DocuSign Frequently Asked Questions
Do I need to modify my IRB to eConsent patients with DocuSign?
If your IRB does not mention utilizing DocuSign for consenting patients, YES you need to modify your IRB to appropriately describe your usage of DocuSign to consent patients. Specific sections of relevance are:
- Section 2.3 Potential Participant Screening and Recruitment
Specify your plan to use DocuSign paired with an approved telecommunication tool for HIPAA usage (Zoom, WebEx). - Informed Consent
Explain your tele-consent process using DocuSign and chosen telecommunications tool. How will you discuss and answer participant questions? How will you communicate the access code for signing documents? What security features are in place to protect the integrity of the consent process (see below)? - Risk of Inappropriate Release of Personal Information
DocuSign is a HIPAA-compliant platform that adheres to the Advanced Encryption Standard. DocuSign requires senders to assign roles/recipients to specific fields to prevent another recipient from incorrectly entering data or signing where they should not. UNC policy for DocuSign requires study teams to assign an access code to documents sent to external recipients and for that code to be transmitted to the recipient independently from the document. The use of access codes ensures that should a recipient’s email be compromised; the document cannot be accessed without the access code.
How can multiple people be assigned to the same role for a template?
Signing groups can be created when requested to allow for multiple people from a study team to sign a document for a single role. For example, two research coordinators can be added to a signing group and when a document is sent using the signing group, either research coordinator can sign the document.
More information on using signing groups is available.
Do I need to assign an access code to a recipient?
If you are using DocuSign to send documents to a study participant, regardless of whether it is an FDA regulated or non-FDA regulated study, study teams are required to set an Access Code for study participants. The Access Code will need to be provided to the study participants by the study team in order for them to complete the signing. An Access Code can be set on the first page of the template creation process. Additional information is available.
Is there a cost to use DocuSign?
NO, for 2021 there is currently no fee for using DocuSign for Human Subjects Research. If this changes, the community will be notified well ahead of any changes to cost structure
Can I use DocuSign to obtain assent from minors?
YES, but specify language must be included in your Informed Consent form (template below) and additional steps must be followed.
To obtain electronic signatures from minors we must comply with additional requirements imposed by the Children’s Online Privacy Protection Rule (COPPA) to protect the children’s information, validity of the parental consent, and the minor’s assent. The following items have been agreed upon by the University Counsel Privacy Officer and the Office of Human Research Ethics to ensure that we comply with all federal requirements regarding electronic signatures for minors. An IRB modification will be necessary to include the below text and is not automatically added to the Informed Consent template at this time, though it may be available in the future.
Requirements:
- utilize the DocuSign Part 11 instance;
- include language within the assent that the parent also consents to having child’s information stored in platform; and
- have in-person identity verification component where the clinician confirms with the parent at initial study visit that they consent to storage of child’s personal identifiable information within the DocuSign platform and document that in a note on the consent
Implementation
- The below template text must be added to the informed consent and approved by the IRB
- The informed consent/parental permission containing the text provided below MUST be sent via the Part 11 compliant DocuSign Account
- Any member of the study team listed as Key Personnel on the IRB can provide the “Clinician Verification”
- The “Clinician Verification” can be completed using any UNC enterprise application approved for PHI, such as UNC’s HIPAA enabled ZOOM (UNC Health Webex it is NOT a UNC Enterprise Application and cannot be used)
Template Language for Informed Consent:
This section is to be included at the end of the Informed Consent
Child’s Name _________________
Legal Guardian Consent
“I consent to the use of UNC’s enterprise instance of DocuSign to store the personal information of [CHILD] to record and store their assent. I understand that revocation or request of deletion from DocuSign may impact [CHILD’s] ability to continue to participate in the study.”
Legal Guardian’s Name ________________ Legal Guardian Signature ______________________
Clinician Verification
“During the study related visit on [DATE] I have verified the minor’s participation in this study as stated on [DATE OF PARENT SIGNATURE], including the Legal Guardian’s consent to have the minor’s information stored in UNC’s enterprise instance of DocuSign”
Clinician’s Name _________________ Clinician Signature _____________________
Can I use DocuSign for in person consenting?
MAYBE, the Part 11 account cannot be used for in person signatures but the however the standard account can be. You must indicate on your IRB that you will use DocuSign for in person signing instead of remote consenting and is not an FDA regulated study.
How do I set my default DocuSign Account?
Your “Default” account is the account you see whenever you log in to DocuSign. With how DocuSign user accounts are provisioned, everyone’s “Default” account is a generic account with no permissions. The account name is the same in both development and production systems:
UNC Chapel Hill SSO Default (Signer Only)
You can change your default account to the Human Subject Research.
- Click on your initials in the top right corner of the page and select “My Preferences”
- Near the center of the page, locate the text “Your eSignature Default Account”
- Click “Switch Accounts”
- From the popup, select the “UNC-CH: Human Subject Research” Account
What is the DocuSign Development Environment?
The DocuSign development environment is a place for study teams and users to create and test new templates. Because each transaction in the production systems incurs a fee, the development environment allows you to test new documents without incurring that fee. Though this fee is not passed on to study teams, we do ask that users leverage this environment to reduce costs and allow this service to continue to be provided for free.