Program Review for UNTHSC Clinical Trials - Guidelines for Human Gene Transfer Trials Research Involving Recombinant and Synthetic DNA

Purpose: Human Gene Transfer (HGT) clinical trials are a rapidly progressing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical HGT are regulated by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present, all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). NIH guidelines are the definitive reference for Recombinant and Synthetic DNA research in the United States and should have adopted by UNTHSC. The purpose of this research is to review the clinical trials program at UNTHSC and incorporate recent revised NIH guidelines on clinical trials involving Recombinant and Synthetic DNA. Methods: NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules, UNTHSC IBCs Biosafety Manual, UNTHSC IRBs Guidance for Human Subject Investigators, have been used as core materials to review. Results: UNTHSC IBC webpage was updated with additional information from the review. Existing clinical trial protocols will be reviewed and validated with the department of clinical trials to confirm that at current active clinical trials at UNTHSC does not involve any HGT trials. Conclusions: For future clinical trials, the material developed based on the review will be shared with investigators, clinical trials department, IRB and IBC webpage.