How often should institutions conduct a continuing review of research studies involving human subjects?

Institutions are required to conduct a continuing review of research studies involving human subjects at least annually to ensure ongoing protection of the participants and compliance with ethical standards. This annual review process includes assessing the research for continued risk to participants, evaluating any adverse events, and ensuring that the study remains aligned with the initial approval.

Conducting these reviews on an annual basis helps to monitor and address any emerging ethical concerns, safety issues, or necessary changes in the risk-benefit ratio of the research. Regular assessments are vital for maintaining participant safety, ensuring that protocols are adhered to, and making any necessary modifications to improve the study’s integrity and participant welfare.

In contrast, conducting reviews every month or biannually may not be required or practical for most studies, and only reviewing upon the researcher's request could overlook critical changes and issues that may arise throughout the study period. Annual reviews strike a necessary balance between oversight and the administrative burden on researchers and institutions.