5 
will not be used in evaluating technical aspects of the proposal but which will 
elicit information pertaining to public policy. 
Mr. Capron said the preamble to Part II of the document might state that the 
purpose of Part II is to accumulate public policy information. 
Dr. Rich felt that until the working group has ascertained which are the most 
relevant questions in either Part I or Part II of the document, the document 
should not indicate sane data requirements are optional. 
Dr. Grobstein suggested the word "each" be substituted for the word "all" in 
the preamble sentence dealing with whether each point must be considered for 
each proposal. 
Dr. Gottesman called a straw vote on whether the preamble should contain language 
indicating that not every point need be addressed for each proposal. 
By a vote of eight in favor, the working group agreed to include the modified 
sentence in the preamble to the document. 
Mr. Capron suggested the language should read as follows: 
"As should be obvious, not every proposal will require attention to each 
of these points." 
Dr. Gottesman agreed to this modification. 
Dr. Nightingale suggested the preamble should cite the pertinent DHHS regulations. 
Ms. Areen said the language in the preamble referring to Institutional Review 
Board (IRB) review is contradictory; the preamble first states the IRB must 
review the proposal, but then indicates that the IRB may, at its discretion, 
defer consideration of particular scientific questions until the Recombinant ENA 
Advisory Ccmnittee (RAC) has reviewed the protocol. 
Mr. Capron suggested a sentence from Dr. Grobstein 's proposed preamble (Attach- 
ment III) expressed these concepts in noncontradictory language. That sentence 
reads as follows : 
"The IRB may, at its discretion, make approvals that are conditional on 
further specific deliberation by the RAC in matters beyond the IRB charge 
or capability." 
The working group agreed to accept Dr. Grobstein 's proposed language and to 
cite the pertinent DHHS regulations. 
Ms. Areen felt the preamble should ask whether the proposal has been submitted 
to another agency for review. She pointed out that at this time it is not 
clear FDA will review all human gene therapy protocols, and the working group 
should consider the possibility that FIA. may not review a protocol when deter- 
mining what would constitute sufficient information in a submission. 
[2ia] 
