What action must occur for future assessments of ongoing studies that were initially IRB approved?

For ongoing studies that have received initial approval from an Institutional Review Board (IRB), it is essential that they undergo a formal ongoing review. This ongoing review serves a critical purpose: to ensure that the research continues to meet ethical standards and that the rights and welfare of participants are adequately protected throughout the duration of the study. These reviews allow the IRB to assess any changes in the study protocol, evaluate new risks that may have emerged since the initial approval, and determine whether the study continues to align with ethical guidelines and regulatory requirements.

The ongoing review process is vital because it assures the IRB that the research adheres to safety measures, informed consent protocols, and the ethical considerations that are fundamental to conducting research involving human subjects. This proactive monitoring helps maintain the integrity of the research and the safety of participants over time, adapting to any emerging challenges or findings that could impact the research.

In contrast, while annual evaluations may be recommended or may seem like a regular practice, they do not substitute for the required ongoing review mandated by IRB policies. Similarly, assessing studies only upon request lacks the systematic oversight necessary to ensure participant safety continuously. Lastly, while encountering new risks does necessitate attention, these situations do not trigger an automatic review; rather, they would