Finalised FDA Guidance Published December 2016
This guidance has been prepared jointly by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). This guidance is intended for institutional review boards (IRBs), investigators, and sponsors engaged in or responsible for oversight of human subject research under HHS and/or FDA regulations.
This guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and 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. HHS requirements regarding the protection of human subjects are set forth in 45 CFR part 46. 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.
If the study is conducted or supported by HHS and involves an FDA-regulated product, the study is subject to both 45 CFR part 46 and 21 CFR parts 50 and 56, meaning that both sets of regulations must be followed. Where the regulations differ, the regulations that offer the greater protection to human subjects should be followed. Research not subject to 21 CFR parts 50 and 56 is also not generally subject to 21 CFR part 11 (FDA regulations regarding electronic records and electronic signatures).
This guidance has been prepared jointly by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). This guidance is intended for institutional review boards (IRBs), investigators, and sponsors engaged in or responsible for oversight of human subject research under HHS and/or FDA regulations.
This guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and 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. HHS requirements regarding the protection of human subjects are set forth in 45 CFR part 46. 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.
If the study is conducted or supported by HHS and involves an FDA-regulated product, the study is subject to both 45 CFR part 46 and 21 CFR parts 50 and 56, meaning that both sets of regulations must be followed. Where the regulations differ, the regulations that offer the greater protection to human subjects should be followed. Research not subject to 21 CFR parts 50 and 56 is also not generally subject to 21 CFR part 11 (FDA regulations regarding electronic records and electronic signatures).
For the purposes of this guidance, electronic informed consent refers to the use of electronic systems and processes that may employ multiple electronic media, including 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.
This guidance clarifies that when implementing an eIC, a variety of approaches may be used to fulfill HHS and FDA regulatory requirements for informed consent and IRB review (45 CFR part 46 and 21 CFR parts 50 and 56) and FDA regulations for electronic records and electronic signatures (21 CFR part 11).
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This guidance clarifies that when implementing an eIC, a variety of approaches may be used to fulfill HHS and FDA regulatory requirements for informed consent and IRB review (45 CFR part 46 and 21 CFR parts 50 and 56) and FDA regulations for electronic records and electronic signatures (21 CFR part 11).
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