All research involving recombinant DNA must comply with federal regulations and guidelines and must be registered with the University (this applies to Campus Schools, Schools of Medicine and Nursing, and Health System investigators). Registration forms must be completed and submitted to the Biological Safety Division of the Occupational and Environmental Safety Office (OESO) for review and approval by the Institutional Biosafety Committee(IBC) in accordance with NIH rDNA Guidelines.
If the research involves viral vectors, there is a separate viral vector registration form that must be completed and submitted to the Biological Safety Division for IBC review and approval. If viral vector work is to be conducted in animals, a Standard Operating Procedure for safe handling of animals must also be submitted for IBC review and approval.
Experiments involving the deliberate transfer of rDNA into human subjects must also be reviewed and approved by the IBC, IRB, and the NIH Office of Biotechnology Activities. The Clinical Research Pharmacy and Infection Control must also approve the clinical procedures when a biological vector is used in a clinical trial.