Which statement describes a proportionate approach to ethical review?

Which statement describes a proportionate approach to ethical review?

• A. Applying delegated review to minimal risk research and full board review to more than minimal risk research.
• B. Fully board review is required for all research.
• C. Minimal risk research must be reviewed by the vice-president only.
• D. No initial risk assessment is required to determine review level.

Answer: (A)

Proportionate oversight means the level of ethics review matches the study’s risk. For minimal risk research, delegated review by qualified board members or a designated administrator is appropriate and efficient. When research presents more than minimal risk, the full board should review to ensure a thorough assessment of protections for participants and the research’s risks and benefits. This balances protecting participants with avoiding unnecessary delays for low-risk studies. Why the other options don’t fit: applying full board review to everything ignores the risk-based allocation of oversight; assigning minimal risk review to a single executive (like a vice-president) isn’t how review is typically structured and bypasses appropriate panel input; and skipping an initial risk assessment would remove the mechanism that determines which level of review is appropriate in the first place.

Proportionate oversight means the level of ethics review matches the study’s risk. For minimal risk research, delegated review by qualified board members or a designated administrator is appropriate and efficient. When research presents more than minimal risk, the full board should review to ensure a thorough assessment of protections for participants and the research’s risks and benefits. This balances protecting participants with avoiding unnecessary delays for low-risk studies.

Why the other options don’t fit: applying full board review to everything ignores the risk-based allocation of oversight; assigning minimal risk review to a single executive (like a vice-president) isn’t how review is typically structured and bypasses appropriate panel input; and skipping an initial risk assessment would remove the mechanism that determines which level of review is appropriate in the first place.