UW Research

Electronic Consent Signatures

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 study team must apply through UW-IT (see Applying through UW-IT to use DocuSign) to use DocuSign. The application process requires uploading a copy of the IRB approval letter (or Exempt letter) that specifically states that approval to use DocuSign has been granted.
    • The study team must promptly retrieve signed consent forms from the DocuSign site and store them, because DocuSign is not a records retention system.
  • Applying through UW-IT to use DocuSign. All documents put into DocuSign must have approval by the legal team overseeing the use of DocuSign at the UW. In addition, there is a mandatory onboarding process to ensure that eSignatures are a good fit for the study’s needs and to confirm that the intended usage meets University policy and guidelines for eSignature usage. As a result, the process of setting up for e-signatures can be time-consuming. Plan ahead! See this website for details and additional information: https://itconnect.uw.edu/work/administrative-systems/esignatures/

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 SUPPLEMENT Other REDCap Installation. 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

Open the accordion below for version changes to this guidance.

Version History

Version Number Posted Date Implementation Date Change Notes
1.0 10/08/2021 10/08/2021 Newly published guidance page