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Institutional Biosafety Committee (IBC)

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The goal of the Institutional Biosafety Committee (IBC) is to help facilitate research and ensure it is done safely, ethically, and legally.

The NIH Guidelines are a set of best practices adopted by the National Institutes of Health (NIH) in 1976. They define how to conduct research with recombinant DNA (rDNA) or synthetic nucleic acids (SNA) in a safe and responsible manner. The NIH Guidelines were developed to protect both the researchers working with this material and the environment from being contaminated by recombinant material or organisms.

Any organization receiving funding from the NIH is expected to follow the requirements listed in the NIH Guidelines. Since CSUF receives funding as an Institution, all researchers at CSUF are expected and required to abide by the NIH Guidelines while conducting biological research, even if their individual grant or lab does not receive funding from the NIH. Failure to abide by the NIH Guidelines can result in suspension or termination of funding for all government-supported research at CSUF.

The NIH Guidelines require that most work involving rDNA or SNA undergo registration with, review by, and approval from the CSUF Institutional Biosafety Committee. In addition, research involving certain biohazards, regardless of whether or not it includes rDNA/SNA, must be registered, reviewed, and approved by CSUF's IBC. This is done by completing an online application using Cayuse Hazard Safety system.  The application will describe the important regulatory and safety information for the biological research performed by your lab.

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Phone: 657-278-7719
E-Mail: ibc@fullerton.edu
Location: ASC-231

Cayuse IBC Log-In

IBC Training Log-In

Zoom

Zoom Training Cayuse IBC Electronic Submission Process
Zoom workshops will summarize the Cayuse IBC process. To schedule your one-on-one Zoom meeting, email ibc@fullerton.edu.

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IBC Lab

Activities Requiring Review

The IBC establishes, recommends, and/or approves policies on the proper use of biological materials including, but not limited to:

  • recombinant/synthetic DNA
  • creation of transgenic animals and plants
  • agents infectious for humans, animals or plants (including bacteria, viruses, parasites, fungi)
  • human/primate sourced materials (including human and primate tissue culture cell lines, blood, serum, plasma, unfixed cells, other potentially infectious materials (OPIM per Cal OSHA)
  • Gene Drive Modified Organisms (GDMO)
  • biologically active agents (e.g. toxins) that may cause disease in other living organisms or cause significant impact to the environment or community

IBC Process Flowchart

If research does not involve biological material, no registration is required. Examples include:

  • Environmental soil or water samples
  • Proteins (except prions or biological toxins) purchased from a vendor and used outside of living organisms
  • Chemicals or nanoparticles without a biological rDNA, or SNA component

IBC Meeting Schedule

These dates are subject to change. Researchers should check this site frequently to view up-to-date information about meeting and/or submission deadlines.

IBC MEETING SCHEDULE
Month
Submission Deadline
Meeting Date
January 2025 NO MEETING NO MEETING
February 2025 02/07/2025 02/28/2025
March 2025 03/07/2025 03/28/2025
April 2025 04/04/2025 04/25/2025
May 2025 05/02/2025 05/23/2025
June 2025 NO MEETING NO MEETING
July 2025 NO MEETING NO MEETING
Fall 2025 TBD TBD

IBC Charter and Guidelines

Institutional Biosafety Committee (IBC) Charter

The CSUF IBC Charter describes current Policies and Procedures of the CSUF IBC and outlines the role of the IBC in ensuring research involving biological materials is conducted in a manner that is safe for staff, students, research subjects, general public and the environment and is intended to help administrators, PIs, and IBC members comply with University guidelines and applicable federal, state and local regulations including other public regulatory authorities that may have jurisdiction over off-campus sites.

While the NIH Guidelines describes, in general, the purpose, composition and charge of an IBC, each entity must have its own charter that outlines in greater detail the operations and functions of the IBC. For PI responsibilities, see Section III.D of the IBC Charter.

*IBC Charter

National Institute of Health (NIH) Guidelines

The NIH Guidelines, administered by the NIH Office of Science Policy (OSP), specify scientifically based practices for the safe construct and handling of recombinant or synthetic nucleic acids, and cells, organisms and viruses containing them. The NIH Guidelines also include information on biosafety and biocontainment requirements for human subjects, animals, plants and insects participating or used in research involving recombinant/synthetic organisms. Institutions subject to the NIH Guidelines must establish and implement policies that provide for the safe conduct of research, and ensure compliance with the NIH Guidelines. In addition, the NIH Guidelines also articulate the responsibilities of institutions, investigators, and Institutional Biosafety Committees for biosafety oversight. Compliance with the NIH Guidelines is a term and condition of grant awards for recipients of funding from the National Institutes of Health and certain other Federal agencies.

*Current NIH Guidelines

Biosafety in Microbiological and Biomedical Laboratories (BMBL)

Biosafety in Microbiological and Biomedical Laboratories is a guidance document developed by the CDC and the NIH. Currently in its sixth edition, the BMBL provides guidance on protecting laboratory workers and the public from exposure to infectious biological materials and regulated biological toxins that pose various levels of risk to human health, and the containment of biological hazards within the laboratory. The BMBL has become the code of practice, authoritative reference, and de facto standard of operations for U.S. laboratory biosafety and biocontainment principles, practices, and procedures. Adhering to the BMBL is a requirement for entities in receipt of funding from HHS for certain research grants and contracts, in accordance with 42 CFR 52, Grants for Research Institutes.

*Current Version of BMBL

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IBC Training

The PI must complete the CSU IBC Compliance Training module online prior to protocol submission. This training must be current for new applications, continuing reviews, and significant modifications.

Training access instructions:

This module describes the types of research involving biological materials that must be registered with the CSUF IBC, how the IBC will conduct a risk assessment for the proposed work, types of infectious agent risk groups and biosafety levels, basic lab practices and personal protective equipment, waste disposal requirements and reporting spills and accidental exposures.

Information for PIs on the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules will be discussed, specifically the Categories that apply to various types of experiments that utilize RDNA/SNA, since PIs will designate which category applies their proposed research.

After completing the training module, PIs should be able to:

  • Outline National Institute of Health (NIH) Guidelines for work with synthetic and recombinant DNA
  • Identify roles and responsibilities of university entities
  • Explain risk assessment and distinguish risk groups
  • Understand IBC authorization prior to initiating work
  • Outline waste requirements for synthetic and recombinant DNA
  • Report and respond to a biohazard incident

NOTE: There is no expiration date for the CSU IBC Compliance Training Module

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Contact IBC

Questions about the IBC and CSUF Policies and Procedures regarding Biosafety in teaching, training, and research can be directed to:

CSUF IBC Chair
Dr. Nikolas Nikolaidis
Department of Biological Science
(657) 278-4526
nnikolaidis@fullerton.edu

Biosafety Officer
Rob Denman
Environmental Health and Safety Office
(657) 278-8118
rdenman@fullerton.edu

Office of Research Compliance
(657) 278-7719
ibc@fullerton.edu

Research Compliance Specialist
Mandie Claussen
Office of Research and Sponsored Programs
(657) 278-3951
ibc@fullerton.edu

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