Which statement about consent and regulatory approval is true?

• A. To guarantee a positive treatment outcome.
• B. To provide legal protection for the sponsor.
• C. To substitute for IRB approval.
• D. To document that the participant or their representative has been informed and agrees to participate in the trial.

Answer: (D)

Informed consent is about respecting the participant’s autonomy by ensuring they understand what the trial involves and voluntarily agree to participate. The best statement reflects this by confirming that the participant or their legally authorized representative has been informed about the study and agrees to participate. This creates a documented record that participation is voluntary and based on an understanding of risks, benefits, and alternatives.

Regulatory approval, such as IRB/IEC review, must occur before the trial starts to protect participants and ensure the study is ethically and scientifically sound. But consent does not replace that approval, nor does it guarantee a positive outcome or provide legal protection for the sponsor.