Electronic Signatures and Waivers of Documentation of Consent


Please note HIPAA-protected data, FERPA-protected data, and FDA-regulated research have stricter policies for electronic signatures than standard research regulations. The information below does not apply to HIPAA-protected data, FERPA-protected data, and FDA-regulated research unless specifically noted.

An electronic signature can be used as legally effective documentation of consent. To be legally effective, the electronic signature needs to be attributable to a verified identity. (Note: This only applies to studies conducted in the United States. If you are conducting research outside of the United States and want to document consent using electronic signatures, you will need to become familiar with the foreign country’s laws regarding what constitute a legal signature.)

One of the justifications (45 CFR 46.117(c)(1)) for approving a Waiver of Documentation of Consent is if the individual’s signature/name on the consent document is the only record linking the participant to the research and the principal risk would be the potential hard resulting from a breach of confidentiality. Based on this justification, it is OPRS’ opinion that documentation of consent requires confirmation of the participant’s name and agreement to participate.

The IRB application should explain the electronic signature process and provide full details on how the researcher will verify the identity or be confident in the identity of the individual agreeing to participate. The IRB and OPRS will consider the study procedures and risks of the research as part of the determination if the plan constitutes effective documentation of consent.

Examples of how this could be accomplished include:

  • Having the potential study participant write their signature on a digital screen when in the presence of a member of the study team (either physically present or remote via a video conferencing platform).
  • Typing of name to indicate electronic signature when the potential study participant is signed into a password protected system. (e.g. DocuSign, RedCap, AdobeSign)
  • Sending an email to a school email address or text message to a phone number given by the potential participant with a link to access the electronic consent included in the message.
  • Using a system/authentication process that records the name and time an individual performs certain actions. For example, if the consent document is behind UIUC authentication, and the program you are using documents the name and date/time an individual presses “Agree”, this may be sufficient documentation depending on the risks of the study. 

If you are conducting a study that requires you to document consent, you must ensure that participants’ electronic consents can be traced to their verified identities for the electronic signature to be legally effective. The ability to verify identity and show that the signature is attributable to the study participant is important to consider when designing the consent process for the study and choosing the electronic platform/program to use for the consent process. Typing out an email address alone may not be considered adequate to verify identity.

Waiver of Documentation of Consent for Electronic Consent

If you are not able to satisfactorily verify the identity of participants, it may be acceptable to request a Waiver of Documentation of Consent for your electronic consent.

Example of when a waiver of documentation of consent should be requested:

  • Research involves an online survey, no identifiable information is being collected and the only risk to participants would be the potential risk of a breach of confidentiality. The consent cover letter or information sheet is the first page of the survey and the participant selects “Agree” or “Continue” if they want to continue through the survey. The survey platform is not collecting identifiable information about the individual.
  • Interview or focus group research, the participants review the consent cover letter or information sheet and continue through the interview or focus group process. No identifiable information is being collected about the individual.

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