Attachment IV - Page 2 
4 
TViis document is intended to provide guidance in preparing proposals for NIH 
consideration under Section III-A-4. Not every point mentioned in the document 
will necessarily require attention in every proposed.. It is expected that the 
document will be considered for revision at least annually as experience in 
evaluating proposals accumulates. 
A proposal will be considered by the RAC only after the protocol has been 
approved by the local Institutional Biosafety Carmittee (IBC) and by the local 
Institutional Review Board (IRB) in accordance with Department of Health and 
Human Services regulations for the protection of human subjects (45 CFR, Part 
46). If a proposal involves children, special attention should be paid to sub- 
part D of these regulations. The IRB and IBC may, at their discretion, condi- 
tion their approval on further specific deliberation by the RAC ard its working 
group. Consideration of gene therapy proposals by the RAC may proceed simulta- 
neously with review by any other involved federal agencies (e.g. , the Food and 
Drug Administration) provided that the RAC is notified of the simultaneous 
review. Meetings of the committee will be open to the public accept where 
trade secrets or proprietary information would be disclosed. The carmittee 
would prefer that the first proposals submitted for RAC review contain no 
proprietary information or trade secrets, enabling all aspects of the review 
to be open to the public. The public review of these protocols will serve to 
educate the public not only on the technical aspects of the proposals but also 
on the meaning and sionificance of the research . 
This document is designed to cover the initial protocols on human gene therapy. 
It is expected that these first cases will involve only one or a very few 
patients using biological material prepared under the direct personal supervision 
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