Human Gene Therapy Subcommittee - 4/5/91 
the table, and Dr. Gellert seconded. The motion passed by a vote of 9 in favor, 0 
opposed, and no abstentions. 
Dr. Mclvor read the wording for section I-B-2 as drafted by Alexander M. Capron: 
"Preclinical studies, including risk assessment studies. Provide results 
that demonstrate the safety, efficacy, and feasibility of the proposed 
procedures using animal and/or cell culture model systems, and explain 
why the models chosen is/are the most appropriate." 
Mr. Capron said it should be "the models chosen are." 
Dr. Leventhal moved to accept the wording. Dr. Erickson seconded the motion. 
Dr. Walters called for a vote on Mr. Capron's motion including the substitute wording. 
The motion passed by a vote of 9 in favor, none opposed, no abstentions. 
VII. FUTURE RESPONSIBILITIES OF THE HUMAN GENE THERAPY SUBCOMMITTEE 
Dr. Walters referred to a copy of a letter Mr. Capron sent before the last subcommittee 
meeting. In the letter, Mr. Capron notes the distinction between gene transfer protocols 
and gene therapy protocols. He also noted that gene therapy may be considered a 
sophisticated drug delivery system, and this subcommittee and the RAC may be called 
upon to render judgments on drug delivery in a wide variety of formats. Mr. Capron 
raises three questions: 
What are the basic objectives of a special human gene therapy review 
process? 
Do these include gene transfer aimed at drug delivery, rather than genetic 
alteration for therapeutic purposes? 
What lines should be drawn around genetic manipulations that may or will affect 
germ line cells? 
Dr. Walters felt these were important questions about the role and future work of this 
subcommittee. He asked for recommendations as to the manner in which to proceed 
with addressing these issues. 
Dr. Parkman thought that the investigators do not currently have the ability to 
scientifically separate some of the biological effects of marking from the biological 
effects of therapy. For instance, if one were to mark keratinocytes in cell culture, return 
Recombinant DNA Research, Volume 14 
[579] 
