DEPAKIME-rr OF HEALTH AND HUMAN SERVICES 
PUBLIC HEALTH SERVICE 
NATIOtAL INSTITUTES OF HEALTH 
RECOMBINANT DNA ADVISORY COMMITTEE 
SUBGROUP OF WORKING GROUP ON HUMAN GENE THERAPY 
MINUTES OF MEETING 
SEPTEMBER 26, 1984 
A meeting was held from 9:00 a.m. to 11:45 a.m. on Septerrber 26, 1984, by a 
subgroup of the Recombinant CNA Advisory Ccnnittee Working Group on Human Gene 
Therapy. Ms. Areen, Mr. Caprcn, and Drs. Anderson, Gam land, Gorovitz, Gottesman, 
Milewski , Miller, Murray, and Walters attended. The purpose of the meeting was 
to develop a discussion draft document for the October 12, 1984, meeting of 
the Working Group on Human Gene Therapy. 
Dr. 'Walters called the meeting to order. Comments which had been sent to the 
subgroup by Drs . Amo Mot ul sky and Howard Temin were distributed to the group 
(Attachments I and II). Dr. Anderson also distributed a copy of a forthcoming 
article pertinent to the discussion (Attachment III) which he said would be 
published in an October issue of Science. 
Dr. Walters suggested the subgroup might begin by addressing the following 
topics: 
I . Materials 
II. Substance of Check list /Guide lines 
A. Risk 3enefit 
B . Informed Consent 
C. Selection of Subjects 
III. Process of Distribution and Commenting 
The subgroup discussed the process and time frame in which a final document 
might be developed. The draft document developed at and after the .September 
26 meeting would be sent to the October 12, 1984, meeting of the Working Group 
on Human Gene Therapy; any document developed by that group -would be sent to 
the RAC for discussion at the October 29, 1984, meeting. The Working Group on 
Human Gene Therapy might or might not have to modify the document following 
discussion of the document by RAC. The resulting document might then be published 
in the Federal Register for a period of public comment. After receiving comments, 
the Working Group an Hunan Gene Therapy would meet again to incorporate suggested 
changes into the document. The document would subsequently be sent for acceptance 
co the RAC. 
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