16 
Mr. Mitchell asked Dr. Gartland hew the document would be disseminated if 
accepted and adopted by RAC. 
Dr. Gartland said the document would be published in the Recombinant DNA 
Technical Bulletin and sent to IRBs and IBCs. 
Future Meeting Dates and Agendas 
Dr. Walters asked the subworking group for suggestions on an appropriate date 
and appropriate agenda items for the next meeting of the Working Group on 
Human Gene Therapy. He suggested the working group in future meetings might: 
(1) continue a process of "self-education;" (2) discuss informed consent issues 
with representatives of OPRR and the NIH legal advisor; and (3) discuss 
qerm line modification. 
Dr. Gartland suggested the working group not focus specifically on germ line 
modification but discuss this issue in the context of other scientific issues. 
Dr. Gottesman suggested the working group might consider meeting on the day 
following the winter/spring RAC meeting. RAC members who wish to attend could 
attend the working group meeting. Alternatively, seme portion of the working 
group discussion could be scheduled as part of the RAC agenda. Certain topics, 
however, such as informed consent might be better discussed at a working group 
meeting. 
Dr. Walters supported the suggestion to combine the working group and the RAC 
meetings; this would accentuate the ties between the RAC and the Working Group 
on Hunan Gene Therapy. 
Dr. Anderson suggested another issue which should be discussed by the working 
group; i.e., when would it be appropriate for investigators to submit protocols 
to the working group for review. Same protocols may be sent to several different 
committees before being submitted for RAC review. He asked if investigators 
might send protocols to the working group before official submission for RAC 
review. He said important time would be lost if investigators must wait for 
IRBs and IBCs to complete review before the working group can begin review. 
Dr. Gottesman thought the points to consider preclude RAC from reviewing the 
proposal before IRC and IRB review is complete. The points do not, however, 
preclude the working group from considering proposals before IRB and IBC review 
is complete. The working group would not, however, offer any recommendation 
before IRB and IBC approval is received. 
Ms. Areen suggested the Introduction of the document might be modified to 
state : 
"Investigators are invited at their discretion to submit their proposal to 
the working group for simultaneous review during IRB and IBC review." 
[345] 
