Hvunan Gene Therapy Subcorranittee - 7/30/90 
submission of protocols. 
There being no further discussion of the motion, Dr. Walters put 
it to a vote. The motion passed by a vote of 13 in favor, none 
opposed and no abstentions. 
Dr. Walters thanked Dr. Brenner for the protocol and said he 
hoped the discussion had been helpful to him. Dr. Anderson asked 
how long a period in advance of the next meeting a response would 
have to be submitted by Dr. Brenner in order to receive written 
comments by the time of the meeting. Dr. Epstein said he felt 
this is a question that needed to be discussed by the 
subcommittee. He said he felt a system should be set up whereby 
an investigator would submit a proposal, have it reviewed and 
have a written response forwarded to the investigator, so that at 
the next meeting the investigator could come prepared to address 
more specifically the result of the review. He suggested that it 
would require at least six weeks to go through such a process. 
Further, he added that it was important that a specific list of 
deficiencies be composed after the initial subcommittee review. 
When the proposal returns to the subcommittee, the issues will be 
concise and there will be no need to readdress the entire 
protocol . 
Dr. Mulligan said the only problem with such a system was what to 
do with new information that is gathered between the time of a 
review and the meeting of the subcommittee. Dr. Leventhal said 
another problem with Dr. Epstein's suggestion is that the 
investigator is only responding to a primary reviewer, and other 
members of the subcommittee may have questions which need to be 
addressed. 
Dr. Epstein moved the following: 
1. That a proposal come to the subcommittee no 
later than 8 weeks before a scheduled 
meeting; 
2. That they be reviewed by primary and 
secondary reviewers within 3 weeks; 
3. That the reviews be written and list specific 
recommendations, if changes are warranted; 
4. That these recommendations be sent to the 
investigator with a response to be received 
no later than 3 weeks prior to the scheduled 
meeting; and. 
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Recombinant DNA Research, Volume 14 
