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Exculpatory Language in Informed Consent Documents

No informed consent, whether oral or written, may include any exculpatory language through which the subject 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. - 45 CFR 46.116

Examples of Exculpatory Language:

• I waive any possibility of compensation for injuries that I may receive as a result of participation in this research

• I voluntarily and freely donate any and all blood, urine, and tissue samples to the U.S. Government and hereby relinquish all right, title, and interest to said items.

Examples of Acceptable Language

• Tissue obtained from you in this research may be used to establish a cell line that could be patented and licensed. There are no plans to provide financial compensation to you should this occur.

• By consenting to participate, you authorize the use of your bodily fluids and tissue samples for the research described above.