What is the purpose of distinguishing between minimal risk and research that is more than minimal risk?

What is the purpose of distinguishing between minimal risk and research that is more than minimal risk?

• A. Minimal risk research does not require REB review.
• B. The distinction helps the REB to determine the appropriate level of ethics review.
• C. It has no practical impact.
• D. The distinction serves only to categorize the types of research proposal the REB receives.

Answer: (B)

The distinction is about applying ethics review in a risk-proportionate way. By separating minimal risk from research that is more than minimal risk, the REB can determine the appropriate level of oversight and safeguards. Minimal risk studies may qualify for lighter, delegated or expedited review with streamlined documentation, while studies with more than minimal risk typically require fuller board review and stronger protections for participants. This approach ensures that the level of ethics review matches the actual risk to participants, providing appropriate protection without unnecessary delays for very low-risk research. It has real practical impact on how reviews are conducted and what safeguards are required. It’s not that minimal risk research bypasses review, and it’s not merely a categorization of proposals; it directly guides the review process and the safeguards put in place.

The distinction is about applying ethics review in a risk-proportionate way. By separating minimal risk from research that is more than minimal risk, the REB can determine the appropriate level of oversight and safeguards. Minimal risk studies may qualify for lighter, delegated or expedited review with streamlined documentation, while studies with more than minimal risk typically require fuller board review and stronger protections for participants. This approach ensures that the level of ethics review matches the actual risk to participants, providing appropriate protection without unnecessary delays for very low-risk research. It has real practical impact on how reviews are conducted and what safeguards are required. It’s not that minimal risk research bypasses review, and it’s not merely a categorization of proposals; it directly guides the review process and the safeguards put in place.