Recombinant DNA Advisory Committee - 03/1-2/93 
The RAC resumed discussion of the revised version of the Cover Sheet for Expedited 
Review (Cover Sheet). This working document will be used solely by ORDA as a 
checklist for the minimum amount of information that is required for submission of an 
expedited review protocol for RAC review. Unlike the Procedures for Expedited Review , 
the Cover Sheet will not be incorporated into the Points to Consider. Several minor 
modifications were made to the Cover Sheet and agreed upon by the members of the 
RAC. 
Dr. Royston questioned the intent of the RAC. He proposed the following scenario: If 
an investigator was approaching the deadline required for Federal Register notice, and the 
protocol in not in final form, would the request be deferred by the RAC if submitted in 
the incomplete format? Presuming that the protocol would be deferred due to 
insufficient information, should an investigator withhold submission of the protocol from 
the regular review process for submission through the expedited review process? Drs. 
Leventhal and Parkman stated that an incomplete protocol would not be accepted for 
either the normal or expedited review processes. All protocols, whether regular approval 
or expedited review, need to be complete and contain all of the information necessary to 
make a rational decision. 
Committee Motion 
A motion was made by Dr. Carmen and seconded by Dr. Miller to accept the Cover 
Sheet for Expedited Review with the incorporation of minor modifications agreed upon by 
the RAC. The motion passed by a vote of 15 in favor, 1 opposed, and no abstentions. 
The revised version of the Cover Sheet for Expedited Review reads as follows: 
COVER SHEET FOR EXPEDITED REVIEW OF A GENE TRANSFER PROTOCOL 
1. What is the gene and vector proposed for the gene transfer protocol? 
2. a. Has the vector been previously approved by the RAC? 
b. If not, attach complete sequence of vector. 
3. What is the target cell for the gene transfer? 
4. What is the transduction efficiency of the vector into the proposed target cell? 
5. a. What is the level of expression in the target cell? 
b. How was expression determined? 
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Recombinant DNA Research, Volume 17 
