Institutional Biosafety Guidelines for Research Involving Human Gene Transfer Products
NYU’s Institutional Biosafety Committee provides researchers with guidance on registering experiments involving human gene transfer products, as well as in preparing and administering such products.
A human gene transfer experiment is one that involves the deliberate transfer of recombinant nucleic acid molecules, DNA or RNA derived from recombinant nucleic acid molecules, or synthetic nucleic acid molecules into one or more human research participants. All such experiments require Institutional Biosafety Committee and Institutional Review Board approvals and evidence of registration with the National Institutes of Health (NIH).
Study participants may not be enrolled in a human gene transfer experiment until the NIH protocol registration process is complete. (See Appendix M-I-B Selection of Individual Protocols for Public Recombinant DNA Advisory Committee Review and Discussion of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).) In addition, researchers must obtain Institutional Biosafety Committee approval from the clinical trial site, as well as approval from the Institutional Review Board and all applicable regulatory authorizations.
The Institutional Biosafety Committee grants final approval of human gene transfer experiments only after it receives notice that the NIH protocol registration process is complete.
Registering Human Gene Transfer Experiments
To register an experiment involving human gene transfer products, researchers submit the human gene transfer Institutional Biosafety Committee registration document, which can be found in Research Navigator. Researchers must also attach the following items to the human gene transfer attachments section of the registration document:
- a copy of the clinical protocol
- a copy of the investigator’s brochure
- a copy of the informed consent form
- notice from the NIH indicating that the registration process of study with the NIH is complete
- response to Appendix M
Researchers should submit all documents to the Institutional Biosafety Committee using Research Navigator.
After a human gene transfer registration has received all required approvals, the researcher conducts the Institutional Biosafety Committee–approved procedures for preparing human gene transfer products and for administering human gene transfer products. These are modeled on the U.S. Occupational Safety and Health Administration’s guidelines on handling hazardous drugs.
Review of Human Gene Transfer Experiments at Initial Performance Sites
Research proposals involving human gene transfer experiments at an initial performance site, such as NYU School of Medicine, are considered through a registration process involving the NIH; oversight bodies involved in the review at the initial site; and regulatory authorities, when appropriate.
Investigators at NYU School of Medicine submit the relevant information on the proposed human gene transfer experiment to the oversight bodies involved in the review at an initial site. These oversight bodies determine if there is a need for an in-depth, public review by the NIH Recombinant DNA Advisory Committee, and makes its recommendation to the NIH. The NIH then makes the ultimate determination regarding the need for an in-depth public review. See a complete description of the NIH review process.