Attachment II - Page 12 
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II . General Social Issues Not Covered by the DHHS Regulations for Research 
Involving Human Subjects * 
A. Financial Support 
What public and private sources will fund the proposed gene therapy 
study? 
B. Patents 
Do the investigators or funding sources intend to patent either the 
products or procedures developed in this study? 
C. Impact on Germ-Line 
Is it considered likely or possible that the gene therapy methods 
proposed in this study will affect the sperm or egg cells of patients 
receiving treatment? On what basis is this probability estimate made? 
D. Implications 
What inpact would the proposed study be likely to have on clinical 
research or the practice of medicine, if it were successful? 
Ill • Requested Documentation 
The Working Group on Human Gene Therapy requests that each investigator or 
group of investigators proposing to perform gene therapy sutmit the 
following documentation: 
♦These topics are not generally considered by IR3s but will be considered by 
the Working Group on Human Gene Therapy. 
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