How does a standard U-M SignNow account differ from an FDA-compliant U-M SignNow account?
- 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.
If I am having technical difficulties using my U-M SignNow account, whom should I contact?
- Contact the ITS Service Center.
Electronic Informed Consent or Assent
The study participant to whom I sent an informed consent or assent document to sign is having trouble accessing the document. How should I guide the participant through this process?
- Please refer to the guidance showing how to sign a document, located here.
Do study participants need a SignNow account to sign a consent or assent document?
- 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.
Are there any resources for how to use SignNow?
- 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.
How do I know if my study is FDA-regulated?
- 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.
My study is FDA-regulated and I previously documented consent from participants using the standard SignNow version. Do I need to obtain re-consent from current participants?
- 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.
My study is FDA-regulated and I previously used a standard U-M SignNow account to obtain signatures on informed consent or assent documents. Do I need to report this to the IRB or submit an amendment for use of the FDA-compliant U-M SignNow account?
- 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.
My sponsored study is FDA-regulated and I used a standard U-M SignNow account to obtain signatures on informed consent or assent documents. Do I need to notify my study sponsor that the version of SignNow that I previously used was not FDA-compliant?
- 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).
I require documentation that the FDA-compliant version of SignNow at U-M meets the requirements of 21 CFR Part 11; where can I find this documentation?
- Documentation of 21 CFR Part 11 compliance is located here.
I currently have a standard U-M SignNow account; how do I switch to an FDA-compliant U-M SignNow account?
- Contact firstname.lastname@example.org and let the ITS E-Signature team know you need your SignNow account switched to an FDA-compliant account.
How long does it take to create an an FDA-compliant U-M SignNow account?
- Account requests are only processed Monday through Friday during regular business hours. Requests may take up to 2 business days to complete.
If I am part of multiple studies, do I need multiple SignNow accounts?
- No, an individual can only have one SignNow account. Documents for all studies are managed within a single account.
Alternatives to SignNow
What FDA-compliant alternatives to SignNow are there for documenting informed consent or assent at the University of Michigan?
- 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.