What is the requirement regarding risk in moral considerations for trials?

• A. Risk must be ignored
• B. Risk must be minimized and balanced with potential benefits
• C. Risks must be high to test safety
• D. Only financial risk matters

Answer: (B)

In ethical human subjects research, the guiding requirement is to minimize risk to participants and weigh that risk against the potential benefits. Trials should be designed to reduce harm as much as possible, and any remaining risks must be justified by the anticipated benefits to participants or to society. This risk-benefit balance is what determines whether a study is ethically permissible. Risks should not be ignored, and they are not justified by pursuing high risk to test safety or by focusing only on financial concerns; rather, all plausible harms (physical, psychological, social) are considered and weighed against potential benefits.