a. When is Institutional Biosafety review and approval necessary, and what regulations apply? more >
The Institutional Biosafety Committee (IBC) reviews all activities that involve recombinant DNA and/or pathogenic substances, and conducts yearly inspections of laboratories where such activities are conducted. 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.
IBC review and approval is required prior to using the following biohazardous agents:
b. Principal Investigator Responsibilities more >
As a Principal Investigator,
I certify that the following training and information is provided for all laboratory personnel:
I certify that the following laboratory environment safeguards are enforced at all time:
I certify that the appropriate containment and disposal safeguards are enforced at all times:
I certify that the information provided in my protocol submission form is accurate; and any protocol changes, including the DNA being cloned, the vector, the host organism, or any other toxic or infectious agents, will be submitted to the IBC for approval prior to initiation.
I further certify that I have read and will comply with all relevant publications, including but not limited to the NIU Institutional Biosafety Committee Policy, the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition and the Department of Health and Human Services National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules.
c. Grants and IBC Protocols more >
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:
d. The Review Process: more >
When a new Institutional Biosafety Committee (IBC) application is submitted, it may be reviewed by one of three processes, depending on its scope:
1. Review by IBC Chair
Biosafety Level 1 or exempt rDNA activity will be reviewed by the IBC Chair. The Chair will notify the PI in writing of the determination of his review, and a copy of the determination along with the application will be maintained in the Office of Research Compliance and Integrity for documentation. As long as the activity does not significantly change, no additional action is required by the IBC or the PI.
2. Designated Review
Blood draws by fingerstick: 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, request modifications, or recommend full committee review. All IBC members receive a copy of these protocols and have the opportunity to comment. Any IBC member may call for a review of the protocol by the convened IBC.
Blood draws using venipuncture require Full Committee review.
Designated review for additional protocols may be used under exceptional circumstances, as determined by the IBC chair, as permitted by federal regulations.
3. Full Committee Review:
Protocols involving non-exempt rDNA activity (as per the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules), or Biosafety Level 2 and higher biocontainment levels (except blood draws by fingerstick) will be reviewed at the next available IBC meeting. Annual continuation, and new applications every three years are also required.
Possible Outcomes Upon IBC Review:
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