Findings
The process of obtaining Informed Consent (IC) involves providing adequate information to facilitate comprehension and must allow subjects the opportunity to ask questions, continuing throughout the research. Electronic Informed Consent (eIC) systems, which can use various electronic media, are increasingly used to supplement or replace paper-based IC processes. The eIC process may be conducted on-site or remotely, but the legal responsibility for obtaining consent cannot be delegated to the electronic system. For FDA-regulated clinical investigations, electronic signatures must comply with 21 CFR Part 11 to be considered equivalent to a handwritten signature.

Recommendations
Presentation & Comprehension: eIC information should be easy to navigate, convey information in understandable language, and may use interactive electronic-based technology (e.g., diagrams, video) to facilitate comprehension. Optional questions can be used to assess a subject’s understanding of key study elements.
Remote Consent: If consent is obtained remotely, the electronic system must include a reliable method to verify the identity of the subject (e.g., official identification, biometric methods).
Signature & Documentation: Electronic signatures are permitted and can be created using methods like biometrics or username/password, provided they are uniquely linked to the individual. The subject must be given a copy of the signed eIC, which can be electronic or paper.
Privacy & Security: The eIC system must be secure with restricted access and include methods to ensure confidentiality of subject information. If HIPAA applies, information must be encrypted unless otherwise documented.

Regulatory Considerations
IRB Responsibility: IRBs must review and approve all eIC materials and any subsequent amendments, including optional comprehension questions and the usability of the eIC materials. IRBs must maintain records (electronic or hard copy) of the approved versions of the eIC materials.
Submissions & Inspection: For IDE applications, copies of all eIC materials must be submitted to the FDA. During inspections, investigators must have site-specific signed eICs, amendments, and materials available (electronic or paper) for FDA review.
HIPAA: HIPAA authorizations may be obtained electronically, provided the signature is legally valid, and a copy must be provided to the subject.