10 
"The consent form must adhere to the requirements of 45 CFR 46 and 21 
CFR 50. Special attention must be paid to the applicability of the 
additional elements of informed consent listed in these regulations. 
(Include a ccpy of the patient consent form as part of the documentation 
requested in Part III, below.)" 
Dr. Walters felt after events such as Baby Fae, he was inclined to believe 
these specific points were worth emphasizing. Ms. Areen suggested a sentence 
to that effect might be added to the preamble of Section I-D. The srbworking 
group agreed, however, that the points to consider document should request the 
patient consent form as part of the documentation. 
Dr. Walters then called the attention of the subworking group to Dr. Miller's 
comment on Section I-E of the points to consider document. Dr. Miller thought 
the initial paragraph under Section I-E, Privacy and Confidentiality , provides 
sufficient information; he suggested Sections I-E-l and I-E -2 be deleted fron 
the document. 
Dr. Childress disagreed with this suggestion; he felt these specific points should 
be mentioned. Ms. Areen agreed with Dr. Childress. Dr. Walters thought the 
first patient to receive human gene therapy would be a celebrity; the patient's 
patient's family should be aware of the difficult issues associated with medical 
firsts. The scbvorking group agreed Section I-E as written should remain in the 
document . 
Dr. Walters then called the attention of the si±> working group to Section II 
of the points to consider document. He said several comments were received on 
this section of the document. 
Dr. Walters said Dr. Miller had commented on Section II of the document. 
Dr. Miller wrote he strongly believed Section II-A was the only point in Section 
II of the document which should be retained. The other sections are not appro- 
priate to this document or are duplicative and should be deleted. He argued 
inclusion of these points reflects incomplete understanding of the concept 
that somatic cell gene therapy is analogous to other conventional medical 
interventions . 
Dr. Walters called the attention of the sub working group to the comment from 
Dr. Eric T. Juengst of the University of California, San Francisco. Dr. Juengst 
suggested same of the questions posed in Section II-C, Social Issues , should 
be moved to Part I, Section A, Objectives and rationale of the proposed research , 
of the document. Dr. Walters said Dr. Juengst had commented that if the working 
group wishes to encourage researchers to think about Section II-C questions as 
an integral part of planning their own work and not as extraneous social kibbitzing, 
these issues might be worked into particularly relevant points in the document. 
Dr. Walters called the attention of the sub working group to the comments of 
Dr. Leon Kass on Section II. Dr. Kass said Section II-C as written suggests 
some members of the working group are not entirely comfortable with the distinction 
between somatic cell therapy and germ line therapy. He argued that gene therapy 
techniques for somatic cells will almost certainly render germ line genetic 
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