Attachment IV - Pg. 1 
Points to Consider in the Design art! Submission of Human Somatic 
Cell Gene Therapy Protocols 
Experiments in which recombinant CNA* is introduced into cells of a human subject 
with the intent of stably modifiying the subject's genome are covered by Section 
III-A-4 of the NIH Recombinant CNA Guidelines, which require such experiments 
to be approved by the RAC and NIH. RAC consideration of the proposal will 
follow publication of the proposal in the Federal Register, an opportunity for 
public comment, and review of the proposed, by a working group of the RAC. 
(GROBSTEIN ERAFT ) 
RAC recommendation on proposal will be forwarded to the NIH Director for considera- 
tion. Final decisions will be published in the Federal Register. This document 
is intended to provide guidance in preparing proposals for NIH consideration under 
Section III-A-4. Every point mentioned in the document will not necessarily 
require attention in every proposal. It is expected that the document will be 
considered for revision at least annually as experience in evaluating proposals 
grows . 
A proposal will be considered by the RAC only after the protocol has been 
approved by the relevant IRB under (45 GFR Part 46) the HHS regulations which 
involve children should give special attention to Subpart D of these regulations. 
Recommendation of the IRB and relevant minutes of its meetings should accompany 
submission of the proposal to NIH. The IRB may, at its discretion, may condition 
its approval on further specific deliberation by the RAC on matters beyond the 
*Experiments using retroviruses (RDNA) vector are also considered to be covered 
by this document and by the NIH recombinant DNA Guidelines. 
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