Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Must be conducted by a convened IRB.
Is limited to review of unanticipated problems.
Must occur within 12 months of the approval date.
Is not required unless additional risks have been identified.
The Correct Answer and Explanation is :
The correct answer is: Must occur within 12 months of the approval date.
Explanation:
When a study involving more than minimal risk is initially approved by a convened Institutional Review Board (IRB), federal regulations (45 CFR 46.109(e) and 21 CFR 56.109(f)) require continuing review to ensure the research remains ethically and scientifically justified.
Why Continuing Review is Required
This process helps protect participants by monitoring compliance with approved protocols and identifying any new risks. Even if no changes occur, the IRB must reassess to confirm that the benefits of the study still outweigh the risks.
Timing of the Review
Continuing review must occur at least annually—within 12 months of the last IRB approval date. This timeline is a strict requirement for studies involving more than minimal risk. If the review is not completed by this deadline, the study must halt all research activities, including data collection and analysis, until the IRB approval is renewed.
Common Misunderstandings
- Not Limited to Reviewing Unanticipated Problems: While the IRB considers unanticipated problems as part of the review, its scope extends to all aspects of the study, including protocol compliance and informed consent processes.
- Not Conditional on New Risks: Continuing review is mandatory regardless of whether new risks have been identified. It is a periodic requirement to safeguard participants.
- Convened IRB Review: For studies posing more than minimal risk, the continuing review must often involve a convened IRB meeting, although some minor changes or minimal-risk activities might qualify for expedited review.
In summary, continuing review within 12 months ensures ongoing oversight, upholds ethical research standards, and protects participants from undue harm.