Are pilot or preliminary studies subject to TCPS 2 review?

• A. No, not reviewed.
• B. Yes, any research involving human participants requires REB review, even if minimal risk.
• C. Only if funded.
• D. Only if the data is sensitive.

Answer: (B)

Any research involving human participants requires review by a Research Ethics Board (REB) under TCPS 2, even if the study is just a pilot or preliminary test and even if the risk to participants is minimal. Pilot studies are typically used to test procedures, recruitment, or data collection methods with people, with the aim of generating knowledge that can inform a larger, generalizable project. Because they involve human participants, they fall under the scope of ethical review to ensure informed consent is appropriate, that risks are minimized and reasonable, and that privacy and data protection are addressed.

Funding or the presence of sensitive data do not determine whether review is required; the key factor is involvement of humans in research. There are exemptions for activities that don’t meet the definition of research or don’t involve human participants in a way TCPS 2 covers, but pilot studies with people generally do require REB review.