UC Irvine Institutional Biosafety Committee
Adverse Event and Non-Compliance to NIH Guidelines Reporting Form
What kinds of incidents must be reported to the IBC?
Compliance with the NIH Guidelines requires that UC Irvine, as a recipient of NIH funds, “reports any significant problems,
violations of the NIH Guidelines or any significant research-related accidents or illnesses”(Sections IV-B-1-j, -2-b-(7), -3-c-(2), 7-a-(3)). Compliance with the Occupational Safety and Health Act General Duty Clause requires that UC Irvine provide “a
place of employment which [is] free from recognized hazards that are causing or are likely to cause death or serious physical
harm to [its] employees” (Sec. 5 Duties).
Reportable Incident: Any accident that leads to personal injury or illness. Any breach of containment. Any violation of the
NIH Guidelines. Examples of reportable incidents include, but are not limited to, spills of infectious agents/toxins or
recombinant DNA materials outside of the biosafety cabinet, needlesticks, animal bites from infected animals, unprotected
skin exposures to biological agents, and the escape or improper disposal of animals used in research.
File this report with the Biosafety Officer at ibc@uci.edu within 24 hours of the event
Type of Reporting (check appropriate box)
Adverse event involving biohazardous agent
(Event that involves contamination of personnel, spill/release of biohazardous agent in the laboratory or the environment and
that has the potential to cause illness or that may cause significant concern to the general public.)
Non-compliance with NIH Guidelines
(Failure of the PI to [1] supervise the safety performance of the laboratory staff, [2] investigate and report any significant
problems pertaining to the operation and implementation of containment practices and procedures, [3] correct work errors and
conditions that may result in the release of a biohazardous material, [4] ensure the integrity of the physical and biological
containment, and [5] report any violation of the NIH Guidelines that results in personal injury.)
Adverse event involving gene transfer experiments
(Any event involving risk to the subject or others, that is both unexpected and associated with the use of the gene transfer
product or any finding from tests in laboratory animals that suggests a risk for human research participants including reports of
mutagenicity, teratogenicity, or carcinogenicity.)
Date
IBC Protocol if known:
Location
Person Reporting
the Event
Nature of the event:
Biohazardous
Agent Involved
Exposure risk to People and the environment:
Action Taken
(Adverse event involving gene transfer experiments must be filed with the IRB. For more information please visit the Office of
Research Website).
For IBC use only
IBC Protocol # :
Receipt Date
Action Take: