Institutional Biosafety Committee (IBC)

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.

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

Charge of the IBC

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.

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.

  1. Core Training series (3 modules) (all protocol staff)
    • Biosafety Course Overview
    • Risk Management: Workplace Practices
    • Risk Management: Personal Protective Equipment
  2. Biomedical Research (5 modules; 2 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 BBP exposure)
    • Autoclave Training* (for staff utilizing autoclaves)

Our IBC is tentatively scheduled to meet the third Thursday of every month. The tentative 2025 meeting schedule is provided below. Please submit your eSafety research registration that involve recombinant DNA / synthetic nucleic acid research at least 4 weeks ahead of the meeting date. 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.

2025 IBC Meeting Schedule

  • January 16, 2025
  • February 20, 2025
  • March 20, 2025
  • April 17, 2025
  • May 15, 2025 – recommended submission deadline: Fri April 18th
  • June 26, 2025 – recommended submission deadline: Fri May 30th
  • July 17, 2025 – recommended submission deadline: Fri June 20th
  • August 21, 2025 – recommended submission deadline: Fri July 25th
  • September 18, 2025 – recommended submission deadline: Fri August 22nd
  • October 16, 2025 – recommended submission deadline: Fri Sept 19th
  • November 20, 2025 – recommended submission deadline: Fri October 24th
  • December 18, 2025 – recommended submission deadline: Fri November 21st

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) fo 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 BSO 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.

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.