Attachment II - Page 6 
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gene into a patient's bone marrow cells in vitro and then reintroducing 
the cells into the patient's body. In germ line alterations, a specific 
atte mpt is made to introduce genetic changes into the germ (reproductive) 
cells of an individual, with the aim of charging the set of genes passed 
on to the individual's offspring. The RAC and its working group will 
not at present entertain proposals for germ line alterations but will 
consider for approval protocols involving somatic-cell gene therapy. 
(R) The acceptability of human somatic-cell gene therapy has been addressed 
in several recent public documents as well as in numerous academic studies. 
The November 1982 report of the President's Commission for the Study of 
Ethical Problems in Medicine and Biomedical and Behavioral Research, 
Splicing Life , resulted from a two-year process of piiolic deliberations 
and hearings; upon release of that report, a House sctocarrmittee held 
three days of public hearings with witnesses from a wide range of fields 
from the biomedical and social sciences to theology, philosophy, and 
law. In December 1984, the Office of Technology Assessment released a 
background paper. Human Gene Therapy , vhich brought these earlier documents 
up-to-date . As the latter report concluded : 
"Civic, religious, scientific, and medical groups have all accepted, 
in principle, the appropriateness of gene therapy of somatic oells 
in htmans for specific genetic diseases. Somatic cell gene therapy 
is seen as ami extension of present methods of therapy that might be 
preferable to other technologies." 
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