Which of the following amendments do NOT require prior IRB approval?

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The correct answer indicates that changes which are immediately necessary for participant welfare do not require prior IRB (Institutional Review Board) approval. This is because, in situations where there is an urgent need to protect the well-being or safety of participants, researchers are permitted to take action without waiting for IRB review. Such changes are generally focused on ensuring that the health or safety of participants is prioritized, which can take precedence over the usual IRB approval procedures.

In contrast, other types of changes, such as those that require documentation for a final report, alterations to research design, or modifications to consent language, typically necessitate prior approval from the IRB. This is to ensure that research adheres to established ethical standards and maintains the protection of participants' rights and welfare before implementing any research modifications.

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