Human Gene Therapy Subcommittee - July 29-30, 1991 
Review Boards (IRBs). If there is an FDA regulated product involved, FDA approval 
is required. The IRBs certainly have a lot of experience with protecting the rights of 
human subjects. The FDA has experience with many different kinds of innovative 
therapies, i.e., cultured cell lines used as therapies, recombinant viruses, 
immunotherapy of various kinds, liposomes used to deliver drugs and biologies, and 
recombinant DNA products. 
Dr. Anderson said at this point, that both NIH and FDA review is necessary, even if 
the process is slower. However, public review is critical. Now is the time to start 
thinking about combining the HGTS and the RAC. Soon the RAC's agenda will 
consist only of gene therapy. If the subcommittee and the parent committee were to 
merge, the RAC would have sufficient expertise to review these protocols. The 
primary interest is the protection of gene therapy as a field. Other clinical research 
protocols require only IRB and FDA review; gene therapy protocols also require 
HGTS and RAC review. With the general feeling that gene therapy is safe, 
investigators will think carefully about getting around the additional review. He said 
his letter was not intended to state that the subcommittee is not doing a good job, but 
that there is a redundancy of review. This makes it difficult for the Office of 
Recombinant DNA Activities (ORDA) staff, for investigators, and for committee 
members. This creates a potential situation where investigators may try to get around 
public review. 
Dr. Rosenberg of the National Cancer Institute said that scientific progress should not 
be slowed down by regulations and bureaucracy in this fast moving field. Gene therapy 
protocols undergo review by large numbers of groups; Institutional Biosafety 
Committees (IBCs), IRBs, the HGTS, the RAC, and the FDA. The problem is that 
every group looks at every aspect of all of the protocols. The HGTS is not doing 
anything different from the RAC or the IBC. Having to take a protocol and put it 
through so many identical reviews discourages innovation. The process needs to be 
streamlined. 
Mr. Capron made a motion of three parts: (1) ORDA is to make sure the protocols 
supply adequate answers to the Points to Consider, so that the HGTS can have an 
expeditious discussion and decide if they are ready for final vote by the RAC. The 
HGTS is a checkpoint toward RAC approval, so its discussion should focus on 
providing information to the investigator concerning unanswered questions prior to 
review. The findings should be communicated to the investigator and to the RAC. (2) 
A working group should be established to classify vectors and their accepted uses. (3) 
A working group should be established to look at the basic objectives of a special 
human gene therapy review process. In particular, it should be determined how to 
examine germ line gene transfer questions. Dr. Leventhal seconded the motion. 
Ms. Areen suggested a motion on how the HGTS will forward a protocol to the RAC. 
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Recombinant DNA Research, Volume 14 
