In therapeutic trials, what are the stated requirements and justification?

• A. Requirements: informed consent and minimal risk; Justification: chance to cause significant potential good to society
• B. Requirements: informed consent and no risk; Justification: societal benefit
• C. Requirements: deception allowed; Justification: market needs
• D. Requirements: randomization only; Justification: to expedite

Answer: (A)

The essential idea is that therapeutic trials must protect participants through informed consent and by keeping risks as low as reasonably possible, while still aiming to generate meaningful benefits for patients and society. Informed consent ensures participants understand what the trial involves, including potential risks and benefits, and agree to participate voluntarily. Minimizing risk reflects the ethical obligation to protect participants from harm and to balance any remaining risks against the potential value of the knowledge gained for future patients. The justification for conducting such trials is that they can produce significant potential good for society by advancing medical knowledge and improving treatments, as long as participants are properly informed and protected.

The other options miss key ethical requirements: deception is not appropriate in therapeutic trials, since it undermines informed consent; claiming no risk is unrealistic because research always carries some possibility of harm; focusing on randomization alone ignores the central duties of consent and risk management; and saying the justification is simply to expedite misses the crucial point that societal benefit must be weighed against participant protections.