Recombinant DNA Advisory Committee - 7/31/90 
document has proven itself to be a good working document. Since 
this document has proved flexible enough to evolve with the 
conditions in this area of clinical research, it has a real 
usefulness . 
He noted the importance of an effective and timely review to the 
field while assuring that research in this area is as safe as is 
humanly possible. He noted the correlation between the reviews 
of this new technology with that of early research with E. coli 
where the knowledge base was very limited and no one knew the 
major problems. However, he said he felt the RA.C and the HGTS 
had responded admirably to assure more timely review of 
protocols, while maintaining a high standard for a very strong, 
sound, scientific review of these protocols. He said that he 
felt the RAC and the HGTS had served the NIH and the general 
public well. He hoped that the patients undergoing this therapy 
would stand a better chance for success in their therapies due to 
these deliberations. 
Dr. McGarrity noted that some future decisions as to scheduling 
of meetings of both the RAC and the HGTS must be made, as well as 
improving the efficiency of the review and its responsiveness to 
the investigators. Furthermore, he said decisions needed to be 
made relative to interactions with local Institutional Review 
Boards (IRBs) and Institutional Biosafety Committees (IBCs) to 
alleviate the necessity for the RAC and HGTS to perform work 
which should be done at the local level. Furthermore, he added 
that the issue of timetables for submissions to the RAC and HGTS 
must be addressed immediately. 
Dr. McGarrity called the members' attention to the regional 
public hearings that are to take place over the next two months. 
He stressed that these would be an excellent mechanism to discuss 
the issue of interaction with local IRBs and IBCs as well as 
timetables for submission and urged members of the RAC to attend 
these meetings. He also asked members to communicate any 
suggestions in these areas with the Office of Recombinant DNA 
Activities (ORDA) . He once again thanked the RAC and the HGTS 
for their concern and thorough scientific review of protocols in 
this field and asked Dr. Riley to take up the matter of the 
review of the minutes of the March 30, 1990, meeting of the RAC. 
MINUTES OF THE MARCH 30, 1990 MEETING OF THE RAC; 
Dr. Riley said she had read the minutes and that they conformed 
to her memory of the meeting with one exception. She said that 
under "Other Business," she felt there was confusion between the 
two topics of human gene therapy and the scheduling of the public 
hearings. She suggested moving the first sentence of the section 
Recombinant DNA Research, Volume 14 
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