20 
an autopsy in the event of the patient's death. Both of these stipulations, 
in the opinion of the working group, are reasonable constraints on the 
autonomy of patients and their families in light of the benefits to future 
gene therapy patients. 
Dr. Walters said some ccmmerrtors had suggested the working group should 
possess additional types of expertise. The working group accepts this 
criticism but notes that no group of 15 people can "cover all the bases." 
The working group is committed, however, to obtaining additional expertise 
by consulting with ad hoc consultants as necessary. 
Dr. Walters said the working group was presenting these points to consider 
not as a finished code of rules but rather as a checklist of the most 
important issues raised by the many thoughtful people who have discussed 
human gene therapy. 
Dr. Walters said the working group will devote further study to two topics: 
(1) measures to disarm retroviral vectors; and (2) technical problems 
currently associated with germ line gene modifications in animal systems. 
In the future, the working group will devote detailed attention to specific 
ethical and legal questions surrounding gene therapy. 
Dr. Walters then thanked the members of the working group, the liaison 
members, and ORDA staff for their efforts. He also thanked the individuals 
who cemented on the points to consider document. 
Dr. Walters identified a problem with the current version of the document: 
footnote one indicates the points to consider apply to both recombinant 
RNA and recombinant DNA. The current NIH Guidelines, however, do not 
officially cover recombinant RNA. He said Dr. Gottesman has a proposal 
for resolving this problem. 
Dr. Gottesman preposed to modify footnote one of the points to consider 
document by eliminating the first sentence and the words "as well as to RNA" 
in the second sentence. The footnote would then read: "Section III-A—4 
applies to both recombinant DNA and DNA derived from recombinant DNA." 
In addition, a proposal to modify the NIH Guidelines to cover FNA derived 
from recombinant DNA could be developed and published prior to the next 
RAC meeting. 
Dr. Friedman said the working group did an excellent job in preparing the 
points to consider document. 
Dr. Rapp said "the continuous request of certain individuals" to have a 
representative "of every stripe" on the Working Group for Human Gene Therapy 
is nonsensical. He said the major issues are how safe is the procedure 
and how can the interests of society be protected. The working group as 
currently constituted has been working well in dealing with scientific and 
social issues. 
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