Recombinant DNA Advisory Committee - 03/1-2/93 
Discussion 
Dr. Walters summarized the deliberations of the Working Group on Expedited Review. 
The working group (Drs. Leventhal, Post, Zallen, and Walters) held a telephone 
conference call in order to develop the draft document entitled: Procedures for Expedited 
Review ; the document was distributed to all of the members of the RAC for discussion. 
These Procedures for Expedited Review were originally proposed by Ms. Buc at the 
January 14 RAC meeting. The working group has incorporated several minor changes to 
the originally proposed procedures; however, these have not been substantive changes. 
Dr. Krogstad reminded the RAC that he had originally suggested that protocols 
approved through the expedited review process should be formally reviewed at the next 
RAC meeting. Specifically, the expedited approval that was granted by the NIH 
Director in December 1992. This step would provide feedback from the RAC members 
to the individuals who are involved in the interim review process. This requirement does 
not appear in the draft document. There was a clear consensus of the RAC members on 
this issue. Dr. Leventhal agreed with Dr. Krogstad's comments and said that all of the 
RAC members should have access to the materials on which an expedited review 
approval is based. 
Dr. Parkman said that the RAC would serve an important function by reviewing 
expedited approvals at the next regularly scheduled meeting. Approval or disapproval of 
an NIH-approved expedited review protocol would serve as a check and balance on the 
quality of the review process. Since the Procedures for Expedited Review were not 
incorporated as a major action to the Points to Consider of the NIH Guidelines at the 
time that the December approval was granted, the requirement for full RAC review at 
the next meeting could not be enforced. 
Dr. Walters asked if the RAC intends to review expedited review protocols using the 
same standards of review as for other protocols. Dr. Parkman agreed that expedited 
review protocols should be reviewed by the same standards used for other protocols. Dr. 
Krogstad explained they would be evaluated for both scientific and medical merit. Dr. 
Wivel reminded the committee members that they had specified that investigators must 
also provide all of the materials that were submitted to the FDA in order to obtain 
approval. 
Dr. Chase said that review of any protocol that receives expedited approval by the NIH 
Director is important information with regard to the rights of these patients. There is a 
chance that a decision for approval of an expedited review protocol by the Director 
could be contradicted by the RAC. This information would be invaluable to those 
individuals who might be tempted to believe that any treatment approved by the 
government is considered scientifically sound and efficacious. 
Recombinant DNA Research, Volume 17 
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