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

The correct answer is that an Institutional Review Board (IRB) must conduct continuing review of an approved protocol at least annually. This requirement is established to ensure ongoing oversight of research projects involving human subjects. Regular reviews help safeguard the rights and welfare of participants while also ensuring that the research remains in compliance with ethical standards and applicable regulations.

The focus of the annual review is to assess whether the study is still meeting the risk and benefit profile considered during the initial approval, review any new information that may affect the risk to participants, and determine if the informed consent process remains adequate and effective. By conducting the review at least once per year, the IRB can monitor any changes in the study's conduct and address any potential issues that may arise, ensuring the continued protection of research participants.

While some studies may require more frequent reviews due to certain factors like potential risks or regulatory requirements, the minimum standard set forth by most governing bodies is an annual review. This periodic oversight is crucial for maintaining ethical conduct in research involving human subjects.