Institutional Biosafety Committee

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. 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 meets every other month on Mondays. Materials are required to be submitted at least 10 business days ahead of each meeting.

The IBC meeting schedule can be found here.

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).

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.

Registration Document for Biohazards.

Instructions for completing the IBC 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

Registration document can be found here

For technical questions concerning the completion of the form, please contact: Mitchell Gayer, Director, EHS Department (973-596-5736, gayer@orkexpo.net).  Completed forms should be submitted to the IBC mailbox: IBC@NJIT.edu

For compliance questions, please contact: Raju Tamot, Assistant Director, Research Integrity and Compliance (973-596-5462, raju.k.tamot@orkexpo.net).

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:

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)

Eun Jung (Alice) Lee (Chair)
Associate Professor, Department of Bio-medical Engineering 
Mitchell Gayer (Co-Chair)
Executive Director, Environmental Health & Safety (Safety Officer)
Atam Dhawan
Senior Vice Provost for Research (Resource)
Eric Fortune
Associate Professor, Biological Sciences
Eric Hetherington
Director, Sponsored Research Programs​
Edgardo Farinas
Professor, Chemistry and Environmental Science
Megan DeJoseph
Director, Office of Risk Management
Sanjiv M. Chokshi, Esq.
Assistant General Counsel for Patents and Intellectual Property
Gale Gage
Chair, Nursing Department, Essex County College (Community Representative)
Gary Sarkins
Director, Student 2 Science Program
Deneen Scuderi
Director, Campus Health Services
Sagnik Basuray
Associate Professor, Chemical & Materials Engineering
Raju Tamot
Assistant Director, Research Compliance and Integrity
Richard E. Arlaus
EHS Coordinator, Biosafety Officer

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. 

For more information, see the Frequently Asked Questions.