Study teams must describe both the consent process and documentation of consent in IRB submissions.

Any method of obtaining informed consent other than a face-to-face consent interview must allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a subject in the research study or is the legally authorized representative of the subject.

Some minimal risk research may qualify for a waiver of written documentation of consent and an altered HIPAA authorization. In determining how to document informed consent, researchers may request that the IRB waive the requirement to obtain a signed form from some or all subjects.

In all cases, research records should clearly document what method was used to conduct the consent process and document that informed consent was obtained, if required, prior to beginning study procedures.

Any use of email as described below must comply with the IRB’s Email Recruitment Guidelines.

For research using a “wet signature”:

• A consent form may be sent to the subject or the subject’s legally authorized representative by mail, facsimile or e-mail, and the consent interview may then be conducted by telephone or via a UW-approved videoconferencing platform (i.e., WebEx, Secure Zoom). This process allows the subject or subject’s legally authorized representative to read the consent form before or during the consent discussion. After the consent discussion, the subject or the subject’s legally authorized representative can sign and date the consent form. If the signed informed consent document cannot be mailed, brought to the next study visit, or collected from the participant’s location and included in the study records, subjects or their LAR may scan the document or take a picture of each page via an appropriate mechanism based on the sensitivity of the study, such as a smartphone or camera and send the document back to the study team via a UW approved document sharing option (e.g., uploads to Secure Box Folder, WebEx) or via email or fax. If a picture is used, the subject should send a picture of the entire consent form so you have a record of what information the subject received, and the full document that was signed. If the entire form cannot be sent back, the subject should send the signature page(s) as well as any pages requiring subject responses, such as checkboxes or initials. In cases where the entire form is not received from the subject, document that the entire consent form was provided to the subject and confirm that the version date and IRB stamp is visible on the page(s) received, to document that the subject signed the correct version. The email conversation with the subject can also provide documentation of timing of receipt and should be retained in the research records.
• Finally, the person signing the consent form must receive a copy of the consent form. Although FDA regulations do not require the subject’s copy to be a signed copy, FDA recommends that a copy of the signed consent form be provided.

For research using an electronic signature:

“Digital signatures” may be acceptable forms of documentation of written informed consent. Electronic, computer, or tablet-based consent documents may facilitate record keeping even when an individual is present and could sign a paper form. Digital signatures may be considered for face-to-face and remote consent, but the technologies and processes used must be described in the protocol or application.
Digital signature generally take three forms:

1. Actual signatures on tablets or computers (where an individual uses a stylus or finger to make a representation of their signature, as available in many retail stores) ;
2. Validated electronic signatures on platforms with password entry (such as those used to sign medical notes or electronically write prescriptions); or
3. 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”); this method is not allowable for FDA-regulated research.

Validated electronic signatures typically require one to “set up” an identity and password within an electronic system and may not be easily and rapidly activated. All forms of digital signature may be used in research in certain settings, but because of tracking, privacy, and identity validation issues, this may be more challenging than it initially appears.

‘Digital signature’ methodologies, if used entirely remotely, are generally approved only for low risk research or other circumstances (i.e., time of national emergencies, pandemics, natural disasters) because it is not always possible to validate the identity of the individual. When a stylus is used to collect a signature in person, the usual methods of identity validation should be used.

Researchers conducting FDA regulated research may also use the University’s instance of DocuSign that is Part 11 Compliant to obtain an electronic signature on the consent/authorization form.

See HRP 314-WORKSHEET- Criteria for Approval; HRP 090-SOP-Informed Process for Research, and HRP 091-SOP-Written Documentation Consent.