UNIVERSITY OF CALIFORNIA, SAN FRANCISCO 
BERKELEY • DAVIS • IRVINE • LOS ANCELES • RIVERSIDE • SAN DIECO • SAN FRANCISCO 
Attachment IV - Page 10 
SANTA BARBARA • SANTA CRUZ 
DIVISION OF MEDICAL ETHICS SAN FRANCISCO, CALIFORNIA 94143 
SCHOOL OF MEDICINE 
DEPARTMENT OF MEDICINE 
Dr. William J. Gartland, 
Director 
Office of Recombinant DNA Activities 
Building 31, Room 3B10 
National Institutes of Health 
Bethesda , MD 20205 
Dear Dr. Gartland: 
I am writing in response ot the request by the RAC Working Group 
on Human Gene Therapy for comments on th "Points to Consider" 
published in the January 22 Federal Register . These guidelines 
represent a commendable effort on the part of the Working Group to 
prepare for the first human gene therapy protocoals, and for the most 
part they are clear and thoughtful. I would like comment on one 
section, hough, that did leave me bewildered, and might merit further 
attentio: 
The onfusing section for me is point C of part II, "Social 
Issues. r This section is potentially one of the most important parts 
of the document, given the issues it raises, but its usefulness in its 
present form is blurred in several ways. 
First, it is not clear how prospective applicants are to take 
this section in planning their proposals. They are requested "to 
discuss, at their discretion, the general issues enumerated in point 
C" [p.2944] . This discretionary freedom is presumably derived from 
the earlier acknowledgement that "not every point mentioned in the 
document will necessarily require attention in every proposal" 
[p.2942] . Yet, under point C itself they are explicitly advised that 
"the following issues will also be considered by the RAC and the 
working group in reviewing each gene therapy proposal" (emphasis 
added) [p.2944]. I think this wording would almost always make it a 
tactical mistake for applicants to exercise their discretionary option 
to make point C one of those they do not treat in their proposal. 
Part of the reason for this is the dynamics of proposal review. 
One of the lessons I learned from four years as a program officer in a 
federal grant-making agency (NEH) was that, when faced with a 
difficult task in weighing the merits of a proposal, the more criteria 
reviewers can justifiably bring to bear, the finer the discriminations 
they can make. The psychology, if not the logic, of the situation 
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