FDA Guidance: Use of Electronic Informed Consent Questions and Answers, 12/16

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In December, 2016, the FDA issued “Use of Electronic Informed Consent, Questions and Answers.” This document provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.

Recommendations within this Guidance are designed to result in electronic informed consent (eIC) programs that …

• Are understandable and easy for users to navigate
• Retain all versions of IC documents
• Include a method to ensure that the person signing the IC is the subject who will be participating in the research study
• Ensure the security of the data and the subject’s privacy (HIPAA compliant)
• Allow for electronic (including digital) signatures compliant with 21 CFR Part 11
• Make copies available to both subjects and the FDA
• Enable documents to be archived and easily retrieved

This guidance also refers the industry to

• 21 CFR Part 11: Electronic Records; Electronic Signatures
• Part 11, Electronic Records; Electronic Signatures – Scope and Application – Guidance for Industry
• General Principles of Software Validation – Guidance for Industry and FDA Staff
• Computerized Systems Used in Clinical Investigations – Guidance for Industry