Exculpatory Language
The consent form must not contain any exculpatory language.
Exculpatory language is wording that waives or appears to waive any of the subject's legal rights, or the rights of the subject's representative, and the consent form must not include such language. Neither must the consent form release or appear to release, or appear to release the investigator, the sponsor, the institution, or its agents from liability for negligence.