11 
nanipulation more possible technically. Fbr this reason, he preferred each 
submitter be asked to respond directly to the question of whether and how the 
proposed work might make more feasible the possibilities listed in Sections 
II-C-3-a and II-C-3-b. 
Dr. Walters said Dr. Maxine Singer of the National Institutes of Health had also 
canrented on Section II-C; she thought the first question of this section is 
a scientific and medical issue and should not be posed among the social issues. 
The questions raised in Sections II-C-2 and II-C-3 should be considered by 
investigators as well as other interested individuals. But these questions 
are not amenable to scientific analysis, and the answers will be diverse and 
reflect the values of the respondent. Since they are essentially political in 
nature, these sections will be a source of contention under all circumstances 
and likely to be very troublesome in the review and approval of proposals. In 
addition, the context in which these questions appear is unusual; the document 
suggests RAC will expect written consideration of these questions but response 
is at the discretion of the investigator. 
Dr. Waiters said Dr. Juengst had also written that Section II-C-2 of the document 
is not clear. Are applicants to respond in terms of existing methods of care 
for the particular disease, or cure they to draw analogies to health care in 
general? If the point is to have the applicants think about hew their procedure 
fits into the traditions and norms of current health care practices, it might 
be more effective to ask explicitly for analogies; i.e., to have the applicants 
detail the similarities and differences they see between traditional modes of 
therapy and human gene therapy procedures. 
Dr. Gottesman agreed Section II-C-1 poses a primarily scientific question; 
she suggested this issue might be highlighted in Part I of the points to 
consider document under the section discussing the advantages of various 
therapies. Dr. Anderson said Section I-B-2-c-( l)-(d) addresses this type of 
issue . 
Dr. Murray said while highlighting these issues in Part I of the document was 
an acceptable approach, the emphases of the different parts of the document are 
different. Part I of the document asks what is the evidence the proposed somatic 
cell therapy will not affect the reproductive cells of the patient; Part II of 
the document is directed towards discussion of social issues and values. 
Dr. Anderson agreed Part II of the document attenpts to inform the public and 
the investigator of the types of social issues the RAC and working group will 
discuss during reviews. 
Dr. Walters said Dr. Juengst had conmented that if the document indicates 
investigators can comment on an issue at their discretion, they will undoubtedly 
submit some comment simply because they feel they must. Dr. Gottesaan said 
the working group and RAC would not wish to see reams of irrelevant information 
simply because the investigators feel they must comment. She felt the sub- 
working group agrees the issues raised in Section II-C should be discussed 
during protocol review. She said she would attonpt to compose some language 
for the introduction which would suggest the working group will consider these 
[ 11 ] 
