11 
Mr. Capron said hurran saratic cell therapy and animal research moves society 
towards the possibility of human germ line gene therapy; some group should 
address this issue. The Working Group on Human Gene Therapy should at the 
minimum recognize the existence of this issue. 
Dr. Gorovitz said the working group cannot skirt these issues by falling back 
on the mandate's limitations. The working group will one day receive a proposal 
which will bring these issues to life. 
Mr. Mitchell said as Chair of the Recombinant ENA Advisory Committee (RAC), 
he would at this time rule out of order a proposal involving germ line modifi- 
cation; the RAC does not currently have guidelines for reviewing human germ 
line gene therapy proposals. 
Mr. Mitchell said the human gene therapy situation is evolving rapidly; as the 
working group learns more, attitudes will change. He felt it was important 
for the working group to focus on reviewing the initial proposals and not 
become so bogged down in potential ramifications that the goal is lost. 
Dr. Gorovitz felt comfortable with the working group reviewing initial protocols 
even though the working group had not yet discussed whether there are "right" 
answers to some questions posed in the points to consider document. He asked 
whether the group agrees proposals should be reviewed. 
Dr. Motulsky said the working group should proceed to reviewing proposals. NO 
public body can state that certain areas of research cannot be explored, it 
is not possible to stop the exploring human mind. 
Dr. McCarthy suggested the points to consider could state the working group's 
purpose and indicate the group would exercise vigilance in cverseeing human 
gene therapy. 
Dr. Gottesman summarized the points which had been made concerning the social 
issues associated with human scmatic cell gene therapy. She said the first 
question is whether the investigator should be required to address these social 
issues as part of the submission. The second question is whether the working 
group will address these issues. She said the working group should determine 
whether it will approve of protocols in the absence of a discussion of social 
issues. The third point is whether the working group should attempt to address 
these issues before the first protocols are submitted. 
Dr. Childress thought the points to consider document should state in a positive 
way that investigators will not be required to specifically address social 
issues associated with human somatic cell gene therapy. The document should 
also explicitly state the limitations imposed by the working group; e.g., the 
vector must be constructed to prevent transmission, and germ line human gene 
therapy protocols will not be reviewed under these points to consider. 
Mr. Capron said these social issues cannot be addressed individually; rather 
they should be addressed generically as parts of a whole. He cited three 
points which should be evaluated at the same time: (1) information generated 
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