Policy Approval Authority | President |
Responsible Division | Division of Research and Innovation Partnerships |
Responsible University Office | Office of Research Compliance, Integrity and Safety |
Responsible Officer(s) | Laboratory Safety Specialist |
Contact Person | Linda Srygler |
Primary Audience |
Faculty
Staff |
Status | Active |
Last Review Date | 04-24-2025 |
Policy Category/Categories |
Faculty & Academics
|
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 types of 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, SelectAgents/Toxins, and of 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 DNA, NIU investigators must comply with all of the following guidelines and regulations that are relevant:
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 Innovation Partnerships (or designee).
The frequency of meetings will be scheduled as needed according to the volume of protocols needing review, the nature of risks of the research, and the need for continuing oversight. IBC will meet as often as necessary to carry out the functions to ensure compliance with the NIH guidelines (Section IV-B-2-b-(5).
The finalized meeting dates and copies of meeting agendas may be obtained by calling the Office of Research Compliance, Integrity and Safety (ORCIS). Per NIH guidelines, IBC meeting minutes and member roster will be posted on the ORCIS website beginning June 1, 2025.
BSL-1 or exempt rDNA activity: The Chair will sign a letter notifying the PI of the determination of his review. A copy of the approval/notification letter and the application will be maintained in the Office of Research Compliance, Integrity and Safety for documentation purposes. As long as the activity does not significantly change, no additional action is required by the IBC or the PI.
Non-exempt rDNA activity, or BSL – 2 and higher biocontainment (except blood draws by finger-stick): The application will be reviewed at the next available IBC meeting. Annual continuation and a new application after three years are required.
Annual Continuations with minor revisions and blood draws by finger-stick: at least one member of the IBC, designated by the IBC chair and qualified to conduct the review, will be assigned to review the protocol and be given the authority to approve, require modifications in (to secure approval), or request full committee review of those protocols. All IBC members will receive a copy of these protocols and may provide the designated reviewer with comments and/or suggestions for the designated reviewer's consideration only. Any IBC member may call for a review of the protocol by the convened IBC.
Note: Blood draws using venipuncture require Full Committee review. Under exceptional circumstances, as determined by the IBC chair, designated review may be used for protocols if not prohibited by federal regulations.
In addition to IBC approval, research involving Select Agents, a subset of pathogenic organisms or toxins, requires submission of an application to the CDC and submitting to Federal Bureau of Investigation (FBI) background check before any research has begun. Please contact the Office of Research Compliance, Integrity and Safety for further assistance if you plan to use select agents.
For minor changes to a protocol, such as a change in personnel (not including the PI), the PI needs to simply notify the IBC. All other changes, (such as a change in previously described procedures, PI, quantity of material, organism or cell lines used), must be submitted to the IBC committee for review before the requested change is implemented.
Basic biosafety training is available online at no cost to participants. CITI Program provides the biosafety training via the module Basic Introduction to Biosafety. Participants must register and select Northern Illinois University as their Organization Affiliation to gain access. An informational questionnaire is provided to assist those who may have multiple modules to complete due to the type of research.
The CITI certification for biosafety is in effect for three years. After three years the individual needs to repeat the Basic Introduction to Biosafety module.
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 Innovation Partnerships 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 one’s laboratory, help ensure that one’s 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 one’s 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:
The PI will notify the IBC when a research protocol involving rDNA and biohazardous materials, agents, and toxins is completed or no longer active. The IBC shall contact the PI if there are any questions or concerns regarding Termination of Approval.
If the PI fails to provide a renewal or resubmission form to the IBC before the protocol expires, a letter will be sent to the PI and copied to the Department Chair. All research activities pertaining to the research described in the expired protocol must cease. If the PI does not provide a renewal or resubmission by the next IBC meeting, this issue is added to the agenda and the IBC determines whether to terminate the IBC protocol. Termination of the IBC protocol may require termination of any related IACUC or IRB protocols and notification of the Vice President for Research and Innovation Partnerships. The Vice President for Research and Innovation Partnerships may in turn notify NIU Sponsored Programs Administration and other relevant agencies (National Institutes of Health Office of Laboratory Animal Welfare, granting agencies) for further action.
Failure to respond to submission review correspondence (administrative, preliminary, or full- committee) within 30 days will result in a Final Notice Letter from the Research Compliance Coordinator. If the PI fails to respond to the Final Notice Letter in 30 days, this will result in withdrawal of the original submission. The PI must contact the Research Compliance Coordinator if unable to respond to correspondence on a timely basis.
A PI who is found by the IBC to be in violation of Federal, State, or NIU guidelines and policy governing the use of biohazardous agents, potentially hazardous human materials, or recombinant DNA molecules may have his/her IBC approval suspended by the IBC, pending further investigation and final action by the IBC. In the event that the IBC’s final action includes revocation of IBC approval of the protocol, the IBC is authorized to notify the Vice President for Research and Innovation Partnerships, who is in turn authorized to notify the Sponsored Programs Administration and other relevant agencies (National Institutes of Health Office of Laboratory Animal Welfare and Office of Biotechnology Actives granting agencies).
Termination of the IBC protocol may lead to termination of related IACUC or IRB protocols.
Allegations, may be reported by concerned individual to any of the following:
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 NIU Whistleblower Policy should be consulted for specific information on individual protection.
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:
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 actionable as determined by the IBC.
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 Innovation Partnerships, the Director of Research Compliance, Integrity and Safety, 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 Innovation Partnerships, 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, Integrity and Safety for forms and additional information pertaining to biosafety, animal research, and human subjects’ research.
Date | Reviewed by | Changes |
---|---|---|
2/19/2019 | IBC | Update training requirements |
11/6/2020 | IBC | Minor revision |
6/27/2022 | Biosafety Officer | Minor revision |
4/22/2025 | Biosafety Officer | Minor revision |
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