TABLE OF CONTENTS
ABOUT THE IBC
PROPOSALS & AMENDMENTS
FACILITY INSPECTIONS
TRAINING
CHEMICALS & OTHER HAZARDS
ABOUT THE IBC
The Institutional Biosafety Committee
The Institutional Biosafety Committee is charged with reviewing and approving projects involving recombinant DNA and other potential biohazards.
The IBC is established to ensure compliance with all applicable state and federal laws including National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules.
To comply with Federal and State laws and the NIH Guidelines. For more information, see the NIH PowerPoint presentation,
"Requirements for Institutional Biosafety Committees under the
NIH Guidelines"
offered on this page.
If you have any questions or need any further information, please contact Tom Schultz at
989-774-3279 or
schul1te@cmich.edu or the Office of Research Compliance at
ResearchConcern@cmich.edu.
CMU policies are derived from laws and regulations of the State and Federal government. As those laws change, so will the policies. Some policies and procedures may change in an effort to improve oversight.
PROPOSALS & AMENDMENTS
Research involving recombinant or synthetic nucleic acid molecules. The IBC at CMU is also charged with oversight of research involving:
Select agents and toxins, Blood borne pathogens, Xenotransplantation involving human derived materials, human stem cell research, "Dual Use" research and
Nanotechnology.
The IBC registration form and instructions on how to complete the form can be found here.
A faculty member or full time lab manager must be the principal investigator on an IBC registration.
The IBC at Central Michigan University reviews research projects involving recombinant DNA, as well as certain biohazards, toxins and infectious agents.
If you're not sure, it's best to ask. Your research may fall into one of the other categories that the IBC oversees.
Fill out the IBC registration form and supporting documentation, and then submit by e-mail to the addresses at the top of the form.
Time to review varies depending on the content of the application and timing of submission, but most protocols can be reviewed and approved in 4-6 weeks (or less).
Fill out the registration form completely. Be sure to include the goals and a brief non-technical summary of the research, as well as how you will mitigate potential biosafety issues. Make sure any training or lab inspections required to obtain approval are in place. Respond promptly to any questions or requests for information from the IBC.
Laboratory Risk Assessments and Biosafety inspection are required, as well as Biosafety training for laboratory personnel. Please contact Tom Schultz at
989-774-3279 or
schul1te@cmich.edu or the Office of Research Compliance at
ResearchConcern@cmich.edu.
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That the proposed research conforms to NIH Guidelines, as well as other applicable laws or guidelines
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That all regulatory authorizations have been obtained
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That the risks associated with the project will be appropriately managed through: training, facility assessment, risk assessment and an appropriate occupational health program
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Documentation of training
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Regulatory authorizations
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IACUC safety form (if working with animals)
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Safety protocols
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SOPs for working with pathogens
It is more likely that the IBC would respond with required changes or request additional information. In the rare instance where a protocol is not approved, it is because the committee cannot verify that the research will comply with NIH Guidelines or other applicable laws or regulations, or that the risks associated with the research cannot be appropriately addressed.
No.
Work may begin once you have received written IBC approval, as well as any other institutional approvals required.
Protocols are approved for the period of time requested by the PI,
up to a maximum of 3 years.
There currently in not an expedited process for IBC protocol review.
Yes.
Any changes in a protocol including personnel changes should be reported to the IBC.
No.
The original approval period will remain even after the approval of an amendment.
All research must be suspended pending a decision of the renewal.
The IBC reviews each individual application on it's own merits. Changes in regulations or the composition of the IBC may also lead to different questions than have arisen in the past.
Submit an amended registration form to the IBC and make sure the personnel to be added have received all required training.
No.
If a project is closed, you must submit a new application for the project.
FACILITY INSPECTIONS
Lab inspections are part of the risk assessment that occurs to ensure compliance with NIH Guidelines.
A laboratory representative can host inspections in the event a faculty member cannot be present.
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Door signage must be appropriate/available
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Training documentation might be requested
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Previous lab survey records
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Other relevant laboratory safety records might be needed
You may state your reasons for disagreeing and ask that the committee reconsider, particularly if you believe additional information might clarify any issues. You may also ask the Vice President for Research to request that the committee reconsider your protocol.
TRAINING
In person training is currently the only option, however online training through CITI may be available soon.
Yes.
CHEMICALS & OTHER HAZARDS
You may find more information
here on Biosafety level criteria.
That the CMU policies and procedures for working with chemicals are being followed. For more details, please go
here.
See the
Chemical Hygiene Plan, especially
Appendices C, D, F,
and
G
for more information.
Information on RMW waste disposal can be found on the
Biosafety Management: Waste Management website.
Information on chemical waste disposal can be found
here.
Updated 5/17/2016
Report a Research Concern