Research with Biological Materials
Note that in August 2026, NIH issued a Draft Biosafety Policy for Research Involving Biohazards (Biosafety Policy). The draft policy supersedes the NIH Guidelines and proposes significant additions to the scope of research reviewed by Institutional Biosafety Committees. It also imposes new requirements to make public certain research details and incident reports. The Biosafety Office has created a website that will be updated with more information about the policy as it becomes available, and any subsequent implementation guidance. Please review it periodically for updates.
Until the new policy is implemented the information and directions below should be considered current.
Research with certain types of biological materials requires institutional review and, in some cases, is regulated by federal law (the NIH guidelines). This includes:
- Potentially infectious material including cultures, or clinical specimens
- Recombinant DNA including viral vectors, expression systems, and gene editing constructs
Investigators must declare the presence, in their labs, of potentially infectious material or recombinant DNA on their Laboratory Assessment Tool and Chemical Hygiene Plan (LATCH). New PIs must meet with a Biosafety Officer if their research involves recombinant DNA subject to the NIH guidelines, or potentially infectious material, including cultures, viral vectors or clinical specimens ([email protected]).
Applicable new research must be submitted for institutional review. Institutional protocol approvals are granted for three years. Investigators must resubmit for institutional review:
- Prior to the expiration of their protocol
- Whenever the scope of the work changes
The University’s Institutional Biosafety Committee (IBC) is charged with facilitating compliance with the NIH’s Guidelines for Research Involving Recombinant DNA Molecules . The “Guidelines” are actually requirements and the failure to adhere to them may result in suspension of NIH funding to an individual PI or the entire institution. The Guidelines apply to all recombinant DNA ( rDNA) activities at an institution where any work with recombinant DNA receives NIH funding. The Guidelines apply to all rDNA work at Columbia regardless of the individual project’s funding source.
The University’s Institutional Biological Research Activities Committee (IBRAC) is charged with reviewing research with biological materials that are not subject to the NIH Guidelines. This include research with potentially infectious agents where generation of recombinant DNA is not involved.
The submission process for the IBC and IBRAC employs the same Hazardous Materials Appendix A in Rascal. Biosafety Officers will route the Appendix A to the applicable institutional review committee.
Approval of the Appendix A is dependent on completion of personnel training.
A new US Government Policy for Stopping High-Risk Life Sciences Research (July 2026) (“Stopping Policy”) will prohibit dangerous gain-of-function (DGOF) research or potential dangerous gain-of-function (potential DGOF) research that could reasonably be expected to create, transfer, or increase unacceptable risk to public health, agriculture, the environment, economic security, or national security. Institutions will be expected to have implemented the Stopping Policy as early as January 2027. Information will be posted to this website as it becomes available.
Enrollment in the University’s medical surveillance program is required for work with animals, infectious agents and human clinical materials.