Under which condition does the FDA permit verbal consent without a signature?

The FDA permits verbal consent without a signature primarily under conditions where the research is considered to present minimal risk to participants. This approach aligns with the regulatory framework designed to facilitate participation in research while ensuring that participants are adequately informed and protected.

When studies are categorized as minimal risk, the FDA recognizes that the burden of obtaining written consent may be greater than necessary given the level of risk involved. In such cases, verbal consent can be sufficient, especially if the study design and the consent process are structured to ensure that participants understand what participation entails, including potential risks and benefits.

This practice helps to streamline the consent process for low-risk studies while still honoring the importance of informed consent principles. The other conditions mentioned do not typically warrant verbal consent without a signature, as high-risk procedures require stringent measures to protect participants, a legal representative indicates the need for formal consent processes, and an inability to read would more likely necessitate additional safeguards rather than a waiver of written consent.