Which of the following represents the greatest ethical challenge in informed consent for clinical trials?

The greatest ethical challenge in informed consent for clinical trials is the potential for coercion or undue influence. Informed consent is not merely about obtaining a signature or providing information; it fundamentally revolves around ensuring that participants voluntarily agree to participate in research without any external pressures that may compromise their autonomy.

Coercion refers to a situation where participants feel compelled to join a study because of threats or undue pressure, while undue influence encompasses scenarios where participants may be unduly persuaded by factors such as financial incentives, authority figures, or desperation—especially among vulnerable populations.

This challenge is particularly critical because it can undermine the integrity of the consent process, leading to ethical violations. Ensuring that consent is truly informed and voluntary is central to respecting participant autonomy and upholding ethical standards in research. Thus, addressing coercion and undue influence is paramount in fostering a trustworthy research environment and protecting participants’ rights and well-being.

In contrast, the other options, while relevant to the informed consent process, do not capture the ethical complexity and potential harm associated with coercion or undue influence. Ensuring transparency and full disclosure is important but does not mitigate the risks of participants feeling pressured. The duty to ensure understanding is essential for ethical practice, yet it cannot fully address the dynamics