UW Electronic 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 electronic signature tools or methods. For full details, review the section on Approvable methods for obtaining electronic signatures in HSD’s consent guidance.

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 requirements that are specific to electronic consent documentation must be met.
  • Docusign cannot be used with any FDA-regulated study because it does not meet the FDA’s 21 CFR 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.
    • If you are unable to identify your department’s delegated administrator, reach out to the eSignatures support team using the Get help with eSignatures (Docusign) form.
  • Signed consent forms must be promptly downloaded from Docusign by the PI or study team. Docusign is not a storage solution.
• Visit eSignatures for additional information about this service.
  • Explore the Docusign Support website and watch this brief, 1-minute video overview: 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 requirements that are specific to electronic consent documentation 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.
  • The UW ITHS-supported version of REDCap cannot be used with any FDA-regulated study because it does not meet the FDA’s Part 11 electronic system requirements.
  • 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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Keywords: Consent