What is the purpose of informed consent in clinical research?

• A. To ensure participants understand risks, benefits, procedures, and rights before participating.
• B. To determine eligibility criteria.
• C. To assign participants to control or experimental groups.
• D. To bypass ethical review.

Answer: (A)

Informed consent centers on autonomy and informed decision-making in research. It ensures that participants receive clear information about what the study involves, the potential risks and benefits, the procedures they will undergo, and their rights, so they can decide to join voluntarily. This ongoing understanding and voluntary agreement protect individuals’ dignity and safety, and it aligns with ethical and regulatory standards for research.

That is why the best choice is to emphasize that participants must understand risks, benefits, procedures, and rights before participating. Informed consent is not about determining who is eligible to join—that’s a screening step—nor about assigning participants to different study groups, which is a study design decision. It also does not bypass ethical review; instead, consent is part of the process guided by oversight to ensure participants are protected. Remember, consent is an ongoing, informative process, with the option to ask questions and withdraw at any time.