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This form is intended for submitting changes to a previously approved MSU IRB proposal, detailing modifications, consent forms, and any issues related to research subjects.
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How to fill out irb revision form

How to fill out IRB Revision Form
01
Begin by downloading the IRB Revision Form from the official website.
02
Fill in the project title and the principal investigator's name.
03
Indicate the date of the original IRB approval.
04
Provide a summary of the proposed changes to the study.
05
Attach any relevant documents that support the revisions, such as updated consent forms or study protocols.
06
Detail any new risks or ethical considerations that arise from the revisions.
07
Review the form for completeness and accuracy.
08
Submit the completed form to the IRB office by the specified deadline.
Who needs IRB Revision Form?
01
Researchers conducting studies involving human subjects who need to make modifications to their previously approved protocols.
02
Investigators who have received feedback from the IRB that requires adjustments to their study design or materials.
03
Any institution or organization that is engaged in research that falls under the jurisdiction of IRB regulations.
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People Also Ask about
What are the problems with the IRB system?
But that ignores known flaws within the research regulatory system. In addition to weak operational support, IRB members do not receive adequate training and can be unfamiliar with the very regulatory frameworks that govern their work.
How to edit an IRB submission?
To submit a change to your approved IRB protocol: Submit an amendment form explaining the changes being made. Submit an updated application with the changes underlined. Submit any other documents that require updating due to the changes being made (informed consent(s), recruitment materials, etc.).
Is IRB approval hard to get?
If your study is more than minimal risk, it will be harder for you to get IRB approval. You will need to justify why you are running the study. Less common types of risk for psychology studies are social, physical, and financial.
Is IRB approval hard?
If your study is more than minimal risk, it will be harder for you to get IRB approval. You will need to justify why you are running the study. Less common types of risk for psychology studies are social, physical, and financial.
What happens if you do a study without IRB approval?
Under 45 CFR 46.103, the IRB must review and approve all non-exempt human subject research. Failure to obtain IRB approval before conducting research could result in the researcher being unable to use data and other information collected through the research process.
How long does it usually take to get an IRB approval?
The IRB review time (steps 3-17) was defined as the number of calendar days from initial submission to the date of the IRB approval memo and ranged from 5 to 570 days (median, 43 days for exempt protocols, 57 days for expedited protocols, and 103 days for full board protocols).
How to format an IRB proposal?
All proposals submitted for either expedited or full review must contain four primary sections: Purpose of investigation and procedures. Anticipated risk and potential benefits to participants. Steps taken to protect the participants. Manner of obtaining participants.
What is an IRB form?
A project requires Institutional Review Board (IRB) review if it includes both research and human subjects. An IRB protocol is a group of documents that conveys all the necessary information about your research with human subjects to IRB reviewers (e.g., consent form, IRB application).
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What is IRB Revision Form?
The IRB Revision Form is a document used to request modifications to an existing research protocol that has already been approved by an Institutional Review Board (IRB). It captures details of the proposed changes and assesses their impact on ethical considerations.
Who is required to file IRB Revision Form?
Researchers or study investigators who have an active IRB-approved study and wish to make changes to the study's design, methods, or any other aspects are required to file an IRB Revision Form.
How to fill out IRB Revision Form?
To fill out the IRB Revision Form, one should provide clear and detailed descriptions of the proposed changes, rationale for modifications, and any impact on risk to participants. It is important to follow the specific instructions provided by the relevant IRB.
What is the purpose of IRB Revision Form?
The purpose of the IRB Revision Form is to ensure that any changes made to approved research will continue to uphold ethical standards, protect participant rights, and maintain compliance with regulatory requirements.
What information must be reported on IRB Revision Form?
The IRB Revision Form must report information including the nature of the changes, rationale for those changes, any potential impacts on participant risk, and how the changes will affect the study's objectives and methodology.
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