Question

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: a. Is limited to review of unanticipated problems. b. Must occur within 12 months of the approval date. c. Is not required unless additional risks have been identified. d. Must be conducted by a convened IRB.

Answer 1

Answer:

The answer is b. Must occur within 12 months of the approval date.

Explanation:

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB, must occur within 12 months of the approval date, even in situations where no extra risks exist; however, if any problems are sensed but not expected, they should be considered during the process of continuing review.