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 or Synthetic Nucleic Acid 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.
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. Blood draws using venipuncture require Full Committee review
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
In addition to IBC approval, research involving Select Agents, a subset of pathogenic organisms or toxins, requires the submission of a background check through Human Resource Services, (including an FBI background check), prior to the initiation of research. Contact the Biosafety Officer for more details
Dual use research is any research that can be used for positive as well has harmful purposes. The subset of research that is the heart of this policy is dual use research “of concern” This is defined as “life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, projects, 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."
Although the general definition is broad, the recently released Federal policy is more specific. A list of organisms and toxins, as well as seven categories of experiments are the items of concern . An example of research that is classified as DURC is the sequencing of the 1918 flu strain. Someone could easily, (with current technology) build this flu from the information obtained from the research and use it for nefarious purposes.