Attachment VII - Page 4 
(3) This document is intended to provide quidance in preparing proposals for 
NIH consideration under Section III-A-4 of the Nil! Guidelines for Research 
Involving Reccmbinant DNA Molecules. Not every point mentioned in the 
"Points to Consider" document will necessarily require attention in every 
proposal. The document will be considered for revision as experience in 
evaluating proposals accumulates and as new scientific developments occur. 
This review will be carried out at least annually. 
(4) A proposal will be considered by the RAC only after the protocol has been 
approved by the local Institutional Biosafety Ccrrmittee (IBC) and by the 
local Institutional Review Board (IRB) in accordance with Department of 
Health and Human Services (DHHS) Regulations for the Protection of Human 
Subjects (45 Code of Federal Regulations, Part 46). If a proposal involves 
children, special attention should be paid to subpart D of these CHHS 
regulations. The IRB and IBC rray, at their discretion, condition their 
approval on further specific deliberation by the RAC and its working group. 
Consideration of gene therapy proposals by the RAC may proceed simultaneously 
with review by any other involved federal agencies 2 provided that the 
RAC is notified of the simultaneous review. Meetings of the ccrrmittee 
will be cpen to the public except where trade secrets or proprietary 
information would be disclosed. The camuttee would prefer that the 
first proposals sutmitted 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 inform the 
The Food and Drug Administration (FDA) has jurisdiction over drug products in- 
tended for use in clinical trials of human somatic-cell gene therapy. For 
general information on FDA's policies and regulatory requirements, please see 
the Federal Register , Volume 49, pages 50878-00, 1984. 
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