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UUSOP-08: Obtaining Written Informed Consent

Supplement A - Remote Consent

Version Date: May 31, 2024

  1. Introduction and Purpose
  2. Definitions and Acronyms
  3. Procedure
    1. IRB Review
    2. Method(s)
  4. References
  5. Revision History


Introduction and Purpose 

There are times when an in-person consent process is not feasible. In these cases, remote consenting may be done via multiple methods including paper consent via mail, fax, e-mail, telephone, video platform (e.g., Zoom), electronic consent form (E-Consent) etc.

The purpose of remote consent is to allow the investigator/designee and potential participant/LAR to engage in the informed consent process in a way that is similar to what would be conducted in-person. 

The type of research and risk level (e.g., greater than minimal risk/minimal risk, FDA-regulated), the unique situation of the participant, as well as the ability to fulfill the requirements to obtain informed consent will need to be considered when choosing a remote consenting method. 

 

Definitions and Acronyms 

Legally Authorized Representative: An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the study.

CFR: Code of Federal Regulations
CTSI: Clinical & Translational Science Institute
ERICA:        Electronic Research Integrity and Compliance Administration program
FDA: United States Food and Drug Administration
GCP: Good Clinical Practice
HIPAA: Health Insurance Portability and Accountability Act
ICF: Informed Consent Form
IRB: Institutional Review Board
LAR: Legally Authorized Representative
SOP: Standard Operating Procedure



Procedure 

  1. IRB Review. The method(s) chosen for consenting participants must be described in the IRB study application (in ERICA) and approved by the IRB prior to utilization. If the method utilized is a change from what was initially approved by the IRB, an amendment is required.

    Your consent plan should include:
    • How the consent form is presented/reviewed,
    • How signature/date of the subject or LAR will be obtained,
    • How the name of study personnel obtaining informed consent will be documented,
    • How copies of the ICF will be provided to subjects 
  2. Method(s)
    1. Remote paper consent - If a paper document is used, mail, fax, or email the consent form to the potential participant/LAR in advance of the remote process. Options for participants to return the signed informed consent document to the study team via a HIPAA compliant method which may include email, fax, mail, etc. The remote environment can be virtual/online or on the phone.
    2. Electronic Consent (E-Consent) - is a method of obtaining informed consent through the use of electronic means instead of a paper consent form (e.g., REDCap, Adobe Sign, DocuSign, etc.) *. With this process, an electronic consent platform displays the consent document(s) to the potential participant and signatures are obtained electronically (e-signature). When electronic consent is utilized, the consent process itself should still be designed to ensure that participants are adequately informed about the research, can easily ask questions, and receive answers, and recognize that participation in the research is voluntary.

      *A 21 CFR Part-11 compliant system must be used for all FDA-regulated research that obtain electronic signatures through an electronic consent system. It is acceptable to fall back to actual, physical signatures instead of electronic signatures if a Part 11 compliant system cannot be used.

    3. Remote Informed Consent Process. The aim is to replicate the capabilities of an in-person consent process. General requirements regardless of the method (i.e., hardcopy or e-consent) include:
      1. The participant/LAR should have ample time and opportunity to review the consent form, and then discuss it and ask any questions together with the designated study team member.
      2. The study participant/LAR will be given contact information for the study team member (i.e., investigator/coordinator) so that they may call or contact with any questions. The study team member can also schedule a time to call the participant to discuss the consent documents.
      3. The physical location of the designated study team member and participant/LAR can be any place convenient to them (e.g., at home) but must provide adequate space for privacy and confidentiality.
      4. As appropriate, the participant/LAR should sign and date the ICF during the remote consent process:
        1. Paper Consent: The participant/LAR signs and dates a hard copy of the consent form and returns it to the study team via email, fax, scanned document, photo image, mail, etc.
          1. The designated study team member must receive the signed consent form (unless specifically exempted by the IRB) prior to initiating any study related procedures, and sign and date as well, on the day it is received.
          2. The study team must provide the person signing the consent form with a copy of the consent document, unless this requirement is waived by the IRB (Note: If sending copy by email, please include PHI in the subject line to encrypt).
        2. Electronic Consent (E-Consent): entire consent document can be provided/collected via an electronic system (e.g., REDCap) with an e-signature obtained.
          1. E-consent process can be in-person or remote:
            • In-person: consent on an electronic device; passed back and forth to sign
            • Remote: Link to e-consent sent (email etc.) to participant/LAR who signs electronically; designated team member then signs electronically
          2. The study team must provide the person signing the consent form with a copy of the consent document, unless this requirement is waived by the IRB.
      5. The designated study team member who consented the participant/LAR will document the informed consent process, clearly conveying the details of the process and discussions about the study with the participant. Please refer to UUSOP 08 Obtaining Written Informed Consent, section 3. Documenting the Consent Process.

References 

 

Revision History 

Version Date

Change Summary

31May2024

Original Version
Last Updated: 6/26/24