Document text
Machine-read from the scan, so expect some errors. Lines that couldn’t be read are left out.
Page 1
Lawrmco Berkalry La bot lg . MEMORANDUM TO FILE: c I Re: Conference on Human Subjects Probleiis This mcm memorial 5zes the conclusions arrived a t i n E. sonferenke on the: above subject on Friday, October 5, 1973, conmencing a t 8:30 a.m. iinose i n attendance were Dr. Clirlton Powell and Mrs. R u t h Haytior of President Vice President Orlons, Eir. Nicholas and Xr. Wolfe of Vice President Perkins' staff; Mr. Sam Cole, representing Lawrence Berkeley and Liverrrore Laboretorics, and Assistant Counsel Dave Dorinson. The agenda of the conference was listed in my memorandum of Scptember 24 t o Powell, Haynor, Owens, Dorinson, Douglass and Nicholas. The main issue was t o attempt to resolve how we should respond to A Kl S declared refusal to treat as "allm~able"either the costs of treatment or care o f patients, o r the costs of insurance.premiums, when such trcatmnt ar care "goes beyond" the prescriptions of DHEN policy. In oversimplified terms; AEC says i t will not pay for treatment of other than short-term and imnediate effects o f experimentation on hunans. After considerahl e discussion, there was a general concensus that the University, in pursuing its announced policy with respect t o human subjects, does indeed have an unfunded potentfa1 liability of unknown and as yet uncalculated magnitude. For example, those present could not recall any existing cases w i t h i n 'the Universlty where long-tern care or treatment has become necessary as a result,,of experinmtal procedures conducted on human subjects. Woreover, w i t h the extension of human subjects criteria, with attendant 'informed consent", t o areas of psychological testing, for example, the size of the population potentially exposed i o r:rk has increased but has not been measured, and m.rou!d inbel-d b2 very difficult to measure. possible, toes tim te the numbers o f those potentially requiring treatment. For these reasons, it i s not feasfble t o attempt t o buy comnercfal insurance, since a prospectfve insurer cannot be rovided with any quant i - i n order to protect himself would have t o set.a premium which would be uncconomically h i g h from the point of view of the University. Itis extremely difficult, perhaps i m - tative measure of risk, in light of the lack of cPaims in this area, and
Page 2
The alternatives, i n relation t o the AEC problem, appear to'bc as follows: -- Modify the UC policy t o make l t inapplicable t o AEC-supported rojects. This could refer not only t o projects a t the major faboratories, but also potentially t o projects on all nine campuses. This alternative was considered impractical, since a project i n - volving human subjects m i g h t almost normally involve mixed funding. Examples are those a t aonner Laboratory and a t the i.ledjca1 Center i n UCLA, where the nuclear medicine program of the Laboratory of Nuclear Medicine and Radiation Biology is conducted in the Medical (under the GEN-12 contract) and by the Medical Center, u s i n g funds from other grants and contracts as well as s t a t e funds. t o experimental procedut+s' being instituted, and as part of of Workman's Compensation premiums; 'the cost o f any subsequent care or treatment would be borne by Eiorknan's Compensation, and the University's liability would be covered.. . The' admfnistraiive diffIcul tfes of this course o f action are formidable. The University's employment rolls would be swollen by an unknown b u t patentlally large number of "employees" a t no actual compensation, but with potential confusion toall employee-related statistics and records, .e.g., the retirement system, and to all statistics (e.9.. ethnic statistics for affirmative action purposes) relating t o numbers o f employees. Finally, the added workload on personnel people on the nine campuses and i n the President's Office would be considerable. This alternative was therefore considered t o be nonviable. -- The third course o f action recognizes as a "given" that UC, determine the need for a reserve or its magnitude i f needed (see discussion of insurance above). zero. Since the risk i s non-quantifiable, a t this time, this problem i s like many others the University encounters i n adopting a course of action. In effect the risk i s lafd off by tacitly pledging the general credit o f the University t o carry out thc adopted program and. polky. In essence, the reserve a t present i s
Page 3
Archivor and Rocorda OMco In the short run, because of the lack of claims i n this area, this position seems acceptable. Dr. Powell expects to initiate a process of identification and analysis of these risks, and in the long r u n more specific information will be available so that financial planning t o cover the cost of risk can be completed. In regard t o the AEC problem, i t was agreed that no further response need be made t o AEC, nor would a conference appear t o be benefical. jlhenever and i f AEC disallows costs o f treatment or care of human subjects, we may a t that time decide to litigate, on the basis that'the UC program does not, as AEC alleges, "go beyond" the DHEW program. In the meantime, other litigation, elsewhere, may wcll have established this premise. .As t o the other three items on the agenda (my September 24 memo): wi 11 write t o Chancel 1ors- t o ascertain the magnitude of the --'UC policy concerning the protection of animals, . i n relation t o the DHEW policy, will be further acted upon by Dr. Powell. Letter will be sent t o Chancellors asking for their comnents on promulgation of. a proposed University policy. Subjects Committees, but should be thinking about creating them, i n the expectation that eventually these laboratories the establishment of such-connittees.- - Livermore and Los Alamos do not now need accredited HumanC' The meeting closed with the understanding that Or. Powell would bring the I above conclusions t o Vice President McCorkle's attention a t the appropriate Assistant Vice President Owens Assistant Counsel Dorinson