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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.

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By ReguVirta
3 min read

What You Need to Know? 👇

Electronic informed consent must comply with 21 CFR parts 11, 50, and 56, containing all required consent elements, using understandable language, and ensuring proper documentation with electronic signatures that meet FDA’s trustworthy and reliable standards.

FDA accepts various verification methods including state-issued identification, personal security questions, biometric methods, or visual verification. The chosen method must prevent fraudulent use and comply with 21 CFR 11.100(b) requirements.

Investigators must submit all electronic and paper forms, videos, web-based presentations, and informational materials that subjects will receive during the eIC process. IRBs must review and approve all content including hyperlinks and optional comprehension questions.

Yes, eIC can obtain both parental permission and child assent when required. However, special considerations include age-appropriate presentation, potential identity verification challenges for children, and ensuring the electronic method doesn’t impede the child’s capability to provide assent.

FDA requires access to site-specific eIC versions, IRB-submitted materials, all amendments, subject-specific signed eICs, and corresponding signatures with dates. These must be available electronically or on paper, including any updates to documentation.

The eIC system must incorporate procedures ensuring electronic documents can be archived appropriately, all IRB-approved versions can be retrieved easily, and all procedures comply with FDA electronic records regulations under 21 CFR part 11.

What You Need to Do 👇

  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

  • Subjects must receive a copy of their signed eIC
  • Hyperlinks used must be maintained and accessible until study completion
  • IRB must review and approve all eIC materials including videos, web presentations
  • Process must allow subjects opportunity to ask questions before and during study
  • Must have procedures for obtaining assent from pediatric subjects when required

Relevant Guidances 🔗

Related references and norms 📂

  • 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 ID: e607cd24bfdd3188bc44358097b1f89d
FDA guidance, Final
Medical Devices Administrative / Procedural Drugs Biologics
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