The method and manner of compensation to trial subjects should...

• A. Be cash only
• B. Be based on investigator preference
• C. Comply with applicable regulatory requirements
• D. Be identical for all subjects

Answer: (C)

Compensation for trial subjects must be set in accordance with applicable regulatory requirements and ethics approvals. This ensures payments are fair, not coercive, and that the plan is reviewed by the IRB/IEC and disclosed in the informed consent. The form and timing of compensation may reimburse travel and other out-of-pocket costs and/or compensate for time and inconvenience, but it should be proportionate to the burden of participation and not so large as to unduly influence enrollment or continued participation. The method (cash, vouchers, or other forms) and schedule should be described in the study documents and approved, and may vary to reflect differences in visits or burdens, provided this variation is justified and compliant with regulations. The key is aligning compensation with regulatory guidance to protect participants and uphold study integrity.