Recombinant DNA Advisory Committee - 09/9-10/93 
Informed Consent documents and the informed consent process were raised. 
Dr. W. French Anderson, University of Southern California, Los Angeles, California, 
stated that the RAC possesses unique expertise and is qualified to propose policy on 
scientific and biotechnology issues, as well as informed consent issues relating to human 
gene transfer. Dr. Anderson suggested that the RAC formulate informed consent 
recommendations to be communicated to the local IRBs through NIH's Office for 
Protection from Research Risks (OPRR). Dr. Parkman agreed that such a process 
would be a useful mechanism. Ms. Buc commented that it would be impractical to 
develop a universal Informed Consent document that would be applicable to all 
protocols. A set of common guidelines would be more feasible. Dr. Motulsky suggested 
that some social science studies should be conducted to obtain practical information on 
the effectiveness of the informed consent process for complicated genetic diseases. 
Dr. Zallen commented on the importance of the Informed Consent document. She 
agreed that the RAC is in a position to provide useful suggestions based on its extensive 
expertise in the review of such documents. 
Committee Motion 
1 
I 
A motion was made by Dr. Krogstad and seconded by Dr. Zallen that the RAC establish 
a working group to frame pertinent questions relevant to Informed Consent documents 
and that the Director of OPRR, NIH, should be invited to the December 1993 RAC 
meeting to address these issues. The motion passed by a vote of 17 in favor, 0 opposed, 
and no abstentions. 
VIII. AMENDMENT TO THE GUIDELINES FOR THE SUBMISSION OF HUMAN GENE 
TRANSFER/THERAPY PROTOCOLS FOR REVIEW BY THE RAC OF THE POINTS 
TO CONSIDER/NIH GUIDELINES /DR. WTVEL 
Dr. Wivel presented amendments to the Guidelines for the Submission of Human Gene 
Transfer/Therapy Protocols for Review by the RAC (Federal Register , February 18, 1993, 
page 9104). These amendments will establish consistency in the submission of human 
gene transfer protocols for RAC review and require Pis to focus their oral responses to 
the RACs questions and comments. The Title and Section I will read: 
"Guidelines for the Submission of Human Gene Transfer Protocols for Review by the 
Recombinant DNA Advisory Committee. 
"I. Investigator Submitted Material: 
l 
1 
"Written proposals must be submitted in the following order: (1) scientific 
abstract-1 page; (2) non-technical abstract-1 page; (3) IBC and IRB 
approvals; (4) Points to Consider-5 pages; (6) protocol-20 pages excluding 
appendices; (7) Informed Consent document-approved by the IRB; (8) 
appendices including tables, figures, and manuscripts; and (9) CVs-2 pages 
Recombinant DNA Research, Volume 18 
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