What does the ethical principle of nonmaleficence require researchers to do in risky studies?

• A. Avoid harm by minimizing risk and ensuring the risk-benefit ratio justifies the research.
• B. Maximize potential benefits regardless of risk.
• C. Ensure participants are paid regardless of risk.
• D. Eliminate all risk entirely.

Answer: (A)

Nonmaleficence means researchers have an obligation to avoid harm to participants. In risky studies, that translates to two core actions: minimize potential harm as much as possible, and ensure that any remaining risks are justified by the potential benefits of the research through a careful risk-benefit assessment. In practice, this involves designing protocols to reduce exposure, implementing robust safety monitoring, establishing stopping rules, using appropriate inclusion/exclusion criteria, and ensuring informed consent so participants understand the risks. If the risks outweigh the potential benefits, the study should not proceed. So, the emphasis is on reducing risk and making sure the remaining risk is justified by meaningful potential benefits.