How are retrospective chart reviews treated under TCPS 2 regarding consent?

• A. Always require consent.
• B. Often eligible for waiver if risk is minimal and obtaining consent is impracticable, with REB justification.
• C. Never allowed.
• D. Always require de-identification.

Answer: (B)

Under TCPS 2, retrospective chart reviews can be approved without informed consent if the study poses minimal risk to participants, obtaining consent would be impracticable, and the REB justifies the waiver. This recognizes that some secondary-use data analyses can yield valuable findings while safeguarding privacy, provided strong measures are in place to protect confidentiality. If these conditions are met, the REB may allow the research to proceed without contacting every individual. The other statements are too absolute: consent isn’t always required in every chart review because waivers exist, but it isn’t never allowed either; and while de-identification is an important privacy protection, it doesn’t by itself determine consent requirements.