MINUTES OF MEETING - December 6-7 
24 
"Whereas a compliance program for non-NIH funded institutions 
undertaking large-scale recombinant DMA activities based 
exclusively on the good faith of such institutions, involv- 
ing no sanctions, and no accountability for breaches in 
compliance is untenable in concept, (1) RAC opposes the 
continuation of NIH's voluntary compliance program, and 
(2) RAC opposes its own use for reviewing protocols for 
large-scale experiments for non-NIH funded firms until a 
mandatory compliance program is implemented, and (3) RAC 
reaffirms to the Director, NIH, its support for uniform 
standards." 
Dr. Novick said that he basically agrees with Dr. Krimsky's 
position but he does not think that the option of opposing 
voluntary compliance is presently available. He suggested that 
if the RAC adopts this type of proposal, industry is invited to 
ignore the Guidelines. He said the purpose of his proposal is 
to indicate that the RAC is not satisfied with voluntary 
compliance as a permanent state of affairs. 
Mr. Thornton said industry would wish to comply with the NIH 
Guidelines for several practical reasons: (1) industry would 
like to have the approval of the NIH and of RAC for this type of 
research; (2) there are strong indications frcm other agencies 
that a failure to conduct research in accordance with NIH Guide- 
lines will result in either a failure to be licensed or the 
possibility of not being able to protect proprietary information; 
and (3) industry would wish to protect itself against civil 
sanctions. He said he opposes Dr. Novick' s proposal. 
Dr. Walters said that he is in sympathy with Dr. Novick's 
proposal but would prefer to stipulate that at the June 1980 
meeting the RAC review the voluntary program rather than state 
that the program will terminate at that time. 
Dr. Goldstein read a section of the Minutes of the May 25, 1979, 
meeting of Peter Libassi, HEW General Counsel, with representatives 
of the Pharmaceutical Manufacturers Association: "Peter Libassi, 
ho/ever, noted the press reports of some conpanies not complying 
with the NIH Guidelines. The article in Nature regarding Genen- 
tech, inc., (a non-PMA firm) was cited. Bill Gartland reported 
that Genentech had told NIH they were proceeding with certain 
experiments that were not in compliance. Further, they had 
stated orally that they would proceed notwithstanding NIH 
objections. Mr. Libassi felt that Genentech should be put on 
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