How often should an IRB re-evaluate a clinical trial?

How often should an IRB re-evaluate a clinical trial?

• A. Every six months
• B. Typically at least annually
• C. Only at the trial's completion
• D. Every month during the trial

Answer: (B)

An Institutional Review Board (IRB) is responsible for the ethical oversight of clinical trials involving human subjects. It is essential for the IRB to conduct re-evaluations of the trial to ensure that participant safety is maintained, that the research remains ethical, and that any new information that may affect the risk-benefit assessment is considered. Typically, the IRB is required to re-evaluate the clinical trial at least annually. This regular review allows the IRB to assess whether the study continues to meet ethical standards, verify that the informed consent process is still adequate, and ensure that any adverse events or changes in the trial's risk profile are adequately addressed. The annual review helps to ensure ongoing compliance with regulatory requirements and protections for participants throughout the duration of the study. While some specific circumstances might necessitate more frequent review, such as emerging safety concerns or significant changes to the trial protocol, the standard expectation is for an annual review. This approach maintains a balance between oversight and the practicalities of conducting research, allowing for the trial to progress while keeping participant protections as a priority.

An Institutional Review Board (IRB) is responsible for the ethical oversight of clinical trials involving human subjects. It is essential for the IRB to conduct re-evaluations of the trial to ensure that participant safety is maintained, that the research remains ethical, and that any new information that may affect the risk-benefit assessment is considered.

Typically, the IRB is required to re-evaluate the clinical trial at least annually. This regular review allows the IRB to assess whether the study continues to meet ethical standards, verify that the informed consent process is still adequate, and ensure that any adverse events or changes in the trial's risk profile are adequately addressed. The annual review helps to ensure ongoing compliance with regulatory requirements and protections for participants throughout the duration of the study.

While some specific circumstances might necessitate more frequent review, such as emerging safety concerns or significant changes to the trial protocol, the standard expectation is for an annual review. This approach maintains a balance between oversight and the practicalities of conducting research, allowing for the trial to progress while keeping participant protections as a priority.