An addition to the ASGT educational sessions
Wednesday, May 30, 2007
4:00 pm to 7:15 pm
Enhancing the Science, Safety and Ethics of Human Gene Transfer Research:
The NIH System of Review and Oversight
This session is intended for investigators who wish to gain a better understanding of the NIH system of oversight of human gene transfer trials and how the NIH system informs and enhances the science, safety, and ethics of this field of research.
The NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) are the policy framework for the NIH oversight system, outlining biosafety practices as well as institutional and federal review procedures that apply as a term and condition of NIH funding to both basic (preclinical) and clinical work involving recombinant DNA. Appendix M of the NIH Guidelines describes the requirements for the design, submission, and review of human gene transfer trials. Investigators conducting human gene transfer research at institutions receiving NIH funding for recombinant DNA research must adhere to the NIH Guidelines, whether or not their own studies are NIH funded.
The information provided in this session will be of interest to investigators who wish to gain an initial overview of NIH requirements or who seek to optimize the benefits they can gain from the review of their protocols by the NIH Recombinant DNA Advisory Committee (RAC).
Topics to be covered include:
- Introduction to the NIH Office of Biotechnology Activities (OBA) and the Resources OBA Offers Investigators
- Comprehensive Summary of Human Gene Transfer Research Nationally: Vectors, Clinical Indications, and More
- Overview of the Policy and Biosafety Framework for Human Gene Transfer Research: The NIH Guidelines for Research Involving Recombinant DNA Molecules
- The “What, When and How” of Submitting Human Gene Transfer Protocols to the NIH for Review by the Recombinant DNA Advisory Committee
- Biosafety Oversight of Human Gene Transfer Research: From Preclinical Studies to Human Trials
- Optimizing the RAC Review Experience
- Informed Consent in Human Gene Transfer Research
The opportunity to attend this session is included as part of your registration fee for the ASGT 10th Annual Meeting.