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Modification Request InstructionsDuring the University Response To COVID19Modification of Exempt Studies If the current study was approved as an exempt study (i.e., study protocol name has an 'X in
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How to fill out irb protocol modification request

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How to fill out irb protocol modification request

01
Log in to the IRB protocol management system.
02
Find the existing IRB protocol that needs modification and open it.
03
Navigate to the 'Modification Request' section of the IRB protocol.
04
Click on the 'New Request' button to create a new modification request.
05
Fill out the required fields such as the reason for modification, specific modifications needed, and any supporting documentation.
06
Review the filled-out modification request for accuracy and completeness.
07
Submit the modification request for review by clicking on the 'Submit Request' button.
08
Wait for the IRB to review and approve the modification request.
09
Once the modification request is approved, implement the approved modifications to the IRB protocol.

Who needs irb protocol modification request?

01
Researchers, principal investigators, or anyone conducting a study or research project that is already approved by the IRB needs to submit an IRB protocol modification request.

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An IRB protocol modification request is a formal document submitted to an Institutional Review Board (IRB) to propose changes to an existing research protocol that has already been approved.
The principal investigator (PI) of a research study is required to file the IRB protocol modification request whenever they intend to make changes to the approved protocol.
To fill out an IRB protocol modification request, the researcher should provide detailed information about the proposed changes, including the rationale for modifications, potential impacts on participants, and updated study materials, if applicable.
The purpose of an IRB protocol modification request is to ensure that any changes to the research protocol are reviewed and approved by the IRB to maintain compliance with ethical standards and protect the rights and welfare of participants.
The information that must be reported includes a description of the modifications, the rationale for the changes, any new risks to participants, and updates to consent forms or study instruments.
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