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GENERAL INFORMATION

FOR RESEARCHERS

FAQ's for Reporting Incidents Related to Research Subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acids to the National Institutes of Health (NIH) Office of Science Policy (OSP)

http://osp.od.nih.gov/sites/default/files/FAQs_about_Incident_Reporting.pdf

1. What kinds of incidents involving recombinant DNA must be reported to the NIH OSP?

2. How serious must a problem be to warrant reporting to OSP?

3. Who is responsible for reporting incidents involving recombinant DNA to NIH OSP?

4. What information should incident reports include?

5. What other information needs to be provided?

6. What does OSP do with this information?

 

1. What kinds of incidents involving recombinant DNA must be reported to the NIH OSP?- 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 significan research-related accidents and illnesses" must be reported to NIH OSP 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 OSP. back to top

2. How serious must a problem be to warrant reporting to OSP? - Any spill or accident involving recombinant DNA research of the nature described above or that otherwise leads to personal injury or illness or to a breach of containment must be reported to OSP. These kings of events might include skin punctures with needles containing recombinant DNA, the escape or improper disposition of a transgenic animal, or spills of high-risk recombinant 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 OSP.

Minor spills of low-risk agents not involving a breach of containment that were properly cleaned and decontaminated generally do not need to be reported. OBA should be consulted if the Institutional Biosafety Committee (IBC), investigator, or other institutional staff are uncertain whether the nature or severity of the incident warrants reporting. OSP can assist in making this determination. back to top

3. Who is responsible for reporting incidents involving recombinant DNA to NIH OSP? - Under the NIH Guidelines incident reporting is articulated as a responsibility of the Insitution, IBC, Biological Safety Officer, Compliance Officer, and Principal Investigator. Institutions have the discretion to determine which party should make these reports, and on report for each incident or set of information is generally sufficient. back to top

4. What information should incident reports include? - Incident reports should include sufficient information to allow for an understanding of the nature and consequence of the incident, as wel 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 from OSP to facilitate reporting of incidents under the NIH Guidelines. Reporting template

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5. What other information needs to be provided? - Depending on the severity of the incident, OSP staff may request the IBC meeting minutes documenting approval conditions for the research, minutes of IBC meetings where the incident was reviewed, policies in place at the time the incident occurred, or any revised policies prepared in response to the incident. Training records for the personnel involved in the incident may also be requested. back to top

6. What does the OSP do with this information? - OSP staff review incident reports to assess whether the insitutional response was sufficient. Depending on the adequacy of the institutional response, OSP may ask the insitution to take additional measures as appropriate to promote safety and compliance with the NIH Guidelines. back to top

 


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Mission Statement

The mission of the Office of Research Compliance, in cooperation with and in support of the Institutional Review Board, Institutional Animal Care and Use Committee, Radiation Safety Committee, and Institutional Biosafety Committee, is to facilitate safe and ethical research conducted by Marquette faculty, staff and students in the areas of human subjects, animal subjects, radiation safety and biosafety.