Recombinant DNA Advisory Committee - 7/31/90 
one, but that it raised another possible issue for consideration. 
He said that most committees that consider clinical protocols 
meet biweekly or monthly. Now that the HGTS is considering 
clinical protocols it is a problem for them as well as the RAC to 
meet only once every four months. He said a four month delay on 
a theoretical issue was one thing. However, in the clinical area 
this is not acceptable in light of even major modifications which 
may have to be examined expeditiously if a new development occurs 
which may bring some benefit to patients. 
Dr. McGarrity said he agreed and said the committee was sensitive 
to this issue. He said the HGTS had discussed this issue and was 
unable to come up with clear-cut answers as far as efficient and 
timely review of protocols. Further, Dr. McGarrity expressed 
concern that this problem would be exacerbated now that the 
initial hurdles of gene therapy had been cleared and the 
subcommittee could expect many more protocols coming to their 
attention at each meeting. He urged people to contribute 
concrete suggestions for dealing with these issues not only 
before the RAC but at the regional meetings which will take place 
this fall. He said it is a pressing issue which must be dealt 
with promptly, and he hoped some individuals or groups could 
assist the RAC in addressing it. 
Dr. Parkman said that Dr. R. Murray brought up the question 
before the HGTS of what its function was, whether it was to aid 
researchers in the development of their proposals, or to make 
sure the best science was done in terms of gene therapy. He said 
in many cases, the protocols coming before the HGTS were not 
complete enough to be instituted, if approved, and were merely 
"think pieces" looking for feedback from the HGTS. He said the 
application from St. Jude's was a case in point. Even if the 
HGTS had approved it, the investigators were not ready to 
institute the protocol. He asked if the HGTS was going to 
continue to be a sounding board for investigators outside the NIH 
or whether there should be criteria set up for all proposals 
coming before it. There should be finished protocols which have 
been approved by local review boards with regard to all other 
scientific, ethical, and IRB issues before they can be submitted 
to the HGTS. 
Dr. Parkman said he felt the committees have a dual function at 
present. He did not want to deprive non-NIH investigators of the 
same kind of benefits which have been afforded to the NIH 
scientists, but at the same time the pressures of increased 
workload may not permit the HGTS and the RAC to perform this 
function. 
Dr. Post asked if it was the intent of this proposed change to 
the "Points to Consider" that all clinical details and 
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Recombinant DNA Research, Volume 14 
