Persons with diminished autonomy require which of the following?

• A. Special safeguards to prevent exploitation in research
• B. No additional protections
• C. Higher compensation
• D. Exemption from IRB review

Answer: (B)

When a person cannot fully exercise independent decision-making, research ethics require extra protections to prevent exploitation and to safeguard their welfare. This means obtaining consent through the appropriate means—assent from the person when possible and authorization from a legally authorized representative when the person cannot consent—and ensuring that participation is truly voluntary, understood, and in the person’s best interests. It also involves minimizing risks, communicating clearly, and maintaining ongoing oversight by an IRB to monitor safety and appropriateness throughout the study. Additional safeguards are not about increasing compensation or bypassing review; those approaches can introduce new ethical problems, such as undue influence or lack of protection. Exemption from IRB review is not appropriate for vulnerable populations, since they require heightened scrutiny and safeguards.