Preparation of the informed consent form can be a challenge for researchers and evaluators. Inclusion of exculpatory language is not permissible according to OHRP. What does this mean? According to 45 CFR 46.116 and 21 CFR 50.20 participants language  that provides a waiver or release or appearance of making the sponsor, researcher or others free from malpractice, negligence, blame fault or guilt. Frequently, the inclusion of exculpatory language is not intentional on the part of the evaluator. As practitioners, this type of language and release may be required. For this reason, adjusting the language may not be intuitive. OHRP has provided examples of language which can be used.

Examples of Acceptable Language

• Although future research that uses your samples may lead to the development of new products, there are no plans to provide financial compensation to you should this occur.

• I voluntarily and freely donate any and all blood, urine, and tissue samples to the [name of research institution] for the research described above.

• Although the results of research, including your donated materials, may be patentable or have commercial value, you will have no legal or financial interest in any commercial development resulting from the research.

• 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.

• Because of hospital policy, the hospital is not able to offer financial compensation should you be injured as a result of participating in this research. However, you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research, including the hospital.

• Because of hospital policy, the 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. However, you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research, including the hospital.[4]

• In the event that you suffer a research-related injury, your medical expenses will be your responsibility or that of your third-party payer, although you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research.[5]

The above examples are permissible under 45 CFR 46.116 and 21 CFR 50.20 because in each example, the waiver or release does not have the general effect of freeing or appearing to free an individual or an entity from malpractice, negligence, blame, fault, or guilt.

Reference: Guidance on Exculpatory Language in Informed Consent, http://www.hhs.gov/ohrp/newsroom/rfc/exculpatorydraft2011.html 

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