What is required for a study initially approved by a convened IRB regarding its review?

For a study that has been initially approved by a convened Institutional Review Board (IRB), continuing review is a crucial process that ensures ongoing oversight of the research project. This review is required to take place at least annually, hence, it must occur within one year of the initial approval. This requirement reflects the necessity to assess any changes in the study’s risk profile, participant safety, and data integrity over time.

Ensuring that the IRB reviews the study periodically allows for the identification of any emerging ethical issues or concerns that may arise during the course of the research. By mandating this annual review, regulatory standards help to safeguard the rights and welfare of research participants, maintaining the ethical integrity of the research process.

Other options do not align with the established guidelines for IRB oversight. There are no provisions for disregarding reviews after one year, nor do studies only require biannual reviews if they are reviewed less frequently to meet the annual requirement.