Prohibition of exculpatory language

The term exculpatory is generally defined as “free from blame.” The literal meaning of this term and the meaning according to the Code of Federal Regulations (45 CFR 46.116) differ. According to the Common Rule, the prohibition of exculpatory language means that there can be no “language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.” A general rule is to state the situation simply and factually, such as, “You do not give up your legal rights by signing this form.” Further guidance regarding the avoidance of exculpatory language may be found here.