Exculpatory Language in Informed Consent Documents for Clinical Research (DRAFT)
This guidance addresses the regulatory prohibition on including exculpatory language in informed consent documents for human subject research conducted or supported by HHS or regulated by FDA. It clarifies what constitutes permissible and impermissible language regarding waivers and releases of rights in informed consent documents.
This is a draft guidance. Not for implementation.
Recommended Actions
- Review all informed consent documents to identify and remove any exculpatory language
- Ensure any waivers of rights in consent forms do not release entities from liability for negligence
- Include clear language about compensation policies for biospecimens if applicable
- Use acceptable example language provided in the guidance when discussing liability and compensation
- Maintain subjects’ right to seek compensation for malpractice or negligence
- Implement a review process to ensure new consent forms comply with these requirements
- Train staff involved in consent form development on acceptable vs. exculpatory language
Key Considerations
Other considerations
- No informed consent may include language that waives or appears to waive subjects’ legal rights
- No informed consent may include language that releases or appears to release investigators, sponsors, institutions from liability for negligence
- Language waiving compensation rights for biospecimens is permissible
- Language must not have the effect of freeing entities from malpractice, negligence, blame, fault, or guilt
- Statements about hospital policies regarding medical care costs are acceptable if they don’t preclude seeking compensation for malpractice
- Clear statements about no financial compensation for commercial development of research results are acceptable
Relevant Guidances
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
- Ethical Considerations for Clinical Investigations of Medical Products in Children (Draft)
- Use of Electronic Informed Consent in Clinical Investigations
- Exception from Informed Consent Requirements for Emergency Research
Related references and norms
- 45 CFR 46.116: Requirements for informed consent
- 21 CFR 50.20: General requirements for informed consent
Original guidance
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