Attachment II - Pg. 2 
Points to Consider in the Design and Submission of Somatic Cell Gene Therapy Protocols 
Introduction: Proposed Text Susan Gottesman 
Experiments in which recombinant DNA is introduced into human cells with 
the intent of stably modifying the genome of cells of a human subject are covered 
by Section III-A-4 of the NIH Recombinant DNA Guidelines, which require such 
experiments to be approved by the RAC and NIH. RAC consideration of the 
proposal will follow publica/ion of the proposal in the Federal Register, an 
opportunity for public comment, and review of the proposal by a working group 
of the RAC. This document outlines "Points to Consider" in preparing 
submissions under III-A-4 for NIH consideration. Not every proposal will 
require attention to all of these points. Revision of the "points to 
consider" will occur at least annually. 
If RAC recommends approval of the proposed experiment, that recommendation 
will ;be forwarded to the NIH Director for his consideration. The final 
decision will be published in the Federal Register. 
Consideration of proposals by RAC should follow approval of the experiment 
by the relevant local IRB under all the requirements of the Office for 
the Protection of Human Subjects. Since it seems probable that some of these 
experiments will be performed on children, special attention should be given 
to Subpart D of the Protection of Human Subjects Regulations. Minutes of 
the IRB meeting and its final decision should accompany submission of 
the proposal to NIH. The IRB may, at its discretion, defer particular 
scientific questions to allow the review by NIH to help in reaching a final decision. 
Consideration of the proposed experiment by any other federal agency (e.g. FDA) 
may proceed simultaneously with NIH consideration. 
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