When should continuing review for a study posing more than minimal risk occur?

Continuing review for a study posing more than minimal risk should occur annually, within 12 months of approval. This requirement is guided by federal regulations that emphasize the need for ongoing oversight of studies that involve higher levels of risk to participants. Conducting annual reviews allows the Institutional Review Board (IRB) to assess the study's progress, evaluate any unanticipated problems, reassess risks versus benefits, and ensure that ethical standards are maintained throughout the research process.

An annual review also provides an opportunity to ensure that the informed consent process remains robust and that participants’ rights and welfare continue to be protected. This systematic evaluation prevents potential issues from arising by facilitating timely discussions about any modifications needed for the study or its procedures.

While other options may reflect circumstances under which review could occur, such as at the end of the study period or in response to significant changes, they do not align with the regulatory requirement for regular, scheduled reviews that specifically address studies with more than minimal risk. Regular reviews afford ongoing scrutiny that is crucial for safeguarding participants in research, thereby aligning with the ethical principles that underpin human subject research.