Test e-Consent Project

Create a record and Enter Participant Information

1. In the left-hand menu, click Add/Edit Records then click the +Add new record button.

2. On the Record Home Page, click the gray circle to the right of the Participant Information instrument

   Open

   

    

3. Enter a first name, last name, and date of birth. 

   1. can be real or fake information. 

4. How would the participant like to complete the e-consent? → Send survey by email

5. Enter a numeric PIN → Enter a 4-digit PIN.

   1. Can be simple during testing (e.g., 1234) but not with real participants

   2. The study team can decide whether they or the participant chooses the PIN

6. Would you like a copy of the signed consent form emailed to you?

   1. Per WashU IRB Policy, the participant must receive a copy of the fully executed consent with both their own signature and a signature of the study team member who completed the consent attestation.  Use the bullets below to guide your answer

      1. Yes if obtaining consent from a distance and no opportunity to give paper consent

      2. Optional if obtaining consent in person and have the option of receiving paper copy

      3. Optional if obtaining consent remotely but participant has subsequent in-person visit and have the option to receiving paper copy

7. Participant’s email address – Enter your email address or the person who will be testing the consent survey

8. WUSTL email address of study team member completing the consent process – enter your email address or the email address of the study team member who is testing the project

9. Change the Complete? dropdown menu to Complete

10. Click Save & Exit Form.

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Deliver e-Consent Survey as Study Team Member

1. Click Survey Distribution Tools → Participant List → Compose Survey Invitations

   Open

   

2. When the Send a Survey Invitation to Participants dialog box opens:

   1. When should the emails be sent? → Immediately

   2. From: Enter name the participant will see, i.e. your name, lab name, study name, etc. in the text box and the email address of the study team member you would like the email to be delivered from in the drop-down menu

   3. In Subject: type Informed Consent Form to Review and Sign

   4. In the Email Body: type the text below.
      Please review this informed consent form at your convenience.

      You may open the informed consent form to review and complete in your web browser by clicking the link below:
      [survey-link]

      If the link above does not work, try copying the link below into your web browser:
      [survey-url]

      This link is unique to you and should not be forwarded to others.

   5. Note: Once you have sent one survey invitation with the text above, you will be able to select the “Select a previously sent email to load it in the Compose box” to autofill the email body.

3. The email address is listed with a blue check mark

4. Click Send Invitations

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Access and Complete e-Consent Survey as Participant

1. Log in to your email → Navigate to email invitation → Click link to open survey

   1. NOTE: If you do not immediately receive the email, follow this guide: When sending out survey invitations, the recipient isn’t receiving the email?

2. Survey Login dialog box → Enter an incorrect PIN and click Log In. The following error should appear:

    

3. Enter the correct PIN that you entered to the PIN field on the Participant Information instrument

4. When the survey opens, confirm that:

   1. The PDF of the consent is showing up correctly (if you choose to keep that field in your project)

   2. Text in the survey matches what is in the .rtf form from the myIRB application including the IRB Stamp field

   3. There is a Save & Return Later button at the bottom of each page of the survey

   4. Fields that require a response from the participant (i.e. initials, signature, date) are marked as required and do not allow the participant to move to the next page or submit the survey until they are completed

   5. Branching logic included on initials fields or other fields is working properly (i.e. an initials field that is only supposed to appear given the answer to previous question is “Yes” is working as it should)

   6. Date and time are automatically added Date of Consent: field and is read only so cannot be edited

   7. You cannot proceed past signature page unless all fields are completed

   8. The final page of the survey, which appears after the participant signature field, allows the participant to review the consent form and requires them to checking a box that all information on the document is correct.

   9. From this page, select Previous Page. This should cause the Signature of Participant field to be erased.

   10. Re-sign the form, select Next Page, review the information in the PDF for accuracy, check the box certifying that the information is correct and click Submit.

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Complete Study Team Signature - Attestation

1. Locate email in inbox of WUSTL email address of study team member completing the consent process with the subject line “Informed Consent Form to Review and Sign”

   1. Click the Informed Consent link. You will prompted to log in to REDCap if you are not already

2. You should now be viewing the consent form that was completed as a survey.

3. Review that all fields that require a response from the participant are completed and are read only. These fields should appear slightly greyed out compared to others

4. Important! If you do not see the participant’s responses when viewing as a form, do you save the form. This may delete the participants responses. Rather, click Record Status Dashboard to leave the form without saving it and then return to the form.

5. Click Edit response at the top of the page

6. Check that responses completed by the participant are still read only and cannot be edited (these fields should appear slightly greyed out compared to the fields that are not read only)

7. Complete the signature and name fields and Click Now next to the Date and Time field

8. Select Save & Exit Form

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Check Fully Executed Consent as Study Team Member

1. After clicking Save & Exit Form, you will land on the record dashboard.

2. The square next Fully Executed Consent should be red indicating the PDF was uploaded. Click the red square

    

3. Scroll to the bottom of the PDF to ensure both signatures are complete and check that the record ID does not appear in the footer of the PDF:

    

4. Click Survey Distribution Tools → Survey Invitation Log → View past invitations if Fully Executed Consent invitation is not visible in View future invitations

    

5. Click the envelope icon under View Invite if you would like to view exactly what the participant sees.

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Receive Fully Executed Consent Form as Participant

1. Navigate to the email entered into the Participant’s email address field

2. Find the email with the subject line: Signed Informed Consent Form for Your Records

3. Click on the survey link and enter the PIN if necessary

   1. If you logged in to the consent survey within the last 30 minutes you will see the alert below and not need enter the PIN

       

4. Scroll to the bottom of the PDF and ensure you can see both signatures:

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