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ccrrmunication between agency committees. Would each group have to independently 
reach solutions? Would concerns be communicated? Would there be any cross- 
fertilization or will each agency advisory ccnmittee go its own way? A central 
review focus would eliminate concerns about communication. 
Dr. Walters suggested the working group may not reach a consensus on an alter- 
native proposed review structure in the brief time available for carurent. He 
Suggested the working group instead attempt to agree on the language proposed 
by Dr. Gottesman . 
Dr. Gottesman suggested alternative language for point II— ( 3 ) as follows: 
"Would changes in the NIH Guidelines and major actions of the RAC require 
the approval of the Biotechnology Science Board? 
"We want to reemphasize the distinction between research and technology. 
We consider it appropriate that RAC continue to function as it new does 
without the addition of any new levels of review. We suggest that the 
Biotechnology Science Board be called the Biotechnology Board and not 
have oversight of basic laboratory research." 
Dr. Walters said a specific request for information on the proposed functions 
of the Biotechnology Science Board is worth posing. Dr. McKinney agreed; 
a clarification of how the Biotechnology Science Board will function as a 
forum for public discussion should be requested. 
Dr. McKinney felt this preposed language did not adequately describe the 
concepts the working group had been discussing; he suggested more forceful 
language be drafted. Mr. Mitchell agreed and suggested members of the working 
group independently attempt to draft stronger language before the April 1, 
1985, ccmment deadline. 
Mr. Mitchell then called the attention of the working group to point II-(4). 
Dr. McKinney said the judgment of the agency wall determine if the data are 
adequate. Dr. Gartland said the statute under which the agency is operating 
determines whether the agency or the investigator must bear the burden of 
proof. 
Dr. Lardy suggested the language referring to risk management not be included 
in point II-(4) . Instead the point should focus on mechanisms for public 
discussion. 
Dr. Walters said the sentence discussing the appropriate determination of 
safety should be deleted frem point II- (4) of the working group response. 
Dr. Walters questioned the status of human gene therapy experiments under the 
proposed oversight scheme. He said RAC had accepted responsibility for over- 
seeing this application of recombinant CNA technology. If the RAC restricts 
its review to research proposals, it could not evaluate human gene therapy 
applications unless clinical trials are considered research . Dr. Gartland 
pointed out that should RAC restrict review to research proposals, a second 
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