IRB continuing review of a greater than minimal risk approved
Subject : Health
Question: IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:
A) Occur at least annually.
B) Include copies of all signed consent forms.
C) Occur only when the level of risk changes.
D) Be conducted by an expedited review.
Expert Verified Solution:
For a protocol that is greater than minimal risk and currently enrolling subjects, the IRB (Institutional Review Board) continuing review must:
A) Occur at least annually.
The IRB is required to review greater than minimal risk studies at least once a year to ensure the ongoing protection of human subjects, assess the study’s progress, and verify that the study continues to meet ethical and regulatory standards. This review process helps ensure that the risks to participants are still justified by the benefits of the research and that any new information or changes in the study are appropriately managed.
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