FAQ’s

• What projects require IBC approval?
  • IBC review is required for any research, testing, or teaching activity involving:
    • Recombinant or Synthetic Nucleic Acid (r/sNA) molecules (e.g., gene editing, viral vectors, transgenic organisms) that fall under the NIH Guidelines.
    • Infectious Agents (bacteria, viruses, fungi, parasites) that are classified as Risk Group 2, 3, or 4.
    • Biological Toxins (e.g., botulinum toxin, ricin) above certain exemption limits.
    • Human-derived materials (e.g., primary cells, tissue, blood) that pose a potential risk due to infectious agent transmission.
    • Select Agents & Toxins.
• How is the biosafety level (BSL) determined for my project?
  • The Principal Investigator (PI) makes the initial BSL determination based on a risk assessment of the agent's infectivity, virulence, dose, route of exposure, and the scale of the experiment. The IBC reviews this determination, referencing the NIH Guidelines and the Biosafety in Microbiological and Biomedical Laboratories (BMBL)
• Can I begin my research or order materials before receiving IBC approval?
  • You must receive IBC approval before beginning any research that involves recombinant/synthetic nucleic acid molecules, infectious agents, or biohazardous materials. Starting research without approval constitutes a serious violation of the NIH Guidelines & institutional policy, which can result in jeopardizing laboratory safety, risking environmental release, & incurring regulatory sanctions.
• What happens if my study is denied IBC approval?
  • When the IBC denies authorization, they will provide concrete feedback on the missing or inadequate containment strategies & necessary biosafety procedures. You are required to revise the protocol then resubmit it, ensuring all concerns related to the safety of personnel in addition to the environment are fully mitigated. Receiving a request for modifications prior to final approval is a standard part of the IBC review process.
• What Happens After a Protocol is Approved by the IBC?
  • Once a protocol receives IBC authorization, the Principal Investigator (PI) is obligated to strictly follow the approved protocol and ensure continuous biosafety oversight. The PI's core responsibilities post-approval include:
    • Conducting the work exactly as outlined in the approved protocol & any associated safety manuals.
    • Maintaining the required containment levels (BSL) for the duration of the work.
    • Ensuring all laboratory personnel maintain proper training, wear appropriate Personal Protective Equipment (PPE), & adhere to approved microbiological practices.
    • Promptly reporting any accidents, spills, personnel exposures, or significant protocol deviations to the IBC and Biosafety Officer.
    • Submitting annual progress reports to the IBC (for ongoing, long-term studies) to document the work conducted and any changes.
    • Obtaining an approved amendment from the IBC before implementing any changes to the protocol that affect risk or containment.
    • Submitting a final report upon completion or termination of the study.
• How does one modify a previously approved study?
  • If you need to make changes to a protocol after IBC authorization (such as modifying the experimental procedure, altering the host/vector system, increasing the scale of the experiment, changing the physical location of the work, or adding new hazardous materials), you must submit a protocol amendment request using the Cayuse system to the IBC for review & approval before proceeding with the changes.
• How often do I need to certify my Biosafety Cabinet?
  • Biosafety cabinets must be certified annually or whenever they are moved, repaired, or whenever HEPA filters are changed. The PI is responsible for ensuring the unit is properly maintained and certified by an accredited professional.
• Do IBC Reviews Apply to Research Outside the U.S.?
  • Yes, IBC authorization is required if the institution sponsoring or overseeing the research is in the U.S. or if U.S.-based personnel are conducting the work, regardless of where the research is taking place (i.e., foreign locations). The IBC review is primarily required to ensure compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules & to mitigate the risks associated with biohazards.
  • Key Considerations for International IBC Protocols:
    • NIH Guidelines: All research falling under the NIH Guidelines must be approved by the U.S. IBC, even if the work occurs entirely overseas.
    • Local Compliance: Research conducted outside the U.S. must also adhere to local, host-country regulations concerning biosafety, biosecurity, or the handling of biological materials & toxins.
    • Permits & Transport: The PI must secure all required international permits for importing or exporting biological materials (e.g., from the CDC or USDA). The PI must confirm materials are transported in compliance with international & local standards; the IBC review often includes verifying these transport plans.
• What are the consequences of non-compliance with IBC requirements and policies.
  • Failure to comply with IBC-approved protocols, institutional biosafety policies, or the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules is taken very seriously. The consequences reflect the potential danger that biohazards pose to laboratory personnel, public health, and the environment. Primary consequences for non-compliance may include Mandatory suspension or termination of research, administrative & disciplinary action, loss of funding & reputational damage, regulatory reporting, and possibly severe legal consequences at federal, state, and local levels.
• Who should be notified immediately after a spill or exposure?
  • The Principal Investigator (PI), the Biosafety Officer (BSO), & relevant Occupational Health personnel must be notified immediately following any significant spill outside containment, sharps injury, or potential personnel exposure to a biohazardous agent.