Recombinant DNA Advisory Committee - 03/1-2/93 
Discussion 
The members of the RAC continued their discussion regarding the Procedures for 
Expedited Review. Dr. Walters summarized the changes that had been incorporated into 
the document based on the RACs previous discussion. 
A lengthy discussion ensued regarding limitation of expedited review to single patient 
protocols. The intent of this requirement is to define the limits for expedited review. 
The committee was concerned that investigators might interpret this statement as 
meaning that any single patient protocol will be reviewed as an expedited review 
protocol. The fact that a protocol involves 1 patient is not justification for expedited 
review. 
The RAC discussed the appropriateness of using the phrase "gene transfer" for an 
expedited review protocol since the word "transfer" infers marking and the word 
"therapy" indicates an attempt to provide a therapeutic treatment. The members of the 
committee agreed that the term "transfer" should be used with the understanding that 
these are unproven Phase I trials, not marking studies. For clarification, the RAC added 
an additional item which specifies that the investigator must provide detailed information 
regarding the necessity of the expedited review. 
The RAC debated whether the statement "Protocols that are deferred or not approved 
by the RAC in its normal review process, are not eligible for expedited review" should be 
deleted from the document. Since the committee was unable to come to a consensus 
with regard to this statement, a vote was called. A motion was made by Ms. Meyers and 
seconded by Dr. Parkman to include this statement as part of the Procedures for 
Expedited Review. The motion to retain this statement was approved by a vote of 12 in 
favor, 4 opposed, and no abstentions. 
The committee agreed that extramural experts must be included in the expedited review 
process. The term "scientist" was changed to "expert" to reflect the importance of social 
and ethical review as well as scientific review. 
Committee Motion 
A motion was made by Dr. Chase and seconded by Dr. Miller to accept the Procedures 
for Expedited Review incorporating the minor modifications agreed upon by the RAC. 
The motion was approved by a vote of 16 in favor, 0 opposed, and no abstentions. 
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Recombinant DNA Research, Volume 17 
