Human Gene Therapy Subcommittee - 11/21-22/91 
The negative aspect of increasing the number of meetings per year is that the 
investigators would have less time to submit additional requested data prior to the next 
meeting. Dr. Parkman said that there is no need to increase the number of RAC 
members. 
Regarding Dr. Parkman's proposal, Dr. B. Murray inquired if the RAC would vote on 
the HGTS's recommendations. Dr. Parkman said that the RAC would vote on the 
recommendations of the subcommittee. Dr. B. Murray said that this procedure would 
not be acceptable because some RAC members would be voting on protocols that they 
had never reviewed. RAC members could not vote in good conscience under these 
circumstances. 
Dr. Erickson stated that the RAC protocol review should be accomplished by a single 
committee; however, he suggested that the Office of Recombinant DNA Activities 
(ORDA) increase its staff size in order to provide a pre-review of protocols before they 
were reviewed by the RAC. Dr. Miller agreed with Dr. Erickson's view that protocol 
review by a single committee would be more efficient. It is time for the RAC to realize 
that the HGTS has assisted them through a learning period. However, the time has come 
for the RAC to recognize that, for the present, its major review responsibility is going to 
be human gene transfer/therapy protocols. Inevitably, the RAC will not have to review 
all types of gene transfer protocols in the future. Once the safety of this procedure has 
been established, the responsibility for review of certain categories of experiments may 
be transferred to the local IRBs and Institutional Biosafety Committees (IBCs). 
Dr. Miller asked Dr. Wivel about the turnover rate of RAC members, their overlap with 
the HGTS members, and the logistics of merging the HGTS with the RAC. Dr. Wivel 
stated that the RAC has a turnover rate of approximately 25% every year. In addition, 
the RAC charter allows for ad hoc consultants for the review of areas where additional 
expertise is required. The HGTS members could be brought on as ad hoc consultants to 
the RAC until such time that they could become members. Dr. Walters added that if a 
consolidation of the HGTS and the RAC occurs, the transfer of HGTS members to the 
RAC should occur because the subcommittee members have made a commitment to the 
HGTS. Dr. Walters encouraged ORDA to include the HGTS members, so that their 
expertise and points of view could be incorporated during the transition phase. 
Dr. R. Murray noted that a problem with bringing the HGTS members on to the RAC 
as ad hoc consultants is that they would not be allowed to vote. However, their input 
would certainly be taken into account. 
Dr. Walters said that there would not be the same level of NIH control over RAC 
membership as there is with the HGTS. NIH appoints the HGTS members, whereas 
NIH proposes appointments to the RAC, but the final decisions are made at the level of 
[262] 
Recombinant DNA Research, Volume 15 
