What is required for clinical trials regarding independent review?

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Independent ethical review is a non‑negotiable part of conducting clinical trials with human subjects. Before a trial starts, an IRB or IEC that operates independently from the sponsor and investigators must review the protocol and the informed consent materials to determine whether the risks are minimized and reasonable in relation to the potential benefits, whether subject selection is fair, and whether participants can give informed consent freely and with understanding. They also check safeguards for vulnerable populations, confidentiality protections, and the overall plan for participant safety. This review is not a one‑time event; ongoing oversight is required through continuing review, approval of protocol amendments, and monitoring of safety data, with timely reporting of adverse events. Internal sponsor reviews cannot substitute for this independent evaluation, and no independent review would omit these protections.