DEPARTMENT OF HEALTH & HUMAN SERVICES 
Attachment IV - Page 2 
Public Health Service 
National Institutes of Health 
National Cancer Institute 
Bethesda, Maryland 20205 
February 28, 1985 
Dr. William J. Gartland 
National Institute of Allergy and 
Infectious Diseases 
National Institutes of Health 
Bethesda, MD 20205 
Dear Bill: 
I write to comment on the "Points to Consider in the Design and Submission 
of Human Somatic-Cell Gene Therapy Protocols" published in the Federal Register 
on January 22, 1985. First, I would like to congratulate the working group on 
a very thorough and thoughtful job. The scientific questions are dealt with 
carefully and sensibly. Second, I have some questions regarding part II, Social 
Questions. Subparts IIA and IIB are straightforward. Subpart IIC is problematic. 
Question 1 is fine, but it belongs among the scientific and medical issues, not 
among the social issues; to place it here in part II implies questions about 
values, which in fact are not part of Question 1 at all, as it is stated. I 
agree that the other two questions raised (IIC2 and IIC3) should be considered 
by the people doing the experiments as well as others. However, the context here 
is unusual. The "Points" seems to say that the RAC will expect written considera- 
tions of these points, at the discretion of the investigators. Yet, they are not 
really amenable to scientific analysis; the answers will be diverse and reflect 
the values of the respondent. Question(s) 3 are the most troubling. While they 
raise interesting matters for discussion, they ask the investigator to be a 
soothsayer. Also, several aspects of this question are essentially political in 
nature. They will be contentious under all circumstances, and likely to be very 
troublesome in the context of the review and approval of proposals. If the 
working group wants the IBCs and investigators to think about these matters, 
they should say so. They should remove their request that the parties discuss 
these matters in writing in the documents submitted for review. Leaving it to 
their 'discretion', as stated in the introduction to Part II, implies that the 
RAC expects this. The questions in II 2 and 3 C are better left to lengthy 
and public analysis by thoughtful and competent people in articles and 
books 
Sincerely yours 
M 
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