Policies & Procedures

Research and Export Control

Policy on Biohazardous Material Use - 1M3

1. Applicability:
   

   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 (NIH) "Guidelines for Research Involving Recombinant DNA Molecules," the U.S. Department of Health and Human Services "Biosafety in Microbiological and Biomedical Laboratories," the "United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern," 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 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.

2. Definitions:
   
   
   1. Biohazardous material: Any biological material or organism which is covered by NIH Guidelines, the Centers for Disease Control (CDC) List of Select Agents and Toxins, 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.
   2. 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.
   3. Dual Use Research of Concern (DURC) in the Life Sciences: Research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security. DURC is any research activity that includes or relates to a Select Agent or Toxin (see II.A) and produces, aims to produce or is reasonably anticipated to produce any of the following effects:
      1. enhances the harmful consequences of the agent or toxin
      2. disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification
      3. confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates its ability to evade detection methodologies
      4. increases the stability, transmissibility, or the ability to disseminate the agent or toxin
      5. alters the host range or tropism of the agent or toxin
      6. enhances the susceptibility of a host population to the agent or toxin
      7. generates or reconstitutes an eradicated or extinct listed agent or toxin
3. Institutional Biosafety Committee:
   
   
   1. Membership
      
      
      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.
      4. The Associate Provost for Research shall appoint an ex-officio member of the IBC.
   2. Responsibilities of the Institutional Biosafety Committee:
      
      
      1. The IBC shall review applications and activities conducted at or sponsored by SIUE for compliance with federal and other appropriate regulations/guidelines governing Use of Biohazardous Material and Recombinant DNA and Dual Use Research of Concern in Life Sciences and shall approve those activities that it finds in compliance. This review shall include:
         
         
         1. an independent assessment of the containment level required by the federal regulations;
         2. 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 University officials of any spill of, or contamination from, biohazardous material.
      6. The IBC shall report to appropriate University officials all significant problems, violations of the NIH Guidelines, and 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, 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, who is responsible for notifying appropriate University and external agency officials, when required, of spills, contamination, accidents, illnesses, and violations associated with biohazardous materials and the relevant actions taken by the University to remedy the situations.
4. Responsibilities of Project Director:
   
   
   1. The Project Director of any activity is responsible for fully complying with all applicable federal, state, local, and University regulations.
   2. The Project Director shall not initiate any use of biohazardous material without the approval of the IBC.
   3. The Project Director shall not modify an activity covered by an IBC approved protocol without prior approval of the IBC.
   4. The Project Director shall immediately report any of the following to the Chair of and the ex-officio member of the IBC:
      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 and violations of the recombinant DNA Guidelines, and accidents involving recombinant DNA.
      4. Changes in the scope of a project and unanticipated research results when the project involves DURC.
   5. 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.
      
   6. The Project Director shall provide and document training and be responsible for all personnel engaged in the activity.
5. Limitation
   
   Possession or use of biohazardous material with a Safety Level or Risk Group of Three (3) or above or culture volumes of experimental recombinant organisms exceeding 10 L will require advance appointment of a qualified and authorized Biosafety Officer according to NIH Guidelines.
   
   
   Approved by Chancellor effective 1/31/19
   This policy was issued on April 2, 2019, replacing the June 12, 2015 version.
   Document Reference: 1M3
   Origin: OP 10/27/89; OC 2/14/11; GR 14/15-09; OC 1/31/19