December 2016 – The U.S. Food and Drug Administration (FDA) finalized its guidance intended for institutional review boards (IRBs), investigators, and sponsors engaged in (or responsible for) oversight of human subject research under the Department of Health and Human Services (HHS) and/or FDA regulations. The guidance, created in conjunction with the HSS and Office for Research Protections (OHRP), provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent.
Human drug and biological products, medical devices, and combinations thereof are included in the guidance. The information presented to a subject, processes used to obtain informed consent, and documentation of the electronic informed consent (eIC) must abide by the regulations set forth in the guidance. The FDA operationally defines eIC as “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 obtain and document informed consent.” It is wise to define a detailed definition of eIC, for the term informed consent can mistakenly be understood as obtaining a handwritten signature on a written consent form. This represents only one piece of the consent process; it also includes providing the subject with adequate information to make a decision, ask questions, and ongoing communication throughout the study.
In addition to defining the full eIC process, the guidance provides answers to commonly asked questions concerning instituting an electronic informed consent process. For questions about the new guidance as it may relate to your current clinical research process, please contact us today to start a conversation.