Amendments involving changes to IRB-approved protocols
Subject : Nursing
Question: Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:
A) They only involve changes to the consent form.
B) The changes must be immediately implemented for the health and well-being of the subject.
C) They are eligible for review using expedited procedures.
D) The investigator keeps careful records of all changes and includes them in the final report.
Expert Verified Solution:
Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:
B) The changes must be immediately implemented for the health and well-being of the subject.
In situations where immediate changes are necessary to protect the health and safety of participants, researchers can implement these changes without prior IRB approval. However, these changes must be reported to the IRB as soon as possible, and the IRB will review them retrospectively to ensure that they are consistent with ethical standards and regulatory requirements.
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