15 
Ms. witherbv thouqht the consent form would have an important impact on the 
workinq Group's decision. Mr. Capron thought it would be a disservice to the 
NIH not to review the consent form since in the absence of such review the NIH 
cannot be assured it is providing the appropriate level of care. Dr. Ackerman 
said the ffa will probably request submission of the consent form as part of 
the TND process for human gene therapy protocols. 
rr. Walters said one issue the workirq group should address is the sequence of 
review; would a protocol require local IBC and IRB approval before submission 
to the work i no group. 
nr. Motulsky thouqht it illoqical that the groups which have the least experience 
with human qene therapy, the local IRRs and IBCs, are the groups which are 
required to perform the first reviews. Dr. Gottesman said the points to consider 
document indicates IRRs and IBCs may condition approval on RAC approval. 
Dr. Gottesman said one suqqestion the Workirq Group on Viruses considered was 
whether NIH could certify vectors for use in human gene therapy protocols. 
While she did not think vector certification would speed up the review process, 
she suqqested the Workinq Group for Human Gene Therapy could extend to invest i- 
oators the option of submitting preclinical data on vector construction for 
review before the clinical protocol is submitted. 
Ms. Areen thouqht the workinq croup should not delay IBC review of protocols 
for a workinq qroup dialoque on vectors. Dr. Grobstein did not think the 
workinq oroup should review preclinical data independent of the protocol; the 
vectors should be considered in the context of the whole protocol. Dr. Mahoney 
said he would not wish this process to be seen as a negotiating process between 
invest ioators and the workinq qroup. Cr. Childress thought the working group 
process should encouraqe an information exchange but should not approve portions 
of experiments. 
Dr. Walters said the workinq group could indicate review of vector data is 
part of the workinq qroup self-education effort. Dr. Anderson suqqested a 
memorandum indicating this position should be published in the Federal Register 
in order to alert investigators to the workinq group's position. Ms. Areen 
suqqested workinq qroup memoranda could also alert IBCs and IRBs of the working 
qrouo's position. 
nr. Walters then asked the workinq qroup to consider the scheduling of the 
next workinq qroup meetings. He said the next RAC meetings are scheduled for 
January 27, 1986; May 12, 1986; and September 29, 1986. He suqqested the 
workinq qroup schedule their meetings to coincide with the RAC meeting schedule. 
Dr. Gartland said ORTA would telephone the members of the workirq group in 
order to select meeting dates. He offered the workirq qroup a schedule (Attach- 
ment V) stowing the deadlines for proposal submission prior to a RAC meeting. 
[581] 
