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.” As mandated by the guidelines, the Institutional Official has appointed an 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.
IBC Application Process
We are excited to announce that the Icahn School of Medicine at Mount Sinai is implementing an online biosafety protocol management application on Friday, May 7, 2021. In line with the successful implementation of eIACUC (research animal protocol management application) and RUTH Portal (IRB system), eSafety, the new biosafety protocol management portal is part of the multi-phased plan to enhance and consolidate research operations and administration.
Like eIACUC and RUTH Portal, eSafety is a regulatory compliant and streamlined system provided by Huron Research Enterprise Suite and will provide a similarly simplified biosafety application form and a refined workflow. Key features of eSafety are:
- Cloud-based and Single Sign-On
- System rapidity and stability
- Protocol copy function for easy duplication of protocols
- Integration with eIACUC to link research animal protocols requiring biosafety review
- Training and certifications imported directly from external sites (e.g., CITI Program)
- Tools to compare different versions of protocols
To submit your protocols for IBC review, please log into eSafety using your Mount Sinai email and password.
IBC requires that all faculty and staff listed on IBC protocols have completed the following required training within a year. These trainings can be accessed on CITI.
- Basic Laboratory Safety (New Hire)
- Hazard Communication
- Personal Protective Equipment
- Laboratory Hazardous Waste Management
- Principles of Biosafety
For IBC policies and review process enquiries, please email firstname.lastname@example.org
IBC Meeting Schedule
Our IBC is tentatively scheduled to meet the third Thursday of every other month. Schedule for the 2019 meeting is as below. Please submit you protocols that involve recombinant DNA at least two weeks ahead of the meeting date. This will give our reviewers enough time to thoroughly and timely review your submissions. Protocols that do not invovle recombinant DNA, such as those working with monoclonal antibodies, are reviewed as designated and as and when received.
2020 IBC Meeting Schedule
- January 21, 2021
- March 18, 2021
- May 20, 2021
- July 15, 2021
- September 16, 2021
- November 18, 2021
Please forward Biosafety Risk Assessment Forms and/or Sponsor's Brochure three full weeks before the meeting date to: email@example.com
What Needs IBC Approval?
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
- Select agents and select 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
Who Needs IBC Approval?
It is the responsibility of the principal investigator to:
- Seek IBC approval for the safe handling, transport, use, and disposal of hazardous biological materials and recombinant/synthetic nucleic acids
- Maintain an approved IBC protocol during the time period these materials are used
- Update your IBC protocol(s) to include any modifications to personnel, locations, materials, procedures, etc.
The medical school is responsible for ensuring that all laboratories that use hazardous biological materials and/or recombinant/synthetic nucleic acids, regardless of funding source, are in compliance with regulatory guidelines and policy. Willful or negligent violation of our established biosafety practices and procedures may result in suspension, limitation, or termination of research activities involving biohazardous materials.
What Is Considered Dual Use Research of Concern (DURC)?
Per the U.S.G policy definition, “Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.”
What is the Charge to 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 select agents and toxins, blood borne pathogens, xenotransplantation, stem cell research, Dual Use Research of Concern (DURC), and nanotechnology.
As part of the review process, the IBC evaluates research protocols to determine if the appropriate risk groups and biosafety levels have been identified by the Principal Investigator.