10 
addresses purity issues. Me said the concept of product purity is inherent in 
the section; i.e., questions concerning DNA sequences cannot be addressed if 
the material is not pure. 
Dr. Gcrttesman suggested a subgroup composed of scientific experts in this area 
might be constituted to discuss these issues. Dr. Grobstein said a subgroup 
might resolve the issue of how much detail the working group document should 
contain. 
Dr. Rich said he would be uncomfortable with simply instructing Dr. Miller to 
communicate with Dr. Anderson; he endorsed the idea of a subgroup evaluating 
Dr. Miller's proposed modified version. 
Mr. Capron and Dr. Gorovitz endorsed the concept of a subgroup evaluating 
Dr. Miller's ccmments. 
Dr. Rich moved that: (1) the working group accept the current document; (2) 
Dr. Miller would circulate his revised version of the document to the working 
group; and (3) a subgroup of the working group would evaluate Cr . Miller's 
suggestions and report back to the working group. Dr. Miller's proposed ver- 
sion would then be considered in context of other ccmments received by the 
working group. Dr. Childress seconded the motion. 
By a vote of nine in favor, none opposed, and no abstentions, the working group 
accepted the motion. 
Dr. Rich asked vvhy the section Research Methods did not address the issue of 
risk associated with laboratory studies. Dr. Grobstein supported Dr. Rich's 
observation; he noted that while there may have been some rationale in sepa- 
rating the question of risk into another section of the document, clinical and 
public health considerations are associated with research. He suggested the 
sections Research Methods and Public Health Considerations be reorganized so 
risk considerations would apply to each stage from research to clinical trials. | 
Drs. Gottesman and Gorovitz agreed. After sore discussion, the working group 
agreed the sections of the document entitled Research Methods and Clinical and n 
Public Health Considerations would be reorganized to contain four sections : 
(1) molecular biology, (2) risk assessment including preclinical testing, (3) 
clinical procedures, and (4) public health considerations. 
Mr. Capron suggested the working group document require the investigator to 
indicate personnel and facilities for each stage frcm research through clinical I 
testing . 
Dr. Rich suggested the reorganized section of the document should consider 
potential long-term harmful effects as well as potential short-term harmful 
effecrts from the treatment. 
Ms. Areen noted that the working group had agreed at the October 12, 1984, 
meeting to include a data feed back reporting requirement in the document. 
She asked vhether the current document contained such a requirement. Mr. Capron 
felt this reporting requirement was included under the section dealing with 
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