Informed Consent Quick Tip #2- Exculpatory Language

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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Do’s and Don’ts of Informed Consent Tip #1

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Informed consent is almost always required of studies, but there are instances in which all or part of the consent can be waived. Today’s tip focuses on the signed consent form and guidelines the Institutional Review Board (IRB) will consider when reviewing a waiver.

 

According to the Code of Federal Regulations, 45 CFR 46.117(c), an IRB has the authority to waive the requirement for signed consent if one of the following two is true:

  1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research and the subject’s wishes will govern; or
  2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context (e.g., drawing a blood sample, or asking shoppers in a mall about the ambient lighting or temperature).

The IRB may still require that participants are provided a copy of an informed consent form. However, if there is documentation of potential harm to the participants as a result of having the consent form, this too can be waived. An example of this might include participants who are involved in instances of domestic abuse. If they are living in an environment where the abuse occurs, having an informed consent or any study related materials might pose a risk. The IRB will carefully consider the merits of the request for waiver of each study to make the appropriate determination.

For additional information about the CFR visit: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.117