Recombinant DNA Advisory Committee- 9/12-13/94 
Dr. Wivel explained that the RAC very often approves a protocol provisionally with a list 
of contingencies to be fulfilled by the investigators before final approval by the NIH 
Director. Under the new system, the contingencies will be followed up by FDA and the 
RAC will have no further input. Minor modifications of approved protocols will also be 
handled by FDA without input from RAC members. Dr. Wivel emphasized that data 
collection on approved protocols will be continued by ORDA and with reports to the 
RAC at six-month intervals to maintain public accountability of gene transfer experiments. 
Dr. Wivel proposed amendments to Sections I, III, IV, V and Appendix M of the NIH 
Guidelines , to reflect this consolidated review process. 
Dr. Miller asked a procedural question about the plan to streamline review that has been 
endorsed by respective agencies, and whether it requires the RAC to vote on this plan. 
He questioned whether the consolidated review will effectively shorten the review process. 
Dr. Wivel said that it is clear from the AIDS Task Force meeting that both the NIH 
Director and the FDA Commissioner are committed to the consolidated process. The 
RAC is specifically asked to amend the pertinent sections of the NIH Guidelines to 
facilitate the streamlined process. In the new review system, applications will be 
processed as soon as they come in; and they will be sent out to the reviewers immediately. 
All the protocols that require RAC review will be collected by a batch method and will be 
presented at the next quarterly RAC meeting. Dr. Secundy asked why the whole review 
process has to be changed to accommodate the demand of a single AIDS group. Dr. 
Wivel said that, as indicated by Dr. Varmus, the current dual review system needs 
streamlining not simply to meet the demand of AIDS protocols, but to respond to the 
expected increase in gene therapy proposals. Responding to a question by Ms. Meyers, 
Dr. Wivel said that the RAC was created by the NIH Director after the Asilomar 
conference to review recombinant DNA research, not as a result of any statutory action. 
Dr. Motulsky expressed his sympathy with the concept of streamlining the process. Dr. 
Zallen was concerned about the deletion of the Points to Consider from the NIH 
Guidelines that will deprive the RAC of its ability to utilize its recent revision of the 
sections dealing with informed consent issues. Mr. Capron shared the concern raised by 
Dr. Zallen and asked whether there is formal commitment by FDA in this regard. Dr. 
Noguchi from FDA said that the Points to Consider will be adopted as part of the 
Investigational New Drug Application (IND). There are 11 sections in this IND 
submission and the Points to Consider will be included in Section 11, Relevant 
Information. He proposed that a working group be formed to solicit public, academic, 
and corporate input to facilitate the long-term consolidation. Mr. Capron expressed his 
inclination to abstain from voting on the proposed guideline changes, indicating that the 
FDA document to adopt the Points to Consider has not gone through publication and 
public comment process. Several outstanding questions regarding review criteria, and the 
new structure of the review system are still evolving. He suggested that the word "to" 
should be changed to "under" for the proposed guideline amendments in "Section m-A-1. 
Major Actions the NIH Guidelines. Dr. Ross expressed her concern about the triage 
process in the new review system. Dr. Wivel reassured her that the triage process will 
involve RAC members. Dr. Noguchi said that the RAC should make decisions that will 
have major impact on the field of gene therapy such as establishing criteria for prenatal 
gene therapy rather than attempting to review all the submitted protocols. Dr. Miller said 
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Recombinant DNA Research, Volume 20 
