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Campurr Research Office Re: Policy and Procedures of the University of California t h e Protection of Human SubThla is fn reply to your memorandum of July 12, 1971. The revi8ed policy i s approved aa to legal qui red by the Office of the President either to modify their guideline8 to comply with the new DHEW Policy nor to filea general asrurance ail required by that policy, I would ruggest that until you rece ive ln struct ion r to do so, that no a ~ aurmc ebe filed with DRCW. The Office o f the Preoident may be seeking modification or clarification of the fourth paragraph of the general arrsurance. particular paragraph doer not impore strict lis bill ty on the University a8 thir term is generally umed, since the matter of compensation for the perrOn&l injuries 8uf fert d would nec c roar ll y be bared on a decision that the University was negligent in rome manner. The cilities m dpr of ers ional attention.I recognize that in mome camer thir requirement can be formidable the Federal Government apparently believes ruch aerumption of risk on the part of the institution to be necer8ary a8 a matter of policy. The Office of the President Since the campuses have not been formally reIn addition, this tions with respect t o hman subject experimentation. To the extent that I can offer rome guidance, your quer t ions and my answers are as 'follows:
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What guidelines and standards u e to be ued for hurnan subjects ina foreign country7 The guideliner m d standards which the law of the particular foreign country make applito be 8upplementad by local curtoms and practice r ? I f you are again referring to a foreign country, the law of tho foraign country would local ti..., etate) law would prevail over the guidelines 08t~abli8hadby the DHEW, the an~weris yes. Each rtate may pa88 l a w s dealing with the hcaxth and welfare of its residents, and may proscribe certain types of rouearch on human subjectr. The que ~ tio nof local custom and practice generally arisea i n medical malpractice Ca.808, and you may be confusing treatment w i t h rarearch. Puccrtionr What are reasonable rtandards i n obtaining hiformed conrent from a member of a primitive illiterate aoc ie ty ? If you are asking whether a more restrictive Answers This question i r too general t o The mswcr would depend upon the factual situaYou have a180 arked what the requirements f o r retention of rignod consent form. are. This i r not e 1.9.1 question but on. of records mmagcmcnt. If you are of the opinion that the the period for retention of consent form ontearonably iacrearer t h e rirk that th oo on fide nti ali ty of the information curnot be premewed, I would suggest that you either seek a rhortcr period for retention of theas recordu, or modify the luthod wod for rtorago. mhould be made to the rtandnrd Univrrrrlty conrant form u a result of the DflEIJ Policy. aecarsitata modification of the atandatb Unfvarrity consent form.I UTI advlaed that the Office of the Pre8idant will issue the necerrary instructions. Your final question ukr whether m y revision Tho DREW Policy will
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that time the presont oonrrnt form may be wad. P1aa.e let ma know if you have m y quortionr.
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STAFF COORDINATOR RUTH MYNOR Re: DKEW Policy on Protection of Gerry Griffin handed mea copy of the Revioed June 16, I971 Institutional Guide. interest that this revision is also entitled a Draft Discussion Copy, which indicate8 that further revis ions will be forthcoming and that input'from the institutions may still have some effect, pared this revision with the March 17, 1971 discussion copy and 1 note the following substantive change; the review committee be composed of sufficient members wit b varying backgrounds to a6sure complete and adequate review of projects and activities comonly conducted by the institution(p.9).X personally do not understand this deletion. As far as I am concornod, unlaco the cornittee is so comprised, any of i t e deci- .ions would be open t o attack. vise the campuses, i f you are i n the process of i rau ing a policy mtatamant, that this requirement i o mandatory. 1, It is no longer a matter of policy. t h a t
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STAPP COOECDZNATOR RUTH EMNOR &t DREW Policy on Protection of Human 8ubj8CtfJ Reference i s made to ay mmormdua of Augucrt 2 , 1971. Personally, I believe this delatian t o be m 8verd g h t , lints one of the new requirements in an inrtitution'a .et of implementing guidelines is a sbtcmsnt of: conduct initial and continuing reviewa. Camdtteo members shall bo identified by name, occupation or position, and by other pertinent fndications of experience and campetonce Ln artaa pertinent t o +he areas of roview such as earned degrms, board cet tif i cations, licensures, Thio requirenent is alao refarred to on page 10 of the Institutional Guide t o DHEW Policy on Protectfon of Runran Thi8 requirement may cause aom difficulty for the newer campuses whos* committee stxucturo m y be too lin it ed by failing to include parsons with the type of background necessary to adequately review, in the opinion of DFiW, 811 projects. T h i s matter nay be appropriate for dircuoaion tat the meting with tho DHCli officials this Monday. 8uggestioa would bo for the cunpus to l i s t tho persons who have boon appointed to serve on the review committee and then to havo an additional rsntanoe i n the guidelines such "Other individuals appointed by the Chnncellor 8t the requast of the revleu committee t o assure compbto and adequate review o f projects ;. 01 ekailar language to this effect. DREW, a l i n t of the other individuals who might be appointed oa 8 project-by-project basis could be appended. If this 608s not eat ls fy I would mtrongly suggest that at the tima you rdvisa the eampurerr of the necearity of drafthg new implsmanting midelinos you arranqo for a Univtrsity-wide meeting to dbcur8 the guldelfnes, a d that the porronm resp aoi ble
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Staff Coordinator Ruth ttaynor for drafting the guidelines be invited t o attend. tfmo Gerald Griffin,Dr.Pwall, you or Iwill bm able to 80 uver the new DBEW roquimmnts, and to .niwr any qwrttoae. I recognire Ihwe an ulterior motive. I do desire to obviate as much corre8pondenca w i t h each carpus as I can. I realize that BOW of the campuses may feel 8Uch an h vi tauon to a nooting t o be prcaunptuoua; however, I do feel t b a t other campuses will welcome the opportunity to have their questions answered.
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bc trp t Tram memorandum of January 28, 1972 irom Assistant Counsel Dorlnson t o Special Assistant Powell In my opinion the rt radu d University consent form ghoul& not include a proriaion for disc ud td hwun materials intht the tvo rubject groups are perrPrirrion t o e.uy recipient of the tissue t o do research on the tissue. In w opinion the campus obtaining the discarded human materibl should insure that requirements of the DHEW policy are met by checking vith the agency from whom t h e materials were obtained, questions en appropriate consent form can then be obtained from a relative or guardian on a case by case buls. A at and ud hospital autopsy form generally grants sufficient If there arc m y
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D.A. Oorinron t o Special Assistant Pwell 5 Subsect: Analreis of body fluids OY tissuts for i l l a d druR s V i c e Churcellor Johnson's memorandum also indicated that you might feel it rppropriate t o have this office device 8 separate consent io= vhere t h e proJoct may involve procedure ruch am M ~ ~ B I Bof body fluldr or tirluer for illegal d r u g s . Again, since these proJccts would appear to have many dir shi lar aspects, I am not pre8cntly a i the opinion that a ct m dard consent form can be brarted to cover all inrturcer o f such usage. I vould w i n , bowever, be 8vnllnble to draft separate consent forms for u w partfcu2u proJect If any cmpur review committee so desires.
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Re: DHEW Institutional Guide of Contracts and Grants Gerald Griffin delivered to this office a copy of the D W Institutional Guide which was formally issued by DREW on December 1, 1971. I assume you have a copy. In comparing this publication to the June 16, 1971 Revised Draft Discussion Policy, I find no aubstantive change. However, mince the InstructAOn.1 Guide has bee;; formally promulgated, I believe it imperative for the President to issue a University policy 8t h i s earliest opportunity requiring the campuses to prePars and issue detailed guidelines in conformance therewith8 subject to the prior review of this office. One inconsistency on page 5. 1I1 indication of policy as stated in the DHEW Grant Administration Manual, Chapter 1-40 : In review of the Institutional Guide, I find The following appears as ;.The institution should adopt a statement of principles that will assist it in the discharge o f its responsibilities for protecting the rights and welfare o f rubjects. This may be an appropriate existing code or declaration or one formulated by the institution itself. It is to be understood that no such principles supersede DREW policy or applicable law.' dicate that this requirement is not mandatory. However, on page lo, again as a statement of policy, the Institutional Guide states: %e use of the word .shouldg would appear to in- .The instftution must include as part o f its amaurame implementing guidelines that specifically provide for: a. The statement of principles that will 8SSiSt the institution in the discharge of i t s responsibilities for protecting the rights and welfare of subjects. This may be an appropriate existing code or declaration or one formulated by the institution
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1 It i s therefore imperative that each campus i n - cipler. Zt may be appropriate for t h e Prerident to BO advi8e the campuses inhis policy directive. As indicated fn rry memorandum of February 29, 1972 toDr.Powell, it would appear that the omupuses who desire t o conduct IND studies should adopt a 'statement of principles which cstablisheo t h e Declaration of Helsinki 1;s +he dnFwrm basis for t h e decisions of the campus review coxunittee. As uistan t Counsel