The NIU Institutional Biosafety Committee (IBC) Policy and Procedures covers the following topics:
Northern Illinois University Institutional Biosafety Committee (IBC) policy promotes safety in research studies, promotes safe handling of biological agents, reduces risk of infection, provides for safe disposal of infectious laboratory wastes, and maintains compliance with applicable institutional policies and regulatory requirements.
The IBC is responsible for monitoring and oversight of the use of biohazardous agents to safeguard the health and safety of NIU personnel, students, the community, and the environment. The IBC must also ensure compliance with applicable federal regulations and guidelines, granting agency guidelines, as well as NIU policies and procedures.
The IBC is committed to incorporating health and safety practices governing all NIU personnel working with biohazardous materials in research and/or teaching activities at NIU. The NIU Biosafety Program is established to reduce the risk of potential occupational exposure and unintended environmental release of infectious agents, biological toxins, Select Agents/Toxins and recombinant deoxyribonucleic acids (rDNA) in a research and/or teaching environment.
IBC review and approval is required prior to using the following biohazardous agents:
NIU policy requires that all research and/or teaching involving infectious agents, biological toxins, Select Agents/Toxin, and rDNA be conducted in a safe manner. Biosafety containment practices protect the faculty, staff, students, volunteers, and visitors from exposure to infectious agents, biological toxins, Select Agents/Toxins, and rDNA and prevent the release of biohazards into the environment. Although federal regulations allow exemptions for some types of rDNA and other agents, the principal investigator (PI) must submit an application for all projects using rDNA and biohazardous materials, agents and toxins so that the IBC is aware of the activities and can verify that they are exempt
To ensure the safe handling of infectious agents, biological toxins, Select Agents, toxins, and rDNA, NIU investigators must comply with the following guidelines and regulations:
The IBC recognizes that a primary mission of a research university is the training and education of student researchers in the undergraduate and graduate ranks. These individuals may design and execute research programs that require the use of rDNA and /or biohazardous materials. This research can be supported by fellowships and grants targeted to undergraduate and graduate students. The IBC realizes that these individuals are competent to independently design, perform and take some of the responsibilities entailed in research. However, the IBC does not believe that members of the undergraduate, graduate and postdoctoral ranks can undertake the full range of responsibilities required nor are the appropriate targets for certain consequences and sanctions resulting from the non-compliant use of rDNA and/or biohazardous materials.
As such, members of the undergraduate, graduate, postdoctoral, visiting scientist, and research associate ranks must seek support from members of the NIU faculty to submit a protocol. In this situation, the faculty member is the PI and the undergraduate, graduate or post-doctoral student is the mentored co-PI. In this case, all communication regarding the protocol approval process must include both the PI and co-PI. It is recommended that the PI should be the student’s thesis advisor or direct supervisor. However, other faculty members could serve as PI, providing the supervising faculty member or thesis advisor submits a letter of permission. If the PI terminates a formal affiliation with NIU, the co-PI must identify another PI to continue the protocol.
Persons with the following academic titles may serve as PIs on projects involving rDNA and/or biohazardous materials:
The IBC must be comprised of no fewer than five members, so selected that they collectively have experience and expertise in rDNA technology and the capability to assess the safety of rDNA research and to identify any potential risk to public health or the environment related to biosafety and physical containment. Membership will include:
No member of the IBC may be involved in the review or approval (except to provide information requested by the IBC) of a project in which he/she has been or expects to be engaged or has a direct financial interest.
A quorum of the committee will be a simple majority of its membership.
Individual members of the IBC will have a term length of three years. After that time, membership renewals will be at the discretion of the Vice President for Research and Graduate Studies (or designee).
Meetings will be scheduled four times a year, generally in January, March, June, and October of each year. Submission deadlines for these meetings will be posted on the IBC website. Additional meetings may be scheduled as required. The finalized meeting dates and copies of meeting agendas may be obtained by calling the Office of Research Compliance.
Minor changes to a protocol, such as a change in personnel (not including the PI), need only notification to the IBC. Major changes, such as a change in previously described procedures, PI, quantity of material,organism or cell lines used, mustbe submitted to the IBC committee for review before the requested change is implemented.
The IBC can approve or disapprove protocols. The IBC is the link between the university and regulatory agencies, and has an overlapping role with other NIU committees, including the Institutional Review Board (which reviews human subjects research), and the Institutional Animal Care and Use Committee (which reviews research, teaching and testing protocols that involve animals). In issues of noncompliance, the IBC makes recommendations to the Vice President for Research and Graduate Studies to stop further research in non-compliant laboratories or for other corrective actions.
Research involving any of the biohazardous materials listed in this document must be registered with the IBC. This will establish a level of biosafety containment for your laboratory, help ensure that your research is conducted in compliance with applicable biosafety regulations, and protect other investigators at NIU and the University from penalties.
Regardless of the source of your funding, non-compliance with NIU biosafety policy may lead to suspension, limitation, or termination of all NIH funding to NIU. Specifically, non-compliance with the NIH Guidelines can result in:
Allegations, preferably in writing, shall be reported to any of the following individuals:
The IBC chair is responsible for the receipt and disposition of all complaints. All allegations will remain confidential to the extent possible. When the complainant wishes to be openly identified, the IBC Chair will acknowledge receipt of the allegations to the complainant in writing.
The IBC Chair will appoint a subcommittee to determine if the complaint has sufficient substance to warrant a full investigation. All persons involved in the investigation will be informed of the purpose of the investigation and the manner in which it will be conducted.
The subcommittee, in its investigation, will examine all pertinent documents and procedures, will interview involved personnel, and will report its findings to the entire IBC. The IBC will then vote either in a convened meeting or electronically for the following options:
If there is indication of serious noncompliance, the IBC may recommend that Vice President for Research and Graduate Studies suspend impacted activities pending the outcome of the full investigation.
Based upon the report of the investigation, the IBC will determine required actions, if any. IBC determinations may include, but are not limited to:
For any noncompliance with IBC policy, the IBC must prescribe corrective actions along with appropriate deadlines and reporting requirements. The IBC must determine whether the noncompliance meets the criteria for “serious or continuing noncompliance” or “serious deviation” so as to require reporting to NIH. Examples of corrective actions include:
The IBC Chair will communicate, in writing, the results of the IBC evaluation of a reported concern to the person responsible for the situation of concern, the PI, the Vice President for Research and Graduate Studies, the Associate Vice President for Research, and the complainant (if the complainant wishes to be notified of the outcome). The communication will include a summary of the concern, the findings of the investigation, determinations of the IBC, and the recommended corrective actions/sanctions. The letter will also inform the person(s) responsible for the situation reported of his/her option to appeal the decision, within ten days of receipt of this letter, by writing the IBC Chair detailing the basis of the appeal and requesting a meeting with the IBC.
The IBC is obligated to report within thirty days, through the Vice President for Research and Graduate Studies, any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to NIH’s Office of Biotechnology Activities unless the institution determines that a report has already been filed by the PI or Biological Safety Officer.
Please visit the Office of Research Compliance website (http://www.orc.niu.edu ) for forms and additional information pertaining to biosafety, animal research, and human subjects research.
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NIU IBC Policies and Procedures (PDF)