
IBC Human Protocol Patient Enrollment Notification Form
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People also ask
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What are the prerequisites for IBC protocol approval?
Prerequisites for Protocol Approval All individuals listed on the application (including the PI) must be enrolled in the Biosafety Occupational Health Program. A successful biosafety lab inspection completed within the past year. PI must submit a current Biological Risk Assessment along with their registration.
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What is the IBC approval process?
The IBC meets monthly to deliberate on the applications submitted for the committee's review. At the meeting, a vote is taken regarding the outcome of that review. The committee may vote to: Approve: the PI can proceed with the proposed work at the indicated biosafety containment level.
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Who needs IBC approval?
Institutional Biosafety Committee (IBC) approval is required before conducting research and teaching activities involving rDNA, biohazardous agents, materials, and toxins.
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What is an IBC registration?
PIs must complete and submit an IBC registration/biological summary to register research or teaching activities that involves the use of biological materials. Biological materials may include, but is not limited to the following: Recombinant / synthetic nucleic acid (rsNA) molecules.
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What is an IBC application?
The Institutional Biosafety Committee (IBC) application is an online questionnaire/form that you complete in the eResearch Regulatory Management (eRRM) system to describe all of your work with potentially hazardous biologics, including recombinant DNA and synthetic nucleic acid molecules.
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What is the purpose of an IBC?
What is the role of the Institutional Biosafety Committee (IBC)? The IBC is responsible for monitoring and ensuring compliance as well as reviewing and approving all research projects that involve biological material, including rDNA materials and human gene therapy/gene transfer protocols.
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