Attachment IV - Page 1 
O f COUN 5 CI 
SANORA e HAMILTON 
BONNIE LOUN5BUR''* 
"UINOtS ANO M*IN( 
i aw or f ices 
EDWARD LEE ROGERS 
suite: i • pno 
I ' I H !■> SIPLt I, N. w 
WASHINGTON. O.l ?QO 3t 
'POP! J8 7-IOOO 
September 18, 1985 
BY MESSENGER 
Director, Office of Recombinant DNA Activities 
Building 31, Room 3B10 
National Institutes of Health 
Bethesda, Maryland 20205 
Jeremy 
Fed . 
Protocols 
Comments of the Foundation on Economic Trends and 
Rifkin on the NIH Notice issued August 19, 1985, 50 
Reg. 33462, re IV. Points To Consider in the Design and 
Submission of Human Somatic-Cell Gene Therapy 
In the Introduction (3), it is stated that the Points to 
Consider document "will be considered for revision at least 
annually". There may well be a need for frequent revisions as 
experience is gained in this field. There should be no a priori 
assumption regarding how soon or often revisions may be 
necessary. A particular experiment (s) may raise issues requiring 
a proposed revision within a few months rather than annually. 
In the Introduction (11), the potential of developments that 
"enhance human capabilities rather than to correct defects in 
patients" is recognized as possible, albeit not as immediate or 
inevitable, results of such research. Accordingly, the working 
group states that it "will cooperate with other groups in 
assessing the possible long-term consequences of somatic-cell 
gene therapy and related . . . experiments ... to define 
appropriate human applications of this emerging technology." 
Inasmuch as rapid developments in this field seem inevitable, we 
recommend that the working group begin immediately to develop the 
procedural structure for such cooperative efforts and to review 
its own composition to determine if it should be broadened or if 
its balance of disciplines should be altered. 
The working groups speaks of cooperating with other groups 
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