On March 9, 2015, the U.S. Food and Drug Administration (FDA) issued draft guidance on the Use of Electronic Informed Consent in Clinical Investigations (document opens as a PDF). In a question-and-answer format, the guidance provides recommendations for 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, and medical devices, and combinations thereof.
Electronic informed consent, or eIC, refers to the use of electronic systems and processes to convey information related to the study and to obtain and document informed consent. Electronic media formats may include text, graphics, audio, video, podcasts, and interactive websites, biological recognition devices, and card readers. Use of electronic systems may allow for rapid notification to study participants of any amendments pertaining to the informed consent, promote timely entry of eIC data into the study database, and allow for timely collection of the informed consent data from remote locations.
The guidance provides answers to these questions:
- How should the 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 ensure that new or additional information is conveyed to the subject during the course of the clinical investigation?
- Does FDA allow the use of electronic signatures to document eIC?
- 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 material and information presented to them in their eIC?
- What steps can be taken to help ensure confidentiality of the information once eIC is obtained?
- Can HIPAA authorizations for research, which are frequently combined with informed consent documents, be obtained electronically?
- 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 documents appropriately?
- What materials or documents will FDA require during an inspection?
The comment period ends May 7, 2015. Users can submit electronic comments using the docket number HHS-OPHS-2015-0002 at the Federal eRulemaking Portal: http://www.regulations.gov.