What is a requirement when making payments to subjects in clinical trials?

In clinical trials, making payments to subjects is a sensitive issue that is governed by ethical guidelines and regulatory oversight, particularly to ensure the protection of human subjects. Prior Institutional Review Board (IRB) approval is necessary to ensure that the payment structure is fair, ethical, and does not unduly influence a subject's decision to participate. The IRB reviews the payment amount, the method of payment, and the timing to confirm that it aligns with ethical standards and does not pose risks of coercion or undue influence on potential participants. This requirement safeguards the interests of subjects and maintains the integrity of the research process, ensuring all elements of the trial are transparent and approved by appropriate oversight committees.

Other options lack this necessary regulatory approval, which is critical to uphold the ethical standards expected in clinical research.