Institutional Biosafety Committee

The NJIT Institutional Biosafety Committee (IBC) is responsible for the oversight of all research that involves biohazards. Biohazards include infectious agents and organisms, biological toxins, recombinant and synthetic DNA and genetically altered organisms. The scope of biohazards overseen by the IBC is defined by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and the CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL).

All research activities and protocols dealing with live cells, tissues, genetically engineered organisms, gene therapy, and any laboratory- or greenhouse-contained experiments must be reported to the IBC for review and approval. The IBC also has the responsibility of reviewing a variety of experimentation that involves hazardous biological materials (such as human bodily fluids, cell lines, infectious agents) and other potentially hazardous agents (such as Select Agents and carcinogens).

Additionally, the IBC is a Federally-mandated review body established under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules to provide local review and oversight of nearly all forms of research utilizing recombinant DNA.

Please submit an NJIT IBC Application Form with full disclosure if you are using any recombinant DNA, hazardous biological agents (infectious or potentially infectious), select agents/toxins, the use of hazardous chemicals used in research with invertebrate or vertebrate animals, and the use of nanomaterials with the above categories.

 

Which Form(s) to Submit

The IBC Registration Document for Biohazards must be submitted for all projects involving potential biohazards. Please include a biosketch (use the template provided but NIH format is also acceptable). Additionally, the IBC Laboratory Hazard Assessment Form must be submitted for all lab work.
 

Instructions for completing the IBC Registration Document for Biohazards

Investigators seeking approval from the NJIT IBC for research involving recombinant or synthetic DNA materials, potentially infectious microorganisms, human derived materials including human blood and body fluids, human and non-human primate cell lines, primary tissue explants and their clonal derivatives, and other biological materials are required to complete the Registration Document for Biohazards.

All applicants are required to complete the following sections:

  • Principal Investigator Information
  • Location of Study
  • Section A: General Administrative Information
  • Section B: Material Use Checklist
  • Section H: Transport
  • Section I: Dual Use Research of Concern
  • Section J: Protocol Specific Laboratory Safety

In addition to the sections above, please complete the appropriate protocol-specific sections that pertain to the proposed research activities:

  • Section C: Exempt Recombinant DNA Experiments
  • Section D: Non-Exempt Recombinant DNA Experiments
  • Section E: Research with Potentially Infectious Biological Agents
  • Section F: Human and Non-human Primate Blood, Body Fluids, Cell Lines, and Tissue Explants
  • Section G: Toxins of Biological Origin

For technical questions concerning the completion of the form, please contact:

Mitchell Gayer, Director, EHS Department
973-596-5736
gayer@njit.edu
 
Completed forms should be submitted to the IBC mailbox: IBC@NJIT.edu 


What Needs to be Reviewed by the IBC

Federal regulations require all faculty members/principal investigators (PIs) to file a protocol when using recombinant DNA molecules or organisms. The use of any potentially hazardous material must also be reported to the NJIT Safety Officer. All research activities dealing with any recombinant DNA molecules, organisms and hazardous materials, regardless of the source of funding, must be reviewed by the IBC.


Recombinant DNA

All researchers using recombinant DNA molecules or organisms must file a protocol, although certain types of experiments will qualify as "Exempt from Full Committee Review". If you work with recombinant DNA, (see Section I-B of the NIH Guidelines: Definition of Recombinant DNA Molecules), a component of the protocol form will require you to identify the sections and appendices of the NIH Guidelines appropriate for your experiments. 

Biohazards  

Any live cell, tissue or biomaterial may impose a biohazard. A biohazard is a potentially dangerous infectious or toxic agent or material (such as tissue, blood or toxin) or a substance whose hazard status is unknown. Human or non-human primate derived cell lines are considered biohazards (per OSHA definition). Infectious organisms include all agents (including prions) capable of causing disease in healthy humans or animals, whether these occur commonly in the environment or not.

The BMBL 5th Edition Manual should be used in completing the Biohazards Protocol section. Researchers or instructors working with human material, e.g. human blood, bodily fluids, unfixed human tissue, organs and established human cell lines must reported to the NJIT Safety Officer. All individuals dealing with such materials must complete Blood-Borne Pathogens (BBP) training annually (OSHA requirement) and be offered a Hepatitis B vaccination. If the Hepatitis B vaccination is declined, a waiver must be signed. Regardless of the source, any research involving human or non-human primate tissue or bodily fluids requires IBC approval.

Chemical Hazards and Select Agents

All projects using chemical listed as highly toxic, carcinogenic (confirmed or suspected), mutagenic, teratogenic or explosive on its SDS must be reported to the NJIT Safety Officer and require IBC approval. All students and research personnel dealing with such material must complete the NJIT Biosafety Training Protocol and be certified before working on the project.

Select Agents are biological substances or toxins regulated by the Department of Health and Human Services or the US Department of Agriculture. All Select Agent use must be reported to the Safety Officer and reviewed and approved by the IBC. A complete description of Select Agents can be found at http://www.selectagents.gov. At this time NJIT IBC only allows work with the following Select Agents in quantities that are not restricted (but still need to be reviewed), as described in the following table:


HHS Toxins [§73.3(d)(3)]

Non Regulated Amount
Abrin 100 mg
Botulinum neurotoxins 0.5 mg
Short, paralytic alpha conotoxins 100 mg
Diacetoxyscirpenol (DAS) 1000 mg
Ricin 100 mg
Saxitoxin 100 mg
Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E) 5 mg
T-2 toxin 1000 mg
Tetrodotoxin 100 mg

Regulated Medical Waste

Regulated medical waste (RMW; also known as biohazardous waste or infectious medical waste) is the waste that is contaminated by blood, bodily fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.  

There are several key categories of waste that are typically classified as regulated. Each category has special handling requirements that may be state-specific. See the Types of Regulated Medical Waste page for more information on the classification of RMW.

Any research that produces any RMW material requires IBC approval and must also be reported to the NJIT Safety Officer.

 

Radiological Hazards

If you are using any radioactive substance or a device or equipment that uses or emits any radiation, please inform the NJIT Safety Officer and submit an IBC application with full disclosure on radiation equipment, type of radiation and radioactive substance used in research for experimentation or with animal or human subjects.  All radioactive materials must be handled in designated Radiation Areas or Restricted Radiation Areas. Radioactive material should be treated as hazardous substances and handled with all cautionary procedures normally accorded such substances.

 

Nanomaterials 

Research and technology protocols involving structures with at least one dimension less than 100 nanometers (nm), frequently with atomic/molecular precision and creating or using structure, devices, and systems that have unique properties and functions because of their nanometer scale dimension must be submitted to NJIT IBC for approval.

 

NJIT Institutional Biosafety Committee (IBC)

Farzan Nadim (Chair)
Professor, Biology Department 

Mitchell Gayer (Co-Chair)
Environmental Health & Safety (Safety Officer)

Atam Dhawan
Vice Provost for Research (Resource)

Verne Hahn
Director, Risk Management (Resource)

James Haorah
Associate Professor, Department of Biomedical Engineering

Eric Hetherington
Director, Sponsored Research Programs

David Livingston, MD
Professor, Surgery, Rutgers New Jersey Medical School

Jessica McCormick-Ell
Rutgers University Biosafety Officer

Somenath Mitra
Distinguished Professor, Chemistry and Environmental Sciences

Angela Retino
Office of Research (Resource)

Norma Rubio
Director, Research Information Systems

Brian Tierney, JD (or designee)
Legal Office
 

2017 - 2018 IBC Meeting Schedule​​

IBC application forms must be submitted at least 10 business days before the next meeting date.  Submit your forms to IBC@njit.edu.

  • Tuesday, September 26, 2017
  • Tuesday, November 28, 2017
  • Tuesday, February 20, 2018
  • Tuesday, April 24, 2018

 

Federal Biosafety Guidelines and Protocols

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules. Click here for NIH Guidelines for Biosafety

  • NIH Guidelines (pdf, 1.01 MB
)
  • FAQs for NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (pdf, 156 KB) 

  • FAQs about Major Actions under Section III-A of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid  (pdf, 383 KB)
  • FAQs About Experiments that are Exempt from the NIH Guidelines  (pdf, 287 KB)
  • Centers for Disease Control and Prevention Guidelines on Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
  • Reference for RMW
  • Reference for Nannomaterials