6 
of Hunan Sanatic-Cell Gene Therapy Protocols" in the January 22, 1985, 
Federal Register . Fourteen letters commenting on the points to consider 
were received by the NIH in response to this announcement. 
These cements were carefully reviewed by the working group at its April 1, 
1985, meeting; and the changes agreed upon by the working group were incor- 
porated into the April 15, 1985, version of the document. That version of 
the document was considered by RAC at its May 3, 1985, meeting; and modifica- 
tions were introduced into the document on the basis of that discussion. 
Dr. Walters then suimarized the differences between the April 15 version 
and the subsequent version published in the August 19, 1985, Federal 
Register : (1) A section entitled "Applicability" was added to the document. 
This section explicitly states that the document applies to projects con- 
ducted at or sponsored by an institution that receives NIH support for 
recombinant DNA research. (2) A footnote, which in the January 22 version 
referred to both recombinant DNA and recombinant RNA, was changed to 
refer only to recombinant DNA, since the current NIH Guidelines only 
explicitly cover recombinant DNA and not recombinant FNA. (3) A footnote 
indicating the Food and Drug Administration (FDA) has jurisdiction over 
drug products intended for use in clinical trials of human somatic-cel 1 
gene therapy was added to the document. (4) A request for submission to 
NIH of the informed consent form was deleted from the document. In general, 
the NIH does not review consent forms; local Institutional Review Boards 
(IRBs) review and approve consent forms. However, language indicating NIH 
may request consent forms for human gene therapy protocols in certain 
circumstances was added to Section II I -A of the points to consider document. 
Dr. Walters said three ccnment letters were received on the revised version 
of the document published in the Federal Register of August 19, 1985. In 
addition, a working group consultant. Dr. Howard Temin of the University of 
Wisconsin, commented by telephone. 
A Sutworking Group on Human Gene Therapy met on September 20, 1985, to 
address these comments. In response to these cements, the sutworking 
group introduced fourteen minor technical amendments into the document. 
Dr. Walters enumerated these modifications. First, the subworking group 
highlighted its intention to revise the document as developments dictate 
by modifying the last sentence of paragraph (3) of the Introduction as 
follows: 
"The document will be considered for revision as experience in 
evaluating proposals accumulates and as new scientific developments 
occur. This review will be carried cut at least annually." 
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