Human Gene Therapy Subcommittee - 4/5/91 
such cells to a patient's skin to look at their trafficking, and find that by putting a vector 
into keratinocytes, the patient didn't develop a tumor, this would be important 
information. In the future, one may want to use keratinocytes as part of a therapy aimed 
at curing some systemic disease. The biological information that is supplied from the 
marking studies may lead to future therapy. Given these possibilities, he is 
uncomfortable about discriminating against marking experiments. 
Dr. Kelley added that genetic diseases are not the only application for gene therapy. 
Acquired diseases are also treatable. The fact that genes are employed does not restrict 
gene therapy to genetic diseases. He said that the subcommittee would see applications 
aimed at acquired diseases as well as genetic diseases. It would be very narrow-minded 
to try to constrict review to genetic diseases. Whether it is gene transfer or gene therapy 
is irrelevant. The subcommittee should continue to consider gene transfer protocols 
because, in almost every case, useful information will be provided, which may then be 
followed by gene therapy experiments. 
Mr. Capron asked that the issue be pursued at an early point on the next agenda. It 
might be helpful if members of the subcommittee could circulate any responses that they 
have to these ideas through Dr. Wivel. 
Dr. Leventhal asked if the subcommittee should be developing criteria to exempt certain 
protocols from full review because the issue or the safety aspects pose negligible risk. 
Therefore, the protocol could be evaluated as would any other protocol within a 
particular institution. 
Dr. Walters said that in the history of the RAC's dealing with biohazards, it has moved 
clearly toward establishing low risk categories that require minimal review. 
Dr. Parkman stated that the subcommittee has to deal with the reality that there will be 
more protocols, and to reduce the amount of time spent per protocol. There have 
always been significant questions about protocols when they have been reviewed for the 
first time. The question is whether there needs to be a limit to the amount of discussion. 
Dr. Walters asked everyone to send additional comments to Mr. Capron within the next 
two weeks, and requested Dr. Wivel to give this topic a place early on the agenda for the 
next meeting. 
Dr. Leventhal asked if there is a format for the investigators with approved protocols to 
report on their progress. Dr. Wivel said that the Points to Consider document states 
reports should be filed within six months of the commencement of the experiment and at 
six month intervals thereafter, informing the committee of the progress made on 
approved protocols. 
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Recombinant DNA Research, Volume 14 
