Recombinant DNA Advisory Committee - 10/7-8/91 
short summary of the critical issues before the HGTS. 
Dr. Kelley said that the RAC and the HGTS may never have enough expertise to review 
some of the protocols as long as the field is as broad as it is right now. The notion of 
using ad hoc consultants is very common and very familiar to the NIH. As long as 
proposals cover many different fields, the process would be well served to try and put ad 
hoc consultants into the mechanism. 
Dr. Walters suggested a new kind of document to come out a short time after the 
subcommittee meeting, a one or two page statement of the critical issues in the review 
process of a particular protocol. 
Dr. Leventhal reiterated that the primary reviewer of the protocol at the subcommittee 
level could write a letter to the investigator stating what needs to be done to have the 
protocol approved. She added that the investigator could respond in writing the second 
time and not come and make the entire presentation all over again. 
Dr. McGarrity summarized the committee's statements. In the interim period, the 
members of the RAC would like to streamline the process by getting minutes out as 
quickly as possible, and sending a summary of specific questions out to the investigators 
as quickly as possible, having them respond in writing. If possible, the same reviewers 
will be used for both reviews if there are two reviews; this will provide continuity. Dr. 
Mclvor suggested that the chair of the committee write the letter to the investigators. 
Dr. McGarrity also suggested this could be done by the Office of Recombinant DNA 
Activities (ORDA). 
The meeting ended its first day's session at 5:05 p.m. on October 7, 1991. 
VII. PROPOSED AMENDMENT TO APPENDIX D OF THE NIH GUIDELINES 
REGARDING A GENE THERAPY PROTOCOL ENTITLED: GENE THERAPY OF 
FAMILIAL HYPERCHOLESTEROLEMIA 
Dr. McGarrity reconvened the committee. He called on Dr. Mclvor to begin the 
discussion. 
Dr. Mclvor noted that he was the secondary reviewer for Dr. Wilson's protocol at the 
subcommittee meeting in July. He said he would give a summary of the proceedings of 
that meeting and how the investigators have answered particular questions about the 
protocol. The proposed treatment is for patients with familial hypercholesterolemia 
(FH) which is characterized by severely elevated levels of cholesterol in the bloodstream. 
These partients are at risk of severe liver coronary disease. The protocol involves the 
surgical resection of a portion of the patient's liver, and the isolation of hepatocytes from 
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Recombinant DNA Research, Volume 15 
