17 
The subworking group agreed the language might read: 
"The principal investigator is invited to submit a ccpy of the protocol to 
the RAC and its working group at the time of submission to the IRB and the 
Ms. Areen said protocols should not be treated as public documents in til IRB 
and IRC review is completed. Dr. Murray agreed the IRB review process could 
be prejudiced by the release of information before completion of review. 
Dr. Gartland said it would be very difficult under the present system to 
maintain confidentiality after submission of a proposal to the working group 
and RAC. 
Dr. Walters suggested it was not appropriate to include ary language on this 
topic in the points to consider without greater consideration of the ramifications 
Dr. Gottesman agreed and pointed out that the points to consider as written do 
not forbid the working group from considering proposals before approval by 
IBCs and IRBs. 
The subworking group agreed this issue should be considered in greater detail by 
the working group. 
The meeting was adjourned at 12:45 p.m. 
IRC." 
Respectfully submitted. 
Executive Secretary 
I hereby certify that, to the best of my 
knowledge, the foregoing Minutes and 
Attachments are accurate and complete. 
Date. 
Chair 
[346] 
