Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Table of Contents
stylenone

Summary
The goal of this tutorial is to show the process required to use the IRB: Consent to Participate in Research template located in REDCap. The Institutional Review Board approved this template (IRB), and it can be used to replace the paper version of the form for an electronic form. This form can be sent to participants as a survey to collect participants’ information and signatures electronically.

Create a new REDCap project using a template

Go to:

Easy Heading Macro

HTML
<style>
	.heading-expand-header { cursor: pointer; }
	.heading-arrow { color: #e87500; }

	body { color: black; }
</style>

Summary

The following document details how to set up an approved Institutional Review Board (IRB) electronic consent (e-consent) using the customized REDCap template, ‘IRB Consent Form: Participant Signature Required’. 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 a survey link.
  2. The e-consent will capture participant information and their electronic signature (e-signature).
  3. Participants will automatically receive a PDF copy of their signed e-consent via email.

Note

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 set up so that the participant cannot 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.

Setting up a New Project

Create Project from Template

  1. Navigate to https://redcap.utdallas.edu and after entering your credentials, click ‘New Project.’
    Image Removed
    Enter project relevant information.Enter the Project Title based on the IRB information.log-in using your NetID and password.

  2. Create a new project by clicking +New Project.
    Picture of Redcap Landing pageImage Added

  3. Enter the following project relevant information:
    1. Project Title
    2. Select Research from the ‘Purpose Purpose of this project’ project drop-down menu.
    3. Enter important administrative Administrative details of the project such as the name of the P.I., email, IRB number, and moreetc.
    4. Specify the type of research that best applies.
      Image Removed
    Select ‘Use a template’ from the Start project from scratch or begin with template? options.
    Select IRB: Consent to Participate in Research and click ‘Create Project.’
    Image Removed

Modify the consent form text based on the project.

  1. 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.
    Image Removed
    Click on 'Choose action' to Rename the form as need it the click on the instrument to modify the text.
    Image Removed
    The consent temple contains 14 fields. Modify the text in red located in each field.
    Image Removed
    1. To access a field, click the edit pencil on the top section of the field.
    Click the Full-Screen icon on the editor bars.
    Image Removed
    Replace red text with study specific language and change the text color to black.
    Image Removed
    Click Save and continue to the next field. Ensure all the red texts throughout the fields is replaced.
    Image Removed
    1. Picture of Create New ProjectImage Added

  2. Under the section, Project creation option select Use a template to activate the list of project templates. Select the IRB Consent Form: Participant Signature Requiredand click Create Project.
    Picture of Create New Project Template AreaImage Added

Send Participant e-Consent Copy

This template is pre-configured to automatically send participants an email with a PDF copy of their signed consent. The body of the email may be configured. There are a few optional settings that can be configured.

  1. Navigate to the Online Designerand click the button Survey Settings for the instrument Consent to Participate in Research
    Picture of Survey InstrumentsImage Added

  2. The Send confirmation email? section settings are pre-configured so that when a participant submits their e-consent, they automatically receive an email with a PDF copy of the signed e-consent. You may modify the body of the email but DO NOT un-check the setting Include PDF of completed survey as attachment or change the Send confirmation email? Option to No.
    Picture of Send Confirmation EmailImage Added

  3. Scroll down to the bottom of the page and click the button Save Changes to commit any changes made to the email message. 
    Picture of Save Changes of Send Confirmation Email Image Added

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’.

Image Removed

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. 

Add users to the project and define their access rights by assigning pre-defined user roles.

Note: It is recommended to review and update who has access to the project throughout the duration of the study.

  1. Navigate to User Rights.
    Picture of User Rights LinkImage Added

  2.  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
  1. a project.

Image Removed

Click ‘Assign Role’ and select between the role of ‘Lab Manager’ and ‘Data Collector.’
  1. Picture of Assign New User to a RoleImage Added

  2. See the image below to view the access rights which pertain to each role.
    1. Lab Manager Role
– The will have
    1. : Have complete control and access to the project. They have access to identifiable information.
    2. Data Collector Role
– The user will have
    1. : Have the ability to create, view, and edit records. Data
will be
    1. is de-identified when performing data
export
    1. exports.
      Picture of User RolesImage Added

Image Removed



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.

Moving the project to production

Modify Consent Language

Modify the language in the consent so that it is specific to your project. 

  1. Navigate to the Online Designer.
    Picture of Online DesignerImage Added

  2. (Optional) Click Choose action and select Rename to rename the form. 
     Picture of Renaming an InstrumentImage Added

  3. Click on the instrument name to modify the language in the consent. 
    Picture of Survey InstrumentImage Added

  4. Edit a field by clicking the pencil icon.
    Note: Text in red requires modification.
    Picture of Edit Field buttonImage Added

  5. Click the full-screen icon to widen the window to better edit the content. Be sure to click Save to commit any changes.
    Picture of Editing e-Consent Text FieldImage Added


Move Project Status to Production

When the project is ready to begin collecting real data, and you have tested that the project logic behaves as expected, a user must request to move their project to 'Production' status. Moving the project to Production status requires the completion of seven steps located

in the ‘Project Setup’ Section’Click ‘Project Setup’ tab

After completing each of the seven steps, click ‘I am done!’

Image Removed

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’.

Image Removed

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.

Image Removed

InfoFor more information, please visit our website REDCap or send us an Email.

on the

top of the page or the ‘Project Setup’ link located under ‘Project Setup and Design.’

Image Removed

Project Setup page. Visit our Project Status guide to move a project to production.(WIP) Note: Any changes made to a project in Production must be approved by a REDCap administrator to protect the integrity of any collected data. 

Note

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 set up so that the participant cannot 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.

Access Consent Copy

  1. Navigate to the Record Status Dashboard and select the Status icon for the desired record.
    Picture of Record Status DashboardImage Added

  2. Click Download PDF of instrument(s) and then select This survey with saved data to download a PDF copy of the signed e-consent.
    Picture of Download PDF of Instruments LinkImage Added


Info

Need help? Contact: redcap-help@utdallas.edu

Have IRB specific questions? Contact: irb@utdallas.edu