As part of the consent process, what do federal regulations require?

Federal regulations require that potential subjects receive information at an appropriate reading comprehension level as part of the consent process. This requirement ensures that participants fully understand the nature, risks, and benefits of the research study they are considering. By providing information that is accessible and understandable, researchers help to promote informed consent, allowing participants to make knowledgeable decisions about their involvement in the study.

This focus on comprehension is critical, as it addresses the need for clear communication tailored to the audience's linguistic and cognitive abilities. It fosters ethical research practices and helps protect the rights and welfare of participants.