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Frequently Asked Questions (FAQs) of Interest to IBCs
Incident Reports to the NIH Office of Biotechnology Activities (OBA)
- What kinds of incidents involving recombinant DNA must be reported to the NIH OBA?
Section IV-B-2-b-(7) of the NIH Guidelines states that IBCs should report "...any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses" to NIH OBA within 30 days. Appendix G of the NIH Guidelines specifies certain types of accidents that must be reported on a more expedited basis. According to Appendix G-II-B-2-k, spills or accidents in BL2 laboratories resulting in an overt exposure must be immediately reported to NIH OBA (as well as the IBC). According to Appendix G-II-C-2-q and Appendix G-II-D-2-k, spills or accidents occurring in high containment (BL3 or BL4) laboratories resulting in an overt or potential exposure must be immediately reported to NIH OBA (as well as the IBC, and BSO).
- Does this responsibility only apply to IBCs?
No. In addition to IBCs, incident reporting is also articulated as a responsibility of institutions, BSOs, and principal investigators under Sections IV-B-1-j, IV-B-3-c-(2), and IV-B-7-a-(3), respectively. 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.
- How serious must a problem be to warrant reporting to OBA?
Any spill or accident involving recombinant DNA research of the nature described in Appendix G (see above) or that otherwise leads to personal injury or illness or to a breach of containment must be reported to OBA. These kinds 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 by an investigator to adhere to the containment and biosafety practices articulated in the NIH Guidelines must also be reported to OBA. 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 staff should be consulted if IBCs, investigators, or other institutional staff are uncertain whether the nature or severity of the incident warrants reporting to OBA; we can assist in making this determination.
- What information should incident reports include?
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.
- To whom should incident reports be sent?
Incident reports should be sent to: Kathryn Harris, Ph.D., Senior Outreach and Education Specialist, NIH Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, Maryland 20892-7985
- What does OBA do with this information?
OBA staff review incident reports to assess whether the institutional response was sufficient. Depending on the adequacy of the institutional response, OBA may ask the institution to take additional measures as appropriate to promote safety and compliance with the NIH Guidelines.
- Do adverse events experienced by participants in human gene transfer trials fall under this incident reporting requirement?
No, adverse events in human gene transfer trials are subject to a separate set of reporting requirements. These are found in Appendices M-1-C-3 and M-1-C-4 of the NIH Guidelines. Serious adverse events that are unexpected and possibly associated with the gene transfer product should be reported to OBA within 15 calendar days of sponsor notification, unless they are fatal or life threatening, in which case they should be reported within 7 calendar days. Other serious adverse events should be reported to OBA as part of the principal investigator's annual report to OBA.
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