Recombinant DNA Advisory Committee - 03/1-2/93 
informed that the patient received hyperfractionated radiation prior to receiving the 
injections of gene-transduced cells. In addition, the patient's response was going to be 
measured compared to pre-radiotherapy. What would actually be measured in this 
situation? Dr. Parkman agreed that he experimental design must be valid in order 
accurately measure any potential response. Dr. Brinckerhoff said item number 1 of the 
Procedures for Expedited Review reads, "The NIH will strongly emphasize that the 
standard method of protocol submission is preferred." The words "strongly emphasize" 
are not forceful enough. 
Dr. Anderson recommended that investigators should be required to indicate that the 
completed protocol, the Points to Consider document, and the vector sequence are 
attached as part of the completion of the Cover Sheet for Expedited Review. He said that 
this document should become a checklist of "yes or no" answers that can easily be 
completed by the requesting individual. 
Dr. Leventhal suggested that the statement, "patient privacy will be maintained," should 
be included as part of item number 7 of the Procedures for Expedited Review. Also, the 
statement, "Protocols that are deferred or not approved by the RAC in its normal review 
process are not eligible for expedited review," will sometimes be difficult to determine. 
For example, Drs. Sobol and Royston had a protocol that was deferred. However, these 
investigators contended that the expedited review protocol submitted was a new protocol. 
In actuality, the differences between the 2 protocols are not very substantive. 
Investigators will always submit their request as a new protocol to satisfy this criterion. 
Dr. Sobol asked about a scenario in which the investigator has data that would support 
an expedited review protocol. Dr. Leventhal said that the investigator should present the 
data at the next RAC meeting. Dr. Sobol asked about a situation in which the patient 
could not wait until the next meeting. Dr. Leventhal responded that the investigator 
would have to convince the RAC there are extenuating circumstances surrounding the 
experiment that are so specific that the opportunity will never present itself again to 
perform the experiment. 
Dr. Sobol said that a situation could arise in which approval of a protocol is deferred by 
the RAC due to insufficient data, and the investigators obtain the requested data several 
weeks following the meeting. For example, under extraordinary circumstances a patient 
could meet the eligibility requirements of the deferred protocol, but the disease is 
progressing at such a rate that he/she was unable to wait until the protocol is reviewed 
at the next RAC meeting. Dr. Leventhal urged the RAC to keep this contingency as 
part of the Procedures for Expedited Review. The majority of protocols that are deferred 
by the RAC are missing significant data that cannot be obtained in a relatively short 
time frame. Protocols that are missing minor bits of data or information are normally 
approved with contingencies. 
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Recombinant DNA Research, Volume 17 
