subcommittee. Dr. Erickson noted that study sections review the 
scientific merit as part of determining whether or not the science 
is worth supporting, not as part of a risk/benefit analysis. 
Dr. Murray suggested that the RAC propose a legal subcommittee to 
consider the ramifications of a review procedure that might empower 
a subcommittee to prohibit a project. Dr. McGarrity explained that 
rejection of a proposal by a subcommittee could be appealed to the 
NIH Director if there was a complaint of not having received a full 
or fair review. 
Dr. McCarthy endorsed the proposed Subcommittee approval 
requirement not .ng that an IRB's negative conclusion cannot be 
overturned by a higher body. Ms. Areen observed that the HGTS is 
not simply a subgroup of the RAC, it is especially constituted of 
outside experts to provide a specific service. Dr. Mahoney also 
pointed out that the Federal Register announcement policy 
provides public access that assures open and fair review, in 
contrast with study section procedures. 
The Human Gene Therapy Subcommittee broke for lunch at 12:30 p.m. 
and resumed at 1:30 p.m. 
II. Public Information Brochure 
Dr. Walters 
Dr. Walters reviewed the history of this document and suggested 
that the Subcommittee: (1) adopt a procedure for dealing with 
minor changes, and (2) discuss the major conceptual issues. 
Mrs . Witherby 
Mrs. Witherby, who has been leading the effort to develop and 
publish the public information brochure, drew the Subcommittee's 
attention to a review of comments on page 177 and to a suggested 
insert on page 175. Dr. Parkman suggested that scientific 
information be made more general in order for the document to 
maintain timeliness. He also cautioned against citing hemophilia 
as a specific example because that is not considered one of the 
early candidate diseases for gene therapy. The Subcommittee 
discussed appropriate examples noting that it is important to 
provide examples of diseases that are familiar to nonscientists, 
but also important not to raise hopes prematurely. On page 100 
(2), line 10, "technology" was inserted following "recombinant 
DNA. " Another general modification was to delete references to 
genetic diseases because it is clear that gene therapy may be 
used in the treatment of a variety of diseases. On page 111 
(13), Dr. Miller proposed deleting references to Science for the 
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Recombinant DNA Research, Volume 13 
