Continuing review of an approved research protocol must occur how frequently?

Continuing review of an approved research protocol must occur at least annually to ensure that the study continues to meet ethical standards and regulatory requirements. This frequency allows for regular assessment of the study's risk-to-benefit ratio and ensures that any new information that could affect the study’s safety or scientific validity is taken into account. The annual review provides an opportunity to monitor participant safety, evaluate the effectiveness of the research design, and ensure that any potential risks have been addressed appropriately.

This frequency is aligned with federal regulations, which stipulate that Institutional Review Boards (IRBs) must conduct reviews of ongoing research at least every 12 months. While some studies may necessitate more frequent reviews due to increased risk factors or other considerations, the standard minimum requirement is an annual review. Other options that propose either six months or two years would not meet this requirement, and relying solely on the discretion of the principal investigator could lead to inconsistent practices and potential lapses in oversight.