The UI has a license for DocuSign. Contact ui-docusign-support@uiowa.edu to set up a DocuSign account. There are two versions of DocuSign. It is important to request the correct version for the type of data that will be collected: 

1) for studies that contain protected health information (PHI) as defined under HIPAA (Health Insurance Portability and Accountability Act)

2) for studies that do not contain PHI as defined under HIPAA. 

It is relatively quick and easy for researchers to set up a DocuSign account. Training is provided through the Purchasing Department. Once researchers set up a DocuSign account, they will need to activate it through the UI system. A UI DocuSign account is not connected to your HawkID. 

Currently, UI staff/departments are not charged to use DocuSign. The UI purchases “envelopes” for UI researchers to use. A DocuSign envelope is essentially an email, which will include the Informed Consent Document to capture electronic signatures.  This video also gives a step-by-step guide.

For the DocuSign program to function properly, documents to be signed must be uploaded as PDFs.  Converting an Informed Consent Document to a PDF does not affect the IRB approval stamp, therefore the DocuSign version of the consent document is compliant with UI policies and procedures. The DocuSign envenlope can also include additional reference materials that do not require a signature, such as a Consent Summary, diagrams, videos, etc. 

• Add documents in the order that you want subjects to see them.
• Add anyone who needs to sign the Informed Consent Document as a recipient.
• If more than one person needs to sign the document, set the signing order. 

Once the subject and/or the parent/legal guardian or Legally Authorized Representative (LAR) has signed the consent document, the person who obtains consent should receive the envelope for the final signature. The study team should ensure that processes are in place to identify the appropriate parent/guardian or LAR to route the Informed Consent Document for signature. The signature of the person who obtains consent should be the research team member who participated in the informed consent conversation and answered the subject’s questions about the study. 

To ensure consistency for all DocuSign emails, the research team should use the same template language when sending the Informed Consent Document and for all reminders. The default is that the reminders use the same language, so researchers do not have to make any changes. DocuSign automatically sends three reminders. The research team can contact potential subjects once by phone if there is no response after the three reminders. 

Email Template

Instructions: Copy and paste the following template language into the appropriate section in DocuSign. Replace the text in brackets with study-specific information.

[Salutation]

Thank you for thinking about enrolling in this study. [I am/We are] sending this Informed Consent Document to provide information and to describe what you will be asked to do if you decide to enroll in the study. You are not required to enroll in this study. [Insert the following statement if the study is clinical in nature.] Your clinical medical care will not be affected by whether you decide to enroll in this study. 

If you do not sign this form, you will receive three reminders from DocuSign. We will attempt to call you if we do not receive a signed Informed Consent Document after the three reminders, to make sure you received the document and to see if you are interested in participating. If you let us know you are not interested in participating, we will not contact you again.

Please do not sign this form if you:

• Have more questions about this study that this Informed Consent Document does not answer or if you don’t understand something.
• If you would like to have a member of the study team go over this Informed Consent Document with you while you are reading it. (This may already be part of the consent process)
• Would like to talk with your family, friends, or medical provider before you agree to participate.
• Do not wish to participate in the study. There may be an option for you to decline in the document or you may contact the research team directly. 

This video shows you how to use DocuSign, the program that allows you to sign/decline the Consent Document.

Please call or email [me / the research team] at [Insert phone number and email address]

[Insert signature block for the research team member or the study]

Add Documents, Recipients, and Template Email

1. Upload the Informed Consent Document

2. a. Check “Set signing order” if multiple people need to sign the document, such as the LAR and the research team member who obtained consent.

   b. Use the dropdown menu to add access/verification code.

3. Be sure to add the recipients in the order they need to sign, the subject/LAR should sign prior to the research team member who obtained consent.
4. Decide if you want to use the DocuSign default subject title or if you want to choose your own.
5. Copy and paste the template email.
6. Review the email before moving to the next section.
7. Click “Next” to designate where subjects select and initial optional agreements and add their eSignature.

Setting Privileges, Reminders, and Expiration Date

1. Dropdown menu to access Advanced Options.
2. Advanced Options allows access to setting privileges, reminders, and expiration dates.
3. Uncheck this box. This prohibits the recipient from forwarding the email or allowing someone else can sign.
4. Check this to set up automatic reminders. The original email automatically gets sent with each reminder.
5. Set the expiration for 35 days to assure subjects will not receive any notices after the last follow-up call, which occurs after the third reminder.

DocuSign has the capability to allow subjects to select and initial optional agreements, sign and date the Informed Consent Document, and decline participation. These options are denoted by specific icons on the left side of the screen. The icons need to be placed exactly on the line where the subject must initial, sign or date. The research team may choose to add the “decline” icon next to the “signature” icon. Subjects should have the option to decline, even if they verbally agreed to participate during a conversation with a member of the research team. There are multiple ways to document that the subject declined. Indicating it in DocuSign provides an audit trail. If the subject clicks the decline icon, all reminders stop, and the research team will not follow up with a phone call. ber of the Compliance Program team will conduct a follow-up monitoring visit six months after the plan is approved to ensure it has been implemented.

• Use the icons on the left side of the screen to configure the Informed Consent Document.
  • Drag the icons to the exact location where the information is required.
  • These icons can be moved with a mouse or trackpad.
• Optional agreements:
  • Radio buttons designate subject preference for optional study activities.
    • The research team will only add radio buttons if the study includes optional activities.
    • The subject must select an optional agreement and add their initials.
    • DocuSign will not allow the document to be “Finished” until the subject selects a response to an optional agreement and adds their initials. This ensures subject response to all optional agreements.
  • Set up optional agreements in DocuSign:
    • Click the “Radio” icon on the left and drag it to the “Yes” option. This will bring two stacked radio buttons.
    • Drag the lower radio button to the “No” option
    • Click the “+” to add more radio buttons, as needed (i.e., “Not Applicable”)
    • Click the “Initial” icon on the left and drag it to the left margin next to the optional agreement
    • Repeat for each optional agreement in the Informed Consent Document
• The recipients drop down menu is in the upper left corner of the page. It shows everyone listed under “Add Recipients to the Envelope” in the first part of the DocuSign set up process.  
  • Use this menu to assign the order of signature for the subject and anyone else (i.e., LAR, or Person Who Obtained Consent).
  • When you select a name, the icons will change color.
  • Drag the appropriate icon (Signature, Date Signed) on the left side of the screen to the section of the Informed Consent Document that each person will complete.

1. DocuSign provides secure storage of all documents sent and received through the program. The system also creates a Certificate of Completion with an audit trail of the Informed Consent Document, which includes the location of the persons who signed the document (i.e., subject, parent/guardian or LAR, and research team member who obtained consent).