Attachment VI - Page 3 
of the principle investigator. If and when gene therapy protocols become rrore 
widely applied and use manufactured biological material, then the FDA publication 
"Points to Consider in the Production and Testing of New Drugs and Biologicals 
Produced by RTNA Technology," or the appropriate document at that time, should 
be consulted . 
The clinical application of reconbinant ENA techniques to human gene therapy 
raises two general kinds of questions. Part I of this document deals with the 
short-term risks and benefits of the preposed research to the patient^ and to 
other people as well as with issues of equity in the selection of subjects, 
informed consent, and privacy and confidentiality. In Part II, investigators 
are requested to address broader ethical and social issues pertaining to the 
research and its longer-term implications. These brooder questions go beyond 
the usual purview of IRBs and reflect general public concerns about biomedical 
research. Part III of the "Points to Consider" summarizes other documentation 
that will assist the RAC and its working group in their review of gene therapy 
proposals . 
T he VJorking Group on Human Gene Therapy has concluded that somatic-cell gene 
therapy does not. differ fundamentally from other accepted practices in medicine, 
such as organ or bone-marrow transplantation. It bases this conclusion on such 
important public-policy documents as the Congressional hearing on "Hunan Genetic 
Ronineerinq" (1982), the report of a presidential conmission entitled Splicing 
rife (1 Q 82), and a recent Office of Technology Assessment background paper 
entitled Human Gene Therapy (1984). In light of this conclusion, the working 
■■■ ■ — ■ . . . T 
‘-The term "patient" and its variants are used in the text as a shorthand 
designation for "patient-subject." 
[ 67 ] 
