Recombinant DNA Advisory Committee - 12/2-3/93 
CERTAIN CATEGORIES OF HUMAN GENE TRANSFER EXPERIMENTS THAT 
QUALIFY FOR THE ACCELERATED REVIEW PROCESS/DR. PARKMAN 
Dr. Parkman, Chair of the RAC Working Group on Accelerated Review provided a 
summary of the proposed amendments to the NIH Guidelines and Points to Consider 
regarding accelerated review of human gene transfer protocols. The proposed 
amendments would: (1) establish an accelerated review process for ceratin categories of 
human gene transfer experiments (i.e., "umbrella" multiple site protocols in which the PI 
is responsible for quality control and data reporting for research conducted at all sites, 
duplicate protocols conducted at sites other than those originally approved by the RAC 
and in which there is a new PI, protocols involving lethally irradiated cells with no 
replication-competent virus, and modifications to previously approved protocols not 
related to gene transfer); (2) allow the NIH (ORDA) to assign the appropriate review 
category to all human gene transfer proposals that are submitted in compliance with NIH 
Guidelines', (3) allow NIH (ORDA) to approve those categories of human gene transfer 
experiments that qualify for the accelerated review process in consultation with the Chair 
and one or more RAC members, as necessary; and (4) exempt certain experiments 
involving the transfer of recombinant DNA or DNA or RNA derived from recombinant 
DNA into one or more human subjects which are not covered by Footnote 21. All 
human gene transfer experiments approved by NIH (ORDA) through the accelerated 
review process would be provided in a report by the Chair at the next regularly 
scheduled RAC meeting and included in the list of approved experiments which is 
available form ORDA. Experiments approved through the accelerated review process 
would be considered Minor Actions to the NIH Guidelines, eliminating the necessity for 
full RAC review and publication of the proposed action in the Federal Register. Human 
gene transfer experiments that are not considered as Minor Actions or Exempt from the 
NIH Guidelines would be considered Major Actions, and require publication in the 
Federal Register , full RAC review, and approval by the NIH Director. 
Committee Consensus 
The consensus of the RAC was that this proposal should be published for public 
comment in the Federal Register and reviewed at the next regularly scheduled RAC 
meeting. 
(Note: The next meeting of the RAC will be March 3-4, 1994, NIH, Building 3 1C, 
Conference Room 6.) 
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Recombinant DNA Research, Volume 18 
