Biosafety in Research

The Icahn School of Medicine at Mount Sinai’s Institutional Biological Safety Program monitors all laboratory activities that involve biohazards materials, including pathogenic organisms and biological toxins, that may present a risk to the environment.

What qualifies as a biohazardous agent or biohazard?

A biological hazard, or biohazard, is a biological substance that poses a threat to the health of humans, animals, and the environment. Biohazardous agents include infectious agents or hazardous biologic materials. Infectious agent includes bacteria, viruses, fungi, other microorganisms and their associated toxins, or substance containing an organism capable of infecting and causing disease in a susceptible human or animal host. We measure the degree of risk based on the virulence of the potential disease or injury, the potential route of exposure and by the availability of preventive measures and effective treatments.

What are recombinant and synthetic nucleic acids?

Recombinant DNA (rDNA) is a molecule of DNA that has been modified, either through genetic recombination or through laboratory techniques, and can replicate in a living cell. Recombinant nucleic acids are constructed by cloning techniques or by recombination of nucleic acid molecules.

Synthetic nucleic acid (sNA) molecules are those that are synthesized or amplified by chemical or other means. This definition includes molecules that are chemically or otherwise modified, but can base pair with naturally occurring nucleic acid molecules.

Molecules that result from replication of recombinant and synthetic nucleic acids qualify as recombinant and synthetic nucleic acids.

What training do you require or recommend to work with biologics and biohazards?

The CITI Program is the default training platform for laboratory biosafety. The training courses, Core Training Requirements and Biomedical Research, are required for all laboratory staff handling biohazards in basic research and clinical laboratories. The supplemental training course, Recombinant DNA & Synthetic Nucleic Acids, is required for any laboratory staff conducting research with recombinant DNA (rDNA) and/or synthetic nucleic acids (sNA). Additional guidance on the Training curriculum for Basic Sciences is available on the Research Roadmap.

What approvals do I need to work with biohazardous materials?

Research projects that involve biohazardous agents, viral vectors, or rDNA/sNA require approval by the Institutional Biosafety Committee (IBC). The Principal Investigator or designated proxy must submit an eSafety research registration that covers use of biohazardous agents in basic research and clinical laboratories.

If the study involves human or animal subjects, you also need approval from the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) approval, respectively. These entities also perform ongoing auditing and monitoring.

The IBC, IRB, IACUC, and Program for the Protection of Human Subjects (PPHS) offer resources to address any questions you may have.

What policies, procedures, and guidelines should I be aware of?

Find policies, procedures, and guidelines on working with biologics in the following:


Last Updated: July 2023