Which statement best describes how an initial risk assessment informs the ethical review process?

• A. Risk assessment is optional.
• B. Conducting an initial assessment of risk to determine level of scrutiny.
• C. Risk assessment should be done only after data collection begins.
• D. Risk assessment is the sole responsibility of the principal investigator.

Answer: (B)

An initial risk assessment is done early to identify potential harms to participants and to decide how much oversight the study needs. By looking at how likely and how severe the risks are, the ethics board can assign the appropriate level of scrutiny: minimal risk studies may qualify for exemption or delegated review, while greater-than-minimal risk studies require standard or full board review. This early assessment also shapes consent language, safeguards, data security, and oversight plans before any data collection begins, ensuring protections are in place from the start. It’s not optional, it isn’t done after data collection starts, and while the researcher leads the risk identification, the ethics board reviews and may require additional protections.