The University’s E-signature Service, SignNow, has a version that is compliant with FDA regulations at 21 CFR Part 11. Research studies that are not FDA-regulated may use the standard version of SignNow to document consent or assent electronically.
SignNow is an electronic signature service available to University of Michigan (U-M) faculty, staff, and learners associated with all University of Michigan campuses (i.e., Ann Arbor, Dearborn, Flint, and Michigan Medicine). The standard version of SignNow in use at U-M was determined not to fully comply with the United States Food & Drug Administration (FDA) electronic signature requirements at 21 CFR Part 11. As of October 27, 2021, U-M offers two versions of SignNow to faculty, staff, and learners:
- A standard version, and
- A new FDA-compliant version (available October 27, 2021)
Study teams conducting FDA-regulated research and using a U-M SignNow account to obtain electronic signatures should use an FDA-compliant account to send documents. FDA-regulated studies still enrolling participants and using SignNow to document consent or assent electronically should transition to the FDA-compliant version of SignNow at the earliest opportunity but not later than December 20, 2021. Studies that are not FDA-regulated may use the standard version of SignNow to document consent or assent electronically.
Importantly, faculty, staff, researchers, and students may have either a standard U-M account or an FDA-compliant U-M account for SignNow, but not both. If an FDA-compliant U-M SignNow account is created, then all SignNow documents managed by the account owner (including any documents unrelated to the study) will be associated with their FDA-compliant account and require additional validation steps for the recipient/signer of the document.
To switch an existing standard U-M SignNow account to an FDA-compliant account:
- Contact [email protected] and let the ITS E-Signature team know you need your U-M SignNow account switched to an FDA-compliant account.
To create a new U-M SignNow account (either the standard or FDA-compliant version), submit a request with ITS here.
Additional guidance, including whether participant re-consent is necessary, is located below. Information for sponsors, including an explanatory letter that can be provided to them, is located here (Note: You must be logged into your U-M Dropbox account to open the file).
An FDA-compliant U-M SignNow account requires additional steps to ensure that the identity of a document recipient/signer is validated. This includes requiring an authentication method (e.g., document password or a code sent to the recipient’s mobile number as a call or text) to access a document and requiring recipients to have a SignNow account.
Contact the ITS Service Center.
Please refer to the guidance showing how to sign a document, located here.
If your study is not FDA-regulated and you are using a standard U-M SignNow account to send documents, then study participants do not need to a SignNow account to sign a consent or assent document electronically.
If you are using an FDA-compliant U-M SignNow account to send documents, then study participants must have at least a basic SignNow account to sign a consent or assent document electronically. If a participant does not have a SignNow account, they will need to follow website instructions to create a basic SignNow account. Basic SignNow accounts are free to study participants.
Refer to the ITS SignNow website for information about using SignNow.
You can also refer to IRBMED Guidance: SignNow for Electronic Informed Consent Procedures or two U-MIC presentations with instructions on electronic informed consent using SignNow: Part One: Overview and Part Two: Managing Templates with Variable Signers.
Your study is likely FDA-regulated if it is a clinical investigation involving the use of FDA-regulated articles in humans. These articles include medical devices, drugs, biological products, dietary supplements that bear a nutrient content claim or health claim, infant formulas, food and color additives, and other electronic products.
No, it is not necessary to obtain re-consent from current participants unless required by a sponsor. Provide study sponsors the explanatory letter located here (Note: You must be logged into your U-M Dropbox account to open the file). If a sponsor indicates re-consent is required, contact IRBMED.
Plan to transition to an FDA-compliant U-M SignNow account by December 20, 2021. The IRB will subsequently query study teams as to their compliance with this requirement. No ORIO or amendment to the IRB is necessary.
No direct notification of the sponsor is necessary unless the sponsor requests information. If they request additional details, provide the explanatory letter located here (Note: You must be logged into your U-M Dropbox account to open the file).
Documentation of 21 CFR Part 11 compliance is located here.
Contact [email protected] and let the ITS E-Signature team know you need your SignNow account switched to an FDA-compliant account.
Account requests are only processed Monday through Friday during regular business hours. Requests may take up to 2 business days to complete.
No, an individual can only have one SignNow account. Documents for all studies are managed within a single account.
If remote documentation of consent is needed, the study team can use methods described in IRBMED guidance for Informed Consent Procedures Using Electronic Systems and Remote Use of Paper Documents under the heading “General requirements and considerations for remotely obtaining informed consent using paper documents.”
The study team can implement an in-person informed consent process utilizing paper consent or assent documents and obtaining wet-ink signatures if appropriate or feasible.
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