What are the elements of informed consent?
Consent forms should be simple and straightforward so that all subjects will have an easily understood form that outlines the proposed research. For most studies, it is recommended that the consent forms be written at an eighth grade reading level. Unless the subjects are themselves medical professionals, scientific or technical terms should either be replaced with or defined in lay language. Legalistic sounding language should not be used. These phrases interfere with a subject’s comprehension of the consent form and lend the appearance of a legal document to the consent form. (Examples include: “You hereby agree,” “You certify that,” “You, the undersigned, do acknowledge that,” “You understand that,” “You realize that,” “You have been told that,” or “It has been explained to you that.” ) When constructing a consent from, the investigator should review the following elements and include them when appropriate to ensure they are in compliance with federal law and UTC Policy. Research pa
