Southern Illinois University Edwardsville (SIUE) recognizes the need to protect faculty, staff, students, and the community from hazards involving the use of biohazardous material (hazardous biological material) at the University. SIUE, therefore, will comply with the most recent versions of the National Institutes of Health, "Guidelines for Research Involving Recombinant DNA Molecules," the U.S. Department of Health and Human Services, "Biosafety in Microbiological and Biomedical Laboratories," and other appropriate state and federal regulations/guidelines.
This policy applies to all University employees and students conducting research and/or educational activities with known or suspected biohazardous material. Responsibility for assuring compliance with the standards for use of biohazardous material shall rest with the Institutional Biosafety Committee (IBC). The Associate Provost for Research and Graduate Dean is responsible for monitoring changes in applicable laws or regulations, for advising the IBC and the faculty of such changes and for recommending modifications to University policy concerning use of biohazardous material.
A. Biohazardous material: Any biological material or organism which is covered by NIH Guidelines, or is deemed by the IBC as a biohazardous material. The IBC will publish and make updates to its definition of the term as needed.
B. Project Director: The person directly responsible for the conduct of any educational or research activity involving biohazardous material. In the case of a student conducting such activity, the project director is the faculty or staff member under whose supervision the activity is conducted.
1. The IBC shall be comprised of no fewer than five members. At least two members shall not be affiliated with the University and shall represent the interest of the surrounding community with respect to health and protection of the environment.
2. The IBC shall include members who are capable of assessing the safety of the activity and any potential risk to the public health or the environment.
3. Members of the IBC shall be appointed by the Associate Provost for Research and Graduate Dean.
4. The Associate Provost for Research and Graduate Dean shall appoint an ex-officio member of the IBC.
B. Responsibilities of the Institutional Biosafety Committee:
1. The IBC shall review for compliance with federal and other appropriate regulations/guidelines governing Use of Biohazardous Material and Recombinant DNA activities conducted at or sponsored by SIUE and shall approve those activities that it finds in compliance. This review shall include:
a. an independent assessment of the containment level required by the federal regulations;
b. an assessment of the facilities, procedures, and practice and training of the personnel involved in the activity.
2. The IBC shall notify the project director of the results of its review.
3. The IBC shall determine the containment level as specified by the federal and other appropriate regulations/guidelines.
4. The IBC shall periodically review all activities to assure compliance with federal and other appropriate regulations/guidelines.
5. The IBC shall appropriately notify officials of any spill of, or contamination from, biohazardous material.
6. The IBC shall report to NIH and to other appropriate officials any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses.
7. The IBC may not authorize the initiation of any experiments involving Recombinant DNA not explicitly covered by federal and other appropriate regulations/guidelines.
8. The IBC shall, via the Associate Provost for Research and Graduate Dean, order the suspension or termination of any activity in violation of federal and other appropriate regulations/guidelines.
9. The IBC reports to the Associate Provost for Research and Graduate Dean whom is responsible for advising appropriate University and external agency officials of relevant actions.
A. The Project Director of any activity is responsible for fully complying with all applicable federal, state, local, and University regulations.
B. The Project Director shall not initiate any use of biohazardous material without the approval of the IBC.
C. The Project Director shall not modify an activity covered by an IBC approved protocol without prior approval of the IBC.
D. The Project Director shall immediately report any of the following to the Chair of the IBC, or in their absence, the ex-officio member of the IBC appointed by the Associate Provost for Research and Graduate Dean:
1. Biohazardous spills - Any significant spill involving Safety Level 2 or higher biohazardous material that occurs outside a biological safety cabinet or containment area.
2. Exposure to biohazardous material - Exposure by inhalation, inoculation, ingestion, or skin contact (including cuts and wounds) to a Safety Level 2 or higher biohazardous material.
3. Anything subject to the NIH Reporting Requirements Involving Recombinant DNA - significant problems with, or violations of, the recombinant DNA Guidelines, and accidents involving recombinant DNA.
E. The Project Director, in conjunction with the Chair of the IBC and other appropriate University officials, shall be responsible for directing cleanup procedures in the event of a reportable spill or contamination.
1. The Project Director shall provide and document training and be responsible for all personnel engaged in the activity.
Possession or use of biohazardous material with a Safety Level or Risk Group of Three (3) or above will require advance appointment of a qualified and authorized Biosafety Officer according to NIH Guidelines.
Approved by Chancellor effective __10/15/2010________
Document Reference: 1M3
Origin: __The Graduate School_______________