Building Your e-Consent Form from Scratch in REDCap

Owned by Ria Jindal (Unlicensed)
Last updated: Aug 02, 2022 by DaniellaG
4 min read

COMPLIANCE CONSIDERATIONS

  • Before using REDCap and the eConsent feature please ensure you have IRB approval to do so.

  • Please ensure your eConsent forms have been stamped and approved by OPRS.

  • It is the responsibility of the study P.I. and research staff to ensure approval, compliance and management of all the study materials, including REDCap forms that utilize the eConsent feature. The same policy applies to your data sharing, data management, user management and user rights.

  • Please ensure compliance with your IRB protocol at all times while storing data in REDcap.

 

To capture participant-specific metadata such as consented IP address, and PDF Archive, you must enable the REDCap e-consent feature. A signature field alone will not capture this information.

Upload an inline copy of your OPRS approved Informed Consent Form as an image in REDCap, for the participant to read through and then provide their consent.

Creating Your Project:

  1. Create a new project from scratch by selecting “New Project.”

     

2. Navigate to the Online Designer and press on “My First Instrument” to begin building your e-consent forms.

 

3. You can additionally rename your instrument by selecting the “Choose Action” tab.

  • Reminder: If you need more information about Redcap design, we recommend watching the “Building a Project” series found under Training Videos in Redcap.

Uploading your e-Consent forms:

  1. Select add a new field and Select “Descriptive Text” as your field type. 

2. Press on the “Upload File” option and upload either a jpg or a png file of your consent form.

3. Lastly, click on “inline image” so your forms are displayed in the survey. Your images must be in a jpg or png format in order to select the inline image option.

 

Adding in Signature Fields:

  1. Use a text box field if you want the participant to type in their first name, last name, date, etc.

     

  2. Add in a signature field for the participant to physically write out their signature.

     


Enabling the E-Consent Framework in Redcap:

  1. Make sure survey settings are enabled for the project and for the instrument.

 

2. Enable Auto-Archiver and e-Consent Framework under Survey Settings.

3. An additional page will be added to the end of the survey for the participant to verify their responses.

 

4. A copy of the survey will be saved as a PDF under the PDF Archive in the File Repository.

 

***IF YOUR STUDY’S CONSENT PROCESS IS CONDUCTED IN A LANGUAGE OTHER THAN ENGLISH, PLEASE USE THE MULIT-LANGUAGE MANAGEMENT MODULE FEATURE IN REDCAP TO TRANSLATE THE SURVEYS, BUTTONS, AND CONSENT AFFIRMATION LANGUAGE***