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Research Compliance

IBC

IBC: To Report a Concern

The Institutional Biosafety Committee (IBC) is charged with oversight of research involving biological materials that can pose a potential risk to public health, lab personnel, the environment, animals, or plants. This means any issue that compromises the approved containment, introduces new hazards, or violates regulations must be promptly reported.

Primary IBC reportable issues:

  1. Accidents, Spills, and Exposures
  • Release/Potential Release:
    • Incidents that involving a release or potential release of biohazardous material, especially recombinant or synthetic nucleic acid molecules, are mandatory reports.
  • Personnel Exposure:
    • Any skin, eye, mucous membrane, or parenteral (e.g., needle stick, cut, or animal bite/scratch) contact with biohazardous materials, including pathogens, toxins, or r/sNA.
  • Significant Spills:
    • Spills of biohazardous or r/sNA material that occur outside of primary containment (e.g., outside a Biosafety Cabinet) or that cannot be easily and quickly cleaned up by a single person.
  • Loss of Containment:
    • Any failure in the containment system that leads to the unintended release of biological material.
  • This includes:
    • Escape or unauthorized release of transgenic animals or plants (e.g., mice containing a recombinant virus, or GM seeds/pollen).
    • Loss of culture due to equipment failure (e.g., centrifuge tube breaking).
  1. Research-Related Illnesses and Injuries
  • To ensure the health and safety of research personnel. Any illness, injury, or severe occupational exposure likely or potentially related to the biohazardous agents, toxins, or r/sNA used in the research must be reported immediately.
  1. Protocol Noncompliance and Violations
  • A failure to adhere to the IBC-approved protocol, institutional policies, or governing federal regulations (like the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules) must be reported.
  • This includes:
  • Serious Noncompliance: Actions that have the potential to pose a significant risk to the health and safety of people, animals, or the environment (e.g., performing a high-risk procedure without proper Personal Protective Equipment or BSL-3 approval).
  • Continuing Noncompliance: A pattern of repeated, intentional uncorrected deviations from IBC-approved protocol, institutional policies, or governing federal regulations.
  • Unauthorized Protocol Changes: Implementing a substantial change in the approved protocol without first receiving IBC approval (e.g., using a new, higher-risk host/vector system, increasing the scale of the experiment, or changing the physical location of the work).
  1. Adverse Events in Gene Transfer Trials
  • In studies involving human gene transfer (a type of clinical trial involving r/sNA), the IBC works closely with the IRB. Adverse Events (AEs) must be reported to the IBC if they are:
  • Serious (e.g., life-threatening, resulting in death, or hospitalization).
  • Unexpected in nature or severity.
  • Potentially related to the gene transfer product or vector.

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General Reporting Timelines

Promptness reporting is critical for biohazards:

This table describes the general reporting expectations for various incident types. Immediate reporting, within 8 to 24 hours, would include exposure to BL2/BL3/BL4 agent, loss of Containment (e.g., escaped animal), and new research-related illness. Immediately reporting or within 5 business days would include serious non-compliance. The things reported in an annual summary, but may need conformation from your local IBC policy, would be minor or nonserious protocol deviations.
Incident Type General Reporting Expectation (May vary by institution)
Exposure to BL2/BL3/BL4 agent Immediate (within 8 to 24 hours)
Loss of Containment (e.g., escaped animal) Immediate (within 8 to 24 hours)
Serious Noncompliance Immediate or within 5 business days
New Research-Related Illness Immediate (within 8 to 24 hours)
Minor or Nonserious Protocol Deviations Often reported in an annual summary, but check your local IBC policy.

The Principal Investigator (PI) is responsible for ensuring the immediate notification of the Biosafety Officer (BSO) and the IBC when any of these events occur.

 

To report any concerns at TAMUK please contact: