June 1, 1990, Human Gene Therapy Subcomnittee Minutes 
University of Michigan asked about the industry-academia-Government interaction in 
this research, the avoidance of potential conflicts of interest, and the ownership of patent 
rights on research of this sort. He also brought up the question of long-term 
commitment by the patients. Dr. Walters replied that the subcommittee preferred to 
operate in the open in considering all parts of protocols. The review process is public. 
He was not aware of the precise details of the CRADA that exists with the Genetic 
Therapy, Inc., and said he was not sure it was relevant to the review. 
Dr. Mahoney said the life-long commitment on the part of the patients may restrict the 
kinds of patients willing to take part in the trial. He was unsure about the 
subcommittee's opinion on this aspect of the study. Further, Ms. Meyers said the patent 
issue was also of interest from the standpoint of the future prospects of researchers and 
the government having to pay a royalty every time they perform gene therapy. She said 
the commercialization of these procedures needed to be evaluated by some committee, 
although it was probably not within the purview of the subcommittee. 
Dr. Parkman said he believed it was irrational not to tell the participants that they would 
be life-long research subjects. Anything else would not be a fair disclosure. However, 
Dr. Zallen said a problem in this thinking is that the parent will be the one giving 
consent for their child. When the child grows up, he or she may wish to make his own 
decisions in this regard. Dr. Parkman replied that in many other cases subjects have not 
followed through with long-term follow-up. It should be made clear that this is the 
intent of the investigators. Dr. R. Murray said all one could do is to ask that they 
continue to participate and ethics dictate that any subject may withdraw at any time. Ms. 
Meyers noted that another problem will occur since health insurance carriers will not be 
willing to cover these individuals. 
Dr. Epstein moved, "approval of the submitted protocol of May 29, 1990, with the 
following provisos: 
1. That the consent form be revised and be reviewed and accepted by the RAC at its 
next meeting; 
2. "That a stronger warning with regard to the potential for malignancy be inserted 
into the consent form; 
3. "That a stop criterion of two therapy-related deaths be inserted; 
4. "That intraperitoneal infusions not be utilized without further approval by this 
committee; 
5. "That proceeding to Part 2B of this protocol would require approval by the IRB; 
and. 
Recombinant DNA Research, Volume 14 
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