Working With Biologics

The Icahn School of Medicine at Mount Sinai’s Institutional Biosafety Program monitors all laboratory activities that involve biohazards, infectious or biologically derived infectious materials, or toxins that may present a risk to the environment.

What qualifies as a biologic or biohazard?

A biologic agent or biohazard is an element capable of infecting and causing disease in a susceptible human or animal host. We measure the degree of concern based on the virulence of the potential disease or injury, and by the availability of preventive measures and effective treatments.

What are recombinant and synthetic nucleic acids?

Recombinant nucleic acids are molecules that are both constructed by joining nucleic acid molecules, and that can replicate in a living cell.

Synthetic nucleic acid 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 also qualify as recombinant and synthetic nucleic acids.

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

We recommend our PEAK Biosafety and Blood Borne Pathogen training and exam, which is available online or through private training sessions.

What approvals do I need to work with biohazardous materials?

Research projects that involve biologics require approval by the Institutional Biosafety Committee.

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

In addition, the Institutional Biosafety Committee, IRB, IACUC, and Program for the Protection of Human Subjects 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: