Please forward Biosafety Risk Assessment Forms and/or Sponsor's Brochure three full weeks before the meeting date to: ibc@mssm.edu
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.