Recombinant DNA Advisory Committee - 12/3-4/92 
human gene therapy protocol, these standards would be adopted for the entire 
community. 
Ms. Buc said that any individual from the EC is welcome to attend RAC meetings since 
they are open to the public. She expressed doubt that the review of a single protocol 
would provide enough meaningful information from which to base policy decisions. She 
stated that she was disinclined to provide the requested review. 
Mr. Barton said that if a European decision-maker asked the RAC to provide advice in 
the same manner that the committee provides advice to the NIH Director, the RAC 
should agree to the request. However, if the request arises from a scientific community 
that mistrusts its regulators and wants the RACs seal of approval in order to persuade 
officials, then the RAC should decline the request. Dr. Geiduschek agreed with the 
statements made by Mr. Barton. Unless this request has a particular origin and a 
particular status within the EC, then the RAC should probably not consider the request. 
Dr. Parkman said that although the issues encompassing informed consent may present 
specific problems, the scientific issues should be universal. He encouraged the RAC to 
consider the EC request. Dr. Chase said that the RAC should not disaggregate the 
review of specific components of a protocol because the committee would not be 
providing a complete review. Conversely, the RAC has received this request from 
friendly nations; and perhaps individual members could volunteer to assist the EC in 
developing their own process. Dr. Chase said that the RAC should be cooperative; 
however, they should not serve as a substitute review body for other countries. 
Ms. Meyers said that the RAC should consider all of the human beings in the world and 
that the goal of gene therapy is to alleviate the suffering of mankind. The RAC should 
do everything in its capacity to assist the EC in its efforts. 
Mr. Pierre Lehn from Paris, France, commented on the issue of RAC review of a 
European human gene therapy protocol. He commended the United States for 
establishing a system of public review, noting that he has attended numerous RAC 
meetings. However, Mr. Lehn agreed with Ms. Buc that attendance at these public 
meetings should provide ample assistance to European investigators and regulators, and 
that the EC should be held accountable for establishing their own process of review. 
Dr. Schaechter agreed with Dr. Chase's comments regarding the inappropriateness of 
review of this protocol by the entire RAC; however, there is sufficient expertise among 
the committee members that a volunteer committee could be established to provide the 
requested review. 
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