Research Responsibilities and Compliance

Biohazard Violation

Office of Research, Institutional Biosafety Coordinating Committee Policy

Willful violation of prudent safety practices (as described in the Institutional Laboratory Biosafety Manual and references) is a violation of university policy and will be dealt with accordingly.

The following steps will be conducted after a university department (unit) is advised of a potential violation (the information can come from within the department, from the Office of Responsible Research Practices (ORRP), the Environmental Health and Safety (EHS), or from some other university department or unit). In all cases the actions taken will be done so in a timely manner that, as used in this context, means with dispatch. The seriousness of the potential violation will indicate the rapidity with which action is to be taken. Any potential violation involving the potential for personal injury or harm to an individuals (i.e., an emergency) must be dealt with immediately!

  1. It is the responsibility of the department chair to monitor and address safety practices. The department chair is notified of the reported violation. Once the department chair becomes aware of a significant or repeat violation or any violation that leads to injury or exposure, it must be reported to ORRP immediately if ORRP has not already been notified. The ORRP will convene a committee consisting of the department chair, the department biosafety officer, the Institutional Biosafety Officer (IBO), an ORRP representative, and the chair(s) of the committee(s) having jurisdiction over the research, that will ask the department chair to conduct an investigation or may conduct its own investigation of the alleged violation. If the department chair feels that the matter can be handled totally within the department (with input from the IBO), the chair may do so, reporting to the committee formed by ORRP. In any case, the report from the chair must be received by ORRP within twenty-four (24) hours in the case of an emergency or within one week in other cases;
  2. In those cases in which the department chair cannot resolve the situation or the committee convened by ORRP in Article 1 is not satisfied with the resulting situation, investigation/inspection by ORRP in cooperation with the IBO, the department biosafety officer (or designee of the department chair), and the chair(s) of any involved committee(s) (Institutional Infection Prevention Committee, Institutional Laboratory Animal Care and Use Committee, Institutional Biosafety Committee, Institutional Biosafety Coordinating Committee) will be conducted;
  3. A report concerning the investigation made in article 2 will be made to the chairs of the appropriate committee(s), the IBO, the department biosafety officer and the department chair. In the case of a perceived violation, a memo stating the required correctional steps will be issued with the concurrence of ORRP, the IBO and the chair(s) of the appropriate committee(s);
  4. If there is no or incomplete compliance by the Principal Investigator (PI), then a “stop work” order will be issued by the IBO in cooperation with ORRP and the chair(s) of the appropriate committee(s). In consultation with the Vice President for Research (VP Research), consideration of withdrawal of research funds by the Office of Sponsored Programs will be explored. In addition, and in consultation with the department chair, the PI may be locked out of his/her laboratory. The PI will be notified of the appeal processes available to her/him;
  5. Appeals from the PI will be forwarded to the appropriate committee(s). The committee(s) will forward their findings to the VP Research who will determine if the committee has acted appropriately. The decision of the VP Research will be forwarded to the PI;
  6. In case of an adverse finding, the PI must take appropriate actions to correct the violation or may appeal the violation to the IBCC, that will contact a number of recognized experts to receive input and make a report of the experts` opinions to the VP Research, who will review the opinions and make a determination in the matter;
  7. The findings of the VP Research will be final. Continued violation will be considered a violation of university policy and be dealt with accordingly.