Purpose

There are many types of informed consent docs / processes:

  1. Informed Consent in Online Research: 
    1. IRBs may waive the requirement for written documentation of informed consent when the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context or when the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Online research involving adults often meets one of these conditions. A consent procedure in which subjects are provided with a written statement about the research followed by a button to click that states, “I AGREE TO PARTICIPATE IN THIS RESEARCH” is often acceptable. See: Guidance on Research Using the Internet > Informed Consent in Online Research
  2. Informed Consent obtained via paper then scanned to electronic certified copy - See PHRC Guidance for Electronic Storage of Research Documents and REDCap HOW TO: Scan and Store Research Documents in REDCap
  3. Informed Consent where a computer/device can be substituted for paper; study team interaction is same as paper process; also know as Paperless Consent or eConsent
    1. NOTE: This is a Handwritten Signature applied to electronic media (21 CFR Part 11 Training )
  4. Electronic Informed Consent (eIC) where a computer / device takes the place of paper and people (everything is online/electronic).

This document refers to 3. Informed Consent where a computer/device can be substituted for paper; study team interaction is same as paper process  - Paperless Consent.  Currently, Partners HealthCare only recognizes using REDCap as a way to collect research consents in situations where someone from the study team is present with the person being consented.  Other uses will be considered on a case by case basis.

 

This HOW TO document will help ensure that you are complying with Partners HealthCare Policies to ensure communication with the participant/subject/LAR is secure.

Requirements

  • You must have IRB approval to use REDCap for paperless consent
  • The participant / subject / LAR must have access to the internet if you're presenting the consent via online survey.
  • If you want to email the completed signed consent form, you must obtain and validate the participant/subject/LAR email address. You must either enable the REDCap Survey Login feature or use SEND SECURE
    • 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
  • 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 process, please email edcsupport@partners.org for assistance. 

 

 

HOW TO: Project Setup

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

A. Enable Survey Settings:Settings defined on the Project Setup page:

  • Surveys must be enabled

Settings defined on the Online Designer page:

  • The Consent document must be enabled as a survey

B. Set User Rights

User Rights – Survey Setting

If study staff will sign the consent form AFTER a the participant/subject/LAR signs and submits the survey, study staff will need ‘Edit Survey Responses’ rights for the consent document.  To enable this from the user rights page:

  • Check the ‘Edit survey responses’ box for the consent form
  • Click ‘Save Changes’

C. 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 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

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.

Instrument 2 – Partners HealthCare Consent to be a Research Subject

This instrument consists of descriptive text fields for each page of the consent document, required fields to capture participant’s first and last name, signature and date of signature, fields to capture full name, signature and date of signature for the consenter. 

Customize as follows:

  • Save your stamped consent document as a JPEG
  • Make sure you have a descriptive text field in the consent instrument for each page of your consent document
    • Upload the first page of the consent document into the first descriptive text field and select “inline image” for display type
    • Repeat the process for each subsequent page
    • When the entire document has been uploaded review the form to verify the pages are in correct sequence and each has the correct stamp
    • Add fields and signature fields to capture any consent checkbox options. For example:

 

Instrument 3 - Consent Copy Distribution

This instrument consists of customized fields to capture how the subject/LAR would like the final consent form distributed. 

  •  Email address and PIN are collected for those wanting to receive consents via email.
Instrument 4 - Signed Consent Copy

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

Survey Login Option:

  • Enable the instrument as a survey. Use Action Tag: @HIDESUBMITBUTTON  to hide the survey submit button so the consented can access the survey and their consent form any time.
  • Enable the Survey Login option for the project and select the "PIN" field at minimum. You may opt to select other identifiers for the subject/LAR to enter.

 

SEND SECURE option:

  • Enter SEND SECURE text in the email subject when emailing survey invitation
Instrument 5 - Consent Tracking

This optional instrument is from the QI Regulator Binder: Documentation of Informed Consent Process

 

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

 

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

From the consent form of the participant 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 prospective participant
  5. Complete and submit the consent survey following either B1 (participant and consenter are in the same location) or B2 (participant and consenter are in different locations) below:

B1. If the prospective participant elects to be a subject for the study and the person consenting is in the same location:

  • The participant will:
    • Type first and last name in each text box provided
    • Sign their name in the signature field
    • Click ‘Today’ by the date field
  • The consenter will
    • Type their name in the text box provided
    • Sign their name in the signature field
    • Click ‘Today’ by the date field
    • Click ‘Submit’ at the bottom of the consent survey to register the consent document into the record

 

B2. If the prospective participant elects to be a subject for the study and the person consenting is in another location:

  • The participant will:
    • Type first and last name in each text box provide
    • Sign their name in the signature field
    • Click ‘Today’ in the date field
    • Click ‘Submit’ at the bottom of the consent survey to register the consent document into the record
  • Once the consent is received, the consenter will
    • Enter the consent form of participant’s record
    • Click ‘Edit survey responses’
    • Type their name in the text box provided
    • Sign their name in the signature field
    • Click ‘Today’ by the date field
    • The consenter will save the record

NOTE HERE about eSign feature vs Signature Field. Preference for eSign feature for lock and print feature.

 

C. Distribute the a PDF version of a signed document from a single record (OPTIONAL)

  1. Click ‘Add/Edit Records’
  2. Select the record of interest from the dropdown menu
  3. Select the form of interest from the left side of the screen
  4. Click ‘Download PDF of instruments(s)’ at top of page
  5. Select ‘this data entry form with saved data’ to create the PDF
  • Print the document to hand to participant
  • Email the document by uploading the file to Signed Consent Copy instrument. Select Survey Options > Compose Survey Invitation. The participant's email address entered on the Consent Copy Distribution email field, will display in the "TO" field. Enter a general subject and message. DO NOT contain any PHI or sensitive information about the study. The participant will be required to click on the survey link, enter their PIN to access their signed consent form.

Example Email Text:

When the subject clicks on the link, they will be taken to a REDCap Survey and prompted for their PIN:

 

HOW TO: Make Changes / Amendments to Consent Forms

A.   Create a new eConsent database

  • Follow the process outlined above in STEP 2 to create a new eConsent database
  • Make sure to append the study name with the amendment tag from eIRB

B.   Extract and store data from existing database

  • Export the data captured in the consent status report

The database template contains a consent status report that captures:

(1) record ID; (2) consent form status; (3) first and last name of person being consented; and (4) date of signature.  It is sorted by name and then date but also contains a live filter based on consent status.

From ‘Data Exports, Reports and Stats>My Reports and Exports>Edit’

  • Rename the consent status report with the name of the database and date created
  • Export the data and save on secure server
  • Download a PDF of all records with data

From ‘Data Exports, Reports and Stats>Other Export Options>PDF’

  • Download the PDFs with data for all records
  • Save with report data on secure server

C.   Archive the existing database

  • From the ‘Project Home’ page of the completed eConsent database, select the ‘Other Functionality’ tab
  • Click ‘Archive the Project’ to remove it from the ‘My Projects’ list and take it offline
  • Click ‘Archive the Project’ on the popup screen

 

 

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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