- For more information see Learning Shot "The Informed Consent Process for Clinical Research "
- How will the consenting process take place
- Purpose of Consent Process
- Consenting Subjects who do not Read, Speak or Understand English Informed
- Consenting Vulnerable Populations
- Re-consenting Requirements
- Maintenance of Informed Consent Documentation
- Assessing Subject's Understanding
Use of Electronic Informed Consent (e-Consent)
Federal guidance on how to implement e-Consent in clinical research
The purpose of this document is to provide guidance on documenting consent other than by obtaining a physical inked signature on paper.
Electronic informed consent (e-Consent) refers to using electronic methods to obtain consent and can apply to either the process of consenting, the documentation of consent, or both. Electronic documentation of consent may be used when researchers conduct the consent process with subjects in person, as well as when potential subjects are not physically present during the consent process. In either situation, the consent process itself should still be designed to ensure that subjects are adequately informed about the research, can easily ask, and get answers to questions, and recognize that participation is voluntary.
When the IRB reviews the study, it will consider how the electronic signature is being created, whether the signature can be shown to be legitimate (confirm the subject or LAR identity using 2 forms of identification), and how the research team plans to provide a version of the consent form to the potential subject for their review and retention. Subjects must still be provided with the ability to access a written version of the consent form that they can retain for their records. All elements of informed consent are required by HHS or FDA regardless of the platform used. Regulations require IRBs to maintain the version of any web-based information containing the study-related information that the IRB has reviewed and approved. This includes text-based information as well as information provided via video, infographics, hyperlinks to external resources and other multimedia sources. If properly obtained, an electronic signature can be considered an ‘original’ for the purposes of recordkeeping. In other words, it would satisfy requirements in case of an audit.
Methods for e-Consenting
- In-person e-Consenting using an electronic device such as a tablet or a computer when subjects are on-site with study personnel present.
E.g., The subject meets study personnel on-site for a discussion. Comprehensive materials and the ability to sign may be provided through a device such as a tablet.
- Remote e-Consenting takes place without the researcher witnessing any or all the consent process in settings such as the subject’s home. Note: The study team must provide adequate justification for requesting remote e-Consent.
E.g., The subject is screened remotely by study personnel through a WebEx or Zoom conference and receive a REDCap/DocuSign/Qualtrics link that allows them to read comprehensive materials and sign electronically (remotely) on a personal computer.
Note: The study teams can use Zoom or Webex for a consent discussion. Zoom (not to be confused with Epic Zoom) cannot be used to share PHI.
To document e-Consent using a verifiable electronic signature AND use an application that meets the required UVA Data Security standards see (Docusign, UVA RedCap) & (Qualtrics) for completion of surveys).
NOTE: The UVA REDCap system is NOT 21 CFR Part 11 compliant. This means that it should NOT be used IF:
- your study is FDA regulated AND the data will be submitted as part of a marketing approval application OR
- your study is FDA regulated AND the study involves eConsent
When providing electronic consent, there are several ways in which an e-signature might be documented.
Some examples include:
- Typing one’s name with an accompanying check box and statement noting an intent to affix a legal signature (e.g., “By checking this box and typing my name below, I am electronically signing this consent form”); or
- Signing with a stylus in an electronic document. In-person e-Consenting versus remote e-Consenting
Researchers should have methods in place to ensure that the e-Consent process provides the opportunity to consider whether to participate, and to ask questions about the study before they sign consent, as well as at any time during the subject’s involvement in the research study. This may be accomplished by a discussion between study personnel and the subject, whether it is in-person, a telephone call, or a video conference. When video conferencing is used during the e-Consent process, study personnel should remind subjects to conduct the e- Consent discussion in a private location. Additionally, the signed documentation of consent from the subject, returned electronically or a digital form with electronic signature, must be obtained.
The electronic informed consent process must include the same information contained within the written ‘paper’ informed consent document; include methods to verbally discuss the consent form; evaluate the subject’s comprehension; and document the subject’s or LAR’s consent. The e-Consent must also contain all elements of informed consent required by federal regulations (45 CFR 46.116 and 21 CFR 50.25). The information must be in language understandable to the potential subject or the subject’s LAR and conveyed in a manner that minimizes the possibility of coercion or undue influence regarding the subject’s decision to participate in a study. The device, system, or platform used to obtain informed consent must allow enough time for completion, the ability to navigate forwards and backwards, and the option to stop and resume later. Electronic methods of communication should allow the subject to contact the researcher again at any point in the process to ask additional questions.
The IRB must review all forms (electronic and paper) and other informational materials, including any videos and Web-based presentations, which the subject will receive and view during e-Consenting. The IRB will also review any optional questions or methods used to gauge subject comprehension of key study elements. During its review, the IRB will review the proposed e-Consent process to determine the usability of the e-Consent materials. If the program uses hyperlinks to convey study-related information, the IRB will review the online materials to ensure that the study-related information is accurate and appropriate.
• Subjects must be instructed how and when they will receive answers to questions, and they must be provided information on how to contact an appropriate individual for pertinent questions about the research and their rights and whom to contact in the event that they sustain a research-related injury.
• Subjects may have difficulty navigating or using electronic systems because of a lack of familiarity with electronic systems, poor eyesight, or impaired motor skills. In such cases, e-Consenting processes should be ADA compliant to meet the needs of these subjects. A paper-based informed consent should be also available to subjects.
• The e-Consent may use interactive electronic-based technology, which may include diagrams, images, graphics, videos, hyperlinks, and narration. The e-Consent should be appropriate for the intended audience, taking into consideration the subject’s age, language, and comprehension level.
• Regulations require identity verification before study personnel establishes, assigns, certifies, or otherwise sanctions an individual’s electronic signature.
• The e-Consent process can be used to obtain assent from pediatric subjects (when applicable) and parental permission from their parent(s) or guardian as well as consent from a Legally Authorized Representative (LAR).
• Subjects should receive a copy of their e-Consent and have easy access to the materials and information presented to them during the consenting process with the ability to ask questions at any time.
• The electronic system used in e-Consent must be secure with restricted access and should include methods to ensure confidentiality regarding the subject’s identity, study participation, and personal information after informed consent has been obtained. Depending on the electronic system, additional clearance from UVA Information Security (INFOSEC) may be needed before IRB approval can be granted.
• Stand-alone HIPAA authorizations may be obtained electronically, provided that the signature of the subject (or the subject’s LAR) is a valid electronic signature under applicable laws and regulations.
• Any changes to the e-Consent materials and processes require submission of a modification to the IRB and subsequent IRB approval prior to their use. Study teams will be required to include the “Consenting Process” template into their revised IRB application.
Version Date: 11-28-22