Who approves the Protocol before a trial begins?

Who approves the Protocol before a trial begins?

• A. Ethics Committee
• B. Sponsor
• C. Investigator
• D. Regulatory Authority

Answer: (A)

An independent Ethics Committee reviews and approves the protocol before a trial begins. This review focuses on protecting participants: assessing the risk/benefit balance, ensuring informed consent is truly understood and voluntary, safeguarding confidentiality, and verifying that vulnerable populations are protected. The sponsor and investigator prepare the protocol, but ethical approval comes from the Ethics Committee, not from them. Regulatory authorities may grant authorization to conduct the trial after the Ethics Committee’s approval, but the initial protocol approval is the Ethics Committee’s job.

An independent Ethics Committee reviews and approves the protocol before a trial begins. This review focuses on protecting participants: assessing the risk/benefit balance, ensuring informed consent is truly understood and voluntary, safeguarding confidentiality, and verifying that vulnerable populations are protected. The sponsor and investigator prepare the protocol, but ethical approval comes from the Ethics Committee, not from them. Regulatory authorities may grant authorization to conduct the trial after the Ethics Committee’s approval, but the initial protocol approval is the Ethics Committee’s job.