Recombinant DNA Advisory Committee - 03/1-2/93 
The revised version 2 of the Procedures for Expedited Review reads as follows: 
Procedures to be Followed for Expedited Review 
1. An investigator submitting a request to the NIH for expedited review of a gene 
transfer protocol must provide detailed information regarding the necessity of 
expedited review. 
2. No protocol shall be considered without Institutional Biosafety Committee (IBC) 
and Institutional Review Board (IRB) approval. 
3. At this time, all gene transfer protocols must be considered experimental. 
4. Regardless of the method of review, the Points to Consider must be the standard 
of review for all gene transfer protocols. 
5. Review of such protocols may include intramural NIH experts but must include 
extramural experts. 
6. Among other factors to be considered by the reviewers, is the similarity of the 
new protocol to previously approved protocols. 
7. The NIH will report to the RAC following expedited review and will include all of 
the materials on which the decision was based. The RAC will formally review the 
protocol at its next scheduled meeting. Patient privacy will be maintained. 
8. Protocols that are deferred or not approved by the RAC in its normal review 
process are not eligible for expedited review. No protocol shall have more than 
one patient approved under expedited review. 
9. As requested in the context of non-expedited review, none of the costs of the 
experimental protocol should be borne by the patient or the patient's family. 
10. Data on all patients undergoing gene transfer shall be provided to the RAC 
within six months of the procedure. 
Discussion 
Executive Secretary Note: The Process to be Followed for Expedited Review printed 
here is the approved NIH version. The NIH Legal Counsel revised item #9 to read 
"should" instead of "will." These procedures were published in the Federal Register on 
April 23, 1993 (58 FR 21741). 
Recombinant DNA Research, Volume 17 
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