If the study protocol is altered during a trial, what must be done at the site level?

When a study protocol is altered during a trial, it is essential to re-consent subjects and inform the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) for approval. This is crucial because any changes to the protocol can significantly impact the safety, rights, and well-being of the participants, as well as the overall integrity of the study.

Re-consenting subjects ensures that they are fully aware of the changes made, understand how those changes may affect their participation, and give their informed consent based on updated information. Additionally, the IRB/IEC is responsible for overseeing the ethical conduct of research and must review and approve any modifications to the study protocol. This process helps maintain compliance with ethical guidelines and regulations designed to protect human subjects in research studies.

By following this course of action, the study maintains ethical standards, safeguards participant interests, and ensures regulatory compliance, which are critical components of responsible clinical research.