Attachment II - Page 7 
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(9) Concurring with this judgment, the RAC and its working group sure prepared 
to consider for approved, somatic-cell therapy protocols, provided that the 
design of such experiments offers adequate assurance that their consequences 
will not go beyond their purpose , vhich is the same as the traditional purpose 
of all clinical investigations, namely, to benefit the health and well-being 
of the individual being treated while at the same time gathering general- 
lzable knowledge. 
(10) Two possible undesirable consequences of somatic-cell therapy would be 
unintentional (1) vertical transmission of genetic changes frem an individual 
to his or her offspring or (2) horizontal transmission of viral infection 
to other persons with whom the individual canes in contact. Accordingly, 
this document requests information that will enable the RAC and its working 
group to assess the likelihood that the proposed serra tic-cell gene therapy 
will inadvertently affect reproductive cells or lead to infection of 
other people (e.g., treatment personnel or relatives). 
(11) In recognition of the social concern that surrounds the general discussion 
of human gene therapy, the working group will continue to consider the 
possible long -range effects of applying knowledge gained from these and 
related experiments. Vhile research in molecular biology could lead to 
the development of techniques for germ line intervention or for the use 
of genetic means to enhance human capabilities rather than to correct 
defects in patients, the working group does not believe that these effects 
will follow irrmediately or inevitably from experiments with sanatic-cell 
gene therapy. The working group will cooperate with other groups in 
assessing the possible long-term consequences of scmatic-cell gene therapy 
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