Human Gene Therapy Subcommittee - 7/30/90 
Dr. Murray called the question on the motion with a second by Ms. 
Areen. Dr. Walters put the motion to a vote. The motion failed 
by a vote of 4 in favor, 9 opposed, an no abstentions. 
Dr. Epstein said he would offer a new motion. Dr. Epstein moved: 
That a two-tiered system be set up. The first tier would 
be: 
1. That a proposal come to the subcommittee no 
later than eight weeks before a scheduled 
meeting; 
2. That it be reviewed by primary and secondary 
reviewers within three 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 three weeks prior to the 
scheduled meeting; and, 
5. That these responses be sent back to the 
reviewers for their final evaluation and 
circulated to all subcommittee members. 
A second tier would be: 
1. That a proposal, with all local IRB/IBC 
approvals, with the exception of merely 
requiring HGTS and RAC approval, come to the 
subcommittee no later than 4 weeks before a 
scheduled meeting; 
2. That primary and secondary reviews with 
specific recommendations be written and sent 
to the subcommittee members and the 
investigator no later than 2 weeks prior to a 
meeting; and, 
3. That applicants not be permitted to respond 
to the reviews at that meeting. 
Dr. Mahoney seconded the motion. 
Dr. Leventhal said she felt such a procedure, not allowing the 
[ 102 ] 
Recombinant DNA Research, Volume 14 
