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Summary
The following documentation details how to setup an approved Institutional Review Board (IRB) electronic consent (e-consent) using the customized REDCap template, "IRB: Web Consent Form Template". This template should not be confused with the "IRB: Consent to Participate in Research Template (PI Signature Required)", as this template requires only the participant to sign the e-consent. This template should be used for online studies that do not involve any interaction with the participant.
The e-consent process works as follows: (1) the e-consent is emailed to participants as survey link, (2) the e-consent will capture participant information and their electronic signature (e-signature), (3) participant will automatically receive a PDF copy of their signed e-consent via email.
| Note |
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If an IRB protocol requires comprehension questions to be included in the e-consent, please contact redcap-help@utdallas.edu for assistance. REDCap e-consent projects with required comprehension questions must be setup so that the participant can't submit and complete the e-consent without answering the comprehension questions correctly. This requires the use of external modules, custom CSS, and custom JS to function as expected. |
Create a new REDCap project using a template
Go to:Setting up a New Project
Create Project from Template
- Navigate to https://redcap.utdallas.edu and after entering your credentials, click ‘New Project.’
Enter project relevant information.Enter the Project Title based on the IRB information.log-in using your NetID and password. - Create a new project by clicking "+New Project"
- Enter the following project relevant information:
- Project Title
- Select Research from the ‘Purpose of this project’ drop-down menu
- Enter important administrative Administrative details of the project such as the name of the P.I., email, IRB number, and moreetc.
- Specify the type of research that best applies
- Under the section Start project from scratch or begin with template? options.
Select , select the IRB: Consent to Participate in Research (PI Signature Required) and click ‘Create Project.’
Modify the consent form text based on the project.
To modify the consent form text click on ‘Designer’ under Project Home and Design or click ‘Online Designer’ under Design your data collection instruments & enable your surveys.
Click on 'Choose action' to Rename the form as need it the click on the instrument to modify the text.
The consent temple contains 14 fields. Modify the text in red located in each field.
- To access a field, click the edit pencil on the top section of the field.
Click the Full-Screen icon on the editor bars.
Replace red text with study specific language and change the text color to black.
Click Save and continue to the next field. Ensure all the red texts throughout the fields is replaced.
The form contain fields for the Researcher's name, signature and date. These fields are hidden while the participant is taking the survey and are meant to be completed after the participant completes the survey.
Warning: The field 'Send signed consent copy to participant' cannot be modified since it affects the Automated Survey Invitations tool that sends the completed copy of the consent to the participant.
Modify the consent question fields that will be used to determine if the participant read the consent.
Replace the field label with the a question based on the consent form.
On the Choices section, replace the answers. Input wrong answers in choice 1 and choice 2. Input the correct answer in choice 3. Do not change the variable name since it affects branching logic and external modules.
Repeat steps 10 and 11 on Questions 2 and 3.Notice that the choices are in different order. Remember that in choice 3 you need to input the right answer for the external module and branching logic to work correctly.
Feel free to modify the incorrect_answer and correct_answer fields text, but do not change the branching logic and the variable names since they affect the branching logic.
Activate the External Modules
The External Modules are already pre-configured on the template. Reminder: Do not change variable names that can affect the behavior of the external modules. The modules needed for the template to work properly are: REDCap CSS Injector and Shazam.
|Click on External Modules located on Applications
Click 'Enable a Module.'
Search the module ' REDCap CSS Injector' and click Enable.
Repeat step 2 and 3 to find the and enable the additional module, 'Shazam.'
You should see the modules in the Currently Enabled Modules list.Reminder: Do not make modifications to the external modules since they are already configured to work with the instruments.
For more information about external modules contact the REDCap Admins.
Add Users and Define User Rights based on Project Roles
The rights of each user accessing a project must be defined depending on the user’s profile and role in the study. It is recommended to check all access rights on a regular basis during the study.
- Under ‘Applications’ on the right-hand side, select ‘User Rights’.
Add users to the project based on their roles.Type the user’s NETID or name in the ‘Assign new user’ text box. A drop-down menu will provide options to select the correct user.
Enable Alerts & Notifications
This template uses a pre-configured "alert" to send participants an email with a PDF copy of their signed consent. When the project is first created, the alert is deactivated and must be re-enabled.
- Navigate to Alerts & Notifications
- Click the checkbox 'Show deactivated alerts'. When the box is checked, a pre-configured alert will appear. In the Options drop-down, select 'Re-enable alert' to enable the alert.
- Be sure to un-check the checkbox to see the newly activated alert.
- (Optional) Edit the alert to customize the email message. For example, you may want to add a Lab or Study name in the body of the email. Note: DO NOT edit the "trigger alert" logic, the "Email To" field, or the "File Upload Field". If these settings are altered, the email may not send as expected.
Add Users and Define User Rights
Add users to the project and define their access rights by assigning them pre-defined user roles. Each role has pre-defined project access rights. Note: It is recommended to review and update who has access to the project throughout the duration of the study.
- Navigate to User Rights.
- Type a user’s NetID or name in the ‘Assign new user’ box. Select the correct user from the drop-down and click relative role to complete adding the user to the project. Note: Users need to log in to REDCap at least once before they can be added to the a project.
Click ‘Assign Role’ and select between the role of ‘Lab Manager’ and ‘Data Collector.’
- See the image below to view the access rights which pertain to each role.
- Lab Manager Role – The will have : Have complete control and access to the project. They have access to identifiable information.
- Data Collector Role – The user will have : Have the ability to create, view, and edit records. Data will be is de-identified when performing data exportexports.
Change a REDCap Project Status to Production
This section will provide the necessary steps to change the project status from Development to Production. Completing these steps allows users to collect real study data. Additionally, it limits the risk of committing real-time changes to the project, which protects the data already collected.
| Note |
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If an IRB protocol requires comprehension questions to be included in the e-consent, please contact redcap-help@utdallas.edu for assistance. REDCap e-consent projects with required comprehension questions must be setup so that the participant can't submit and complete the e-consent without answering the comprehension questions correctly. This requires the use of external modules, custom CSS, and custom JS to function as expected. |
Modify Consent Language
Modify the language in the consent so that it is specific to your project.
- Navigate to the Online Designer
- (Optional) Click 'Choose action' and select 'Rename' to rename the form.
Click on the instrument name to modify the language in the consent.
- Edit a field by clicking the pencil icon. Note: Text in red requires modification.
- Click the full-screen icon to widen the window to better edit the content. Be sure to click 'Save' to commit any changes.
- The form contains fields for the Research personnel's name, signature, and date; these fields are hidden from the participant when they are filling out the e-consent form.
Move Project Status to Production
When the project is ready to go live, and you have tested that the project logic behaves as expected, you must request that the project be moved to 'Production'. Moving the project to production status requires the completion of seven steps located in the ‘Project Setup’
Section’page. Note: Any changes made to a project in Production must be approved by a REDCap admin to protect the integrity of any collected data.
Click ‘Project Setup’
tab on the top
At the bottom of the page
or the ‘Project Setup’ link located under ‘Project Setup and Design.’
After completing each of the seven steps, click ‘I am done!’
After clicking on the last step ‘Move project to production’, the ‘Move Project to Production Status?’ dialog will open.
Select ‘Keep ALL data saved so far’ or ‘Delete ALL data, calendar events, documents uploaded for records/responses, survey responses (if applicable), and any logging events pertaining to data collection.’
- If ‘Delete ALL data… ‘ is selected, a message box will open to confirm that you want to delete all the data. Click Yes, ‘Move Project to production’.
Complete the survey Move My Project to Production provided by the Office of Research Information Systems. The survey will guide you on moving your project to production more efficiently.
Upon submitting the survey, the REDCap Administrator will be emailed to start approving your study. After approval, your project will be moved to production.
, click the button 'Move project to production'
A window will pop-up asking if all existing data should be kept or deleted. It is highly recommended to delete all test data when moving a project to Production. Click the 'YES, Move to Production Status' to complete the request.
A window will pop-up with a questionnaire survey that is intended to capture information about the project and to serve as a check-list to ensure the project has been sufficiently tested. A REDCap administrator will receive the request and approve the move to Production. When the request is approved, the researcher will be notified via e-mail.
Signatures & Consent Copy
Add Researcher Signature
When a participant completes signing and submitting their e-consent, a researcher must also sign the e-consent and then send a copy to the participant.
- Navigate to the Record Status Dashboard.
- Click the green status icon for the instrument 'Consent to participate in Research' of the record that needs a researcher signature.
- Click 'Edit response.'
- Enter information in the following fields:
- Researcher First Name
- Researcher Last Name
- Signature of Researcher Obtaining Consent
- Researcher Signature Date
- Save the record by choosing the option in the drop-down 'Save & Mark Survey as Complete.' Note: The record MUST be saved this way in order to update the PDF so that it includes the added researcher signature.
Send Fully Signed Consent
- Navigate to the Record Status Dashboard and click the status icon for the instrument 'Participant PDF Consent Form' of the record which has a fully signed e-consent that needs to be sent to the participant. Note: When the status icon is red, this indicates that the e-consent copy may not have yet been sent to the participant.
- Click the radio-box '
Access Consent Copy
- Navigate to the Record Status Dashboard and click the status icon for the instrument 'Participant PDF Consent Form' of the record that belongs to the desired participant.
- Click on the file link to download the PDF copy of their e-consent.
| Info |
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Need help? Contact: redcap-help@utdallas.edu Have IRB specific questions? Contact: irb@utdallas.edu |