How frequently must an IRB conduct continuing review of an approved research protocol?

An Institutional Review Board (IRB) is required to conduct continuing reviews of an approved research protocol at least once a year to ensure that the ongoing study maintains the ethical standards and compliance with regulations that protect the rights and welfare of the human subjects involved. This annual review involves assessing whether the research is still being conducted as originally approved and evaluating any new information or changes in circumstances that could affect the risk-balance for the participants.

The frequency requirement of at least once a year is a safeguard to monitor the research for any emerging risks, changes in the study’s methodology, or updates in the regulatory or ethical landscape. Regular reviews also help ensure that informed consent processes are up to date and that participant welfare remains a priority throughout the duration of the study.

While changes in risk level or requests from the investigator may prompt reviews, they do not replace the annual review obligation. It's important that IRBs have a structured and routine process for evaluating ongoing research to protect participants continuously.