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West Virginia University Office of Human Research Protections
WVU Research Office

SOP 055: Electronic Consent

Document Version # Effective Date
SOP-0055 1.0 06/01/2020


  1. Purpose

    1. This SOP outlines the process and policy related to investigator submissions and WVU IRB review and approval\acknowledgement of the electronic informed consent (eIC) process.
    2. For the purposes of this document: 

      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 research projects and to obtain and document informed consent from participants.

      Informed Consent– The process of providing the potential participant with adequate information about the research to allow for an informed decision about voluntary participation in the research project.

    3. The scope of this SOP is the process, technologies and media used to obtain informed consent of human subjects for research under the HHS or FDA regulations. This SOP does not include the recruitment of subjects using electronic media.
    4. Begins: - Development of the eIC to be submitted to WVU OHRP.
    5. Ends: – Submission of the eIC to WVU OHRP for review and approval.

  2. Responsibility

    1. The PI is responsible for ensuring that the eIC meets institutional and regulatory requirements.

  3. Procedures

    1. Review SOP 012 – Informed Consent
    2. Develop the eIC process and media according to HHS and/or FDA regulations, as applicable
      1. The FDA’s requirements for electronic records/electronic signatures, informed consent, and IRBs are provided in 21 CFR parts 11, 50, and 56, respectively.
      2. HHS requirements regarding protection of human subjects are set forth in 45 CFR part 46.
      3. The information presented to the subject, processes used for obtaining informed consent, and documentation of the eIC must meet the requirements of these and other applicable regulations and institutional policies.
      4. Additional guidance from both FDA and HHS related to the use of eIC can be found at hhs.gov.
    3. Signatures must be legally binding digital signatures as directed by the jurisdiction where the research is to be conducted.
    4. Contact WVU OHRP for questions about eIC submissions.
    5. Submit the forms (electronic and paper) and informational materials, including videos and web-based presentations to be used during the eIC process to WVU OHRP via the WVU+kc system.
      1. Describe the electronic components in written format in addition to submitting the media.
      2. When WVU is not the IRB of Record – an acknowledgement is provided. (Amendments are not required to be submitted to the WVU IRB).
    6. Obtain IRB approval for subsequent modifications to the submitted information whether electronic or in hard copy if WVU is the IRB of Record.
    7. Maintain copies of the IC/eIC materials that have been approved such that the materials (paper or electronic) can be reproduced, opened, executed, and played in the event of an audit or inspection.
    8. Amendments to the eIC materials are required to be submitted to WVU OHRP when WVU is the IRB of Record.

  4. References

    WVU Institutional Policy

    • HRPP Policy Letter
    • SOP – 055 – Electronic Consent
    • Federal Regulations
    • 21 CFR Part 11
    • 45 CFR 46.116, 46.117
    • 45 CFR part 160, part 164 (subparts A and C) – Electronic HIPAA Authorizations
    • 21 CFR 50.25
    • HIPAA Security Rule
    • E-Sign Act (Public Law 106-229) – Electronic HIPAA Authorizations
    • UETA – Electronic HIPAA Authorizations
    • 21 CFR 312.23(a) (11) – FDA Record Archival
    • 1 U.S.C 355(o) –FDA Record Archival

    AAHRPP

    • Element II.3.F -
    • Element II.3.F.1 – Elements of Content Disclosure
    • Element II.3.G – Waivers
    • Tables II.3.G.1, II.3.G.2 – Waivers and Alterations DHHS and FDA

    WVU OHRP Forms

    • OHRP-23 ICF OMR Expedited\Exempt Template
    • OHRP-24 ICF OMR Flex Template
    • OHRP-25 – IC Cover Letter Template
    • OHRP 26 – ICF Full Board Template
    • OHRP-35 – Child Assent Template
    • OHRP-36 – MMR Parent and Child Consent\Assent Template
    • OHRP-37 – OMR Parent and Child Consent\Assent Template
    • OHRP-38 – HIPAA Authorization Consent
    • OHRP-21 – HIPAA Waiver of Research Authorization Form

    WVU OHRP Guidance

    • G-01 IC Assent
    • G 06 IC Consent and Parental Consent
    • G-13 Elements of IC
    • G-55 Electronic Consent