Institutional Biosafety Committee (IBC)

About the IBC

The University at Albany is committed to actively supporting biological research in our laboratories. 

The Office of Environmental Health and Safety (EH&S), the Office of Regulatory & Research Compliance (ORRC) and the Institutional Biosafety Committee (IBC) are equally committed to ensuring that researchers, their staff, students and the community are not harmed or negatively impacted by the activities of the University.

Please review the IBC Charter for more information about the committee. Campus community members interested in committee membership should please contact [email protected] or 518-437-3850

Please use this page to complete the following tasks:

 

 

Access the Biosafety Manual

The UAlbany Biosafety Manual, maintained by the IBC, is a comprehensive resource for faculty, staff and students working with biological materials in research or teaching settings. It outlines the requirements for IBC approval, training obligations for biosafety and animal biosafety, and the development of Standard Operating Procedures (SOPs) to ensure safe and compliant laboratory practices. 

The manual addresses federal and New York State regulations governing the use of biohazardous materials, biological agents capable of causing Laboratory Acquired Infections (LAIs), and research involving Dual Use Research of Concern (DURC) and Potential Pandemic Pathogens (PEPP). 

It also provides detailed guidance on decontamination and sterilization, transportation of biological materials, biohazardous waste disposal, and containment practices. By supporting a strong culture of biosafety and regulatory compliance, the manual plays a critical role in protecting researchers, the public and the environment. 

Review a list of biological agents at use at UAlbany with LAIs documented elsewhere. Note: Please use your UAlbany NetID and password to access the following documents.
 

manual

 

Contact the IBC 

To promote safe conditions in our laboratories and classrooms, researchers, instructors, staff and trainees are asked to use these contacts:  

 

contact

 

Determine if IBC Approval is Required

Federal and state regulations require that UAlbany ensures a safe working environment and responsible use of potentially biohazardous materials. The IBC is UAlbany’s means to document an individuals’ training and plan to meet safety standards.
 

requirements
Activities that Require IBC Review
Activities that Require IBC Review

IBC review and approval of a Biosafety Protocol is required before initiating any of the following activities:  

  • Substances or agents in Risk Group 2 or greater, such as:
    • Recombinant and synthetic nucleic acid molecules
    • Hazardous biological agents (such as viruses, bacteria, fungi, parasites, prions, rickettsia, etc.)
    • Other potentially infectious materials (such as human or non-human primate blood, serum, plasma, body fluids, unfixed tissue, organs, and cells)
    • Select agents and biological toxins
    • Transgenic animals or plants
    • Any research that would increase the function of a biological substance’s ability to cause infection or resist treatment
    • Human gene transfer
    • Sheep and any tissues derived from them (these tissues can transmit Coxiella burnetii, the causative agent of Q-fever)
    • Field studies involving wild animals, wild animal vectors, or their tissues potentially infected or experimentally infected with BSL2 or higher agents
  • For work with potentially infectious agents involving human subjects or experimental animals, IBC review is required in addition to review by the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC), as appropriate.

If you have questions about whether your activity needs review by the IBC, please contact [email protected].

IBC review is not required for the collection of saliva if the samples are not expected to contain blood and are not cultured to increase infectious particles. When samples are not cultured, the number of infectious particles does not increase; therefore, the theoretical risk to laboratory personnel remains low. However, the Principal Investigator (PI) should consult with EH&S to ensure that appropriate protocols for sample collection and storage are followed.

Additionally, if human samples are being collected for research purposes, IRB review and approval is required to ensure compliance with human subjects protection regulations. The following activities do require IBC review and approval prior to initiation:

  • The use of regulated plant pathogens or pests (refer to the U.S. Regulated Plant Pest List)
  • The use of toxins derived from plants, animals or microorganisms that could have adverse effects on humans or animals
  • Any changes to existing protocols involving the above substances or procedures
IBC Processes for Activities Requiring Review
IBC Processes for Activities Requiring Review

When research activities involving biohazardous materials are registered with the Institutional Biosafety Committee (IBC), the following processes apply. Please visit the Obtain IBC Review section for detailed instructions.
 

Initial Review & Record-keeping

The IBC will review your submission and maintain records of your registered activities. The review process may require you to make changes to your proposed project prior to approval.
 

Ongoing Oversight & Annual Updates

All registered or approved activities are subject to inspection by the IBC or designated University officials to ensure compliance with institutional policies and biosafety standards.

The IBC conducts periodic reviews of all biohazardous work at UAlbany. The frequency of protocol reviews will be determined by the IBC, based on the nature and risk level of the work.

Principal Investigators (PIs) are responsible for ensuring all IBC approvals remain current for the duration of the work. IBC oversight remains in effect until all biohazardous materials related to the project have been properly disposed of or exhausted.

For ongoing research, you must confirm the status of your activity annually. The IBC is implementing a system to provide reminders for annual reviews and check-ins.
 

Changes to Registered Work

When submitting a new funding proposal to an external sponsor that involves previously registered or reviewed work, researchers must:

  • Submit a new IBC application if the proposed work includes new procedures, additional substances will be used or there are changes that may affect the risk level of the activity.
  • Submit a modification if the only change is the addition of a new project using the same previously approved procedures and materials. Note: The IBC reserves the right to request a full renewal or new application if a submitted modification is deemed substantial. 

 

Complete Required Training  

To promote a safe research environment and ensure compliance with institutional, federal and state regulations, all individuals working in laboratory settings must complete biosafety training that is specifically tailored to the nature of the work being performed. 

The type and scope of required training depend on the materials, agents and procedures used in the lab, such as recombinant or synthetic nucleic acids, human-derived materials, high-risk biological agents, chemicals, or animals.

Completion of the appropriate training programs is a prerequisite for IBC approval and for beginning laboratory work. All Principal Investigators (PIs) and personnel listed on a biosafety protocol must provide proof of completed training, which will be verified during IBC review and laboratory inspections. 
 

training
Explore Required Trainings
Explore Required Trainings

The following trainings are required based on the type of research conducted:

  • Biosafety Complete Training Series: Available online via the CITI Training Program. Required for all laboratory personnel before starting work in Biosafety Level 1 (BSL-1), Biosafety Level 2 (BSL-2) and teaching laboratories. PIs are not required to renew the training annually; however, all other lab members must complete the annual refresher course titled "Training for Investigators, Staff, and Students Handling Biohazards."
  • BSL-2 Training or Laboratory Biosafety Training: Required for all personnel working with BSL-2 agents, including those in biology laboratories where BSL-2 agents are handled or in shared spaces where BSL-2 work is conducted. Covers topics such as bloodborne pathogens, biosafety cabinet usage, and the safe transportation of infectious substances, including the import/export of infectious materials and biowaste management. The training must be completed before beginning lab work and renewed annually, fulfilling both the one-year refresher requirement and onboarding for new trainees.
  • Bloodborne Pathogen Standard Training: Available online via the CITI Training Program. Required for personnel handling human materials, cells or cell lines, non-human primates, or any bloodborne pathogens. This training must be completed before beginning work and renewed annually.
  • Bloodborne Pathogens Training for Custodial Staff: Custodial staff must complete in-person training annually.
  • IBC Policy & Recombinant DNA Training: Available online via the CITI Training Program. Required for all PIs and personnel involved in protocols containing recombinant or synthetic nucleic acids. This training must be completed before engaging in any protocol activities and renewed annually at the time of protocol renewal.
  • Select Agent and Agent-Specific Trainings: Laboratories working with high-risk biological agents may require additional training on handling select agents and toxins. This training must be renewed annually.
  • Animal Biosafety & IACUC Animal Training: Available online via the CITI Training Program. Required for personnel working with animals in the laboratory. This training must be renewed every three years.
  • Chemical Safety and Radiation Safety Training: All personnel working with hazardous chemicals or radioactive materials are required to complete annual chemical and radiation safety training. For more information on this training, contact the Chemical Safety Officer at 518-591-8542 or the Radiation Safety Officer at 518-442-3497.

 

Obtain IBC Review  

If your activity requires approval by the IBC, please follow the instructions below to obtain an IBC review.

Please submit your materials by the posted deadlines to ensure it is reviewed in a timely manner, especially when approvals are required to meet funding deadlines.  
 

MonthIBC Review MeetingSubmission Deadline
May 2025May 14, 2025April 23, 2025
June 2025June 18, 2025May 28, 2025
July 2025July 16, 2025June 25, 2025
August 2025August 13, 2025July 23, 2025

 

review
Step 1: Complete an IBC Protocol Evaluation Form
Step 1: Complete an IBC Protocol Evaluation Form

All submissions to the IBC must include a completed IBC Protocol Evaluation Form, which outlines a risk assessment and management plan. 

Step 2: Collect or Create Biohazardous Agent Reference Documents (BARDs)
Step 2: Collect or Create Biohazardous Agent Reference Documents (BARDs)

For each agent, a BARD needs to be included in the review request:

The extended template is recommended for protocols that require additional space to provide detailed information—such as complex procedures, multiple biological agents or enhanced biosafety measures. 

BARD templates for biological agents or toxins currently on campus are available. 

Please review the Biological Agents & Toxins with Existing BARDs to determine if templates exist for any of the biohazardous agents involved in your activity. Note: Please use your UAlbany NetID and password to access the document.

To request an existing BARD, please email [email protected] or [email protected].
 

What is a Biohazardous Agent Reference Document (BARD)?

A Biohazardous Agent Reference Document (BARD) is a guidance resource that reviews and summarizes the nature of a pathogen or biotoxin and offers safety requirements for work with the agent in the laboratory.  

The document includes characteristics of the agent, laboratory and health hazards, precautions, containment and personal protective equipment (PPE) requirements, spill and disinfection procedures, exposure procedures, required follow-up, and additional references.  

The BARDs provided here are general templates, and laboratory-specific BARDs may be created by the IBC to address additional risks or requirements specific to the research in each individual laboratory.

The BARD is provided as an additional guidance tool and is not suitable for risk assessment, biosafety training, laboratory-specific training or a formal IBC master protocol registration.  

This document should be readily available in the laboratory, and it is the responsibility of the laboratory supervisor or principal investigator to ensure that all laboratory personnel have read, understood, and signed the document.  

The BARD is for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis or treatment. Please consult a healthcare provider for any medical questions or concerns.   

Step 3: Complete a Required Form for rDNA/sNA research, if applicable
Step 3: Complete a Required Form for rDNA/sNA research, if applicable

In accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, all PIs conducting rDNA/sNA research must complete the NIH Review Categories for Recombinant or Synthetic Nucleic Acid Research Form.

The form consolidates all required information for compliance, including classification under NIH Review Categories (Sections III-A through III-F), containment levels, host/vector details, and risk-related criteria. Submission ensures proper documentation, supports institutional oversight and helps determine the appropriate level of review. 

Depending on the nature of the experiment, IBC approval may be required prior to initiation or simultaneous with registration. Other federal and state biosafety standards may also apply to such research, including those outlined in the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL).

For questions or clarification, contact the IBC at [email protected] or 518-437-3850

Step 4: Submit All Materials to the IBC
Step 4: Submit All Materials to the IBC

Once you have completed Steps 1 through 3, you should submit all collected materials to [email protected] by the deadlines posted above. 

 

Understand Principal Investigator (PI) Responsibilities

PIs at UAlbany are required to fulfill the following responsibilities to ensure safety, compliance, and ethical conduct in research. 
 

PI
Laboratory Safety & Biosafety Oversight
Laboratory Safety & Biosafety Oversight
  • Adhere to all institutional policies and procedures related to safe laboratory operations.
  • Ensure that all laboratory personnel receive appropriate biosafety and operational training.
  • Maintain current biosafety training and certifications.
  • Hold valid Institutional Biosafety Committee (IBC) approvals where required.
  • Conduct all research in full compliance with the approved biosafety protocol. 
Recombinant & Synthetic Nucleic Acid Research
Recombinant & Synthetic Nucleic Acid Research
  • Do not begin or modify recombinant or synthetic nucleic acid research requiring IBC approval until formal approval is obtained.
  • For Risk Group 1 (RG-1) Substances: Determine if institutional registration is necessary at project initiation, and follow relevant policy. 
Reporting
Reporting
Dual Use Research of Concern (DURC) & Pathogens with Enhanced Pandemic Potential (PEPP)
Dual Use Research of Concern (DURC) & Pathogens with Enhanced Pandemic Potential (PEPP)

To adhere with federal policy, PIs must take the following steps to address potential Category 1 and/or Category 2 research risks:

  1. Determine whether the proposed research falls under:
    • Category 1 (DURC): Research that can be misapplied to pose a significant threat to health, safety, agriculture or national security.
    • Category 2 (PEPP): Research involving pathogens that are or could be modified to have pandemic potential.
  2. Complete the PI Self-assessment for Category 1 and/or Category 2 Research Designation at the time of grant proposal submission.
  3. Collaborate with the IBC and ORRC to:
    • Evaluate risks and benefits associated with DURC/PEPP-designated research.
    • Design and implement appropriate risk mitigation plans.
  4. Ensure all personnel involved in DURC/PEPP research receive documented training on:
    • The scope and risks of DURC/PEPP work
    • Safe handling and responsible communication procedures
    • Ensure any communication or publication of DURC/PEPP findings aligns with the approved mitigation strategy and is responsibly presented.
       

Review Process for DURC & PEPP (Category 1 & Category 2)

  1. PI Initial Assessment & Notification: PI assesses whether proposed or ongoing research may be within the scope of Category 1 or Category 2 based on biological agents or toxins and experiments. If so, the PI notifies the federal funding agency and IBC.
  2. Federal Funding Agency Notification: If considering funding the proposed research, the federal funding agency notifies the research institution of the PI's initial assessment.
  3. IBC Risk-Assessment: IBC assesses whether research meets the three-step criteria for Category 1 or Category 2 oversight. The research institution notifies the federal funding agency of its assessment.
  4. Federal Funding Agency Verification: The federal funding agency evaluates and verifies the research institution's assessment.
  5. Risk-Benefit Assessments and Risk-Mitigation Plan:
    • Category 1: IBC and PI develop and submit a risk-benefit assessment and risk mitigation plan for Category 1 research to the federal funding agency. Category 1 research may not begin or continue until the federal funding agency has approved the risk mitigation plan.
    • Category 2: IBC and PI develop and submit risk-benefit assessments and a risk mitigation plan for Category 2 research for department-level review.
  6. Departmental Review of Category 2 Research: The federal department convenes a multidisciplinary review entity to evaluate the research, including the risk-benefit assessment and risk mitigation plan, and makes recommendations to inform the federal funding agency's funding decisions. Category 2 research may not begin or continue until the federal funding agency has approved the risk mitigation plan.
  7. Research Conduct and Ongoing Oversight: PI and research institution conduct and oversee federally funded research in accordance with the approved risk mitigation plan and applicable regulations, policies, and guidelines.

If research does not meet Category 1 or Category 2 criteria, PI continually assesses for any changes that may alter an assessment of whether research is Category 1or Category 2. All other relevant regulations, policies and guidelines still apply.

For more detailed information on the DURC/PEPP Policy, please visit Chapter 11 of the Biosafety Manual.

For an infographic representation of this review process, please review the Flowchart of the Review Process for DURC and PEPP (Category 1 and Category 2).