When must a continuing review of an approved and ongoing protocol take place according to regulatory standards?

A continuing review of an approved and ongoing protocol must take place within 12 months of the approval date as per regulatory standards. This requirement is in place to ensure that the study is still aligned with ethical guidelines and that any new information that may affect the risk-benefit ratio is taken into consideration. Regular reviews allow for the monitoring of ongoing research to address any issues that arise and to make necessary adjustments to enhance participant safety.

Performing this review annually is a safeguard mechanism designed to protect the welfare of study participants and maintain compliance with regulatory requirements. It ensures that the research remains ethically sound and that the oversight body can make informed decisions regarding the continuation of the study based on current information. This review process is crucial for upholding the integrity of the research and protecting the individuals involved.