Setting up a REDCap project for using e-consent involves the following activities:
- Building the e-consent survey/form per the IRB guidance, which is the main focus of this page.
- Configuring the distribution of the e-consent survey/form to the potential participant, which is specific to the requirements of the study, and for which considerations are covered here.
- Optionally, if after completing e-consent, consented participants are directed to complete a study survey, configuring the connection from the e-consent survey to the study survey, which is specific to the requirements of the study, and for which considerations are covered here.
Disclaimer: This page refers to features and functionality that are covered in Basics and Survey trainings, 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:
Will Special Help be Needed?
Before starting to build a project using e-consent, first determine if setting up your project and your e-consent survey to accommodate your study's consent requirements will involve special help from the REDCap Team, for which there are charges.
Special help from the REDCap team is needed for the following types of consents or consent requirements:
- Re-consent
- Consent/assent with participants under 18
- Consent with an LAR or translator/interpreter
- Consent in other languages besides English
- Adding consent to a project in production
If any of the above apply to your project, contact the REDCap Team at redcap@ohsu.edu.
Key Transformations for Converting a Paper Consent to an Electronic Consent
The list below, outlines at a high level, the key transformations that are involved in digitizing a paper consent form for electronic use in REDCap.
- All paper consents forms are digitized as e-consent surveys.
- All e-consent surveys include a yes/no (agree to participant/do not not agree to participate) radio button to capture the participant's consent decision.
- A participant signature on an e-consent survey is captured by the participant entering their first and last name into text fields.
- A participant does not enter the date of their consent on an e-consent survey, the timestamp captured by REDCap when the participant submits the e-consent survey is considered the date of consent.
- A participant does not enter their initials to agree to any options included on the e-consent survey, options are converted to yes/no radio button fields and participant selects yes to consent to indicate their agreement.
Building Instructions
OCTRI worked closely with OHSU's IRB to apply the IRB's guidance regarding the use of electronic consent to using REDCap for e-consent. The instructions for building the e-consent survey are embedded in the e-consent templates were derived from this guidance.
Step 1: Start with the Paper Form
A REDCap e-consent survey is a digitally transformed version of your study's IRB approved paper form or physical consent document. The paper consent form and the e-consent survey have the same requirements. This means the e-consent survey will be a one-to-one match with the language and dates on the approved paper form, and other elements that make up the approved paper form, such as signatures and optional components that require initials, will be transformed to capture a participants consent decisions(s) in a digital format.
If the study team has not submitted a paper consent document to the IRB and needs help determining which OHSU consent form would be appropriate to use for the study, contact OCTRI Research Navigator and request a consultation.
Step 2: Download a Template
To simplify the electronic transformation of the paper consent form, OCTRI has created e-consent templates. These templates were created at the request of IRB. Each template was developed to:
Encapsulate the IRB guidance for using REDCap for e-consent
Comply with the institutional and legal requirements for obtaining a valid consent electronically
Incorporate step-by-step instructions outlined on this page
Promote overall readability and usability in the web environment
Using an OCTRI e-consent template is required for using REDCap for e-consent.
Project builders can access e-consent templates via:
Downloading an instrument zip file posted to this page and uploading it your project.
Importing an instrument into your project from the
REDCap Instrument Library.Starting your project from an OCTRI E-Consent project template.
We do not recommend copying an e-consent survey from one project to another because the requirements and language for consent are specific to each study, and the a project that a builder copies from could have set up an e-consent survey before the guidance outlined here went into effect.
Support Track Availability
Intended Audience
Survey project builders/project point persons
Prerequisite Knowledge & Experience
Basics & Survey trainings.
Working knowledge of the Online Designer, Survey Settings, and optional survey tools.
Project Templates: Resources
Download OHSU logo.
Download: Information Sheet zip
Download: Information Sheet & Authorization zip
Download: Research Consent & Authorization zip
Download: Study Staff-Consent Attestation zip
Download: Child Assent zip
↓ 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.
Paper Consent Document | Instrument Zip | REDCap Instrument Library | Project Template |
|
|---|---|---|---|---|
Information Sheet Participant signature is not required | OHSU Information Sheet Template (participant signature waived) | E1. OHSU E-Consent Template 2.0: Information Sheet | ||
Information Sheet and Authorization Participant signature is required | OHSU Information Sheet And Authorization Template (participant signature required) | E2. OHSU E-Consent Template 2.0: Information Sheet & Authorization | ||
Consent and Authorization Both the signatures of the participant and the study staff obtaining consent are required | OHSU Research Consent & Authorization Template 2.0 OHSU Research Consent - Study Staff Attestation Template 2.0 | OHSU Research Consent Template (participant & staff signatures required) OHSU Study Staff Consent Attestation Template | E3. OHSU E-Consent Template 2.0: Research Consent and Authorization | |
Child Assent | Contact the REDCap Team at redcap@ohsu.edu if you plan on e-assenting. The requirements for your the study may require additional help from the REDCap Team, such as if different age groups complete different types of consent/assent forms. | |||
When to use a specific template type | You are building a project and your project is in | You are building a project and your project is in | You are requesting a new project |
|
Instructions for Consuming Template |
|
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| |
Instructions for Editing Template | Research Consent & Authorization 2.0 | |||
Step 3: Edit Template(s) to Match Your Paper Consent and Consent Requirements
Instructions for editing the e-consent template to match your paper consent and comply with IRB guidance are embedded in each template. For reference, we've provided example screenshots of 1) a template before it's been edited by the study staff, with its embedded instructions, and 2) a template after it's been edited by the study staff and instructions have been removed.
Information & Authorization Template
Edited Information & Authorization Template
Step 3A: Edit Consent Attestation Template (when study staff's signature is required on your paper consent document)
The e-consent survey completed and certified by the participant cannot be used to also capture the signature of the study staff. This is because enabling a completed e-consent survey to be editable risks invalidating a participant’s e-consent submission. A separate Consent Attestation survey, which is completed by the study staff, is the solution approved by the IRB for capturing the staff's signature on an e-consent survey.
Study Staff Consent Attestation Template
Edited Study Staff Consent Attestation Template
Step 4: Add Survey Settings
Instructions for adding and editing the Survey Settings to support your consent requirements and comply with IRB guidance are embedded in each template. For reference, we've provided screenshots that highlight the pertinent settings for an e-consent survey.
Survey Settings Related to an E-Consent Survey
Survey Settings Related to a Consent Attestation Survey (when study staff's signature is required on your paper consent document)
Step 5: Configure E-Consent Framework & PDF Snapshot Settings
Instructions for adding and editing the E-Consent Framework & PDF Snapshot Settings to support your consent requirements and comply with IRB guidance are embedded in each template. For reference, we provided screen shots that highlight the e-consent framework settings, which are only pertinent to an Information Sheet and Authorization form and Consent and Authorization form, and screenshots of the PDF snapshot settings, which are pertinent to an Information sheet, Information Sheet and Authorization, and Consent and Authorization form.
E-Consent Framework
Accessing the E-Consent Framework
E-Consent button in the Online Designer
E-Consent framework tab and button
Enable e-consent framework pop-up and drop-down
E-Consent Framework Settings for an E-Consent Survey
Configuring e-consent framework settings for an e-consent survey
E-consent framework enabled for an e-consent survey
E-Consent Framework Settings for a Consent Attestation Survey (when study staff's signature is required on your paper consent document)
Configuring the e-consent framework for the attestation survey
E-consent framework enabled for the attestation survey
PDF Snapshots
Accessing PDF Snapshots & Configuring a Snapshot Trigger
PDF Snapshots of Records tab
PDF Snapshots trigger button
Configure PDF Snapshot trigger
PDF Snapshot configured for Information Sheet
PDF Snapshot configured for Information Sheet and Authorization
PDF Snapshot configured for Study Staff Consent Attestation (when study staff's signature is required on your paper consent document)
Step 6: Test the E-Consent Survey
Vetting and testing the e-consent survey is a critical step in the building process. Testing is the only way to determine if the e-consent survey works as expected, uncover any issues, and get familiar with how e-consent related functionality works.
Minimum Testing Requirements
- Complete the e-consent form as a survey as a participant would.
- Complete the e-consent survey and agree to participate.
- Complete the e-consent survey and disagree to participate.
- Check that a PDF copy of the e-consent survey has been saved to the File Repository.
- Check that the footer contains the date and time the e-consent survey was submitted.
- For an Information Sheet and Authorization e-consent survey and Consent and Authorization e-consent survey, check that the footer of the PDF contains the participant's first and last name.
- When study staff's signature is required on your paper consent document, test the attestation survey as follows:
- Complete the attestation as survey.
- Check that a PDF copy of the attestation survey has been saved to the File Repository.
- Check that the footer of contains date and time the attestation survey was submitted and the participants first and last name.
For reference, we've provided some screenshots of the e-consent survey and attestation survey pertinent to the testing requirements outlined above.
Information and Authorization E-Consent Survey to Be Completed by the Participant
Information Sheet and Authorization e-consent survey being completed by participant
Certification page added to Information Sheet and Authorization e-consent survey for the participant to complete
Completion message displayed to the participant after they submit Information Sheet and Authorization e-consent survey
PDF Copy of the Completed Information and Authorization E-Consent Survey
Page 1 of a PDF copy of a submitted Information and Authorization e-consent survey
Close-up of the footer of the PDF copy of a submitted Information and Authorization e-consent survey
PDF copies of submitted Information and Authorization e-consent surveys saved to the File Repository
Study Staff Consent Attestation Survey to Be Completed by the Study Staff (when study staff's signature is required on your paper consent document)
Opening the Consent Attestation as a survey
Study staff completing the Consent Attestation survey
Certification page added to Consent Attestation survey for the study staff to complete
PDF Copy of the Completed Study Staff Consent Attestation Survey (when study staff's signature is required on your paper consent document)
PDF copy of a submitted Attestation survey
Close-up of the footer of the PDF copy of a submitted Attestation survey
PDF copies of submitted Attestation surveys saved to the File Repository
Step 7: Attend a Drop-In Session
At the request of the IRB, the REDCap Team reviews each project using REDCap for e-consenting to check that the implementation of the e-consent survey in their project meets IRB guidance.
The REDCap Team conducts these reviews at drop-in sessions. Pleas sign up for a drop-in after:
- Downloading the appropriate e-consent template to your project.
- Editing the template to match your paper consent and consent requirements.
Often, attending more than one drop-in session is needed to help the builder set up the e-consent survey and to complete the review.
Step 8: Submit Final Version of E-Consent Survey to IRB
Study teams are expected to submit to the IRB the final version of the e-consent survey set up in REDCap. We've outlined the steps below for obtaining the artifacts from REDCap, as well as included pertinent screenshots.
- In the Online Designer download a PDF of the e-consent survey, which can be submitted to the IRB.
- When study staff's signature is required on your paper consent document, down a copy of the attestation survey, which can be submitted to the IRB.
- For an Information Sheet and Authorization e-consent survey OR a Consent and Authorization e-consent survey:
- Download a screenshot example of the certification page, which can be uploaded to the IRB as an example of the certification page participants are required to complete as part of the e-consent survey.
Download PDF of E-Consent Survey via the Online Designer
Example of the Certification Page for an Information Sheet and Authorization E-consent Survey or a Consent and Authorization E-consent Survey
Distribution Considerations
By distribution, we mean how is the study staff sharing the link to their e-consent survey with their potential participants. Survey distribution options and mechanisms are covered in detail in Survey training. The REDCap Team works with the project builder/point person at drop-in to help set up the distribution of the their e-consent survey link.
Sending an Email Invitation to Potential Participants
If the study team is sending an email to each potential participant with a link to the e-consent survey, it is highly recommended the study get IRB approval to collect the participant's email address in REDCap before a participant consents, and use one of the mechanisms in REDCap to send the email invitation through REDCap. These
The benefits of sending an email through REDCap are:
- The e-consent survey link, which will be unique for each potential participant, is automatically embedded in the email invitation sent through REDCap.
- Easy tracking of the following items:
- Who was invited to complete the e-consent survey.
- When the invitation was sent.
- The status of the participant's response, including tracking bounce back emails, potential participants asking not to be contacted, etc.
- Tracking reduces the risk of re-sending email invitations to participants who have asked not to be contacted or declined on the e-consent survey.
- Automating reminders for potential participants who do not respond to the first email.
- Ensuring the invitation has the IRB approved language for the message.
- If the data collection is not anonymous, connecting the identifying e-consent survey to the record created in REDCap.
By using REDCap to manage sending invitations and tracking responses, instead of managing these activities through spreadsheets and sending emails through the study team's OHSU Outlook account, it should also reduce the effort and time the study staff need to devote to this activity.
Posting a Public Invitation or Sharing a Link with a Stakeholder or on a Listserv
If the study team is recruiting from the public, such as posting a recruitment message to social media site with a link to the e-consent survey, or recruiting through a stakeholder, such as sending a link to e-consent survey to department head, for the department head to distribute to eligible members of their staff, the study team will need to set up their project to use a public survey link, which will be connected to their e-consent survey.
Any time a project is set up to share a public survey link, the study team should plan for managing the risk that the link will be shared more broadly than they intended, and along with that, manage the increased potential for fraudulent responses.
Complex Distributions including Dyads (ex: child/parent)
For projects that include child assent, it is recommended that the consent process be done synchronously to ensure the correct document reaches the correct person and is signed appropriately. This also allows for a dialogue between the study staff and the participant in the even there are questions about the study or technical questions regarding the e-consent.
Considerations for Connecting the E-Consent Survey to a Subsequent Survey
If after completing an e-consent survey, a consented participant should be directed to complete a subsequent study survey, the project builder should consider the following requirements in setting up the connection from e-consent survey to the subsequent survey.
- Checking that the e-consent survey has been submitted.
- Checking that the participant agreed to participate in the study.
- For an Information Sheet and Authorization e-consent survey OR a Consent and Authorization e-consent survey, returning to the participant a PDF copy of the e-consent survey they submitted.
- For an Information Sheet e-consent survey for which the participant is not required to enter their first or of last name, providing the participant with a PDF copy of the Information Sheet.
The REDCap Team works with the project builder/point person at drop-in to help set up connections between the e-consent survey and survey following it.
User Permissions
No user should be given the user permission for Data Viewing Rights > Edit survey response on an e-consent survey or a consent attestation. Editing a subject's completed e-consent survey would invalidate a subject’s consent.
Pre-Production Checklist
The following list is to help builders assess the production readiness of their e-consent survey(s).
- E-Consent template updated as follows:
- The version that you will launch at production
- Your IRB approval and expiration dates on your paper consent
- Language and content that matches your paper consent and includes your IRB number
- Yes/no consent decision radio button updated with your IRB approved language
- For Information Sheet e-consent survey (that does not require the participant to first and last name)
- PDF Snapshot configured
- For an Information Sheet and Authorization or Research Consent and Authorization e-consent survey (that requires the participant to enter their first and last name)
- E-consent Framework configured
- For a Research Consent and Authorization
- Consent Attestation updated with your IRB number
- E-consent Framework configured
- Survey Settings configured as follows:
- Survey title set to Name of Study - Agreement to Participate
- Survey instructions include study contact info
- Survey them is set to
DefaultorFlat White - Pagination is set to
Single page Download a PDF the completed responseenableCustom numberedenabledMust provide valuemessage for required fields enabled- Save & Return Later disabled
- Survey completion message includes study contact info
- Testing completed as follows:
- E-consent survey tested as a survey
- Agreed to participate and submitted survey
- Decline to participate and submitted
- Reviewed PDF of submitted e-consent survey(s)
- Confirmed PDF of submitted survey stored in
File Repo > PDF Snapshotsfolder