12 
using animal systems will contribute to developing hunan germ line gene therapy 
techniques; (2) techniques are not yet sufficiently deveicped to implement 
germ line therapy in humans; and (3) society should consider mechanisms to control 
the way in which germ line therapies are implemented. He said he is not convinced 
at this time that human germ line therapy would per se present ethical problems. 
Dr. Childress said social forces will determine the effect of somatic ceil 
therapy protocols on germ line therapy. Society will not step the accumulation 
of knowledge but can attonpt to control application of that knowledge. 
Dr. Gottesman said the issue is how to deal with the consequences of increased 
knowledge. The language in the points to consider document could be rephrased 
to onphasize this issue. Mr. Capron said this language should be carefully 
drafted and should simply indicate it is worthwhile to evaluate these issues. 
Dr. Walters thought the document's introduction might include a statement of the 
working group's current thinking. He asked Drs. Gottesman and Childress if 
they would be willing to attenpt to redraft language for this section of the 
document o/er the lunch hour. Dr. Childress asked if Mr. Capron could assist 
in drafting this portion of the document. The working group then adjourned 
for lunch. 
Following lunch. Dr. Walters called the attention of the working group to 
.Section I-A, Objectives and rationale of the proposed research , of the docu- 
ment (Attachment IV); he said no changes had been made in this section of the 
document. 
Dr. Walters said one change had been made in Sect ion I-B, Research design, 
anticipated risks and benefits ; Section I-B-l-b had been modified to read: 
"What are the structure and composition of the material that will be administered 
to the patient?" 
Dr. Temin asked why the word "composition" had been added to this section of 
the document. The pertinent question is what is the structure; the concept 
of composition is included in the concept of structure. 
Dr. Anderson said the addition of the word "composition" was an attempt to be 
responsive to the comments of Dr. Henry Miller of the FDA. 
Dr. Motulsky thought the points to consider document should be clear and con- 
cise; he did not think it reasonable to muddy the document in an attonpt to 
meet political considerations. He suggested the working group delete the word 
"composition" from Section I-B-l-b. The working group agreed. 
Dr. Grobstein asked whether the term "conposition" might be relevant in Section 
I-B-l-b- (1) of the document which requests information on materials vhich might 
be administered to the patient. The working group agreed the word "composition" 
should ranain in Section I-B-l-b- (1). 
Dr. Walters called the attention of the working group to Section I-B-l-b- (l)-(b) 
to the document. He noted that the words "nucleic acids" had been substituted 
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