4 
The subgroup agreed that Dr. Walters would generate a preliminary Part I of the 
proposed document using this outline, the human subject regulations, the FDA. 
staff manual, and sources such as "Splicing Life." 
The subgroup then discussed what larger longer-range questions might be addressed 
in Part II of the document. Those topics considered included: 
1. The issues involved with somatic cell versus germ line cell manipulations; 
2. Patent issues and the availability of information; 
3. Assessment of unintended consequences; 
4. Specific questions in Part I which might require further review; 
5. Whether the techniques would be transferrable to in vitro fertilization 
studies and other investigations in this area; 
6. What will be the expected '"knowledge fallout;" what will be learned if 
the experiment works; what will be learned if the experiment doesn't 
work; and what avenues this experiment wall open? 
Eli^beth Milewski, Ph.D. 
Rapporteur 
William J. Gar inland 
Executive Secretary 
Date 
Chair 
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