Environmental Health & Safety

Institutional Biosafety Committee (IBC)

About the IBC

George Mason University’s Institutional Biosafety Committee (IBC) reviews research and educational activities involving biohazardous materials. These include microorganisms, recombinant or synthetic nucleic acid molecules experiments as defined by the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines), human and non-human primate materials, and biological toxins. 

The committee evaluates risks and mitigation strategies to protect researchers, the broader university community, and the environment. All applicable projects must be registered and reviewed by the IBC—this applies to all Mason researchers, regardless of NIH funding. 

The IBC ensures compliance with external regulations or guidelines including: 

Frequency: The IBC meets monthly, typically on the first Friday of the month, except in January and July, when meetings are held on the second Friday. Meetings are open to the public. If you would like to attend, please email the IBC Administrative Specialist or the Biosafety Officer. 

Deadlines: To be considered for review, RAMP Safety submissions must be received at least 15 business days prior to the IBC meeting. 

Click here for IBC Meeting Dates & Deadlines 

Submission deadlines are firm, and late submissions will be reviewed on a future meeting date. 

Contact Information: 

IBC: [email protected] or phone: 703-993-8448 

Environmental Health & Safety (EHS): [email protected] 

In accordance with recent NIH Guidelines updates, George Mason University’s Institutional Biosafety Committee (IBC) will post approved meeting minutes for all meetings held on or after June 1, 2025. 

Implementation Update: Promoting Maximal Transparency Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. 

Meeting minutes are prepared, reviewed, and posted only after receiving committee approval and completing all necessary redactions to protect sensitive information and institutional security. Meeting minutes will remain publicly posted for a minimum of five (5) years in accordance with Section 8.4.2 of the NIH Grants Policy Statement and record retention requirements found in 2 CFR 200.334. 

Meeting Minutes 

2025 2026
- January 2026
- February 2026
- March 2026
- April 2026
- May 2026
June 2025 June 2026
July 2025 July 2026
August 2025 August 2026
September 2025 September 2026
October 2025 October 2026
November 2025 November 2026
December 2025 December 2026

For more information regarding meeting minutes, contact the IBC Administrative Specialist at [email protected]. 

Principal Investigators must submit protocols for IBC review and approval before beginning work.

IBC review and approval is required for any biological research involving: 

  • Recombinant or synthetic nucleic acid experiments as defined in the NIH Guidelines, and including transgenic animals or plants, human gene transfer or related clinical trials,
  • Human or non-human primate materials (blood, body fluids, tissues, established or primary cell lines),
  • Microorganisms including human, animal, or plant pathogens (bacteria, viruses, fungi, parasites) and those considered low risk, contained at Biosafety Level 1 (BSL-1),
  • Select Agents or Toxins regulated by federal law,
  • Biologically-derived toxins from animals, plants, or microorganisms with an oral LD₅₀ < 50 mg/kg in rats (oral),
  • Experiments involving research animals and any of the above.

Protocols Involving Research Animals: IACUC protocols involving biohazardous agents—including recombinant or synthetic nucleic acids and transgenic animal experiments must be reviewed and approved by both the Institutional Biosafety Committee (IBC) and the Institutional Animal Care and Use Committee (IACUC). For non-vertebrate transgenic animals, only IBC approval is required (e.g., Drosophila, C. elegans, etc.) 

Submission Process: Protocols are submitted separately to the respective committee through the RAMP system. IACUC will not issue final approval until full IBC approval has been granted.  

To access RAMP IACUC click here. 

Principal Investigators (PI) seeking IBC approval are required to complete and submit a web-based Safety Submission in RAMP. Once received, protocols are reviewed as follows: 

  1. Pre-Review: The Biosafety Officer (BSO) conducts an initial review for completeness and inputs comments for the PI to address. Responses are due at least two weeks before the IBC meeting. 
  2. Risk Assessment: The BSO determines the appropriate containment level and evaluates potential risks. 
  3. Agenda: The protocol is available in RAMP for review and comment by all committee members for discussion at the meeting. 
  4. Committee Review: The full committee reviews the protocol and makes a final determination. 
  5. Determination & Notification: Following review, the IBC issues one of the following, notifying the PI of:
    • Full Approval: The protocol is approved as submitted. Research activities may begin upon receipt of the IBC approval letter. 
    • Modifications Required: The protocol requires minor revisions. Research may not begin until all required modifications are adequately addressed. Once all conditions are met, the IBC Administrative Specialist will issue full approval. No additional committee review is required. 
    • Deferred: The protocol requires substantial revisions and must be resubmitted for full committee review and vote at a future meeting. 
    • Approval Withheld: The protocol contains significant deficiencies that prevent approval. This may include noncompliance with IBC, EHS, or George Mason policies, or repeated failure to address previously requested revisions. 

Response Deadline: PIs must respond within thirty (30) calendar days of the date on the determination letter. Failure to respond within this timeframe may result in termination of the protocol. 

Administrative Review: The Biosafety Officer administratively reviews submissions not requiring the full committee. Administrative review may include addition of a cell line with a similar risk profile to previously approved ones, addition/removal of personnel, room changes, etc. 

Submitting research or instructional protocol is done online through the RAMP Safety platform. IBC approval is valid for three years and expires at the end of the month in which it was last renewed.  

Submit your protocol in RAMP Safety: Create a Safety Submission
Need help? Training modules for using RAMP are available through MasonLeaps. 

Deadlines: RAMP Safety Submissions are reviewed monthly and due at least fifteen (15) business days prior to an upcoming meeting. See Meeting Schedule & Deadlines for details. 

Review Timeline: The Biosafety Officer (BSO) will pre-review the submission and PIs and Instructors are encouraged to submit early to allow time for any necessary revisions before the meeting. 

Safety Submission Types: 

A New protocol submission is required when initiating a research or instructional project involving biohazardous materials for the first time.  

An Amendment submission is for modifying an existing, approved protocol. Some amendments may qualify for administrative review, while others require full IBC review depending on the scope and level of risk. Following initial IBC approval, and prior to the three (3) year renewal date, PIs may amend their protocol at any time. 

  • Adding or removing personnel does not require IBC review and can be administratively approved by the Biosafety Officer.  
  • Adding a new lab space may require IBC approval and a visit from the Biosafety Officer to ensure biosafety features are in place (e.g., facility, equipment, work practices).  

 A Renewal submission (also referred to as Continuing Review) is required every three (3) years to maintain an active protocol. This submission updates the IBC on the status of the project and ensures continued compliance. 

  • PIs will receive automated reminders through RAMP at least 60 days prior to the expiration date.  

A Termination submission is used to formally close an IBC-approved protocol. This may occur when the project is complete, discontinued, or transferred to another PI. Termination ensures proper documentation, decommissioning of materials, and closure of associated laboratory spaces. 

  • Principal Investigators or Laboratory Supervisors not actively working with biological materials but maintaining (in storage) must be registered with the IBC. 
  • Contact the Biosafety Officer [email protected] for guidance regarding storage only of biological materials and proper disposal and decommissioning requirements for laboratory closure. Departing Faculty should advise EHS on protocols requiring termination or transfer to another PI. 

All personnel listed on an Institutional Biosafety Committee (IBC) protocol complete training appropriate to the biosafety containment level of the work. EHS training must be current and documented (recorded in EHSA) before protocol approval is granted. Laboratory-specific training is provided by the Principal Investigator (PI) or Laboratory Supervisor.  

Personnel working with biohazardous materials must complete the following EHS training: 

  • Laboratory Safety Orientation  
  • Hazard Communication Training  
  • Hazardous Chemical Safety Training 
  • Biosafety for BSL-2 Laboratories Training (initial and annual refresher) 
  • Bloodborne Pathogens Training (initial and annual refresher) 
  • Animal Research Safety Training (if applicable) 

Laboratory Safety Refresher Training (LSR) is not required if completing both BBP and BSL2 refresher trainings.  

Click here to access EHS training.

All biosafety incidents or exposures must be reported immediately to your Principal Investigator (PI) or Laboratory Supervisor, followed by prompt notification of Environmental Health and Safety (EHS).  

Emergency Procedures: Follow lab-specific emergency procedures. Seek medical attention when needed at the nearest emergency department, urgent care, or from your personal healthcare provider. 

Forms: Submit using the appropriate form below. 

IBC Reporting Requirements: Report any exposure incidents in BSL-2 or BSL-3 labs to EHS immediately. The NIH requires the IBC to report incidents involving recombinant or synthetic nucleic acid materials. The Biosafety Officer (BSO) submits these reports on behalf of the IBC.

Frequently Asked Questions

Yes, meetings are held virtually and open to the public unless confidential information is discussed. Submit a request to [email protected] letting us know your preferred date for attending. 

For questions or assistance with IBC protocol submissions, please contact the Biosafety Officer at [email protected] . 

Principal Investigators (PIs) are responsible for full compliance with non-exempt research subject to the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines), regardless of NIH funding. 

Throughout the course of conducting research, PI requirements include: 

  • Performing a thorough risk assessment of all protocols or project proposals involving recombinant or synthetic nucleic acid material.
  • Determining which sections of the NIH Guidelines are applicable to your research (e.g., Sections III-A through III-E for non-exempt; III-F Exempt).
  • Proposing appropriate containment levels and submit clearly written protocols to the IBC for review and approval.
  • Obtaining IBC approval before starting any non-exempt research and securing NIH approval (in addition to IBC approval) for experiments under Sections III-A and III-B. 
  • Submitting protocol amendments for changes in scope of work, agents, locations, personnel or as regulatory updates occur.
  • Reporting significant problems, violations, or incidents to EHS and the IBC as appropriate.  
  • Ensuring laboratory personnel are trained in good microbiological techniques and implement biosafety best practices.

 More information can be found in NIH Office of Science Policy brochure,  Investigator Responsibilities.

For research subject to Section III-C of the NIH Guidelines, the IBC is responsible for ensuring the safe and ethical conduct of human gene transfer research, protecting both research subjects and personnel.   

  • The IBC must assess biosafety issues related to clinical research (e.g., gene transfer product administration, shedding, and disposal as well as personnel training, facilities, etc.). 
  • Research may not be initiated until IBC approval at the clinical trial site, and all other applicable institutional and regulatory authorization(s) and approvals have been obtained. 
  • IBC oversight may conclude after the last participant is administered the final dose of product. However, IBCs may choose to establish other end points for oversight, based on their biosafety assessment of the proposed research.

Additional information on IBC review of human gene transfer research is available in the NIH FAQ, Points to Consider for IBCs Reviewing Human Gene Transfer Protocols. 

Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) refers to research that could be misused to pose significant threats to public health or security. Principal Investigators (PIs) must self-assess their research projects for potential risks and determine if the research results in DURC or PEPP. 

For more information on DURC/PEPP contact the Biosafety Officer at [email protected].  

Yes. All research involving biohazards must be submitted through a protocol for review, even if the work is considered exempt. 

  • Lower-risk activities (e.g., BSL-1) are reviewed and administratively approved by the Biosafety Officer. 
  • Higher-risk work (BSL-2 or above) and any protocols involving concurrent BSL-1 and BSL-2 or BSL-3 activities are reviewed by the Institutional Biosafety Committee (IBC). 

Yes. George Mason University’s IBC must review any work conducted under its supervision. 

 

Yes, if they involve biohazardous materials, including microorganisms, recombinant or synthetic nucleic acid molecules experiments as defined by the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines), human and non-human primate materials, and biological toxins. 

Typically, the process takes 4 weeks, depending on the timeliness and completeness of the Safety Submission. Final approval depends on whether there are any outstanding issues or corrections by the Principal Investigator (PI). Administrative reviews take approximately 1 business week. Please note that delays may occur if additional information or corrections are not promptly addressed. 

The IBC reviews: 

  • New protocols;
  • Renewals of existing protocols (e.g., three-year renewals); and,
  • Amendments to approved protocols (some modifications may undergo administrative review).

Yes. The terminology used in the RAMP online platform is “Safety Submission” and is the same as the protocol submission. 

 

Contact the IBC Administrative Specialist or any BSO for assistance at [email protected].  

If your research protocol or educational activity involves work with biohazards, you must obtain IBC approval before starting work. 

Steps to create a Safety Submission (protocol): 

  1. Log into RAMP Safety and create a Safety Submission.
    Need help? Training is available on MasonLeaps 
  2. Submit Early. Submit at least 15 business days before the IBC meeting when you want your protocol reviewed. Make sure that associated IACUC or IRB approvals are in place. 
  3. Respond promptly to requests from the BSO or IBC Committee. Be available to answer questions during the pre-review and committee review process. 
  4. Pre-Review by Biosafety Officer (BSO). The BSO will assess your submission and determine whether it qualifies for: 
    • Administrative Review (typically BSL-1), or 
    • Full Committee Review (BSL-2 or BSL-3) 
  5. Once the BSO clears your submission, it will be sent to the IBC for review. Delays may occur if pre-review comments are not addressed promptly. 
  6. You’ll be notified of your protocol’s approval status after the IBC review. 

Amendments: Complete and submit an Amendment in RAMP Safety for any changes to personnel, materials, or project scope.

  • Personnel changes (e.g., adding/removing) do not require full committee review.
  • Changes to materials (or risk), scope do require full IBC review.
  • Room changes will be evaluated by the Biosafety Officer and type of review as determined by risk.

Renewals: Protocols must be renewed every 3 years from the last approval date. 

  • RAMP will send automated reminders to the Principal Investigator or Course Coordinator before expiration. 
  • For older protocols not in RAMP, reminders will come from the IBC Administrative Specialist at [email protected]. 

Need help? Training is available on MasonLeaps. 

Principal Investigators (PIs) will review and update at least annually (e.g., for personnel updates) by submitting amendments, with full renewal due every 3 years. 

 Researchers will receive email reminders from [email protected] approximately sixty (60) days prior to protocol expiration. It is the PI’s responsibility to submit renewals in a timely manner to avoid lapses in approval.

Yes. Principal Investigators (PIs) can designate a proxy (such as a lab manager or senior staff member) to assist with protocol submissions and updates in RAMP Safety. 

To assign a PI Proxy in RAMP Safety: 

  • The PI must add the individual as a protocol team member within the protocol. 
  • Once added, the proxy will have access to assist with drafting, editing, and submitting protocols on behalf of the PI. 

Note: While proxies can assist with submissions, initial submissions and final certification must be completed by the PI.

Yes. All laboratories listed as BSL-2 (or higher) registered with the Institutional Biosafety Committee (IBC) will be audited by the Biosafety Officer within one year of protocol approval. These audits are conducted at the same time as the EHS laboratory safety inspection. 

What the inspection includes: 

  • Review of laboratory facility biosafety level and work practices,
  • Confirmation of appropriate safety equipment,
  • Verification of required documentation, training, etc. 

Audit results are shared with the Principal Investigator (PI) or Laboratory Supervisor. Any necessary corrective actions must be addressed to maintain compliance with the approved protocol.