Which of the following criteria must be met for a waiver of informed consent?

For a waiver of informed consent to be granted, it is essential that the research involves no more than minimal risk to subjects. This criterion ensures that the potential for harm or discomfort to participants is low, thereby justifying the lack of individual consent in certain circumstances. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations.

The rationale behind this requirement reflects the ethical principles outlined in the Belmont Report, particularly respect for persons and the need to protect those who may be vulnerable. When risks are minimal, the ethical justification for waiving consent is stronger because it reduces the likelihood of harming participants while still allowing the research to proceed.

Understanding this criterion is crucial, as it emphasizes the balance between advancing research and safeguarding participant welfare. Other criteria, such as those concerning compensation or oversight, do not directly relate to the ethical justification for waiving informed consent in the same way that the level of risk does.