4 
Dr. Gottesman drew the attention of the working group to the preamble of the 
wofkirw group document (Attachment II) . She asked whether the preamble 
overlooked important issues or whether inappropriate concepts had been 
included . 
Dr. Gottesman questioned whether the preamble should indicate that not every 
point in the document had to be considered for every proposal. She thought 
the working group should not require every point be addressed for every 
proposal . 
Dr. Rich preferred the preamble not indicate that every point need not be 
addressed. This type of statement would obligate investigators to justify why 
a specific question was not addressed. In addition, he thought the preamble, 
written in general terms, could not offer guidance on which points were impor- 
tant in specific protocol reviews. 
Dr. Childress said the preamble should not state that e/ery point need not be 
addressed as the working group has not determined vhich are the relevant or 
decisive questions. 
Ms. Areen felt the pertinent issues could not be predicted in advance and did 
not feel the preamble should indicate seme points would be more important than 
others . 
Dr. Harmison thought the title of the document "Points to Consider" informs the 
investigator not all points need be addressed for every protocol. 
Dr. Gottesman feared the points to consider document might be turned into stone; 
in the absence of a statement indicating not every point need be considered, 
the NIH might be taken to court if RAC did not require that every point, vhether 
pertinent or not, be addressed for every protocol. She suggested the working 
group treat the points to consider document as they would a legal document. 
Dr. Miller said interpretations can be very broad and a disclaimer indicating 
that not every point need be addressed for every protocol should be added to 
the working group document (Attachment II). He said such a disclaimer can be 
found in FDA, EPA, and USDA documents. 
Mr. Capron said the investigator should submit what he feels is relevant infor- 
mation; the working group will then determine vhether the investigator has 
provided sufficient relevant information. 
Dr. Gorovitz thought the preamble should only indicate that certain information 
will not bear on the technical aspects of review but is requested because the 
working group wishes to accumulate public policy information on human gene 
therapy. 
Dr . Walters asked whether the working group agreed the investigator should use 
discretion in deciding which information should be included in the proposal; 
the working group may ask for information in Part II of the document which 
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