Informed consent for access to experimental therapies must include which elements?

• A. Presume consent if patient asks.
• B. Consent is not required for experimental therapies.
• C. Provide clear information, assess risks and benefits, ensure voluntary informed consent, and involve ethics or oversight when applicable.
• D. Make decisions on patient's behalf.

Answer: (C)

Understanding informed consent for experimental therapies centers on respecting autonomy while protecting safety. The person must receive information presented clearly about what the therapy involves, including potential benefits, known risks, and the uncertainties that come with experimental approaches. They should be able to understand this information and use it to decide voluntarily, without coercion or undue influence. Capacity to consent matters: the decision should come from a person who understands and can weigh options, or from a legally authorized surrogate if appropriate. For experimental therapies, an additional layer of protection comes from ethics review or oversight to ensure the research is justified, safeguards are in place, and monitoring is in place. When these elements—clear information, assessment of risks and benefits, voluntary informed consent, and appropriate ethics oversight—are all present, the process aligns with ethical and legal standards for offering access to experimental treatments.