Recombinant DNA Advisory Committee - 1 /21/SO 
meetings each year there was concern that unnecessary delay and 
interruption in experimental procedures would result. Although 
the primary purpose of the RAC and the HGTS is to ensure public 
health and safety with regard to aspects of recombinant DNA 
research and human gene therapy research, the committees should 
eliminate any barriers to research in progress. There is a 
belief that minor changes in a protocol need not go through the 
complete review. 
Mr. Brewer said it is important to understand that there are two 
judgments which the committees are delegating to the Chairs: 
1. To determine if the change is minor or major; and, 
2. If the change is deemed to be minor, whether it should 
be approved. 
Mr. Brewer said this provides sufficient latitude for the Chairs 
to exercise judgment and not simply be a "rubber stamp." 
Further, it gives the investigators the flexibility of going to 
the Chairs with a proposal for a minor change, thus streamlining 
the process for continuing their research without going through 
the entire process of HGTS approval and RAC approval. 
Further, Mr. Brewer said he did not believe this contradicted an 
interpretation of the "Points to Consider" made on December 9, 
1988, that, "the substitution of a vector with superior 
properties is within the accepted flexibility of a protocol which 
is inherent within the definition and approval of an existing 
protocol." He said this should be clarified one way or the 
other. He noted that it was subject to FDA approval and RAC 
notification. 
Mr. Brewer also said the wording in discussion of risk needed to 
be looked at and suggested that the phrase "... does not 
unreasonably increase risk...." be added to the first sentence to 
allow the Chair some latitude in determining what is a minor 
modification as regards risk to the patient. 
Dr. Parkman said he felt that as an IRB Chair, most Chairs tend 
to be conservative when utilizing such a procedure. If there 
were any significant questions, most Chairs would tend to bring 
the issue to the full forum. 
Dr. McGarrity said he felt he would not be making any decisions 
unilaterally, but rather he would confer with members of the 
committee or the subcommittee before making a decision on whether 
any issue was a major or minor modification. 
Dr. Rosenberg said he felt the proposed change was an excellent 
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