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Use of Electronic Informed Consent in Clinical Investigations

This guidance provides recommendations on the use of electronic systems and processes to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations. It covers the use of electronic media to provide information, evaluate subject comprehension, and document consent. The guidance applies to institutional review boards (IRBs), investigators, and sponsors.

  1. Develop secure electronic system compliant with 21 CFR Part 11 requirements
  2. Create eIC materials that are:
    • Easy to navigate
    • Appropriate for intended audience
    • Include methods to assess comprehension
    • Allow for questions/discussion
  3. Establish procedures for:
    • Identity verification
    • Electronic signature capture
    • Providing copies to subjects
    • Archiving all versions
    • Maintaining hyperlinks
  4. Submit all eIC materials to IRB for review including:
    • Electronic forms
    • Videos/web presentations
    • Assessment methods
    • Amendments
  5. Implement security measures:
    • Restricted access
    • Encryption
    • HIPAA compliance if applicable
    • Identity verification
  6. Create documentation process for:
    • Subject signatures
    • Dates
    • Amendments
    • Archiving
  7. Establish backup paper-based consent option

Key Considerations

Human Factors

  • The eIC must be easy to navigate, allowing users to move forward/backward and pause/resume
  • The system should be appropriate for the intended audience considering age, language and comprehension level
  • Subjects should have the option to use paper-based or electronic methods
  • Study personnel may assist subjects with navigating the eIC technology if needed
  • The system should include methods to assess subject understanding of key information

Software

  • The electronic system must be secure with restricted access
  • Must include methods to ensure confidentiality of subject identity and information
  • Must be able to capture and record the date of consent
  • Must allow for archiving and retrieval of all versions of IRB-approved eIC
  • Must comply with 21 CFR Part 11 requirements for electronic records/signatures

Cybersecurity

  • The system must be secure with restricted access
  • Must include encryption of subject information
  • Must comply with HIPAA Privacy, Security and Breach Notification Rules if applicable
  • Must have methods to verify identity before establishing electronic signatures

Other considerations

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

Original guidance

  • Use of Electronic Informed Consent in Clinical Investigations
  • HTML / PDF
  • Issue date: 2016-12-15
  • Last changed date: 2021-01-26
  • Status: FINAL
  • Official FDA topics: Medical Devices, Administrative / Procedural, Drugs, Biologics
  • ReguVirta summary file ID: e607cd24bfdd3188bc44358097b1f89d
This post is licensed under CC BY 4.0 by the author.