Institutional Biosafety Policy

The Institutional Biosafety Committee (IBC) at Northern Illinois University (NIU) oversees all research and classroom activities conducted at or sponsored by NIU, that involve recombinant DNA, potentially pathogenic substances/ toxins, and/or human tissue/ body fluids. Said research and classroom activities must be carried out in accordance with applicable federal, state and local regulations and this policy, irrespective of the source of funding.

The IBC follows the policies and procedures set forth in the aforementioned federal guidelines and regulations. Furthermore, the IBC exercises its right to create additional safeguards as deemed necessary. The composition and duties of this committee are mandated by the federal government, as a condition of NIU receiving federal funding for research.  Minutes of meetings shall be copied to members for approval and retained by the Office of Research Compliance (ORC).

Committee Responsibilities

The IBC shall:

1. Establish institutional policy governing all research and teaching activities conducted by NIU personnel that involve the use of recombinant DNA, potentially pathogenic substances, toxins, and/or human tissue/body fluids in accordance with the applicable regulations.
2. Provide researchers and appropriate instructors with copies of the current guidelines, regulations and laboratory safety information, as they are made available.
3. Review and approve all research and instructional activities involving human tissue/body fluids, pathogenic organisms, toxins and register recombinant DNA research before the initiation of the project or course. Some recombinant DNA research projects require only that the IBC be notified simultaneously with the initiation of the research. However, the investigator must submit a Protocol Submission form with the necessary Biosafety Level information to the IBC chair for ratification of the categorization as exempt.
   
   Note: Research involving Select Agents, a subset of pathogenic organisms or toxins, requires submission of an application to the CDC http://www.cdc.gov/od/sap and submitting to Federal Bureau of Investigation (FBI) http://www.fbi.gov/terrorinfo/bioterrorfd961.htm background check before any research has begun. 
4. Inspect the laboratory facilities, in which research or laboratory courses occur involving recombinant DNA, potentially pathogenic substances/ toxins, and/or human tissue/ body fluids, to ensure that satisfactory laboratory safety measures are in use. Inspections will be based on criteria established in the appropriate federal guidelines and regulations and laboratory practices under the appropriate biosafety levels. The Biosafety in Microbiological and Biomedical Laboratories Manual, issued by the Centers for Disease Control and Prevention and the NIH, will also be used as a primary source of information. Unannounced inspections will be made annually at minimum. Additionally, the IBC must inspect animal care facilities when researchers are using infectious agents. In all other cases, the inspection of the animal care facilities for biosafety practices falls under the jurisdiction of the NIU Institutional Animal Care and Use Committee (IACUC).
5. Take disciplinary action when a laboratory facility or researcher is found to be in noncompliance with the federal guidelines and regulations. Such actions may include but are not limited to the following:
   
   a) Informing the principal investigator and the Department Chair of the noncompliance
   b) Re-inspection to substantiate the facility is subsequently in compliance
   c) Referring issues of noncompliance to the Vice President for Research, for further action.
   d) Possibly contacting the appropriate federal oversight agency, if significant noncompliance continues to
       occur.
6. Be familiar with the federal guidelines and regulations, IBC policies, and proper laboratory safety methods to ensure that they are properly executing their responsibilities.

Committee Membership

The Institutional Biosafety Committee is appointed by, reports to, and is advisory to, the Vice President for Research. Membership of the committee shall consist of the following:

• Three faculty members with expertise in recombinant DNA and/or biological safety;
• One administrator with expertise in research policy from the Office of Sponsored Projects (Supportive Professional Staff);
• One technical staff member with appropriate expertise;
• The NIU Biosafety Specialist;
• Two community representatives not otherwise affiliated with Northern Illinois University.

The chair of the committee will be appointed by the Vice President for Research.

Length of term is indefinite, depending on availability to serve.

Department Chair's Responsibilities

The Department Chair shall inform all faculty of the existence of the IBC and ensure that the appropriate faculty receive all pertinent information (e.g., copies of the IBC and federal guidelines and regulations). Should the Department Chair not have this information, it may be obtained from the Office of Research Compliance in the Graduate School. Additionally, chairpersons shall direct researchers to register with the IBC as specified in the next section.

Principal Investigator's Responsibilities

Principal Investigators are required to:

1. Comply with the IBC Guidelines and appropriate federal guidelines or regulations and all conditions stated in the protocol approved by the IBC.
2. Submit protocol applications for all activities or modifications of activities involving recombinant DNA, potentially pathogenic substances, toxins, and/or human tissue/body fluids and obtain approval of the IBC prior to initiation of the activities or modifications.
   
   Ongoing projects must be reviewed at least annually, and the IBC has the right to require more frequent monitoring if necessary. If there is a significant change in the experiment (i.e. in the containment level, etc.), a new and complete form must be submitted; minor changes can be granted expedited approval by the IBC Chair, subject to review by the IBC members at the next meeting. To obtain an extension of approval of a previously approved project with no changes (except personnel) to the protocol, the researcher should submit a completed "Protocol Continuation Form" to the IBC. Approval must be obtained in writing from the IBC Chair before the researcher may continue the project past one year from the date of the original approval. Protocols are to be submitted to: IBC Chair, Office of Research Compliance, the Graduate School.
3. Ensure that all laboratory personnel, including students, are trained in accepted procedures in laboratory safety procedures, accident techniques, and precautionary medical practices.
4. Submit to the IBC, via the ORC, curriculum vitae as evidence that they are properly trained in microbiological and biosafety practices.
5. Develop a Laboratory Safety Plan, including an emergency action plan for accidents and spills, as an addendum to the university emergency safety plan.