In IRB waiver considerations, the research must present no more than what level of risk?

• A. Moderate risk
• B. Minimal risk
• C. High risk
• D. Unknown risk

Answer: (B)

The main concept here is that an IRB waiver is allowed only when the research involves no more than minimal risk to participants. Minimal risk means the chance and magnitude of harm or discomfort are not greater than what people ordinarily experience in daily life or during routine physical or psychological exams. For a waiver to be approved, this minimal-risk level must be part of a set of safeguards: the waiver or alteration should not adversely affect subjects’ rights and welfare, the research could not practicably be carried out without the waiver (or without obtaining consent), and appropriate protections for privacy and confidentiality should be in place. Higher levels of risk—moderate, high, or unknown—would not qualify for a waiver.