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Multiple Choice

Who should ensure that compensation to trial participants does not present problems of coercion or undue influence?

Compensation must be designed to avoid coercion or undue influence, and the body responsible for safeguarding this is the IRB/IEC. They review the plan for participant payments as part of the protocol and consent materials, ensuring that amounts compensate for time and travel or inconvenience without becoming an inducement to join or stay in the study. The IRB/IEC considers whether the payment structure could pressure someone to participate despite risks, whether it’s clearly explained in the consent form, and whether it would inappropriately sway ongoing participation. While sponsors propose the compensation and investigators obtain consent and carry out the study, the ethical review and ongoing oversight to prevent undue influence rests with the IRB/IEC.

Compensation must be designed to avoid coercion or undue influence, and the body responsible for safeguarding this is the IRB/IEC. They review the plan for participant payments as part of the protocol and consent materials, ensuring that amounts compensate for time and travel or inconvenience without becoming an inducement to join or stay in the study. The IRB/IEC considers whether the payment structure could pressure someone to participate despite risks, whether it’s clearly explained in the consent form, and whether it would inappropriately sway ongoing participation. While sponsors propose the compensation and investigators obtain consent and carry out the study, the ethical review and ongoing oversight to prevent undue influence rests with the IRB/IEC.