Recombinant DNA, Biohazard and Animal Incident Reporting

The Ohio State University is required to report certain incidents involving recombinant DNA or biohazard research to the National Institutes of Health. This policy outlines the information necessary to determine the nature and extent of the incident, as well as the appropriate reporting requirements and process.

Reporting Responsibilities

The university personnel involved will immediately report the incident to the Institutional Biosafety Officer, who will contact the Senior Director of Environmental Health and Safety, the Director of University Lab Animal Resources, the Chair of the Institutional Biosafety Committee and the Offices of Responsible Research Practices and Research Compliance as needed.
The Institutional Biosafety Officer and the Principal Investigator will collectively complete a biohazard, rDNA biohazard Incident Report form. The form will be completed in a timely manner as determined by the nature of the incident and agency reporting timelines. The report will be provided to the Institutional Biosafety Committee (IBC) for review.
Following review by the IBC and the University’s Office of Research Compliance, the Chair of the IBC and Office of Responsible Research Practices will submit the final incident report with the Chair’s signature to the respective federal agency on behalf of the university. Copies of the incident report will be provided to the University Office of Legal Affairs, the Associate Dean for Research of the College involved, and the Chair of the Department involved.

Reportable Incidents and Timelines

The following incidents should be reported immediately to the Principal Investigator, the Institutional Biosafety Officer, and the Chair of the Institutional Biosafety Committee:
1. Spills or accidents in a BSL2 laboratory resulting in an overt exposure, injury or illness of personnel, including bites/exposures to animals intentionally infected with RG2 agents or potential zoonotic diseases.
2. Spills or accidents in a BSL3 laboratory resulting in an overt potential exposure, injury or illness of personnel, including bites/exposures to animals intentionally infected with RG3 agents or potential zoonotic diseases.
3. Release of a Risk Group 2 or 3 agent / genetic material from a primary containment device (e.g., biological safety cabinet, centrifuge, or primary container into the laboratory)
4. Spills or accidents that lead to personal injury or illness or breach of containment (e.g., aerosols released outside of containment, skin punctures with needles containing Risk Group 2 or 3 agents or genetic material from these agents).
5. Failure to adhere to the containment and biosafety practices described in the NIH Guidelines.
The following timelines will be used for institutional incident reporting to the agency:
1. Section IV-B-2-b-(7) of the NIH Guidelines for Research Involving Recombinant DNA 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 the Office of Biotechnology Activities (OBA) within 30 days.
2. Appendix G of the NIH Guidelines specifies that certain types of accidents/incidents (i.e., 1.a and 1.b) must be reported immediately. A follow-up report will then be submitted as needed.

Online URL: https://ohiostateresearch.knowledgebase.co/article/recombinant-dna-biohazard-and-animal-incident-reporting-80.html