Compassionate use of experimental therapies requires what when possible?

• A. Explicit Consent Is Never Required for Compassionate Use
• B. Informed Consent, Weighing Risks and Benefits, Avoiding Exploitation, and Ensuring Protections
• C. Only Physician Approval Is Required
• D. No Oversight or Review

Answer: (B)

Compassionate use, or expanded access, hinges on treating patients with serious conditions in a way that respects their rights and safety even when a therapy is still experimental. When possible, this means four things working together: informed consent, weighing risks and benefits, safeguarding against exploitation, and having appropriate protections in place.

Informed consent means the patient understands that the therapy is investigational, the possible benefits and unknowns, the specific risks, and any alternatives, and then voluntarily agrees to pursue access. This respects the patient’s autonomy and empowers shared decision-making.

Weighing risks and benefits requires a thoughtful assessment of whether the potential benefits justify the possible harms and uncertainties. It’s not about forcing treatment; it’s about ensuring that the choice aligns with the patient’s values and the medical reality.

Avoiding exploitation focuses on preventing manipulation or taking advantage of a patient’s desperation. It involves clear information, fair access, and no guarantees of a cure or outcome.

Ensuring protections covers the necessary oversight, safety monitoring, privacy, and regulatory compliance—often involving ethics review or institutional oversight—to safeguard patient well-being and data integrity.

Other options are incomplete because they omit consent, rely only on physician approval, or assume no oversight is needed, which would fail to protect the patient and undermine ethical practice.