Which entity is responsible for approving the consent process in a trial?

Which entity is responsible for approving the consent process in a trial?

• A. Sponsor
• B. Investigators
• C. CRO
• D. IRB/IEC

Answer: (D)

Approval of the informed consent process is handled by an IRB or IEC. They review and approve the consent document and the way consent is obtained to ensure that information is clear, complete, and presented in a way that supports voluntary, informed participation, including disclosure of risks, benefits, and alternatives. This approval must be in place before the trial starts and whenever the consent form or process is updated. The investigator is responsible for obtaining consent according to the IRB/IEC-approved plan, but does not grant the approval themselves. Sponsors and CROs may prepare and manage the consent materials and trial procedures, but the ethical and regulatory endorsement comes from the IRB/IEC.

Approval of the informed consent process is handled by an IRB or IEC. They review and approve the consent document and the way consent is obtained to ensure that information is clear, complete, and presented in a way that supports voluntary, informed participation, including disclosure of risks, benefits, and alternatives. This approval must be in place before the trial starts and whenever the consent form or process is updated. The investigator is responsible for obtaining consent according to the IRB/IEC-approved plan, but does not grant the approval themselves. Sponsors and CROs may prepare and manage the consent materials and trial procedures, but the ethical and regulatory endorsement comes from the IRB/IEC.