Informed Consent Procedures Using Electronic Systems and Remote Use of Paper Documents

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. Under some circumstances the IRB can approve a waiver of the requirement for documentation of informed consent.

Electronic informed consent (eIC) refers to

• the use of electronic processes and systems (i.e., information presented via computers, tablets, websites, smartphones)
• in order to
  • convey study information and/or
  • document informed consent from a participant or Legally Authorized Representative (LAR).

The participants and the study team are not necessarily remote from each other.

Research studies using eIC must comply with

• federal Health and Human Services (HHS) requirements at 45 CFR 46; and
• University of Michigan Human Research Protection Program Operations Manual; and 
• if subject to Food and Drug Administration (FDA) regulations, requirements at 21 CFR 11, 50, and 56;
• if using or disclosing Protected Health Information (PHI) must comply with Health Insurance Portability and Accountability Act (HIPAA) requirements at 45 CFR 160 and 164.

Remote informed consent procedures (i.e., the participant and the study are physically separated from each other) may be still conducted with paper informed consent materials (or electronically viewed images thereof) when it is not possible to develop an eIC process due to time constraints or technological limitations. See “Remotely Obtaining Informed Consent Using Paper Documents” below.

SignNow is electronic signature service available for use by UM personnel and students. The service is available in two versions: a standard version and an FDA-compliant version. Both are HIPAA-compliant but only the FDA-compliant version meets 21 CFR Part 11 requirements. FDA-regulated studies using SignNow must transition to the new FDA-compliant version. Instructions on electronic informed consent using SignNow are available through:

• U-MIC Part One: Overview
• and Part Two: Managing Templates with Variable Signers

• ITS: eSignature Service: SignNow (webpages, videos, and Quick Reference Guides)