In order to enhance the depth and value of public discussion
relevant to scientific, safety, social, and ethical implications of gene
therapy research, the NIH Director will convene GTPCs at regular intervals. As appropriate, the NIH Director may convene
a GTPC in conjunction with a RAC meeting.
GTPCs will be administered by NIH/OBA.
Conference participation will not involve a standing committee
membership but rather will offer the unique advantage of assembling numerous
participants who possess significant scientific, ethical, and legal expertise
and/or interest that is directly applicable to a specific gene therapy research
issue. At least one member of RAC will
serve as Co-chair of each GTPC and report the findings of each GTPC to RAC at
its next scheduled meeting. The RAC
representative for each GTPC will be chosen based on the participant’s area of
expertise relative to the specific gene therapy research issue to be
discussed. All RAC members will be
invited to attend GTPCs. GTPCs will have
representation from other Federal agencies, including FDA and OHRP. GTPCs will focus on broad overarching policy
and scientific issues related to gene therapy research. Proposals for GTPC topics may be submitted by
members of RAC, representatives of academia, industry, patient and consumer
advocacy organizations, other Federal agencies, professional scientific
societies, and the general public. GTPC
topics will not be limited to discussion of human applications of gene therapy
research, i.e., they may include basic research on the use of novel gene
delivery vehicles, or novel applications of human gene transfer. The RAC, with the Director’s approval, will
have the primary responsibility for planning GTPC agendas. GTPC findings will be transmitted to the NIH
Director and will be made publicly available.
The NIH Director anticipates that this public policy forum will serve as
a model for interagency communication and collaboration, concentrated expert
discussion of novel scientific issues and their potential societal
implications, and enhanced opportunity for public discussion of specific issues
and potential impact of such applications on human health and the environment.