Documenting Consent Electronically or for Remote Subjects Guidance

Version Date: October 21, 2020

The purpose of this document is to provide guidance on documenting consent obtained from subjects utilizing methods other than pen and paper. Most frequently, subjects document informed consent by providing their written signature in the provided space, at the end of the consent form. This guidance describes other methods that are also sufficient documentation of informed consent.

Electronic documentation of consent may be used when researchers conduct the consent process with participants in person, as well as when potential participants are not physically present during the consent process. In either situation, the consent process itself should be designed to ensure that participants are adequately informed about the research, can easily ask and get answers to questions, and recognize that participation is voluntary.

Electronic Signatures

Federal regulations allow electronic signatures to document informed consent (see Joint Guidance on Use of Electronic Informed Consent). The revised Common Rule [implemented January 2019] also includes language that clarifies, “informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject…”

Subjects must be provided with a version of the consent form that they can retain for their records, whether it is a hard copy or an electronic version.

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, and how the research team plans to provide a version of the consent form to the potential subject for their review and retention.

Per the US Office of Human Research Protections (OHRP): “One method of allowable electronic signatures in some jurisdictions is the use of a secure system for electronic or digital signature that provides an encrypted identifiable ‘signature.’ If properly obtained, an electronic signature can be considered an ‘original’ for the purposes of record keeping.” In other words, it would satisfy requirements in case of an audit. The FDA has specific requirements for electronic signatures that apply to FDA-regulated research. See FDA-regulated studies – electronic signature requirements below for details.

Faxing Copies of Signed Consent Forms

It is permissible for subjects to fax a signed copy of the consent form to the research team. If there are questions and/or check boxes embedded throughout the document for the subject to complete, the research team should check to ensure that these pages are included. Good Clinical Practice (GCP) or other guidelines may require that the study team receive a complete copy of the signed consent form. In cases where subjects are faxing a consent form to the research team, the subject need not provide the investigator with the original signed consent document.

Emailing Copies of Signed Consent Forms

Email is a convenient method of communication, and subjects may request to send or receive copies of documents through email. If the consent form or information sheet would reveal information about the potential subject’s health (e.g., “You have been invited to participate in this study because you have [disease/condition],”), then the subject should not email it to the study team unless you get their prior permission to communicate with each other through email for research purposes. Getting this permission requires making sure subjects are aware of the risks associated with sending health information via email. Please see our guidance regarding the use of email for research purposes for a more comprehensive discussion of these requirements.

Online Consent

For web-based surveys or questionnaires, the consent form may be presented online, and require participants to perform some action, such as clicking “I agree,” before proceeding with any research activities (e.g., answering survey questions on a website). This is an acceptable approach for low-risk research conducted online. However, be aware that this method does not document informed consent and therefore may only be used if the IRB has waived documentation of consent for the study. Other issues to address when using online consent:

Confirming Identities in Online Research

A study’s data validity or reliability could be fallible without verifying subjects’ identities. Examples include when there are critical eligibility criteria, or when there is a likelihood of repeat or fraudulent participation, whether for mischief or to collect multiple payments. When designing a research study, investigators should take into consideration the importance of identity to their study.

Studies that pose more than minimal risk, or that involve the transmission of sensitive information, may consider implementing a process by which they confirm identities using authentication that relies upon multiple factors, for example a password that is delivered to subjects by telephone or by postal service, or by using identity verification software.

For FDA-regulated studies, if any or all of the consent process takes place remotely and is not personally witnessed by study personnel, the electronic system must include a method of identity verification. Acceptable examples include state-issued ID, biometric methods, visual methods, or personal questions.

Completing the Consent and Authorization Sections of ARROW - Alteration of Informed Consent

When research teams interact with potential subjects face-to-face, they retain some control in the consent process in terms of describing research procedures, stopping to solicit information from subjects, and also observing whether potential subjects become inattentive. When making consent information available online, where the potential subject will read the information alone, researchers may wish to focus on the elements of consent most relevant to their type of study. If the research team wants to omit any of the required elements of consent (e.g., including a phone number for whom to contact with questions about research subjects’ rights), then an alteration of informed consent must be requested from the IRB.

Electronic Documentation of Consent vs. Waiving Documentation of Informed Consent

It is important to understand the difference between using methods other than paper and pencil to document informed consent and waiving the requirement to document informed consent altogether.

When providing consent online, there are a number of ways in which an e-signature might be documented. Some examples include:

All constitute “signatures.” A waiver of documentation of informed consent is not required for these procedures.

When a consent procedure will not include a written signature, it requires a waiver of documentation of informed consent. Common examples include online consent where participants are directed to begin a survey after reading an information sheet, or eligibility screening performed over the telephone with a potential subject. In these cases, the research team must request a waiver of documentation of informed consent from the IRB. More information about requesting this waiver, as well as the requirements of both the Common Rule as well as the FDA, can be found at Waiver of Signed Consent.

FDA-regulated studies – electronic signature requirements

If your study is FDA-regulated, requires signed consent (i.e. cannot justify a waiver of documentation of consent) and you intend to use electronic (digital) signatures rather than handwritten signatures, best practice is to obtain electronic signatures using a method that complies with 21 CFR Part 11 (FDA regulations related to electronic records and electronic signatures).

One such method is the Part 11-compliant version of DocuSign licensed by UW-Madison. To obtain a UW-Madison DocuSign account, fill out the RedCap form found on DoIT's webpage. For DocuSign Part 11 Compliance, select permission set "Part 11 Compliance Needed for Clinical Trials." For questions related to implementing DocuSign, contact Danae Wolff for UWCCC studies and Tina Graber in the Office of Clinical Trials for non-UWCCC studies.

Your IRB application should confirm that you will use an FDA Part 11 compliant tool appropriately set up by your information technology (IT) team.

Oral Consent Facilitated by Technology

When consent is obtained via audio/video real-time communication, using applications such as Skype or Facetime, the requirements are the same as if a research team were obtaining oral consent when face-to-face with a study subject. The study team must request a waiver of documentation of informed consent. More information about requesting this waiver, as well as the requirements of both the Common Rule as well as the FDA, can be found at  Waiver of Signed Consent.

HIPAA and Electronic Consent

Where the HIPAA Privacy Rule applies, the Rule allows a HIPAA authorization for research to be obtained and signed electronically, provided any electronic signature is valid under applicable law. Therefore, an alteration of HIPAA would not be required when electronically documenting subject’s signature.

As with consent, however, obtaining consent without a signature (e.g., click an OK box or providing oral consent via Skype) would require an alteration of HIPAA.

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