch issued, on June 25, 1970, a University policy concerning research involving human subjects. That University policy provided that the USPHS policy '' . . . ahall be applicable to all investigations involving human subjects for which the University is responsible, not just On April 15(1971, the USPHS policy was superseded by a Department of Health, Education, and Welfare policy. a revised policy statement, to supersede the University's June 25, 1970 the Office of the President, and the Office of the General Counsel it became clear t h a t certain modiffcations of the March 29 policy were needed. These have been incorporated in the attached policy which 5s to be effec- (1) the extension of t h e applicability of the policy as required by DHEW to a broader scope of activities than just research, i.t., to classroom activities, demonstrations, and other activities in which human subjects may be at risk; and (2) the permissibility of obtaining consent after t h e fact in unusual circmstancea. Consequently, I issued on March 29, 1972-H5952 During subsequent discussions with representatives of the campuses, The principal changes in the revised statement cLTe AS was the care with the USPHS policy, the new OHEW policy shall be applicable to all activities involving human aubjects (as defined in t h e DHEIJ policy) for which the Univcroity i o responsible except for those supported by other granting agencies which have their own regulations. of conflict between rogulationr of another funding agency and DHEW, the more restrictive regulations shall prevail. In the case The Unfvcrslty policy has three attachmentsf: Grants Administration Manual Chapter 1-40 (dated April 15, 1971) which (1) a copy of DHEW *These attachments are not being circulated with this revised policy, since they are identical to the attachments sent with the March 29 policy with one correction: the title of attachment ( 3 ) should be changed from "Supplement to The Policy on Rcsearch Involving Hman Subjects" to "Supplement to The Policy on The Protection of Human Subjects."

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s Lncludes a basic m tata ent of tho policy, itm applioability, and implementi m g proc.bure8r 42) a oooy of TJw Iaatituttmul Guide to DXEW Policy on of thnaur Subject.,. oonmimting of a compilation of ~ m ~ i d 8frm the c.mpuees, tlie Office of tbo ~ n s i d e n t ,urd tho Office of .the Ganeral Counsel on meveral ismues related b the implunent.tlon of t h e polifl. * The DEBU policy %e clearly derived froor t h e old PXS policy, with t w o differences which 6m-e mpecial mentlonr for two typom of umurances, a ngenual ~ ssur ~ nce ”and a %peeid changes have been made in the “Informed Consent” provisions Wid., pages 2, 16 and 17) and the applicable ones have been incorporated in Am was mentioned in connection w i t h the issuance of the earlier Univer8ity policy, no policy such as this can provide for all possible circummturcer. Thus we recognize that, in practice, this policy will have to be interpreted w i t h erne flexibility, although this must be done with 8 W i C t adherence to its spirit. For example, while this policy applies Of h a m -- physical, psychological, oociological, or other -- as a conmaquence of any activity which goes beyond the application of those established and accepted methods necesrary to meet his needs,” there will be many instances, particularly in the social urd behavioral sciences, for which it will be difficult to determine whether t h e applicability of this palicy is indicated. As t h e policy 8t.tesr “The determination of when an individual is at r i s k is a matter of the application of cormon rense and sound profercional judgment to the circumstances of the activity in question. Responsibility for this determination resides at ~ 1 1leVe1S of institutional and Deparfmental review. (1) The DHEW policy provides Other Vice Premidentm Special Amrirturt Powell Amsistant Vice President Everett

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I Offict k the President POLICY ON THE PROTECTION OF HUI4AN SUBJECTS The responsibility for compliance with regulations concerning activities in which human subjects may be at risk shall rest with the Chancellors, the Vice President -- Agricultural Sciences, and the Vice President -- Extended Acadamic and Public Service Programs. The policy of the Department of Health, Education, and Welfare, as contained in the attached copy of Grants Administration Manual Chapter 1-40 (April 15, 1971), shall be applicable to all activities involving human subjects (as defined in that Chapter) for which the University is responsible, not just those funded by the DHEW, except for those supported by other granting agencies which have their own regulations. In the case of conflict between regulations of t h e funding agency and DHEW, the more restrictive regulations shall prevail. 1 order to provide maximum protection from legal liability the individuals responsible for activities in which human subjects may be at risk, t h e campus review committees, and The Regents, one of the two attached standard and "(Short Form)", respectively, is to be used on all campuses and in all cases except those where the Committee has determined that consent is 'I. . . implicit in voluntary participation in an adequately advertised 7-8 of the attached copy of The Institutional Guide to DHEW Policy on Protection of Human Subjects). Either of these forms may be modified, if deemed necessaxy, with the approval of t h e campus review committee. keeping with the opinion of the General Counsel, in those cases in which the basic elements of informed-consent are to be presented orally to t h e subject, i.e., cases for which a Short Form is to be used, the complete statement of what is to be said to the subject is to be approved by the Committee, not just "written summaries," as required by the "Institutional Guide" (page 16). In those cases in which the Committee agrees to waive the requirement of informed consent altogether, the Comittee pust have been advised of the information which is to be provided to the subjects. Only in rare and unusual circumstances, where the obtaining of informed consent would prejudice the outcome of a proposed activity, may the committee approve an activity which does not provide for consent. committee approval for such a procedure is required and is to be given only after consideration of the proposed justification for the waiver of the consent requirement. In all such circumstances, the committee shall require debriefing of the subject and shall approve the debriefing Adequate preparations shall be made and adequate facilities shall be Provided to protect a subject against even remote possibilities of injury,

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disability, or death. tion which may be required during or as a result of an experiment. this regard, attention is invited to Vice President McCorkle's letter of February 2, 1972 (Attachment B of the Supplement). This includes medical treatment and hospitaliza6. The campuses shall submit to the Office of the General Counsel the policies and procedures required to be formulated and submitted to DHEW to assure that legal and policy requirements are met, prior to promulgation or nubmission of the campus' general assurance to DHEW. i n the event that, in connection with a specific research proposal, the investigator or the campus review cornittee identifies a significant legel issue, approval of that proposal shall be sought from the General In order to assist the researchers as well a5 the campus review committees i n t h e i r effort to identify the common types of legal issues which might be presented and to develop criteria for their resolution, the General Counsel bas provided the following list of criteria which may be used in determining whether to submit a particular project f o r legal The involvement of minors. The involvement of adults whosc competence to give an informed consent may, in the opinion of the principal investigator, or the campus review committee, be subject to question. Doubt in the minds of t h e principal investigators or members of the campus review committee as to whether the explanation set forth on the consent form is sufficient fully to inform the subject of the activity in regard to the procedures to be performed and the risks attendant thereto. The necessity for t h e principal investigator or those working under his direction to perform acts requiring licensure under the provisions of law relating to t h e healing arts. Questions concerning interpretation of DHEW policy. 7. If a proposed activity is to include students of the University as subjects, the Student Health Service Director of the campus responsible for the activity to be conducted, if not already a member of the campus review cornittee, shall be consulted in the review of that particular activity.

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U N IVBRSITY OF CALI FONJ IA FONSEIJT TO ACT AS IWuI*lAIJ SURJECT and/or such assistants as may be selected by him to perfonn t h e following proccdure(s1 and/or fair explanation OZ thc proccdurc(s) to be followcd, including an i den Li fic a - tion of those which are experimental. 1 (Describe in detail in lanquogc which will provide a has (have) been explained to me by

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3. f understand that the procedure (SI and/or investigation (SI described i n Paragraph 1 involves (involve) the following possible risks and discomforts: (Describe in detail) and that t h e possible benefits of the procedure (s) and/or investigation ( 5 ) are as follows: (Describe in detail) [Name of person(s) who will perform procedurcls) and/or such assistants as may be selected by him will answer any inquiries I may have at any time concerning the pro5. X understand that I may terminate my participation in the study at any timc, and that, owing to the scientific nature of the study, the investigator may in h i s absolute discretion terminate my participation at any the. In the Went that I am being compensated for m y participation

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and my participation is tenn in at cd by me or by the investigator I understand that I will be entitled to payment of a sum based upon the scientific value to the study of the information obtained from my participation ; provided, however, that in no event shall I receive less than per cent of the agreed compensation ifI continue to participate beyond the (Describe the applicable time period) of the study. (If subject is a minor, or othcrwisc unable to sign, complete the following) : Subject is a minor (age I,or is unable to sign because Ho ther Other person and relationship

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CONSENT TO ACT A S HUWN SUBJECT Nunc of Project: I hereby consent to be a participant in the activity named above. An explanation of the procedure (s) and/or in vc stig ation (s) t o be fol lor cd, including an identification of those which arc expcrimcntal , was provided to me by . I was provided with a description of the attendant discomforts and risks to he expected. I was in vc stig ation(s) would be answered. I was assured that I am free t o withdraw my consent and t o discontinue participation in the project or activity (To oral presentation and signature (If subject. is a minor. or otherwise unable to sign, complete the following) : Subject is a minor (age 1,oris unable to sign because Mother Othcr pcrson and relationship