Recombinant DNA Advisory Committee - 09/9-10/93 
the amendments to Sections III, IV, and V and Appendix C and F of the NIH Guidelines. 
The motion passed as proposed by a vote of 16 in favor, 0 opposed, and no abstentions. 
XVI. AMENDMENTS TO SECTION III AND APPENDIX D OF THE NIH GUIDELINES 
REGARDING ACTIONS TAKEN UNDER THE GUIDELINES/DR. WIVEL 
Dr. Walters called on Dr. Wivel to present his request for an amendment to Section in 
and Appendix D. Dr. Wivel stated that these amendments would eliminate the 
requirement for publication of Appendix D (Actions Taken Under the Guidelines) in the 
Federal Register and to allow distribution of these actions by the Office of Recombinant 
DNA Activities. Section m>A and Appendix D is proposed to read: 
"Section III-A--Experiments that Require RAC Review and EBC Approval Before 
Initiation. 
"...Specific experiments already approved in this section may be obtained from the 
Office of Recombinant DNA Activities, National Institutes of Health, Building 31, 
Room 4B11, Bethesda, Maryland 20892." 
"Appendix D--Actions Taken Under the Guidelines. 
"As noted in the subsection IV-C-l-b-(l), the Director, NIH, may take certain 
actions with regard to the Guidelines after the issues have been considered by the 
RAC. An updated list of these actions are available from the Office of 
Recombinant DNA Activities, National Institutes of Health, Building 31, Room 
4B11, Bethesda, Maryland 20892." 
Committee Motion 
The RAC approved a motion made by Mr. Capron and seconded by Dr. Chase to accept 
the amendments to Section III and Appendix D of the NIH Guidelines. The motion 
passed as proposed by a vote of 16 in favor, 0 opposed, and no abstentions. 
XVII. WORKING GROUP REPORT ON CATEGORIES OF HUMAN GENE TRANSFER 
EXPERIMENTS THAT ARE EXEMPT FROM RAC REVIEW/DR PARKMAN 
Dr. Walters called on Dr. Parkman, Chair of the Working Group on Categorization of 
Protocols, to summarize the conclusions of the working group. Dr. Parkman stated that 
the working group proposes three possible categories of experiments that may be eligible 
for accelerated review by the RAC: (1) protocols conducted at satellite institutions 
under the responsibility of the PI, (2) protocols that are identical to another NIH- 
approved human gene transfer protocol under the responsibility of a new PI, (3) 
protocols that are similar to NIH-approved protocols; however, minor changes have been 
introduced that do not affect the gene therapy aspects of the study, and (4) protocols 
that use lethally irradiated cells (the RAC did not reach a consensus about the kinds of 
vectors that would qualify). 
Dr. Parkman proposed the following: (1) ORDA would assume the responsibility for 
making determinations whether protocols would qualify for accelerated review status and 
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