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.
Recommended Actions
- Develop secure electronic system compliant with 21 CFR Part 11 requirements
- Create eIC materials that are:
- Easy to navigate
- Appropriate for intended audience
- Include methods to assess comprehension
- Allow for questions/discussion
- Establish procedures for:
- Identity verification
- Electronic signature capture
- Providing copies to subjects
- Archiving all versions
- Maintaining hyperlinks
- Submit all eIC materials to IRB for review including:
- Electronic forms
- Videos/web presentations
- Assessment methods
- Amendments
- Implement security measures:
- Restricted access
- Encryption
- HIPAA compliance if applicable
- Identity verification
- Create documentation process for:
- Subject signatures
- Dates
- Amendments
- Archiving
- 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
- Electronic Records and Electronic Signatures - Scope and Application
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
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
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