Final answer:
IRB continuing review is required for ongoing studies that present greater than minimal risk to participants, ensuring ongoing compliance with safety guidelines, risk minimization, and informed consent.
Step-by-step explanation:
IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must adhere to strict guidelines to ensure the ongoing safety of the participants. The process involves monitoring and evaluating the research study to make certain that risks remain minimized and that informed consent from the participants is obtained and maintained. Additionally, the IRB ensures that the benefits continue to justify the risks, and that the study protocols are followed as approved.
The IRB must conduct these reviews periodically and as often as the risk level of the study dictates. This ensures that ethical considerations and subject welfare are continuously maintained throughout the research. The IRB also has the authority to suspend or terminate approval of research that is not being conducted by the IRB's requirements or that has been associated with unexpected serious harm to subjects.