3 
Ms. Areen did not agree with Dr. Miller's suggestion to include a reference to 
FDA's human subject regulations. She questioned whether the Institutional 
Review Boards (IRBs) followed these FDA regulations. Dr. Murray said IRBs review 
proposals under their specific guidelines vhiie the FDA reviews proposals under 
its statutes. He did not understand the purpose of Dr. Miller's suggestion. 
Dc. Gartland questioned whether the points to consider document should attonpt 
to define the boundaries of the National Institutes of Health (NIH) and FDA 
review. The subworking group agreed it would not attempt to define boundaries. 
Dr. Gottesman thought the introduction of the points to consider document might 
simply inform investigators that FDA has human subject regulations. Dr. Anderson 
suggested modifying to this end the sentence indicating RAC consideration may 
proceed simultaneously with other agencies' reviews. 
Dr. Walters thought the subworking group might check with the NIH Office for 
Protection against Research Risks (OPRR) to determine whether FDA human subject 
regulations should be mentioned in this section of the document. 
Dr. Walters then called the attention of the subworking group to Dr. Miller's 
second cement on the introduction to the points to consider document. Dr. Miller 
had suggested the language dealing with proprietary information should note that 
the option to hold closed sessions will be available. 
Dr. Walters said companies may protect confidential business information in two 
ways: (1) by obtaining patents; or (2) through trade secrets. Info mat ion is 
protected in the U.S. when the firm files for a patent; the data may then be 
publicized in open meetings or published. He preferred that submitters of human 
gene therapy protocols protect business information in this way rather than 
requesting closed review sessions. 
Dr. Gartland said companies may ignore NIH if no provision for closed sessions 
exists since companies are not required by statute to abide by the NIH Guidelines. 
Dr. Anderson said he had no problem with the points to consider document indicating 
a limited amount of information might be reviewed in closed session. 
Dr. Murray felt controversy might arise if the document specifically indicates 
closed sessions would be held. The current system adequately handles the issue; 
under that systen submitters may request that their proposal be reviewed in 
closed session. 
Dr. Childress wondered whether the introduction should indicate the working 
group's position on this issue. Dr. Walters suggested the points to consider 
document might state the working group preference and encourage submitters to 
apply in a way that permits review in open session. Dr. Gottesman agreed; she 
said the working group should not conmit itself to closed sessions but should 
not rule out the possibility entirely. She felt the working group could nego- 
tiate with submitters as to the amount of material reviewed in closed session 
even though the working group hopes the initial proposals wall not contain 
proprietary information and may be reviewed in public. 
[ 3 ] 
