What requirement must be met for informed consent in clinical studies?

Informed consent is a fundamental ethical principle in clinical research, ensuring that participants are fully aware of the study's nature, risks, and benefits before agreeing to participate. For informed consent to be valid, it is crucial that subjects provide their consent voluntarily and without any form of coercion or undue pressure. This means they should feel free to make their decision based on a clear understanding of what participation entails, rather than feeling forced or manipulated into agreeing.

While understanding medical terminology can enhance a participant's comprehension of the study, it is not a strict requirement for informed consent. Approval by the FDA is also important for clinical studies but does not directly relate to the necessity of informed consent from participants. Lastly, while legal age can affect the capacity to consent, it does not universally apply to all contexts or jurisdictions, making voluntary consent a more critical aspect in the broader scope of informed consent regulations.