March 30, 2021
For the Record – March 30, 2021: COVID Recovery Phase 3 & Human Subjects Research; E-signature Updates
- Washington State COVID Recovery Phase 3
- UW eSignatures (DocuSign) for HIPAA Authorization
- Other E-signature Options
- External IRB Requirements for E-signature
- Required Consent Information for E-signature
Most of this issue is about new options and requirements related to the use of e-signatures for capturing documentation of informed consent and HIPAA authorizations. Check out our updated GUIDANCE Electronic Informed Consent for complete information on this topic.
Washington State COVID Recovery Phase 3
What does it mean for allowable UW human subjects research?
Effective March 22nd, the entire state of Washington (including King County) entered Phase 3 of the Healthy Washington: Roadmap to Recovery. The state Department of Health will re-evaluate each county every three weeks, with the first evaluation scheduled for April 12th.
The Office of Research and the Human Subjects Division (HSD) are working with UW experts to identify any appropriate changes to what types of UW human subjects research is allowed. No changes will be made before the April 12th re-evaluation of King County.
UW eSignatures (DocuSign) for HIPAA Authorizations
eSignatures (DocuSign) tool can be used to obtain legally-valid electronic HIPAA authorization signatures for release of Protected Health Information from their institutions. This is in addition to the previously approved use of the UW ITHS REDCap e-consent tool for HIPAA authorizations as well as consent. Prior IRB approval for use of e-signatures is still required. For studies using an external IRB, approval must be obtained from both the external IRB and HSD.
Other E-signature Options
In our October 15, 2020 newsletter we indicated that HSD would continue to work on developing a process by which other e-signature tools could be used, in addition to the UW-vetted ITHS REDCap and eSignatures (DocuSign). HSD already permits use of non-UW REDCap systems that meet all of the requirements outlined in the SUPPLEMENT Other REDCap Installation.
We now have a formal process in place to review and approve other e-signature tools. The process is based on vetting and attestation by appropriate individuals with technical knowledge about the tool. Researchers must provide (as part of their HSD application) a signed Other E-signature Attestation Letter
External IRB Requirements for E-signature
Effective March 25, 2021, UW research that is being reviewed by an external IRB instead of the UW IRB must obtain HSD concurrence before implementing the use of e-signatures for consent and/or HIPAA authorization. This is accomplished by answering the e-signature questions in the REQUEST External IRB Review form and, if applicable, uploading the SUPPLEMENT Other REDCap Installation or Other E-signature Attestation Letter to the Local Site Documents SmartForm in Zipline.
Studies previously authorized to use an external IRB who later decide to add use of e-signature for documentation of informed consent must submit a modification to their application in Zipline and obtain HSD concurrence before submitting a modification to the reviewing external IRB.
Required Consent Information for E-signature
Washington State and federal e-signature laws require specific information to be provided to participants when signatures are obtained electronically or through capture of a handwritten signature as an electronic record. This includes:
- A statement that a copy of the consent information (e.g., consent form) will be provided electronically, including a description of the hardware and software requirements necessary to access/read the document;
- Information regarding how a participant can request and receive a paper copy of the consent form at no cost;
- Information regarding how a participant can withdraw consent (for example, by contacting the researcher, including a description of how).
Language addressing these elements is included in our TEMPLATE Consent Form, Standard. You may need to customize the information depending on the e-signature tool being used.
Check out our updated GUIDANCE Electronic Informed Consent for more information regarding options for communicating this information to study participants, especially for studies reviewed by an external IRB instead of the UW IRB.