Recombinant DNA Advisory Committee - 10/7-8/91 
Mr. Mannix said the question of improving the working relationship between the 
subcommittee and the parent committee, with respect to human gene therapy proposals, 
should be separated from the question of what to do with the rest of the NIH Guidelines 
issues. The more urgent business is deciding how to handle the human gene therapy 
proposals. Combining the committees and meeting more often than three or four times 
a year is a good idea. In the longer term, the question of what to do with the rest of the 
NIH Guidelines and the other proposals that do not involve human subjects will have to 
be addressed. 
Dr. Epps agreed with the combination of the two committees. She was also concerned 
that too much time is allowed for the presentations. The RAC is often not being 
advisory but educating the individuals. Those who were expert in certain areas certainly 
were very generous with the information that they provided. However, the RAC should 
not rush into dissolving the subcommittee. Dr. Leventhal should complete her working 
group assignment. 
Dr. Kelley said one way is to approach this issue with some general principles to which 
the RAC would agree. One principle would be that efforts should be made to facilitate 
development of the field of gene therapy. A second principle might be that one should 
have only one scientific review at this level. Another principle might be that a scientific 
review should include experts in the specific area involved. Another principle, that is 
more debatable, is that whatever mechanisms are developed, they should be time-tested 
at the NIH so that it is not a completely different approach than the one that the NIH is 
accustomed to using. 
Dr. Leventhal said the subcommittee had started giving contingent approval to a number 
of protocols to save time. However, there has to be a way to ensure that the second 
committee and the investigator knows what is expected for approval. A good way is the 
reporting of the deliberations of the scientific review body back to the investigators so 
that they can present clear answers to those questions. She proposed that the primary 
reviewer of the protocol take notes during the discussion and clarify the requirements for 
approval in a letter to the investigator. That letter then becomes part of the record. 
Mr. Capron said it is possible to have a sequence in which a protocol comes before the 
subcommittee; and if it falls into one of the categories where there is little reason for 
concern, the members could approve it. If there are unresolved questions, those are 
then stated for the investigator who has the opportunity at the RAC meeting to come 
forward with provisional approval and satisfy the points of concern that were raised by 
the HGTS. He added that it is clear from today's proceedings that the requirements 
stated in the Points to Consider need to be clarified for RAC and the investigators. The 
Points to Consider are a means of indicating the categories of information which this 
committee is likely to want to know. They are not guidelines. They are not regulations. 
[32] 
Recombinant DNA Research, Volume 15 
