What is the maximum time frame for the continuing review of an approved protocol?

The maximum time frame for the continuing review of an approved protocol is 12 months from the approval date. Institutional Review Boards (IRBs) are required to conduct continuing reviews at least annually to ensure that the research remains ethically sound and that no new information affects the risk-to-benefit ratio of the study. This regulation helps maintain oversight on research activities, protecting the rights and welfare of participants.

The annual review process allows the IRB to evaluate any changes in research procedures or new findings that could impact participant safety or the study's ethical considerations. By limiting the review period to 12 months, regulatory bodies ensure that researchers submit updates and address any concerns regularly, thus promoting rigorous adherence to ethical research standards.