Notes Regarding Human Use Forms, Procedures and Reviews

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Notes regarding Human Use forms, procedures and review. 1 . Donner Human Use Committee: Does I t meet or are protocols circulated to the members in dl vl du ally ? I f the latter,should i t meet instead ? Are there records(minutes or notes for the file,etc.)of all the protocols presented and the action taken ? Where are these records located ? In addition to protocols of all new procedures has the committee,in accordance w lt hour AEC human use assurance to Have they obtained and reviewed protocols for same? What about consent forms for subjects and patients on procedures carried out strictly under our AEC support ? Are they necessary or desirable(see below also) ? 2 . Campus Human Use Committee: Of nec ess ft yall procedures as soc late d with research grants or fellowships coming thro ug & the Campus research office must have a protocol submitted to the Campus Human Use Committee (Chmn : Dr. Diamond). This commlttee i s now requiring a copy of the consent form as well. Should these protocols also be submitted to the Donner Human they goto the Campus or does the timing matter ? (There is no way of avoiding the submission of these protocols to the Campus because,w l th out certification of CamDus commi ttee approval, the research grants and fellowships will not be awarded or knowledge o f such protocols so they can keep an eye onall human use in the Lab ? How should this be accomplished ? What will happen when we have a n NIH proposal made through Donner Research, NIH i s accwrtomed t o having human use assurance from Professor Diamond‘s camDus cornmlttee. Will we submit the ,/-a;.%, which Involves human use ? With respect to

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protocols associated with such grants to this committee? Is that likely to open the door for requiring us to submit all protocols to them, including those related to strictly AEC studies ? Or will NIH accept an assurance signed by the of the Donner committee? Will i t be necessary to submit the formal assurance form atall ? Perhaps NIH will delegate to the AEC the matter of human use regulation and accept the AEC's assurance that we arein compliance with AEC on the subject. 4 . Consent Forms: Campus Research office appears to be r e - qui ring a consent form to exist and be submitted for approval along with each protocol.Sofar we have complied tothe extent that consent forms have been composed, typed,a few copies duplicated and some sent to the Campus research office. The remaining copies are filed in the Bus f ness Office. The intent of the consent forms is clearly that we use them. Shall we begin using them? What mechanism will we follow ? Whose responsibility - the principal investigator ' s ? What will be the role of the Clinic and / or the Pavilion ? And what of the procedures affiliated with strictly AEC research projects, where there has not been the unavoidable pressure to create consent forms, much less use them, because receipt of AEC money is not contingent on their existence. 5.Procedures to be Covered: Which procedures are to be covered and which, ifany, exempted because they are recognized as standard routine medical procedures. Campus requires the human use protocol and a consent form even for the drawing of normal humen blood. Shall we do the same on AEC funded pro - jects ? Or shall we form an overall policy for the Laboratory based on our own judgment, and then modify it in the direction of greater stringency only when forced to do soby Campus procedures re qu t red for release of grant money?

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Further note concerning Human Use Ero ble ms : arises concerning the secondary use for investigative purposes of b loo li withdrawn from patients for the primary pur pore of staff members at the Lb bara tory hold that since the b bdd must be withdrawn anyway for purposes not requiring a consent for a and since the identify of the individual is not revealed to the researcher having the secondary use,the individual is not " at risk " and the consent form is unnecessary. NIH has stated " there are also medical and biomedical projects concerned e ol ely with organs,tissues,body fluids,and ocher materials obtained in the course of the routine perform anca of at autopsy.The use of these material obviously in volvo rno element of physical risk to the subject.However.their u oc for many research,training,and services purposes may pre a en r psychological,sociological or legal risks to the subject or his su thor i zed representatives.In these instances application of the policy requires review to determine that the c irc um it ances under which the materials were procured were appropriate and that adequate and appropriate consent was or can be obtained for the use of these materials for project purposes. " The above appears to indicate that NIB requires consent from patients for secondary use in research projects. Our staff may question the necessity or the wisdom of such a policy but it does not appear that they can realistically question iB s existence. The NIH wording cited above does use the vor d "may". We must then balance the administrative burden of securing consent forms 1089bq S from patients against the possible future problem of a conflict

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with NIH over instances where they believe consent should have been obtained and w e felt that it was unnecessary.