Which statement about IRB amendments is correct?

Which statement about IRB amendments is correct?

• A. Amendments modify the protocol and require IRB oversight
• B. Amendments never require review
• C. Amendments automatically take effect without notice
• D. Amendments only relate to consent forms

Answer: (A)

The main idea is that any change to an approved human subjects research protocol must go through IRB review. An amendment is a formal request to modify the protocol or the consent materials, and it must be reviewed and approved by the IRB before the changes are implemented. This ensures that participant protections remain in place even when the study is updated—for example, adding a new data collection method, changing inclusion criteria, updating study procedures, or revising the consent form language. It isn’t true that amendments never require review, or that they take effect automatically without notice, or that they only relate to consent forms.

The main idea is that any change to an approved human subjects research protocol must go through IRB review. An amendment is a formal request to modify the protocol or the consent materials, and it must be reviewed and approved by the IRB before the changes are implemented. This ensures that participant protections remain in place even when the study is updated—for example, adding a new data collection method, changing inclusion criteria, updating study procedures, or revising the consent form language. It isn’t true that amendments never require review, or that they take effect automatically without notice, or that they only relate to consent forms.