Preparing informed consent forms can pose a significant challenge for researchers and evaluators. One critical aspect to consider is the use of exculpatory language, which is not permissible according to the Office for Human Research Protections (OHRP).
What is Exculpatory Language?
According to 45 CFR 46.116 and 21 CFR 50.20, exculpatory language is any wording within a consent form that appears to waive or limit a participant’s legal rights, implying that the sponsor, researcher, or others are free from liability for malpractice, negligence, blame, fault, or guilt. Often, researchers do not intend to include such language, as it might be unintuitive to detect.
Acceptable Language Examples
OHRP provides guidelines for acceptable language in informed consent forms. Here are a few examples that align with the regulations:
- Future research using your samples may lead to new products; however, there are no plans to provide financial compensation if this occurs.
- You voluntarily donate all blood, urine, and tissue samples to [research institution name] for the specified research.
- Although research outcomes might be patentable or commercially valuable, you will not have a legal or financial stake in these developments.
- Tissue from this research may develop into a patentable cell line. No financial compensation is planned for you.
- By participating, you authorize the use of your bodily fluids and tissue samples in the research outlined.
- Due to hospital policy, financial compensation for injuries from participation is not offered. However, this does not prevent you from seeking compensation for malpractice or other faults.
- 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.
These examples comply with 45 CFR 46.116 and 21 CFR 50.20 as they do not give the impression of freeing any party from responsibility.
For further guidance, refer to the OHRP’s Guidance on Exculpatory Language in Informed Consent or you can check out our blog on general consent here.