Attachment V - Page 1 
DR. GROBSTEIN'S ALTERNATIVE VERSION OF SEVERAL SECTIONS OF THE J 
POINTS TO CONSIDER DOCUMENT 
of the principle investigator. If and vhen gene therapy protocols become more 
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 RENA Technology," or the appropriate document at that time, should 
be consulted. 
The clinical application of recombinant 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 proposed 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 broader questions go beyond 
the usual purview of IRBs and reflect general pcblic 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. 
The Working Group on Human Gene Therapy assumes that somatic-cell gene therapies 
need not differ in clinical terms from other accepted practices in medicine, 
such as organ or bone-marrow transplantation. It bases this assumption on 
such important public-policy deliberations as the Congressional hearing on 
"Human Genetic Engineering" (1982), the report of a presidential commission 
entitled Splicing Life (1982), and a recent Office of Technology Assessment 
background paper entitled Human Gene Therapy (1984). In light of the 
n - - ■ 
The term "patient" and its variants cure used in the text as a shorthand 
designation for "patient-sibject." 
[ 112 ] 
