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Get the free AMENDMENT REQUEST FOR IBC APPROVED RECOMBINANT DNA/BIOHAZARD RESEARCH - utoledo

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This document is used to request amendments to previously approved recombinant DNA or biohazard research protocols at the University of Toledo's Institutional Biosafety Committee. It requires details
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How to fill out amendment request for ibc

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How to fill out AMENDMENT REQUEST FOR IBC APPROVED RECOMBINANT DNA/BIOHAZARD RESEARCH

01
Obtain the AMENDMENT REQUEST form from the Institutional Biosafety Committee (IBC).
02
Fill in the project title and reference number of the original IBC approved research.
03
Clearly indicate the specific amendments being requested in the designated section.
04
Provide detailed descriptions and justifications for each amendment.
05
Include any new risk assessments related to the changes made.
06
Ensure all co-investigators and staff involved review and sign the form.
07
Submit the completed form to the IBC office for review.

Who needs AMENDMENT REQUEST FOR IBC APPROVED RECOMBINANT DNA/BIOHAZARD RESEARCH?

01
Researchers who have an approved recombinant DNA or biohazard research project and wish to make changes to their current research protocol.
02
Any individual involved in biological research that requires modifications to comply with safety regulations.
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Amendments to IBC Protocols Submit an amendment when adding: new species/strains of animals for the same work. a non-viral vector to an approved recombinant DNA protocol. new genes of interest that are not tumor suppressors, oncogenes, or that would enhance the virulence of an organism.
The Institutional Biosafety Committee (IBC) must review and approve all clinical trial research involving potentially hazardous biological agents before they may be initiated.
The IBC is responsible for reviewing projects that involve, but are not limited to, recombinant DNA, RNAi, pathogens, human materials and other potentially infectious material, as well as transgenic animals.
While a single IRB (sIRB) can oversee research protections for a protocol being conducted at multiple sites, the IBC uniquely focuses on biosafety at the site level. This means IBCs are constructed to focus their risk assessment locally at each research site.
Prerequisites for Protocol Approval A successful biosafety lab inspection completed within the past year. PI must submit a current Biological Risk Assessment, attached, along with their registration. Form for PIs to complete a biological risk assessment.
The Institutional Biosafety Committee (IBC) must review and approve all clinical trial research involving potentially hazardous biological agents before they may be initiated.

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An Amendment Request for IBC approved Recombinant DNA/Biohazard Research is a formal submission to the Institutional Biosafety Committee (IBC) to propose changes or modifications to an already approved research project involving recombinant DNA or biohazardous materials.
Researchers or principal investigators who have an existing IBC approval for recombinant DNA or biohazardous research and wish to make alterations to their research protocol are required to file an Amendment Request.
To fill out an Amendment Request, one must provide detailed information regarding the changes being proposed, including a description of the previous approval, the nature of the amendments, and any new risks or safety measures associated with those changes.
The purpose of the Amendment Request is to ensure that any modifications to the research comply with biosafety regulations and to assess any potential risks associated with the proposed changes.
The information that must be reported includes the project title, original IBC approval number, specifics of the proposed amendments, rationale for changes, potential impacts on safety, and updated risk assessments, if necessary.
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