How does TCPS 2 guide REB decisions on approvals, modifications, or denials?

• A. REB decisions must be documented with reasoning; researchers may appeal or modify and resubmit as required.
• B. REB decisions require no documentation.
• C. REB decisions are final and cannot be appealed.
• D. REB decisions must be made within 24 hours.

Answer: (A)

When a Research Ethics Board (REB) reviews a study, the decision process centers on transparency, accountability, and a path forward for researchers to address concerns. TCPS 2 requires that REB decisions be documented in writing, with clear reasoning so researchers understand exactly why an approval, modification, or denial was given. This written rationale helps researchers see what must be changed or clarified to proceed and creates a record that supports responsible oversight.

Beyond just documenting the decision, TCPS 2 anticipates that many issues can be resolved through modifications and resubmission. Researchers can revise the protocol to address the board’s concerns and request a re-review. There is also an avenue for appeal or reconsideration if a researcher believes the decision didn’t adequately reflect policy or the specifics of the project. This combination of written rationale, opportunities to modify and resubmit, and an appeal pathway ensures decisions are fair, justified, and aimed at protecting participants.

The other ideas—having no documentation, final decisions with no chance to appeal, or decisions required to be made within an unrealistically short timeframe—do not fit how REB decisions are structured under TCPS 2.