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Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures

This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA's informed consent regulations for clinical investigations. It provides comprehensive guidance on the informed consent process, requirements, documentation, and responsibilities of different stakeholders involved in clinical research.

  1. Develop comprehensive informed consent forms and processes that meet all regulatory requirements
  2. Establish procedures for:
    • Documenting informed consent
    • Handling non-English speaking subjects
    • Managing subject withdrawal
    • Informing subjects of new findings
    • Protecting subject privacy and confidentiality
  3. Implement appropriate safeguards for vulnerable populations
  4. Create process for IRB review and approval of consent materials
  5. Establish system for maintaining and updating consent documentation
  6. Train staff on proper informed consent procedures
  7. Develop procedures for electronic consent if applicable
  8. Create process for handling study suspension/termination
  9. Establish procedures for multi-center studies coordination
  10. Implement system for tracking and managing consent form versions

Key Considerations

Clinical testing

  • Informed consent must be obtained before subject participation in clinical investigations
  • Ongoing informed consent process throughout study participation
  • Special considerations needed for vulnerable populations
  • Process for handling subject withdrawal and data retention

Human Factors

  • Language must be understandable to subjects
  • Process should minimize coercion and undue influence
  • Special considerations for subjects with impaired consent capacity
  • Provisions for non-English speaking subjects
  • Considerations for subjects with low literacy or disabilities

Software

  • Electronic informed consent processes are acceptable if they meet regulatory requirements
  • Must ensure proper documentation and security measures

Safety

  • Must disclose reasonably foreseeable risks and discomforts
  • Process for informing subjects of new safety findings
  • Requirements for reporting study suspension/termination
  • Provisions for injury compensation and medical treatment

Other considerations

  • 21 CFR Part 50: Protection of Human Subjects
  • 21 CFR Part 56: Institutional Review Boards
  • 21 CFR Part 11: Electronic Records; Electronic Signatures
  • 45 CFR Part 46: Protection of Human Subjects (Common Rule)

Original guidance

  • Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
  • HTML / PDF
  • Issue date: 2023-08-15
  • Last changed date: 2024-04-11
  • Status: FINAL
  • Official FDA topics: Medical Devices, Pediatric Product Development, Good Clinical Practice (GCP), Drugs, Biologics
  • ReguVirta summary file ID: 84b4f8c58952aa96f7a6a8ab88c8060e
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