Incident Reporting – December 2023
The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) states that “…any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses” must be reported to NIH OSP.
Any spills, accidents, or other incidents that result in breach of containment, environmental release or exposures to laboratory or other research personnel or animals to viruses, cells or organisms containing recombinant or synthetic nucleic acid molecules shall be reported to Institutional Biosafety Committee (IBC), NIH OSP, and if applicable, the Animal Facility Director and other appropriate authorities. These kinds of events might include overt exposures as described below, the escape or improper disposition of a transgenic animal, or spills of high-risk recombinant or synthetic materials occurring outside of a biosafety cabinet. Failure to adhere to the containment and biosafety practices articulated in the NIH Guidelines must also be reported to NIH OSP.
Additional reportable violations include: failure to obtain or maintain IBC approval, or when necessary, NIH OSP approval for research subject to Section III-A and III-B of the NIH Guidelines, or failure to request approval to use lower containment as described in NIH OSP Review of Requests to Lower the Minimum Required Biosafety Containment Level for Research Subject to the NIH Guidelines.
Exposures of laboratory or other research personnel to viruses, cells, organisms or animals containing recombinant or synthetic nucleic acid molecules would typically be considered an overt exposure. In addition, NIH OSP typically considers an incident to be an overt exposure if an employee sustains a personal injury while conducting research subject to the NIH Guidelines, especially when medical follow-up is obtained. These kinds of overt exposures might include (but are not limited to) skin punctures with needles, cuts, animal bites or scratches, and direct contact with mucosal membranes (e.g., eye splash).
Significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses must be reported to NIH within 30 days. Certain types of accidents must be reported on a more expedited basis. Spills or accidents in BL2 laboratories resulting in an overt exposure must be immediately reported to NIH. Spills or accidents occurring in high containment (BL3 or BL4) laboratories resulting in an overt or potential exposure must be immediately reported to NIH.
Minor spills of low-risk agents that do not involve a breach of containment and that were properly cleaned and decontaminated generally do not need to be reported. If an incident involves a personal injury, or medical consultation is sought after the incident, it would typically be considered significant enough to be reportable to NIH OSP (as noted above, this would typically be considered an overt exposure). If an incident that occurs during the conduct of research involving recombinant or synthetic nucleic acid molecules is reported to another federal agency, it should be reported to NIH OSP.
NIH OSP should be consulted if the IBC, investigator, or other institutional staff are uncertain whether the nature or severity of the incident warrants reporting; NIH OSP can assist in making this determination.
Under the NIH Guidelines, incident reporting is articulated as a responsibility of the Institution, IBC, Biological Safety Officer, and Principal Investigator. Institutions have the discretion to determine which party should make these reports, and one report for each incident or set of information is generally sufficient.
Incident reports should include sufficient information to allow for an understanding of the nature and consequences of the incident, as well as its cause. A detailed report should also include the measures that the institution took in response to mitigate the problem and to preclude its reoccurrence. An incident reporting template is available to facilitate reporting of incidents under the NIH Guidelines. The template may be found on the NIH OSP website. OSP encourages the use of the template, but it is not required, and other report formats may be acceptable.
For incidents that must be reported immediately, there may be instances when not all of the information is available to submit a full report. In such cases, an initial email notification detailing what is known about the incident at that time may be submitted. This initial notification should be followed by a final report as soon as the institutional assessment is complete.
NIH OSP staff review incident reports to assess whether the institutional response was sufficient. Depending on the adequacy of the institutional response, NIH OSP may ask the institution to take additional measures as appropriate to promote safety and compliance with the NIH Guidelines.