Exculpatory Language in Informed Consent Documents: Examples of Acceptable and Unacceptable Language (OPRR Letter, 1996)

Office for Protection from Research Risks (OPRR)

Cooperative Oncology Group Chairpersons Meeting
November 15, 1996

"Exculpatory Language" in Informed Consent

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:

• By agreeing to this use, you should understand that you will give up all claim to personal benefit from commercial or other use of these substances.

• 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.

• By consent to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the research.

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

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.

• This hospital is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research.

• This hospital makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research. Medical services will be offered at the usual charge.