The Human Gene Therapy Subcommittee voted to approve the motion 
with 12 in favor, none opposed and none abstaining. Dr. Kelley 
had submitted a vote by proxy that was not included in the final 
vote on advice from counsel. However, his support, as well as that 
expressed in writing by Drs. Mulligan and Temin, is noted for the 
record. 
Dr. Walters commended the Subcommittee and the commentors for their 
diligent efforts in providing careful review of this proposal. 
Looking back on the first heart transplant 21 years ago. 
Dr. Walters observed the great strides that have been made since 
then. 
Dr. McGarrity 
Dr. McGarrity reviewed the events leading to this approval. He 
noted that this was the first time in his eight year involvement 
with the RAC that approval by the parent committee had been voted 
over a subcommittee recommendation to postpone action. He realized 
that this had raised concerns among the Subcommittee members. 
Dr. McGarrity pointed out that in trying to utilize the expertise 
of the RAC and the Subcommittee, while providing a service to the 
public, the gene transfer proposal had proceeded along 2 review 
tracks simultaneously. This led to the dilemma resulting when the 
HGTS decided to defer approval and the RAC voted to approve the 
same project. 
Although there was no formal requirement to obtain Subcommittee 
approval prior to RAC review, this chain of events had been very 
uncomfortable for all involved. Dr. McGarrity stated. 
Dr. Wyngaarden, NIH Director, met with Drs. McGarrity, Walters, 
Moskowitz, and Ms. Levinson, to discuss this issue. A decision was 
made to refer the Anderson-Blaese-Rosenberg proposal back to the 
Subcommittee with a mail ballot being sent to the RAC following 
Subcommittee approval. In this way, a formal record of a final RAC 
vote could be obtained without undue delay of the research. 
However, the broader issue of orderly review procedures remains. 
Dr. Wyngaarden has proposed establishing a procedure for obtaining 
Subcommittee approval prior to submission to the RAC. Dr. Parkman 
stated that there is a role for parallel review as long as 
Subcommittee approval is required prior to RAC vote. This can 
accelerate the review process. 
Dr. Neiman referred to Dr. Mulligan's question on the mandate of 
the Subcommittee and the RAC--specif ically whether or not the 
charge is to consider scientific merit overall, or to restrict 
comment to safety issues. Dr. Parkman commented that bad science 
is unethical science--so that the science must be assessed. 
Dr. Neiman wanted a formal statement of the charge to the 
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