In research, what is the purpose of IRB oversight and enhanced risk disclosures?

• A. IRB oversight ensures participant protection with detailed risk disclosures and voluntary participation
• B. IRB oversight is only concerned with financial aspects
• C. IRB oversight applies to clinical care delivery
• D. IRB oversight is optional for all research

Answer: (B)

IRB oversight exists to protect people who participate in research by reviewing study plans to minimize risks and by ensuring informed consent is meaningful. Enhanced risk disclosures are part of this process because they require clearly and fully communicating potential harms, their likelihood, and any alternatives so participants can make an informed, voluntary choice. Voluntary participation means individuals aren’t pressured or coerced to enroll or stay in a study.

The other ideas don’t fit: financial aspects are handled separately from IRB oversight, which is about protecting participants rather than finances; routine clinical care delivery isn’t what IRB oversight covers unless that care is part of a research study; and IRB oversight for human subjects research is not optional where it applies.