NIH Requirements for Registration of Recombinant DNA Experiments

TO: Investigators, Faculty, Lab Managers, and Instructors working with recombinant DNA
FROM: Institutional Biosafety Committee (IBC), Garry Coulson, Biological Safety Officer, Mary Beth Koza, Executive Director, Environment Health & Safety

The intent of this communication is to remind all researchers on campus working with recombinant DNA (rDNA) or synthetic nucleic acids of the requirements by the National Institutes of Health (NIH) and UNC policy to register their research with the Institutional Biosafety Committee (IBC). On behalf of the Institution, the IBC is responsible for reviewing recombinant DNA research conducted at or sponsored by UNC for compliance with the NIH Guidelines and approve those research projects that are found to conform with the NIH Guidelines.

It is the policy of this University that the Principal Investigator (PI) is responsible for complying with the NIH Guidelines regardless of the source of the funds supporting research. Registration of recombinant DNA experiments is performed via submission of a Schedule G form through the Laboratory Safety Plan (LSP) and must be approved by the IBC before initiation of experiments.

Common activities performed on campus that are subject to the NIH Guidelines include, but are not limited to, the following:

Purchase of transgenic animals from commercial vendors or acquisition of transgenic animals from colleagues and collaborator at UNC or elsewhere (registered with the IBC via Schedule H)
Creation of transgenic animals/plants (including the use of CRISPR/Cas technology to create knock-out or knock-in animals/plants)
Experiments conducted with transgenic animals/plants. IBC approval is not just restricted to the CREATION of transgenic animals/plants but also to the USE of transgenic animals/plants. Acquisition of a transgenic animal/plant from a vendor or colleague does not preclude registration of any experiments with those animals/plants with the IBC.
Experiments with recombinant DNA in animals (transgenic or otherwise)
Recombinant manipulation of Risk Group 2 or 3 (RG2 or RG3) agents or transfer of DNA from RG2 or RG3 agents into nonpathogenic prokaryotes or lower eukaryotic host-vector systems
Transduction of cells in vitro with viral vectors OR transfer of vector-transduced cells into animals.

Please note that this is NOT an exhaustive list of activities subject to the NIH Guidelines. It is the PI’s responsibility to determine whether their research is covered by the NIH Guidelines. The IBC should be consulted if there is any doubt as to whether experiments are exempt from registration.

Thank you for your commitment to research compliance at UNC-Chapel Hill. For any questions regarding this communication, please contact the IBC at ibc@unc.edu.