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.

Posted
By ReguVirta
3 min read

This is a draft guidance. Not for implementation.

What You Need to Know? 👇

Exculpatory language is language that frees or appears to free investigators, sponsors, or institutions from malpractice, negligence, blame, fault, or guilt. It’s prohibited in informed consent documents under 45 CFR 46.116 and 21 CFR 50.20.

Can research subjects waive their rights to biospecimen compensation in medical device trials?

Yes, subjects can waive rights to biospecimen compensation as this doesn’t free researchers from malpractice or negligence. Such waivers are permissible when they don’t absolve parties of responsibility for fault or blame.

What’s the difference between acceptable waivers and prohibited exculpatory language?

Acceptable waivers don’t free parties from malpractice or negligence (like biospecimen compensation waivers). Prohibited exculpatory language releases parties from responsibility for fault, blame, or negligent conduct during research.

Disclaimers stating no compensation for injuries are prohibited if they appear to release researchers from malpractice or negligence. However, statements clarifying hospital policy while preserving subjects’ legal rights are acceptable.

Researchers can include language where subjects relinquish property rights to biological samples or data, provided it doesn’t release investigators from malpractice, negligence, or fault in conducting the research.

What regulatory agencies oversee exculpatory language requirements for medical devices?

The Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) jointly oversee these requirements under HHS regulations 45 CFR part 46 and FDA regulations 21 CFR parts 50 and 56.

What You Need to Do 👇

  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

  • 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 đź”—

Related references and norms đź“‚

  • 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 ID: 576d407f470b65f5c870209a3d7a9802
FDA guidance, Draft
Medical Devices Drugs Good Clinical Practice (GCP) Biologics
This post is licensed under CC BY 4.0 by the author.