Attachment II - Pg. 12 
( Proposed Draft on General Social Issues — Saa Gororitz and James Childress ) 
II. General Social Issues Not Covered by the DHHS Regulations for Research 
Involving Hunan Subjects * 
A. What effect, if any, is the proposed somatic-cell therapy likely to have 
on the reproductive cells of treated patients? Please provide laboratory and/ 
or bibliographic references that pertain to the answering of this question. 
B. What inpact would the proposed study be likely to have on patient welfare, 
public health, clinical research or the practice of medicine, if it were 
successful? 
C. Is the intervention intended or likely to have any consequences other than 
the cure or prevention of a recognized disease or the restoration of 
functioning? If so, please explain. 
D. Is the proposed work likely to raise or exacerbate public fears, justified 
or unjustified, about genetic engineering? If so, provide a statement 
suitable for public release, explaining why the work is justifiable despite 
such fears. 
E. What provisions exist to ensure that accurate Information is available to 
the public with respect to such public concerns as may arise about this work? 
P. Will there be any restrictions on the free flow of scientific information 
because of funding sources or any other reasons? If so, please explain. 
G. Do the investigators or funding sources intend to patent either the products 
or the procedures? 
* These topics are not generally considered by IRBs but will be considered by 
the Working Group on Human Gene Therapy. 
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