Under what circumstances may an REB grant a waiver or alteration of consent?

• A. When risk is minimal, obtaining consent is impracticable, rights/welfare are not affected, privacy is protected, and data can be de-identified.
• B. When researchers forget to obtain consent.
• C. When participants are non-English speakers without translator.
• D. When the study is funded by private donors.

Answer: (A)

A waiver or alteration of consent is allowed only when the research involves no more than minimal risk and is supported by safeguards that protect participants. The key conditions are that obtaining consent is impracticable under the circumstances, the rights and welfare of participants would not be adversely affected, privacy and confidentiality are protected, and data can be de-identified to minimize risk. When these criteria are met, an REB can approve the waiver or alteration. The other scenarios don’t fit: simply forgetting to obtain consent isn’t a valid basis, language barriers don’t automatically justify a waiver without ensuring information is accessible to participants, and funding source has no bearing on whether a waiver is appropriate.