Training study staff on how to use their project's e-consent is critical for the study to be able to:

1) Obtain valid consents from participants

2) Reliably collect data for which obtaining consent is required.

Adding untrained staff to a project using e-consent elevates the risk of study team members creating flaws in the consent process, which can result in reportable regulatory issues, and/or the loss of any consent-dependent data that was collected without having obtained a valid consent.

The study team is responsible for training staff on their project's e-consent.

Our goal, with the information we've collected here, is to help the trainer get started with planning their e-consent training, by focusing on best practices and topics common to all projects set up for e-consent. 


Disclaimer: This page refers to features and functionality that are covered in Basics and Survey training, or well documented in REDCap itself. These features will not be described in detail here. For help with any of this functionality, once you've completed trainings and started building your e-consent project, please contact the REDCap Team or sign up for a drop-in.


Topics Covered:


When to Conduct Training

E-consent training should be routine, as part of study team's onboarding process when they add new users to their REDCap project. 

Consider also conducting group training periodically at time points such as:

  • After the first several consents are obtained, to ensure operations went as expected and answer questions. 
  • Annually, as a group to refresh staff memories if needed 
  • Group training at the start of a big recruitment initiative, or as aligns with activities within the protocol (i.e. adding a new cohort to the study). 

 
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Training Topics

Participant Access to the E-Consent Survey 

Training should address how the potential participant will access the e-consent survey. Training materials should describe access in terms of REDCap survey features and functionality, the set up of which is specific to the project, but is typically managed via one of the following methods:

  • Sending potential participants an email with a link to the e-consent survey

    • Using REDCap to send an email: 

      • Identify the email address that is used for sending email invitations.
      • For a project set up with an Automated Survey Invitation, describe the data the staff should enter to trigger the invitation and cancel the invitation.
        • Describe when the Automated Survey Invitation will be sent relative to when it was triggered and scheduled.
        • If reminders are enabled for the Automated Survey Invitation, document under what conditions a participant would receive a reminder.
      • For a project set up for study staff to manually send an email:
        • Describe the tools the staff are expected to use, such as the Compose Survey Invitations feature embedded into the Participant List.
        • Describe how to select the email for the sender.
        • Identify the study staff or study roles who have access to the Survey Distribution Log to help monitor and troubleshoot email invitations being scheduled and sent.

  • Using OHSU Outlook to send the e-consent survey link to key stakeholders who will share the link with with potential participants:

    • Include the Public Survey Link to the instructions so staff can copy and paste the link into their email(s).
    • Identify the study staff or study roles who have access in REDCap to recovering the Public Survey Link  in the event it is deleted from the instructions.

  • Posting a link to the e-consent survey in online spaces that the IRB has approved for the study team to use for recruitment purposes:
    • Include the Public Survey Link to the instructions so staff can copy and paste the to post link to the approved site.
    • Identify study staff or study roles who have access in REDCap to recovering the Public Survey Link  in the event it is deleted from the instructions.

  • Connecting the potential participant to the e-consent survey after they have completed the project's screening surveys:
    • Describe what happens when eligible participants complete the screening survey with regard to accessing e-consent survey:  
      • Participants are automatically connected to the e-consent.
        OR
      • Participants experience a pause and are required  to click on a button to start the e-consent.
    • Identify the REDCap feature that was set up to create the connection between the screening and e-consent surveys:
      • The Survey Queue
        OR
      • The Survey Setting > Auto Continue to the next survey.
    • Identify the study staff or study roles who have access to these features and can help troubleshoot any issues with connections between the screening and e-consent surveys.

Support Track Availability

Standard Service for Research


Consent / E-Consent Homepage


Intended Audience & Prerequisites

Intended Audience

  • Project point persons

  • Principal Investigators

Prerequisite Knowledge & Experience

  • Knowledge of consent process and requirements

  • Knowledge of IRB guidance for using e-consent in RECap
  • Knowledge of the study's REDCap project set-up



E-Consent Workflow in REDCap

↓ Study staff share the e-consent survey link with the participant.

↓ Participant completes the e-consent survey.

↓ REDCap saves a PDF copy of the submitted e-consent survey.

↓ Study staff provide participant with a copy of the submitted e-consent survey, or a copy of the consent form if the participant signature is not required.

↓ For a Consent and Authorization e-consent survey that requires the documentation of the study staff obtaining consent, study staff completes the Consent Attestation survey.

REDCap saves a PDF copy of the submitted Attestation survey. 

Obtaining Valid Documentation of Consent

Training should address what the study staff need to know to manage the participant completing the e-consent survey so that it is compliant with: 1) the IRB guidance for obtaining the valid electronic documentation of informed consent, and 2) the consent process described in the study protocol and approved by the IRB. Training materials should describe the requirements in terms of REDCap survey features and functionality, the set up of which is specific to the project, but at a minimum, the following items should be included:

  • Description of acceptable use of e-consent survey:
    • Include instructions that the e-consent survey can only be completed as a survey by the participant.
    • Include instructions that study staff cannot use the e-consent survey as a form or a survey to:
      • Document obtaining verbal consent or that consent was obtained on paper.
      • Consent on behalf of the participant.

  • Description of the introduction message presented to the participant at the start of the e-consent survey:
    • Include the study contact information the participant was instructed to use for questions or troubleshooting.

  • Description of the type of e-consent survey set up in the project, as well as the requirements specific to completing the project's e-consent survey, which we've summarized at a generic high level, specific study information should be customized by the trainer:

    • Information Sheet survey:
      • At the bottom of the e-consent survey the participant is presented with a radio button field set up to explicitly capture the consent decision and for which a response is required. 
        • A participant agrees to participate in the study by selecting the yes option.
          OR
        • A participant declines to participate in the study by selecting no option.
      • The participant submits the e-consent survey and the REDCap system marks the survey response as complete.
        • The date of consent is considered to be the survey timestamp, which is the date and time the survey was completed that is automatically captured by REDCap.

    • Information Sheet and Authorization OR Consent and Authorization survey:
      • At the bottom of the e-consent survey the participant is presented with a radio button field set up to explicitly capture the consent decision and for which a response is required. 
        • A participant agrees to participate in the study by selecting the yes option.
          • The participant is prompted to enter their first name and last name in two separate corresponding text fields.
          • The participant clicks on the next page button, and on the next page, is prompted to review and inline PDF transformation of the e-consent survey they completed.
            • If the participant made a mistake or changed their mind they can click the previous page button.
              • A window pops up that prompts the participant to erase their signatures to return to the previous page.
          • The participant is prompted check a box to certify the information they are submitting is correct and confirming they understand that submitting the form is the electronic equivalent of signing a physical document.
          • The participant submits the e-consent survey and REDCap marks the survey response as complete.
            • The date of consent is considered to be the survey timestamp, which is the date and time the survey was completed that is automatically captured by REDCap.
        • A participant declines to participate in the study by selecting no option.
          • A window pops up that prompts the participant to end the survey.
            • If the participant made a mistake or changed their mind they can click on return and edit response button, which will return the participant to the e-consent survey and automatically reset the radio button field set up to explicitly capture the consent decision.
          • The participant clicks on the end survey button.
          • REDCap automatically submits the survey and marks the survey response as complete.

    • Consent Attestation for the Consent and Authorization survey:
      • For every participant who agrees to participate, study staff complete a corresponding Consent Attestation survey/form, after the participant completes the e-consent survey.
      • Study staff complete this form as a survey by using the Open Survey feature for the form.
      • Study staff check Consent Attestation checkbox to confirm that participant gave consent.
      • Study staff enter the date they are completing the the Consent Attestation in a date validated text field.
      • Study staff enter their first name and last name in two separate corresponding text fields.
      • Study staff clicks on the next page button, and on the next page, is prompted to review and inline PDF transformation of the Consent Attestation survey they completed.
        • If the study staff made a mistake or changed their mind they can click the previous page button.
          • A window pops up that prompts the participant to erase their signatures to return to the previous page.
        • Study staff is prompted check a box to certify the information they are submitting is correct and confirming they understand that submitting the form is the electronic equivalent of signing a physical document.
        • Study staff submits the e-consent survey and REDCap marks the survey response as complete.
          • The date of consent is considered to be the survey timestamp, which is the date and time the survey was completed that is automatically captured by REDCap.
    • For all three types of e-consents, a PDF copy of the e-consent, and when it's completed, the Consent Attestation survey, is automatically stored in the PDF Survey Archive in the File Repository.
  • Description of the consenting process, which is either:
    • A participant self-directed process that consists of the participant reviewing study information in the recruitment materials, as well the e-consent survey itself, and initiating contact with study team if they have  questions.
      OR
    • A study staff directed process that involves a consenting session with the participant, over phone or video conferencing session, during which the study staff explains the study, review the e-consent survey and answer the participant's questions.
      • For staff directed consenting process, describe how the study staff sends the e-consent survey link to the participant as part of the consenting process.

  • Description of how the study staff provides a copy of the completed consent to the participant, which is typically accomplished through one of the following options:
    • Upon submission of the e-consent survey, participants are directed to use the download button to download a PDF copy of the e-consent survey they completed.
    • Study staff use their OHSU Outlook to email the participant a PDF copy of consent as follows:
      • For for signed e-consents staff retrieve a PDF copy of the e-consent the participant completed from the File Repository ,
      • For e-consents that did not require a participant's signature, staff can use a PDF copy of the paper consent approved by IRB.

  • Identify the study staff or study roles who have access to the Online Designer to help troubleshoot issues with e-consent surveys.

Training should address how the staff are expected to manage other data collection efforts in the project that are dependent on obtaining a valid consent. Training materials should describe the requirements in terms of REDCap survey features and functionality, the set-up of which is specific to the project, but at a minimum, should describe any programmatic guardrails that were set up to check for a participant's consent in components such as Automated Survey Invitations, Form Display Logic, and/or the Survey Queue.

Managing Participant Errors or Decision Reversals

Training should address how the staff are expected to manage any errors a participant reports upon completing e-consent, such as a participant enter a typo in their name, or if a participant changes their mind, such as a participant wanting to participate in a study option they declined. Training materials should describe the requirements in terms of study operations, the study staff designated to address these issues and any actions that should be carried out in REDCap itself.


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Training Materials

The best practice is for the study team is to create step-by-step instructions, illustrated with screen shots from their REDCap project, that address the material outlined below. These instructions should easily accessible to the study staff added as users to the REDCap project.

REDCap Tools for Sharing Materials

  • Descriptive Text Fields
    • One or more descriptive text fields that outline e-consent related instructions can be added to a data entry form.
    • Media, such as an image, a video or audio file, a pdf or word doc, can be embedded or attached to a descriptive text field.

  • File Repository
    • PDFs and word docs that contain e-consent related instructions can be uploaded to the project's File Repository.
    • Permission to the File Repository is managed via the User Rights tool.

  • Project Dashboard
    • A Project Dashboard can be created to document e-consent related instructions. The end result would be "web page" accessible only to study staff added to the project. 
    • Media, such as an image, a video or audio file, a pdf or a word doc, can be embedded or attached to a descriptive text field.

Training Project

Study teams can create a copy of their project to use for training purposes. 



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