HOW TO: REDCap eConsent / Paperless Consent

Table of Contents
Purpose

There are many types of informed consent docs / processes as outline on INFO: REDCap: eConsent / Paperless Consent


Partners HealthCare/Mass General Brigham (MGB) has developed a REDCap eConsent Framework that will turn the paper-based participant consenting processes into an electronic consent process.  MGB is currently validating the REDCap eConsent Framework with respect to appropriate areas of compliance with internal requirements, health authority expectations and other regulatory requirements, including FDA 21 CFR Part 11. The final validation package will consist of approved and executed plans, test scripts and test results, reports and supporting documentation; and will be made available to sponsors and auditors once complete.


This HOW TO document will help ensure that you are complying with MGB Policies and where applicable 21 CFR Part 11.

Requirements

  • You must have IRB approval to use REDCap eConsent for each protocol using the tool (see FAQs for details)
  • The Subject / LAR must have access to the internet if you're presenting and distributing the eConsent/signed eConsent online via REDCap survey.
  • To distribute the completed signed eConsent form, you must obtain the Subject/LAR's email address or phone number (text message with link). You must either enable the REDCap Survey Login feature (recommended) or use SEND SECURE. This Template does not use SEND SECURE, it uses the Survey Login Feature.
    • Please note that SEND SECURE makes the user click on a link and register an account to access the email body/text. The account initiation can deter participants from accessing and reading the email. See this article on the user experience: HOW TO OPEN A SEND SECURE EMAIL
    • See: SEND SECURE FAQ
    • See: REDCap and Send Secure
  • How do I get and document someone’s agreement to communicate by non-secure email?
    Individuals may read or have read to them the following information, and then can agree by signing or verbally acknowledging that they agree to receive un-secured email. Researchers are required to document this agreement, including the date of the agreement, by noting it in research records, or retaining the participant’s a signature.

  • If you are new to REDCap and unfamiliar with the basic terminology and features, there are short tutorial videos provided on the REDCap site under the ‘Training Resources’ tab to help you.  “Detailed Overview,” “Data Entry Overview” and “Online Designer” are 3 videos that cover much of the basics you will need.

If you have a specific question about this REDCap eConsent, please email edcsupport@partners.org for assistance. 

REDCap eConsent Use Cases & Workflows

There is currently one template in REDCap that can be used and modified based on your eConsent Use Case and workflow.

Validated Use Cases General Modifications to make to Template

Use Case 1: Subject/LAR approached in-person at an MGB clinic, accesses the REDCap survey via iPad or other portable electronic device. All consent stakeholders (Subject/LAR, study doctor, witness, interpreter) are available to sign same survey all at the same time.

Original eConsent Template was built on this Use Case and since COVID-19, has been modified to accommodate Use Case 2. You can combine all the required signatures to display on the Research Consent Form for Use Case 1.
Use Case 2: Subject/LAR approached remotely (via phone, virtual meeting) and consent stakeholders (Subject/LAR, study doctor, witness, interpreter) are each sent an email to review and sign consent.  Included in Template.

Use Case 3: Subject Self-initiates access of consent forms on personal portable electronic devices using posted QR codes or web-links on study posters, brochures, or websites. Self-initiated accesses of consent forms may occur in clinic or at home.

This requires the Research Consent Form to be the first form in the project and have the Public Survey URL enabled. Participant Info (ex. Subject Name, DOB, MRN) would be moved to Research Consent Form and be collected directly from person signing consent.

Other use case workflow additions:

  • The ability to include LAR to sign Consent for the subject
  • The ability for a subject to review LARs signed Consent PDF form and sign “Continuation of Consent” form
Included in Template. If LAR is not applicable to your study, delete out references to LAR and "Continuation of Consent" form

Other use case workflow additions:

The ability for a witness to sign

Included in Template. If witness is not applicable to your study, delete out references to witness

Other use case workflow additions:

The ability for short forms (multiple languages) and interpreter signatures / documentation

Included in Template. If short forms are not applicable to your study, delete out references to short forms.

Enable External Module: Multilingual

Other use case workflow additions:

The flexibility to allow for different users: signer, study doctor, witness, interpreter; to sign remotely via survey and at different times.

Program Alerts and Notifications to automate email invites for signatures.

HOW TO: Project Setup

A. Request a New Project using the project template: Electronic / Paperless Consent Template

B. Customize Survey Settings: 

  1. Surveys are enabled for Research Consent Form, Confirmation of Consent Investigator, Short Forms, Witness, Signed Consent Copy, Continuation of Consent.

2. At minimum, add the Research Study Name, Investigator and Contact information to EACH survey's Survey Instructions and Survey Completion Text.

Template for Thank You Survey Screen:

Thank you for your participation in the research study:

PROTOCOL NAME

If you have any questions, please contact:

Site Principal Investigator:

xxx-xxx-xxxx
Study Website Link

3. Survey Login is enabled for the Research Consent Form and Signed Consent Copy. This will require the Subject/LAR to enter the Subject DOB prior to accessing the Survey. You may opt to select other identifiers for the Subject/LAR to enter.  Survey Login Settings can be modified on the Online Designer page. 

  • Update the error message to include study contact information.
  • Error message display Template: Site Contact Info

    If you have trouble accessing this form, please contact Site PI

    Site Principal Investigator:

    xxx-xxx-xxxx


4. Ensure either Auto-Archiver + e-Consent Framework or External Module: Survey eSignature Certification is enabled on each survey and will label the PDF with Subject First Name, Last Name, MRN or DOB

When to use Auto-Archiver + e-Consent Framework vs External Module: Survey eSignature Certification

  1. If you're using the INLINEPDF={viewer} feature - You must use External Module: Survey eSignature Certification for better Participant/Lar survey experience.
  2. If you plan to collect Subject/Lar and Study Doctor signatures on the same survey, you'll require the ability to EDIT the survey response to add the Study Doctor signatures and therefore you must use Auto-Archiver + e-Consent Framework with the option "Allow e-Consent responses to be edited by user?" checked.

4a. Enable Auto-Archiver + e-Consent Framework on the Online Designer > Survey Settings page

4b. Enable the External Module: Survey eSignature Certification:

  1. Navigate to Applications (left navigational panel) > External Modules
  2. Click on +Enable a module
  3. Search for "eSignature" > Click Enable

Configure Survey eSignature Certification for eConsent:

  1. Default attestation settings: Default - English; User-Defined if you have Multilingual External Module enabled
  2. Server-Side PDF process: Enable
  3. Instrument Settings - Enable for ALL surveys that have INLINEPDF={viewer} in the form build. Otherwise, do not enable and use Auto-Archiver +e-Consent Framework
    1. Template Attestation Instrument = research_consent_form
  4. Logging of attestation - Check if you are collecting and sending to Subject/Lars via email address
  5. Logging Custom Identifier: subject_email or lar_email 
  6. PDF Survey Archival: Check
  7. eConsent Distribution: Uncheck

Once saved - the Survey eSignature Certification will display on the Online Designer > Survey Settings page instead of the Auto-Archiver + e-Consent Framework option.


C. Set/Edit "Custom Record Labels"

In accordance with MGB IRB policies, the subject's name and medical record number or date of birth should be recorded on each page of the informed consent documents. 

From the Project Setup page, click on "Additional Customizations"

The project template will automatically include the following: "[subject_firstname] [subject_lastname], [subject_dob]"

This ensures that the specified fields automatically display at the top of each informed consent document when downloaded as a PDF.

The labels can be updated to reference additional variables in your project or you could optionally edit the labels to look something like: "Subject Name: [subject_lastname], [subject_firstname] Subject DOB: [subject_dob]"

D. Customize the Data Collection Instruments

From the Project Setup page, click on “Online Designer” to customize the data collection instruments

Projects will typically have 2 - 5 instruments as follows:

Instrument 1 - Participant and Consent Information

This instrument consists of customized fields such as:

  • Subject identifying information
  • LAR identifying information - LAR fields can be removed if study is will not consent via LAR
  • Witness identifying information - can be removed if study will not use Witness
  • Interpreter / Non Interpreter identifying information - can be removed if study will not use short forms or requires interpreters / non interpreters

This instrument can be enabled as a survey. Advantage of NOT enabling as a survey is that you can disable auto-numbering and assign study specific subject IDs to each record. The Subject ID appears on the printed/PDF copy for each page of the consent form.

Shazam Fields: Allow you to enter one list of Investigators/People Obtaining Consent in the field (investigator_consent) with the format: code, Name Name (email) - and this will auto-fill the name and email fields separately for piping into forms and alerts. Do not modify the other 3 fields or the variable names - this will break the Shazam Code.

By selecting a drop down option, the Investigator Name and Investigator Email will be parsed to individual fields:


Consent Version (consent_version)

For a new project with the first version of the consent form, modify the option label "v1 Label" to the current version ID of your Consent form.

  • When you need to add a new consent form versions to your project in the future, you will update this field. For example, you will add "2, v2 Label" and change the default Action tag to @DEFAULT='2'


Instrument 2 – Research Consent Form

This instrument consists of a descriptive text field with the IRB Approved Consent Form, required fields to capture Subject/LAR's signature and date of signature.

Customize as follows:

  • Edit the Full PDF and replace the example with study's IRB Approved Consent Form (highlighted to xRemove current file example)
  • Add INLINEPDF={viewer} Action Tag to Full PDF of Research Consent form. This feature allows the PDF to be displayed with a scroll bar on the survey view.
  • If you have multiple consent forms (assent, fully translated...), you can add additional fields, one for each form. You can use branching logic to hide/display consent forms to the subject/lar.

  • Add/modify fields and signature fields to capture any consent checkbox options. For example:


Instrument 3 & 4 - Confirmation of Consent

These instruments will allow you to collect signatures for Study Doctor, Witness, Interpreter.

Instrument 5 - Signed Consent Copy

This instrument allows you to upload a PDF of the completed consent form to distribute to the participant. For email notifications: You must either enable the REDCap Survey Login feature or use SEND SECURE.

To ensure the survey always displays the consent document, add @HIDESUBMITBUTTON Action Tag to the file upload field.

Survey Instructions Template Language:

Thank you for your participation in the research study:

Protocol Name
If you have any questions, please contact:
Site Principal Investigator: 
xxx-xxx-xxxx

Study Website

Please download the copy of your signed consent form below.

Instrument 6 - Continuation of Consent

This instrument allows a Subject to review LAR signed eConsent and sign to consent to continue in the study.

Can be deleted if LARs are not signing Consents for your protocol.

Instrument 7 - Consent Tracking

This template is from Research Navigator: QI Study Management Tools > Documentation of the Informed Consent Process Checklist Apr2020

Template Examples of Short Forms / External Module: Multilingual - Coming Soon

E. Program Alerts & Notifications

Alerts & Notifications are not required, but can be helpful to streamline your workflow. Setup Alerts and Notifications to automate notifications to study doctors, witnesses, interpreters when Subject/Lar has signed consent. Automatic Survey Invitations and Survey Notifications can also be used in your workflow.

REDCap eConsent: Alerts and Notifications

Alerts and Notifications can be programmed to automate the sending of emails to Subject, LARS, Co-Is, Witnesses and Interpreters. If you use the template Alert and Notifications, you MUST change the "from" email no-reply@partners.org to your study group email or point of contact. Some email services are moving emails from no-reply to spam/junk folders OR blocking the email altogether.

Alert Example 1: After initial contact (phone, zoom), Emails are sent to Participant / LARS, inviting them to sign eConsent

Email Template Language:

From Email Address = Study Group Email or Site Investigators Email

Subject: eConsent for Research Study 

Dear Participant [Guardian or Authorized Representative],

Per your request, I’ve including a link to the electronic consent (eConsent) for participation in the research study as described during our telephone conversation. 

Research Consent Form [survey-link:research_consent_form]

If you have any questions, please contact me at xxx-xxx-xxxx 

Thank you,

Site Investigator’s Name

Alert Example 2: Once Subject/Lar signs consent, Co-Is, Witnesses, Interpreters can receive emails for signatures

Email Template Language:

From Email Address = Study Group Email or Site Investigators Email

Subject: Action Required: Confirmation of Consent

A consent form has been signed by Subject/Lar for (Protocol Name)

Click link to confirm consent: [survey-link:confirmation_of_consent_investigator]

Alert Example 3: Once all required signatures are obtained, Emails are sent to Participant / LARS, to distribute signed copy of eConsent

Email Template Language:

From Email Address = Study Group Email or Site Investigators Email

Subject: Copy of Research eConsent

Dear Research Participant,

A copy of your voluntary research consent can be obtained by following the link:

Signed Consent Copy [survey-link:signed_consent_copy]

If you have any questions, please contact me at xxx-xxx-xxxx 

Thank you,

Site Investigator’s Name


F. When set-up and testing are done, move project to production status.

**All features (surveys, email alerts) work the same in development as they do in production. Please test by entering your email into subject_email / lar_email fields to see how the alerts and the surveys work. You can also open surveys by adding new records, navigating to the surveys and opening via Survey Options (top right on forms enabled as surveys):


HOW TO: Production Project - General instructions to consent the participant

A.  Create the participant record

  1. Select ‘Add/Edit Records'
  2. Click ‘Add new record’ to open the first instrument
  3. Enter data.
  4. Select ‘Complete’ for form status
  5. ClickSave Recordif you are setting up the record prior to consenting the participant and log out or add the next record.  ClickSave and go to next formif you are setting up the record at the time of consent, and continue on to part “B” below

B.  Access record-specific consent form as a survey and submit

1. If the Subject/LAR and stakeholders are in same location:

From the consent form of the subject record created above:

  1. Click on the “Survey Options” menu in the upper right corner
    1. Note: You must enter the consent form from the ‘Participant Information’ form to trigger the ‘Survey Options’ feature.
  2. Select ‘Log out + Open Survey’
  3. Once the form opens as a survey, ensure that only the survey remains open
  4. Review the consent document with the Subject/LAR.  The Signature Field allows for a handwritten signature to applied to electronic media: meaning that the participant will click on the "Add Signature" button, and then need to use a finger or stylus to sign the area in the pop-up box. Then click "Save Signature".
  5. All stakeholders can pass around the device to sign where applicable.

2. If the Subject/LAR and stakeholders are remote:

  • The Subject/LAR can be emailed the Consent, then click on the link and:
    • Sign or initial in the signature field(s)
    • Click ‘Today’ in the date field(s)
    • Click ‘Submit’ at the bottom of the consent survey to register the consent document into the record - The Subject/Lar should see a signature attestation screen to certify signatures.
  • Once the consent is saved to REDCap, the Alerts&Notifications can be programmed to notify study doctor, witness and/or interpreter to view summary consent info and:
    • Sign their name in the signature field
    • Click ‘Today’ by the date field
    • Submit and certify signatures

C. Distribute the a PDF version of a signed document

  • Print the document to hand to participant (Due to COVID-19, many are reducing paper copies)
  • Email the document by uploading the file to Signed Consent Copy instrument. Automate this process using External Module: Paper Trail and Alerts & Notifications.

Example Email Text:

When the Subject/LAR clicks on the link, they will be taken to a REDCap Survey and prompted for their Survey Login (DOB):


HOW TO AUTOMATE PDF PROCESS:

To Enable External Module: Paper Trail

  1. Navigate to Applications (left navigational panel) > External Modules
  2. Click on +Enable a module
  3. Search for "Paper Trail" > Click Enable

To Configure Paper Trail for eConsent

  1. Click Configure
  2. Select use-case: Single Use-Case (Multiple Use-Cases not available yet tbd)
  3. Server-Side PDF processing: Enabled
  4. Specify form(s) by selecting form names from the drop down list. Click + to add forms.
    1. For eConsent it is recommended you select: research_consent_form + confirmation_of_consent_investigator + (other "always" required signed forms)
    2. For forms that sometimes require signatures (witness, interpreter), multiple use case is coming soon!
  5. Select target upload field: signed_consent_form_copy
  6. Set the target form status to: (up to study team - recommend settings to "Unverified" to review the first few consents to ensure copies are correct and then manually set form status to "complete")
  7. File prefix to be used: Default = eConsent, but can be edited to other study file naming convention
  8. Store a copy of the generated document in the PDF Survey Archival: Must be checked for eConsent
  9. Type of upload
    1. Recommended = Automatic (included in template) - Select the fields where signatures are required (consent_signature + obtainconsent_signature + all other "always" required signed fields)
    2. Also Recommended = Controlled (not included in template) - Create a Yes/No field so that after manual review of REDCap record and signed consent fields, indicate Yes to trigger PDF creation.
    3. Hide all link labels from target upload field = Yes.
      1. This must be hidden so that subjects/lars cannot delete or remove the file; they can only download and view

HOW TO: Make Changes / Amendments to Consent Forms

Prior to COVID-19 - Recommendation was to Create a new eConsent database 

  • Follow the process outlined above  to create a new eConsent database
  • Make sure to append the study name with the amendment tag from eIRB

Now: To Version Consent Forms

  1. Add a new field to the Participant and Consent Information form to list version numbers (field included on template as of  ).

2. Add new consent form version(s) to the existing Research Consent Form

3. Use branching logic to display new version when the new field indicates new version to be collected (included an @Default action tag to default to the current and correct version to be used).

4. ***Currently, you will then have to add a NEW Record to reconsent a participant. Labelled something like RECORD01-RC1*** This is because you will need to maintain the original record as is  and ensure data is available for review. 

Contact edcsupport for help with Versioning.



FAQs:

Q: Can eConsent be included with project data?

A: YES. eConsent can be a stand alone project or included with project data. TO NOTE: The Custom Project Labels WILL appear on ALL forms that are PDF'd for download. 

There is no requirement that the ICF is maintained with other subject-specific CRFs, although it is convenient and the usual practice.  When a team maintains paper files for a protocol, there are typically the regulatory binders for the essential documents and individual subject binders for all subject-specific forms. Generally the signed and dated informed consents are maintained in the subject files along with other CRFs such as the Demographic, Eligibility, AE Log, Con Med Log, Drug/Device Accountability, Lab Reports, Procedures Reports, Study Visit Notes, etc.  Anyone on the IRB-approved study staff list has the right to see identifiers as do regulatory inspectors, monitors, and auditors.  User Rights in REDCap gives the team adequate control of access to identifiers.

Q: If I have an existing REDCap project collecting study data, how do I add the eConsent template/forms?

A: If you want to add eConsent to an existing REDCap project already in production and collecting study data, its best to request a new REDCap eConsent Template project for testing. You should develop and test the REDCap eConsent workflow according to your study requirements. Lastly, you should export the Data Dictionary from your study data project, COMBINE it with an exported Data Dictionary from your REDCap eConsent project, and uploaded the COMBINED data dictionary to your test project. Then test.  Items to consider:

  • Record ID / Unique identifier - Will you be able to use your current study data project's unique ID or will you need to modify when combining the processes?
  • If your study data project is longitudinal, External Module: Paper Trail cannot reference across events. If your consent process is in one event, the feature will work. No road map or timeline estimate for this enhancement.
  • If you're already collecting emails and identifiers in your study project, you may need to move those fields to the REDCap eConsent Participant Info page.
  • Once you test your project, you will then need to export the final data dictionary. Enter DRAFT mode on current study project, upload and review the changes. Once changes are committed, you will then need to:
    • Enable surveys and re-program those to match your REDCap eConsent Test project.
    • If you're using External Modules, you'll need to enable and reconfigure those to match your REDCap eConsent Test project.
    • If you're using Alerts & Notifications, you will also need to reprogram to match your REDCap eConsent Test project.
    • We recommend adding a test record to ensure it's working properly on production project and then you can delete out that test record.

Q: Is their a way to remove the subject ID from the consent header?  We are required to upload ICFs to EPIC and do not want the “link” between subject ID # and name easily accessible to non-study staff.

Typically, the subject ID is not on the paper ICFs, although some study teams do include the study ID.  When study teams enroll their subjects in a study in Epic, they often include the study ID number in the enrollment so when QI runs an enrollment report from Epic, they get the list of subjects with their MRNs, date of Epic enrollment, enrollment status, and participant ID.  So the key to the code is often already in Epic in the study enrollment section.   

Epic is a secure system and only individuals authorized to use Epic have access.  All users must log in with their username and password, activity in the system is tracked, and per policy users must only look at what they are entitled to look at adhering to the minimum necessary standard.  In addition, all employees sign a confidentiality statement annually.  As such the key to the code linking study ID to the subject is still being maintained securely.       

If you have additional questions or concerns, please contact MGB Human Research Quality Improvement Program at humanresearchqi@partners.org

Best Practices & Warnings

Create a study folder in REDCap to group your study’s databases/projects

A.  Create the study folder

  • Once on the REDCap site, click “My Projects”
  • Click the “Organize” button
  • Enter the name of your study in the text field displayed
  • Click “Add”
  • Customize the folder and save

B.  Assign study projects to the folder

  • To assign an existing project to this folder
    • From the “My Projects” page click the “Organize” button
    • Select the study’s folder from the dropdown menu
  • Place a check next to each project assigned to this study folder
  • To assign a new eConsent project to this folder check the box provided on the “Create New Project” screen (STEP 2A below)


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