Memo to M Owens, Subject: Protection of Human Subjects - Responsibility for Medical Care (Human Subjects II LBL & Ucsf 1974 -1975) (Companion Docs Are 713702 - 713746)

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Lawrrnco Borkoley Laborrtq OFFICE OF TllE GENERAL COUNSEL PRESIDENT MARX OWENS, JR. Protection of Human Subjects - Responsibility for Medical Care On Thursday, March 20, 1975, I received a copy of your memorandum of February 11, 1975 t o Associate Director George Pappas. you set forth the background correspondence concerning the issue whether LIe University ' s assumption of responsibility for the care of subjects is.ovtr and above the responsibility recognized i n DHEW policy, and whether the AEC would be requiqed t o reimburse the University as an allowable cost the costs o f such treatment or care. As you indicated, the University agreed either to press the AEC further in order to change University policy or rather proceed on the basis that University policy is consistent with DIlEW policy and face any consequences when they arise. of action is still valid. By a copy of your memorandum to Associate Director Pappas you request Special Assistant Powell and me to again look at the issue and to attempt t o determine whether there have been any applicable(court or other)decisions during the intervening period which might change the Univereity'a decision. decisions which bear on this issue. As you know, however, the University ' s position primarily rests on an interpret a - , tion of DIIEW policy as expressed in Chapter 1-40 of the DHEW Grants Administration Manual. In this chapter there i8 a sample General Assurance t o which, as far as I am aware, no modifications have been accepted by DHEW. At the present time, however, there is an open question whether or not the policy expressed in Chapter 1-40 i s still current.In Volume35, Number 105 of the Federal Register (Thursday, Hay 30, 1974) Subjects was added generally to codify with some changes In your memorandum You indicate that, - in your opinion,this course I am unaware of any court or administrative

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Lawrrnco Barkrly Laboram in exf sting departmental policy set forth in Chapter Chapter 1-40 and, accordingly, as these new Federal Regulations do not pr wide for the language of the General Assurance, it is arguable whether the pre a ent policy is still applicable.. Section4G.t of the Regulations provides in relevant part : I n my opinion,this codification now supersedes "General assurances shall be submitted i n such form and manner as the secretary At the present tine I understand that the Secretary has not issued any instructions to those institutions presently operating under a General Assurance approved by DIIEW an tothe form that the General Assurance must take under the new regulations.I would argue that until such time as the Secretary modifies the requirements of the General Assurance, DBEW'a present policy has not or wish to discuss this matter further. Please let me know i f you have any questions Associate Director Pappas