Last update: 8.28.2020
Study teams developing plans for remote consent processes should follow IRB Documenting Consent Electronically or for Remote Subjects Guidance when possible.
For FDA regulated studies, that require signed consent (i.e. they cannot justify a waiver of signed consent), if study teams intend to use digital signatures as opposed to handwritten signatures, best practice is to obtain digital signatures through a method that is FDA Part 11 compliant, such as the Part 11 version of DocuSign through the UW-Madison licensed version. UW-Madison now has Part 11 Compliant DocuSign. 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." Please contact Danae Wolff for UWCCC studies and Tina Graber in the Office of Clinical Trials for non-UWCCC studies for questions related to implementing Docusign. However, given the unusual circumstances as a result of the pandemic, the FDA has issued comprehensive guidance outlining alternative means of obtaining informed consent when neither wet ink signatures, nor Part 11 compliant electronic signature are possible.
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 clinical investigation or is the legally authorized representative of the subject.
For example, the 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). 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 or collected from the patient’s location and included in the study records, subjects or their LAR may scan the document or take a picture of each page via 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, note that it is best practice for the subject to email a picture of the entire consent form, because then the study team has a record of what information the subject received, and the full document that was signed. If it is not possible to send back the entire form, the subject should email 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 provided, study teams should confirm that the version date and IRB stamp is visible on the page(s) received, in order to document that the subject signed the correct version. The email from the subject can also provide documentation of timing of receipt and should be retained in the research records. See Documenting Consent Electronically or for Remote Subjects Guidance. Alternative methods for obtaining a signature may be appropriate in certain circumstances, as outlined in the FDA guidance referenced above.
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.
As per posted IRB guidance, the use of email to send or receive information that may reveal information about the potential subject’s health requires prior permission. Please see our Use of Email for Research Purposes Guidance for a more comprehensive discussion of these requirements.
Research records should clearly document what method was used to conduct the consent process and document that informed consent was obtained prior to beginning study procedures. Additionally, any alternative consent processes must be reviewed and approved by the IRB prior to implementation. Study teams are advised to avoid using specific product names (e.g. DocuSign, Webex) when describing the consent process in IRB documents, but rather to state that any electronic signature or videoconferencing software will comply with institutional requirements. Study teams conducting research that is subject to HIPAA regulations should consult with their departmental IT and/or HIPAA security officer. Please also see this guidance for a link to HIPAA compliant tools for exchanging and storing PHI.
Please see Remote Study Activities Guidance for more information about how recruitment, research interventions, and data collection can occur remotely.