Committee | Icahn School of Medicine

RESEARCH

Institutional Biosafety Program

The Icahn School of Medicine at Mount Sinai, as an institution receiving research funds from the National Institutes of Health (NIH), is subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). As mandated by the NIH Guidelines, the Institutional Official impaneled the Institutional Biosafety Committee (IBC) to ensure that the research that Mount Sinai conducts or sponsors complies with the NIH Guidelines, regardless of the source of funding. The IBC provides additional evaluation of protocols involving human subjects or animals. The IBC also serves as a resource for obtaining information on how to conduct research activities in a safe manner.

The IBC reviews and approves relevant laboratory activities involving recombinant and synthetic nucleic acid molecules, biohazards, and potentially infectious materials to ensure that proper precautions are observed. Special review responsibilities include review of biological select agents and toxins, bloodborne pathogens, xenotransplantation, Human Gene Transfer (HGT) research, and nanotechnology. As part of the review process, the IBC evaluates research registrations to determine if the appropriate risk groups and biosafety levels have been identified by the Principal Investigator. The Institutional Biosafety-Biosecurity Program (IBSP) assists with the review of the biomedical research and serves as a resource for the Basic Sciences research community. As needed, the Chairperson may identify a chemical safety professional to review research involving chemical hazards.

Institutional Biosafety Committee Charter Biosafety Guidelines for SARS-CoV-2 (COVID-19): Research Laboratories

In line with the successful implementation of eIACUC (research animal protocol management application) and RUTH Portal (IRB protocol management application), eSafety is the management portal for basic and clinical research registrations.

Like eIACUC and RUTH portals, eSafety is a regulatory compliant and streamlined system provided by Huron Research Suite and will provide a similarly simplified research registration form and a refined workflow. Key features of eSafety are:

Cloud-based and Single Sign-On
SmartForms that provide branching and flexibility
System rapidity and stability
Registration copy function for easy duplication of protocols
Linkage with eIACUC such that research registrations complement animal care and use protocols
Training certifications imported directly from the CITI Program
Tools to compare different versions of protocols
Live status updates of registration reviews
Database of biohazardous agents stored and used in basic and clinical research laboratories

To submit your research registration for IBC review, please log into eSafety using your Mount Sinai Single Sign-On (SSO).

The IBC and IBSP requires that all faculty and staff listed on eSafety research registrations have completed the following required CITI training. These trainings can be accessed on CITI. Please note that additional training is requested based on scope of research. Clinical Researchers are exempt from IBC-specific CITI training requirements.

Core Training series (three modules) (all protocol staff)

Biosafety Course Overview
Risk Management: Workplace Practices
Risk Management: Personal Protective Equipment

Biomedical Research (five modules; two electives*) (only research staff involved with procedures)

Laboratory-Acquired Infections
Biohazard Risk Assessment
Medical Surveillance
Risk Management: Emergency and Spill Response
Risk Management: Engineering Controls
Work Safely with Sharp Instruments* (for staff working with sharps; without human or NHP bloodborne pathogen exposure)
Autoclave Training* (for staff utilizing autoclaves)
Animal Users* (for in vivo work)
OSHA Bloodborne Pathogens * (clinical or human specimen work)
Recombinant DNA and Synthetic Nucleic Acids* (rDNA work)
BSL-3/ABSL-3 Biocontainment Research Training* (High Containment work)

IBC meetings are tentatively scheduled for the third Thursday of every month. The tentative 2026 schedule is provided below. Please refer to the recommended submission timelines. This aims to provide sufficient time for the administrative review process before your research registration can be added to the IBC meeting agenda. Studies that do not involve recombinant DNA/synthetic nucleic acids are assigned as Designated Member Review after the administrative review process.

2026 IBC Meeting Schedule (Committee determinations are provided via eSafety by End of Day the following Monday)

January 15, 2026
March 5, 2026 (re-scheduled February 19)
March 19, 2026
April 16, 2026
May 21 - recommended submission deadline: Friday. April 24
June 18 - recommended submission deadline: Friday, May 22
July 16 - recommended submission deadline: Thursday, June 18
August 20 - recommended submission deadline: Friday, July 24
September 17 - recommended submission deadline: Friday, August 21
October 15 - recommended submission deadline: Friday, September 18
November 19 - recommended submission deadline: Friday, October 23
December 17 - recommended submission deadline: Friday, November 20

2025 IBC Meeting Schedule

January 16, 2025
February 20, 2025
March 20, 2025
April 17, 2025
May 15, 2025
June 26, 2025
July 17, 2025
August 21, 2025
September 18, 2025
November 5, 2025
November 20, 2025
December 18, 2025

To maintain safe conditions and regulatory compliance in research and teaching areas, the IBC must review any work involving the following list of biological materials. Please submit information to the IBC for authorization in advance of starting work. Relevant biological materials are:

Recombinant/synthetic nucleic acid molecules, as covered by the NIH Guidelines
Infectious agents (viruses, bacteria, fungi, parasites, prions, etc.) that can cause disease in healthy humans and/or significant environmental or agricultural impacts, as covered by the Biosafety in Microbiological and Biomedical Laboratories (BMBL) guidelines
Biological select agents and toxins, as covered by the Federal Select Agent regulations
Human materials (including all fluids, tissues, excretions, secretions, or cell lines) as covered by the U.S. Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard
Nonhuman primate materials (including live animals, all fluids, tissues, excretions, secretions, or cell lines) as covered by the BMBL and OSHA Bloodborne Pathogen Standard
Genetically modified animals and whole plants, as covered by NIH Guidelines
Certain animals or animal specimens known to be reservoirs/vectors of zoonotic diseases
Certain animals or animal specimens known to be reservoirs/vectors of zoonotic diseases

Research that does not meet the above criteria is reviewed by a Designated Member review process involving the IBSP and, if relevant, the Chemical Hygiene Officer (CHO).

It is the responsibility of the Principal Investigator (PI) to comply with the requirements of Section IV-B-7, Principal Investigator (PI) for the NIH Guidelines. These responsibilities include:

Submitting the initial research registration and any subsequent changes, if covered under Sections III-A, III-B, III-C, III-D, III-E of the NIH Guidelines, to the IBC for review and approval or disapproval;
Initiating or modifying recombinant or synthetic nucleic acid molecule research covered by Section III-E of the NIH Guidelines only after obtaining IBC approval;
Making an initial determination of the required levels of physical and biological containment in accordance with the NIH Guidelines;
Reporting any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illness to the Biological Safety Officer and the IBC within 30 days;
Being adequately trained in good microbiological techniques;
Adhering to IBC-approved emergency plans for handling accidental spills and personnel contamination;
Complying with shipping requirements for recombinant or synthetic nucleic acid molecules;
Remaining in communication with the IBC throughout conduct of the project;
Seek IBC approval for the safe handling, transport, use, and disposal of hazardous biological materials and recombinant/synthetic nucleic acids;
Maintain an approved eSafety research registration during the time period these materials are used;
Update your eSafety research registrations(s) to include any modifications to personnel, locations, materials, procedures, etc.;
Requesting NIH containment level if biohazardous agent is not listed under the Appendix B of the NIH Guidelines.

Mount Sinai is responsible for ensuring that all basic or clinical laboratories that use hazardous biological materials and/or recombinant/synthetic nucleic acids, regardless of funding source, are in compliance with regulatory guidelines and policies. Willful or negligent violation of our established biosafety practices and procedures may result in suspension, limitation, or termination of research activities involving biohazardous materials.

The Federal Select Agent Program (FSAP) is comprised of the Centers for Disease Control and Prevention, the U.S. Division of Select Agents and Toxins (DSAT) and the U.S. Department of Agriculture. The FSAP oversees the possession, use, and transfer of biological select agents and toxins. Every individual or entity that possesses, uses, or transfers these agents or toxins must be registered with the FSAP. For information regarding select agents or toxins, contact the Responsible Official.

The following toxins are not regulated if the amount under the control of a Principal Investigator or treating physician does not exceed, at any time, the amounts indicated in the table below.

HHS Toxins [§73.3(d)(3)]	Amount
Abrin	1000 mg
Botulinum neurotoxins	1 mg
Short, paralytic alpha conotoxins	200 mg
Diacetoxyscirpenol (DAS)	10,000 mg
Ricin	1000 mg
Saxitoxin	500 mg
Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E)	100 mg
T-2 toxin	10,000 mg
Tetrodotoxin	500 mg

The Select Agent Regulations require the Principal Investigator use “due diligence” when transferring an amount of a U.S. Department of Health and Human Services -select toxin otherwise excluded under the Regulations. This provision requires the Principal Investigator to take reasonable actions to ensure that the recipient:

Is eligible to receive the select toxin (Principal Investigator, treating physician or veterinarian, or commercial manufacturer or distributor).
Has a legitimate need (i.e., reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose) to handle or use such select toxins.

The IBC monitors all activities as required by the National Institutes of Health (NIH) “Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules." Additional guidance is provided by Biosafety in Microbiological and Biomedical Laboratories (BMBL), which outlines biosafety practice and policy in the United States. The IBC ensures that the research that the Icahn School of Medicine at Mount Sinai conducts or sponsors complies with the NIH Guidelines irrespective of the source of funding.

The following provides federal policies and training resources: