What must an IRB find to grant a waiver of informed consent requirements?

To grant a waiver of informed consent requirements, the Institutional Review Board (IRB) must find that the research could not be conducted without the waiver. This emphasizes the need for flexibility in research where obtaining informed consent may be impractical or impossible due to the nature of the study.

The rationale behind this is that some research involves conditions where informing participants or obtaining their consent would compromise the study's integrity, such as studies that require observation of natural behaviors without interference. This requirement ensures that the waiver is only applicable in scenarios where the research's goals would be unachievable if consent were mandated, thus maintaining ethical standards while facilitating valuable research.

The focus on feasibility reinforces the balance between ethical considerations and the necessity of conducting important research that could benefit society. Other considerations, such as the nature of risks and benefits or the validity of the research objectives, may influence overall ethical assessments but do not directly satisfy the specific criterion for granting a waiver of informed consent.