Reportable Events

Institutions such as Indiana University must report accidents, exposures, or other problems to the National Institutes of Health Office of Science Policy, as outlined in the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines).

IU researchers, laboratory staff, and animal care staff must immediately report any of the following events to the campus IU Environmental Health and Safety Office, Biological Safety Program Manager or designee and to the Principal Investigator, if the reporting researcher is not the PI:

• Any overt or potential personnel exposure to recombinant or synthetic nucleic acid molecule-containing material, at any biosafety level, whether or not that exposure leads to illness. Overt exposures also require that an immediate report to the NIH be submitted by IU's Office for Research Compliance, Research Safety Office. These exposures include but are not limited to:
  • Needle sticks
  • Splashes to mucous membranes
  • Bites from infected animals
• Any significant spill of recombinant or synthetic nucleic acid molecule-containing material outside of a biological safety cabinet. Spills that do not include an overt exposure require that a 30-day incident report  be submitted to the NIH by IU's Office for Research Compliance, Research Safety Office. A significant spill is defined as:
  • A spill of recombinant risk group 1 agent-containing material that requires emergency spill response or other environmental remediation, or
  • Any spill of recombinant risk group 2 or 3 agent-containing material

• Any incident that results in the release of recombinant or synthetic nucleic acid molecules to the environment (including the escape of a transgenic animal). Loss of containment also requires a 30-day incident report to the NIH by IU's Office for Research Compliance, Research Safety Office.

• Any breach of or failure to adhere to biosafety level 2 or 3 containment levels or any other significant problems with or violations of the NIH Guidelines. These incidents also require a 30-day report to the NIH by IU's Office for Research Compliance, Research Safety Office.

• Any spill of and/or exposure to any biohazardous materials outlined in a previously approved IBC protocol.

In the case of an incident that requires an immediate report to the NIH Office of Science Policy (OSP):

• IU Environmental Health and Safety Office, Biological Safety Program will contact the Office for Research Compliance, Research Safety Office with details of the incident, including all information available at that time.

• IU's Office for Research Compliance, Research Safety Office will contact the NIH OSP via email within 24 hours of being notified of the incident.

• The Office for Research Compliance, Research Safety Office will notify the PI and the IBC Chair(s) of the incident facts, such that the whole IBC can be made aware of the incident as soon as possible.

In the case of an incident that requires a 30-day report to the NIH OSP:

• IU Environmental Health and Safety Office, Biological Safety Program will submit an initial report to IU's Office for Research Compliance, Research Safety Office.

• The Office for Research Compliance, Research Safety Office will prepare a draft of the NIH report, which will be submitted to the IBC Chair(s), IU Environmental Health and Safety Office, Biological Safety Program, and the Principal Investigator involved for review and/or edits. All parties will have one week to provide clarifications, comments, and/or edits on the report to the Assistant Director of Research Safety.

• The draft report will be distributed to the full IBC for discussion at the next scheduled IBC meeting.

• After the IBC meeting, the Assistant Director of Research Safety will provide a final draft of the NIH report to the IBC Chair(s), IU Environmental Health and Safety Office, Biological Safety Program, and the Principal Investigator approximately 24 hours before the NIH report deadline.