Question

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

Answer 1

Answer: Option(b) is correct

Step-by-step explanation:

According to the question, if any on-going study is found to have more than minimum risk while getting reviewed after getting acceptation from convened IRB members then it is should be occurs in the period of 12 months according to approval date. This study approval is given by majority members of convened IRB group.

Other options are incorrect because it is needed when additional risk is seen,is not limited till unexpected problem occur and neither conduction through only convened IRB is required.Thus, the correct option is option(b).