爱豆社区

UW E-Consent Tools

This webpage provides instructions to researchers intending to use UW eSignatures (powered by Docusign), UW Florence eConsent, UW Medicine Research Information Technologies (RIT) REDCap Part 11,聽 or UW ITHS REDCap e-consent tools. The UW IRB may be able to approve other electronic consent tools or methods. For full details, review the section on Approvable methods for obtaining electronic signatures in HSD’s consent guidance.

Using UW eSignatures (powered by Docusign)

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

Conditions for using eSignatures:

• All applicable requirements for 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.
• Approval to use eSignatures for electronic consent and/or HIPAA authorization signatures must be obtained from:
  • UW IRB, for UW-reviewed studies, or
  • the external IRB and HSD, for studies under external IRB review.
• 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鈥檚 delegated administrator, reach out to the eSignatures support team using the聽听蹿辞谤尘.
• Signed consent forms must be promptly downloaded from Docusign by the PI or study team. Docusign is not a storage solution.

Visit for additional information about this service. Explore the website and watch this brief, 1-minute video overview: .

Using UW Florence eConsent

UW Florence eConsent is an electronic consent tool maintained by the UW Clinical Trials Office (CTO) that meets FDA 21 CFR Part 11 requirements for FDA regulated research. You can save all signed forms from UW Florence eConsent to your study鈥檚 regulatory binder or download them to your computer.

Conditions for using UW Florence eConsent:

• All applicable requirements for electronic consent documentation must be met.
• Approval to use UW Florence eConsent for electronic consent and/or HIPAA authorization signatures must be obtained from:
  • UW IRB, for UW-reviewed studies, or
  • the external IRB and HSD, for studies under external IRB review.
• Use of UW Florence eConsent requires:
  • A one-time fee for industry-sponsored-and-initiated studies only. Study teams are advised to wait until contracts are finalized and IRB approval is granted before requesting setup for fee-incurring studies.
  • Required training for all study team members who will access the system, provided by Florence.
  • Study participants to authenticate their identity using an email-based account. Study teams may need to guide participants through the account creation process.

For more information, visit the UW CTO Florence website or email UW CTO at uwcto@uw.edu with UW Florence eConsent in the subject line.

 

Using UW ITHS REDCap

罢丑别听UW ITHS version of REDCap, accessed via a web browser on any device, can be configured to capture legally valid electronic signatures on consent forms and HIPAA authorization forms when the appropriate electronic consent templates and project settings are used.

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 obtained with REDCap Mobile are not considered legally valid under federal and Washington State law, so REDCap Mobile may only be used when the IRB has granted a waiver of documentation of informed consent.

Conditions for using REDCap:

• All applicable requirements for electronic consent documentation must be met.
• Approval to use REDCap for electronic consent and/or HIPAA authorization signatures must be obtained from:
  • UW IRB, for UW-reviewed studies, or
  • the external IRB and HSD, for studies under external IRB review.
• 罢丑别听UW ITHS version of REDCap聽cannot be used with any FDA-regulated study because it does not meet the FDA鈥檚 Part 11 electronic system requirements.
• The REDCap consent 鈥渟urvey鈥� (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. Review the ITHS online tutorial for details.
• 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.

Using a Non-UW or Other UW-managed REDCap Installation (Excluding UW ITHS REDCap and UW Medicine RIT REDCap Part 11)

Some studies may be required to use a REDCap system operated by another institution or wish to use a UW-managed REDCap installation that is not UW ITHS REDCap or UW Medicine RIT REDCap Part 11.

In these cases, research teams must complete the Other REDCap Installation Supplement. Data collection and electronic signatures may not begin in the other REDCap system until the supplement has been reviewed and approved by the UW IRB or, for studies under external IRB review, 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.

Keywords: Consent