FDA DRAFT Guidance for Industry

Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers

DRAFT GUIDANCE

March 2015

This guidance 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. FDA’s requirements for electronic records/electronic signatures, informed consent, and IRBs are set forth in 21 CFR parts 11, 50, and 56, respectively. The information presented to the subject, processes used for obtaining informed consent, and documentation of the electronic informed consent (eIC) must meet the requirements of these and other applicable regulations.  For the purposes of this guidance, electronic informed consent refers to using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, audio, video, podcasts and interactive Web sites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent.

This guidance provides recommendations on procedures that may be followed when using an eIC to help:

  • Ensure protection of the rights, safety, and welfare of human subjects
  • Ensure the subject’s comprehension of the information presented during the eIC process 
  • Ensure that appropriate documentation of consent is obtained when electronic media and processes are used to obtain informed consent
  • Ensure the quality and integrity of eIC data included in FDA applications and made available to FDA during inspections.

Although FDA believes that the informed consent process begins with subject recruitment, recommendations on using electronic media and processes for subject recruitment are outside the scope of this guidance. Other applicable recommendations may be found in the following guidance documents:

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

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Use of Electronic Informed Consent in Clinical Investigations