On December 14, 2016, the U.S. Food and Drug Administration (FDA) released a Questions and Answers (Q&A) guidance on the use of electronic informed consent in clinical investigations.
FDA says that the guidance document was developed to enhance human subject protection and reduce regulatory burden. The guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic media (e.g. text, graphics, audio, video, podcasts, passive and interactive Web sites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent for both HHS (Department of Health and Human Services) -regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.
The Q&A document provides recommendations on procedures that may be followed when using an electronic informed consent (eIC) to help:
Ensure protection of the rights, safety, and welfare of human subjects,
Facilitate the subject`s comprehension of the information presented during the eIC process,
Ensure that appropriate documentation of consent is obtained when electronic systems and processes that may employ multiple electronic media 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.
The document contains the following 16 questions (and corresponding answers):
How should information in the eIC be presented to the subject?
How and where may the eIC process be conducted?
How and when should questions from subjects be answered?
What steps may be taken to facilitate the subject’s understanding of the information being presented?
What steps may be taken to convey additional information, including significant new findings, to the subject during the course of the research?
How can electronic signatures be used to document eIC?
What methods may be used to verify the identity of the subject who will be electronically signing an eIC for FDA-regulated clinical investigations?
What special considerations should be given to the use of eIC for pediatric studies?
Should subjects receive a copy of their eIC and have easy access to the materials and information presented to them in their eIC?
What steps can be taken to help ensure privacy, security, and confidentiality of the eIC information?
Can HIPAA (Health Insurance Portability and Accountability Act of 1996) authorizations for research, which are frequently combined with informed consent documents, be obtained electronically?
What eIC materials should the investigator submit to the institutional review board (IRB)?
What are the IRB’s responsibilities in the eIC process?
What eIC documentation does FDA require for submission with applications?
What steps can be taken to ensure the system archives the eIC materials appropriately for FDA-regulated clinical investigations?
What materials or documents will FDA require during an inspection?