Recombinant DNA Advisory Committee - 3/34/94 
Footnote 21 will be amended to read: 
"Human studies in which the induction or enhancement of an immune response to 
a vector-encoded microbial immunogen is the major goal, such an immune 
response has been demonstrated in model systems, and the persistence of the 
vector-encoded immunogen is not expected, are not covered under Section III-A-4 
of the NIH Guidelines. Such studies may be initiated without RAC review if 
approved by another Federal regulatory agency." 
X. REPORT FROM THE RAC WORKING GROUP ON ACCELERATED REVIEW- 
AMENDMENT TO THE NIH GUIDELINES AND THE POINTS TO CONSIDER 
REGARDING ACCELERATED REVIEW OF HUMAN GENE TRANSFER 
PROTOCOLS/DR. PARKMAN 
Minor Actions-Dr. Parkman 
Dr. Walters called on Dr. Parkman, Chair of the RAC Working Group on Accelerated 
Review, to summarize the proposed amendments to the NIH Guidelines and Points to 
Consider. Dr. Parkman presented a flow diagram that outlined the proposed NIH review 
process for human gene transfer experiments. The proposed amendments define three 
categories of review: (1) RAC Major Actions, (2) NIH/ORD A Minor Actions, and (3) 
NIH Director Actions. Human gene transfer experiments considered as Major Actions are 
described under proposed Section IV-C-l-b-(l) of the NIH Guidelines. Major Actions 
require Federal Register announcement 15 days prior to the RAC meeting at which the 
proposal will be reviewed and an opportunity for public comment, full RAC review, and 
NIH Director approval. Human gene transfer experiments considered as Minor Actions 
are described under proposed Section IV-C-l-b-(2) of the NIH Guidelines. NIH/ORDA 
will determine whether a protocol qualifies as a Minor Action in consultation with the 
RAC Chair and one or more RAC members as necessary. A human gene transfer 
experiment that qualifies as an NIH Director Action is considered under proposed 
Appendix M-VI, Single Patient Expedited Review Protocols. A protocol considered as a 
Single Patient Expedited Review Protocol must be reviewed by extramural experts (may 
include intramural experts) and approved by the NIH Director. Protocols approved 
under the Minor Action and Single Patient Expedited Review categories will be reported by 
the RAC Chair at the next scheduled RAC meeting. Principal investigators of protocols 
approved under all review categories will be required to comply with the semi-annual 
data and adverse effect reporting requirements. 
Dr. Parkman said that an additional category has been created for potential future use. 
These will be experiments that can be initiated simply by registration with NIH/ORDA, 
and the progress of the study will be tracked by the RAC. 
Dr. Straus asked what kinds of experiments will be encompassed under the Minor Actions 
category. Dr. Parkman said that several categories of experiments will be discussed later, 
such as those involving lethally irradiated tumor cells. Another possible example will be 
a protocol moving from Phase I to Phase II and III trials. Some protocols will be moved 
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Recombinant DNA Research, Volume 19 
