UW E-Signature Tools

This webpage provides instructions to researchers intending to use UW DocuSign or UW ITHS REDCap e-signature tools. The UW IRB may be able to approve other e-signature tools or methods. Review the section on Approvable methods for obtaining electronic signatures in HSD’s consent guidance for full details.

Note that UW DocuSign and UW ITHS RedCap are the only two acceptable methods of obtaining e-signatures for HIPAA authorization to access PHI held by UW Medicine and Seattle Children’s. Review Special considerations in HSD’s consent guidance for additional information.

Using UW eSignatures (DocuSign)

eSignatures Service (DocuSign) is an electronic signatures service provider, centrally managed and supported by UW-IT.

• Conditions for using DocuSign:
• All of the applicable general requirements for e-signatures must be met.
• It cannot be used with any FDA-regulated study because it does not meet the FDA’s Part 11 electronic system requirements.
• Specific approval to use it for consent signature and/or HIPAA authorization signature must be obtained in advance from the UW IRB. For studies reviewed by an external IRB, approval must be obtained from the external IRB and HSD.
• After obtaining IRB approval to use it, the PI or study lead can request a DocuSign “Sender” account from their DocuSign Delegated Administrator. Reach out to the eSignatures support team if you are unable to identify your department’s delegated administrator.
• The study team must promptly download signed consent forms from the DocuSign site and store them, because DocuSign is not a document storage/records retention system.
• For additional information about eSignatures visit, https://itconnect.uw.edu/work/administrative-systems/esignatures/.
  • Review the DocuSign company website for a 1-minute video demonstration. Scroll down the homepage to the Video: How it works.

Using UW ITHS REDCap

REDCap is a secure web-based application for building and managing online surveys and databases. While REDCap can be used to collect virtually any type of data, it is specifically geared to support online or offline data capture for research studies and operations. The UW ITHS-supported version of REDCap that is accessed via web browser (on any device, including a mobile device) can be configured to capture legally valid electronic signatures on consent forms and HIPAA authorization forms. Please note that the REDCap Mobile application does not support the same secure set-up and records retention requirements. It is a separate software application for use with a mobile device when internet service is absent or unreliable. Electronic signatures captured with the mobile version are not considered legally valid under federal and Washington State law. Use of the mobile app is only permitted under an IRB-granted waiver of the requirement to obtain documentation of informed consent.

• Conditions for using REDCap:
• All of the applicable general requirements for e-signatures must be met.
• Specific approval to use the REDCap electronic signature process for consent signature and/or HIPAA authorization signature must be obtained from the UW IRB. For studies reviewed by an external IRB, approval must be obtained from the external IRB and from HSD.
• REDCap may also be used for FDA-regulated studies. The UW-ITHS-supported version of REDCap meets the FDA’s Part 11 electronic system requirements. To fully comply with Part 11, researchers must also implement all other procedural requirements for Part 11 (e.g., limiting system access to only authorized users). A complete list of requirements is outlined in the FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application (September 2003).
• The REDCap consent “survey” (the term used for consent forms in REDCap) must be set up for the individual project using one of the ITHS REDCap e-consent templates. See the ITHS REDCap website for an online tutorial on how to do this.
• The signed consent form must be retained in REDCap on the REDCap server. REDCap will automatically store the consents so long as no records or the project itself are deleted. The researcher is responsible for ensuring the signed consent forms are retained for the appropriate record retention period.
• Studies that are required to use a non-UW REDCap system (i.e., that is run by another institution) must provide HSD with a completed Other REDCap Installation Supplement. The use of the REDCap system cannot begin until it has been approved by the UW IRB or, if review if from an external IRB, by HSD.

E-consent tutorial

This short, interactive tutorial provides a quick overview of electronic consent – Electronic Consent: What you need to know.

Version Information

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