Recombinant DNA Advisory Committee - 01/14/93 
Ms. Buc moved that the aforementioned recommendation is the consensus of the RAC. 
The motion was seconded by Dr. Parkman. 
Ms. Meyers stated that she did not agree that any experiment should go forward without 
review and recommendation by the RAC. The RAC may recommend that a protocol 
should not be approved, and Dr. Healy will have the authority not to accept the RACs 
advice. However, the protocol should still be reviewed by the RAC for the sake of 
public discussion. No protocol should be approved without RAC review. She stated that 
she had also been a member of the HGTS, which voted itself out of responsibility. Ms. 
Meyers said that everyone hopes that the RAC will eventually be unnecessary; however, 
the RAC is still needed to assure that the NIH Guidelines are followed. The need for 
public discussion of every single protocol is still necessary. 
Dr. Krogstad addressed the issue of time. He recognized the fact that a patient's status 
can change radically within a short period of time; however, cells cannot be transduced, 
cultures defined, and assays performed within a matter of days. One possible approach 
would be for the investigator to notify the RAC at the time a patient is asked to sign the 
informed consent document granting permission to transduce their cells. The burden is 
placed on the investigators at the time they are considering transduction to notify the 
RAC. 
Dr. Schaechter noted that he would not be able to remain on the telephone conference 
for the remainder of the meeting; however, he gave the RAC his proxy vote in favor of 
Ms. Buc's proposal. 
Dr. Post said that he is in support of Ms. Buc's motion. It would be a very exceptional 
that approval of a protocol would happen before a RAC meeting. The proposed 
mechanism would still allow for public review, at most 2-3 months after the date that 
approval was granted. There would be a continual calibration of the RAC's standards 
versus the NIH Director's standards. 
Ms. Buc explained that the real constraint on the RAC approval process is that the RAC 
is subject to a variety of statutes, guidelines, and regulations, that do not allow the 
committee to function in the same way that a government agency functions, i.e., to take 
executive action. The RAC has to deal with problems associated with establishing a 
quorum. 
Ms. Meyers stated that the Federal courts have found that gene therapy must involve 
public disclosure. Ms. Buc said that the Federal courts have stated that advisory boards 
must function in public; however, there has never been a ruling regarding the necessity 
to seek the recommendations of an advisory board. The Federal government has the 
power to govern and to choose when it will seek the advice of an advisory committee. 
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Recombinant DNA Research, Volume 17 
