Which factor is NOT typically considered by an IRB when evaluating risk?

• A. Potential risk to participants.
• B. Informed consent process.
• C. Publication dates of results.
• D. Privacy protections.

Answer: (C)

When evaluating risk, the emphasis is on protecting participants: what harms could occur, how those harms can be minimized, and whether the potential benefits justify any risks. IRBs look at the kinds of risks participants might face—physical, psychological, social, or privacy-related—and assess how the study design reduces those risks. They examine the informed consent process to ensure participants truly understand what they may experience and can make an autonomous decision to participate. They also scrutinize privacy protections, including data handling, confidentiality, de-identification, data security, who can access data, and any plans for sharing results, to prevent unintended disclosures of sensitive information.

Publication dates of results, while important for dissemination and transparency, do not affect the level of risk to participants or the protections in place. They don’t change the likelihood or severity of potential harms, so they aren’t typically part of the risk assessment.