Post

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This is a draft guidance. Not for implementation.

  1. Review all informed consent documents to identify and remove any exculpatory language
  2. Ensure any waivers of rights in consent forms do not release entities from liability for negligence
  3. Include clear language about compensation policies for biospecimens if applicable
  4. Use acceptable example language provided in the guidance when discussing liability and compensation
  5. Maintain subjects’ right to seek compensation for malpractice or negligence
  6. Implement a review process to ensure new consent forms comply with these requirements
  7. Train staff involved in consent form development on acceptable vs. exculpatory language

Key Considerations

Other considerations

  • 45 CFR 46.116: Requirements for informed consent
  • 21 CFR 50.20: General requirements for informed consent

Original guidance

  • Exculpatory Language in Informed Consent Documents for Clinical Research
  • HTML / PDF
  • Issue date: 2011-08-19
  • Last changed date: 2021-07-21
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Drugs, Good Clinical Practice (GCP), Biologics
  • ReguVirta summary file ID: 576d407f470b65f5c870209a3d7a9802
This post is licensed under CC BY 4.0 by the author.