9 
Dr. Davis said the working group did an extraordinarily good job of thor- 
oughly analyzing the situation. He stressed that RAC's responsibility is 
to protect public safety; it is not to decide "vhat is good science." He 
did not wish to see RAC become "a fountain of orthodoxy for scientific 
research . " 
Dr. Johnson commended the working group for an excellent job. He expressed 
concern that some points may be too specific. He suggested the word "may" 
be substituted for the word "will" in Section I-D-5-a. Dr. W. French 
Andersen of the NIH, a member of the Working Group on Human Gene Therapy, 
said Dr. Johnson's suggested modification is a good one since at this stage 
it is difficult to predict which effects will be reversible. Dr. Walters 
accepted Dr. Johnson's suggested modification as the fifteenth technical 
change to the points to consider document. 
Dr. Walters said RAC should address the issue of whether the NIH Guidelines 
and the points to consider document should explicitly cover recombinant 
FNA since the FNA-containing retroviruses will almost certainly be the 
vectors used in the first human gene therapy protocols. Several RAC members 
agreed. 
Dr. Talbot said under the aegis of the NIH Guidelines, the points to consider 
document provides guidance on the type of information to be submitted for 
review of hunan gene therapy protocols. Procedural ly, the points to consider 
document should not refer to recombinant RNA when the NIH Guidelines do 
not specifically refer to recombinant FNA. The NIH Guidelines can be 
modified after publication of the proposed, in the Federal Register for 
comment, review, and recommendation by the RAC and approval by the NIH 
Director. 
Dr. Walters suggested a generic proposal to modify the NIH Guidelines 
to refer to recombinant RNA be brought to RAC at the January 1986 meeting. 
He said the Working Group on Hunan Gene Therapy could then offer a proposed, 
to modify footnote one of the points to consider document to explicitly 
address recombinant RNA. 
Dr. Claves suggested the first footnote is superfluous if no reference 
to recombinant RNA can be made; the footnote should be deleted. 
Drs. Talbot and Gottesman said the first footnote indicates DNA derived 
from recombinant DNA is also covered by the points to consider document; 
Section III-A-4 explicitly indicates the NIH Guidelines cover ENA derived 
from recombinant DNA. This section applies to human gene therapy protocols 
in which restriction enzymes would be used to excise the cloned "foreign 
DNA" from the recombinant vector. 
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