Updated April 9, 2020
Electronic and remote informed consent procedures are permitted by IRBMED and must meet the same regulatory and institutional requirements of an in-person paper-based informed consent process. This guidance is intended for research studies that require signed informed consent.
Electronic informed consent (eIC) refers to the use of electronic processes and systems (i.e., information presented via computers, tablets, websites, smartphones) to convey study information and/or to document informed consent from a participant or Legally Authorized Representative (LAR). Research studies using eIC must comply with federal Health and Human Services (HHS) requirements at 45 CFR 46 and the University of Michigan Human Research Protection Program Operations Manual. Research projects that are subject to Food and Drug Administration (FDA) regulations must comply with FDA requirements at 21 CFR 11, 50, and 56. Research projects using or disclosing Protected Health Information (PHI) must comply with Health Insurance Portability and Accountability Act (HIPAA) requirements at 45 CFR 160 and 164. The participants and the study team are not necessarily remote from each other.
Remote informed consent procedures (i.e., the participant and the study are physically separated from each other) may be still conducted with the use of paper informed consent materials when it is not possible to develop an eIC process due to time constraints or technological limitations. The section titled “General Requirements and Considerations for Remotely Obtaining Informed Consent Using Paper Documents” provides guidance for these situations.