Attachment IV - Pg. 2 
2 
IRR charne or capability. Consideration of proposals by any other involved 
federal aaency (e.q., FDA) may proceel simultaneously with Mill consideration, 
with appropriate notification of the agencies involved. The RAC expects that 
the approval process for human gene therapy will serve to educate the public 
not only on the technical aspects of the proposals but on the meaning and 
significance of the research, e.q., is the preposed gene therapy technology 
unprecedented? If not, vhy not? 
What aspects of the proposal have been, or may becane, subjects of public 
concern and controversy? What steps to alleviate such concern have been, or 
will be, undertaken? 
(CAPRON DRAFT) 
The special attention required by the NIH Reccmbinant DNA guidelines for clinical 
application of reccmbinant DMA to human gene therapy focuses on two general 
kinds of questions. Part I raises points about the short-term risks and benefits 
of the proposal to the patient, to other people, or to the broader environments; 
in Part II, investigators are requested to address broader ethical and social 
issues of the research and its longer-term implications that go beyond the usual 
purview of an IRB. In addition to the points specifically outlined in this 
document, the RAC welcomes further comments that will help to decide whether 
discussion of the wider implications of the research is needed. 
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