Recombinant DNA Advisory Committee - 12/3-4/92 
approved glioblastoma protocol, but she was informed that the protocol is not ready for 
her at this time. 
Dr. Royston stated that he would be happy to send the FDA single patient IND 
exemption material to anyone who wishes to review it. Dr. D. Miller noted that the 
FDA material had not been included as part of the information that was forwarded to 
the NIH Director. Dr. Royston stated that he was not asking for RAC approval today, 
but to urge the RAC to develop a mechanism in which he can communicate with the 
RAC. 
Dr. D. Miller said that the NIH Director would have to decide whether she would allow 
a change in the procedures that are in place for the evaluation of a request that is not 
within the RACs purview. Dr. Royston noted that the request for this discussion 
originated from the NIH Director. Dr. Wivel stated that the NIH Director can request 
that the RAC modify or amend the NIH Guidelines regarding this issue. The RAC could 
make a specific recommendation regarding the NIH Guidelines , which the Director can 
either accept or reject. 
Dr. Post asked Dr. Royston how this situation developed; namely, that the investigators 
are in a position where their protocol is far enough along that it can be submitted to the 
FDA, but has not been formally submitted to the RAC. Dr. Royston said that he was 
not aware that the RAC would entertain a single patient protocol. Dr. Royston said that 
he had consulted the Director's office on this issue, and that he had not been advised to 
submit a single patient protocol. Dr. Royston said that it may not be appropriate for the 
entire RAC to entertain a single patient request. Dr. Murray reminded Dr. Royston that 
the RAC has approved protocols with as few as 3 patients. There are no limitations to 
patient enrollment. Dr. Royston stated this issue goes beyond this one patient. 
Dr. Chase said that he was troubled by the fact that the original request came from a 
U.S. Senator to the NIH Director. The RAC is an advisory committee. The NIH 
Director is free to accept or reject the RACs advice. The RAC has been put in the 
position of assuming an executive authority that it does not possess. This request is 
completely inappropriate for an advisory body. 
Dr. Parkman stated that it is his understanding that no substantive actions can be taken 
by the RAC that are not part of a public meeting. Therefore, it is appropriate to make 
minor modifications to approved protocols outside of the public forum. There is no 
mechanism, based on the NIH Guidelines, for the RAC to review a protocol outside of a 
public meeting. In order for the RAC to review protocols between meetings, an 
amendment would have to be made to the NIH Guidelines. 
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Recombinant DNA Research, Volume 16 
