Under what condition does the FDA permit verbal consent in a research study?

The FDA permits verbal consent in research studies primarily when the study is considered minimal risk. This means that the potential harm or discomfort that an individual may experience during the study is no greater than what they would encounter in their everyday life. When research poses minimal risk, the regulatory framework acknowledges that there may not always be a need for a formal written consent process, allowing for more flexible approaches such as verbal consent.

This flexibility can facilitate participation in studies where the procedure is straightforward and where written consent may be seen as an unnecessary barrier to participation. It is important to note that even when verbal consent is permitted, adequate documentation of the consent process must occur to protect both the participants and the integrity of the study.

In contrast, other conditions such as illiteracy or the involvement of a legally authorized representative do not inherently qualify a situation for verbal consent. While these factors can sometimes necessitate different consent procedures, they do not automatically justify the use of verbal consent in accordance with FDA guidelines. Similarly, studies involving greater than minimal risk typically require more stringent informed consent processes to ensure that participants fully comprehend the potential risks involved.