Research with Biological Materials

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.

Enrollment in the University’s medical surveillance program is required for work with animals, infectious agents and human clinical materials.