Review How the Consent Process is Implemented with Real Subjects
It's essential that the personnel building and managing the project understand the activities that will be involved in the implementation of the consent process with real subjects. They will need to consider the workflow that pertains to their study's consent process as they plan for 1) testing the project, 2) training the study team on using the project for consenting, and 3) documenting consent operations.
Consent Processes and their Corresponding Workflows for Obtaining Consent
| Agreement to Participate
| Agreement to Participate + Participant Signature
| Agreement to Participate + Participant Signature + Live Consent Process
|
---|
Also referred to as | Information Sheet | Information Sheet and Authorization | Consent and Authorization |
---|
Signature Requirement | - Waiver of signature
- Waiver of signature on HIPAA authorization (if PHI involved)
| Participant signature required | Participant signature required- Signature of person obtaining consent required
- Live virtual or in-person consent process
|
---|
Consent Workflow | Consent survey link distributed to potential participant. On their own, participant completes and submits consent survey. Once the survey is submitted, a participant can download a PDF copy of their completed consent survey.
| Consent survey link distributed to potential participant. Participant completes consent survey, verifies the information entered in the survey is correct and then submits the survey. Once the survey is submitted, participant downloads a PDF copy of their completed consent survey. The system automatically saves the PDF copy of the completed survey in project’s file repository.
| Consent survey link distributed to potential participant. During a consent session with the study staff, either held in-person or virtually, participant completes consent survey, verifies the information entered in the survey is correct and then submits the survey (e.g. Live consent process). Once the survey is submitted, participant can download a PDF copy of their completed consent survey. The system automatically saves the PDF copy of the completed survey in project’s file repository. Study staff who obtained consent completes a consent attestation survey, verifies the accuracy of the information entered, and then submits the survey. If necessary, study staff download a PDF copy of the staff completed attestation to send to the participant. The system automatically saves the PDF copy of the completed survey in project’s file repository.
|
---|
↑ top of the page
Step by Step Instructions for Setting Up Your REDCap Project
BEST PRACTICE: Start with the OCTRI Template that corresponds to the consent document submitted to and approved by IRB.
Effective May 1st, 2021, project builders must utilize one of the REDCap templates, as described in the section below, to not incur charges. Fees are associated with any help, including help at drop-in, for consent forms built from scratch.
| Form Template Zip | Form Template REDCap Instrument Library | Project Template |
---|
When to use each template type | Add a template to an already existing project: - You've already started building your REDDCap project.
- Your project is in
Development.
| Add a template to an already existing project: - You've already started building your REDDCap project.
- Your project is in
Development.
| Start a new project from a template: - You haven't already requested a project.
- There is not an existing project for the study you've started building.
|
Agreement to Participate (participant signature NOT required) | ↓ Information Sheet zip
| Download template from the Instrument Library: OHSU Information Sheet Template (participant signature waived) | C. OCTRI Consent Template - Information Sheet Only |
Agreement to Participate + Participant signature required | ↓ Information Sheet and HIPAA Authorization zip
| Download template from the Instrument Library: OHSU Information Sheet And Authorization Template (participant signature required) | D. OCTRI Consent Template - Information Sheet with Required Signature |
Agreement to Participate + Participant signature required + Study staff signature required + Live virtual or in-person consent process | ↓ Consent and Authorization zip ↓ Study Staff-Consent Attestation zip
| Download templates from the Instrument Library: - OHSU Clinical Research Consent Template (participant & study staff signatures required)
- OHSU Study Staff - Consent Attestation Template
| E. OCTRI Consent Template - Consent and Authorization |
Instructions for Using Template | - Do not open zip.
- Upload zip into your project via
Online Designer > Upload button. - Follow instructions on this page and in the template to:
- Edit the consent form to match your study's consent document.
- Enable the form(s) to be a survey(s).
| - Follow instructions on this page and in the template to:
- Edit the consent form to match your study's consent document.
- Enable the form(s) to be a survey(s).
| |
Modify a Template (NO CHARGES) | Build From Scratch (CHARGES STARTING AT $100) |
---|
- If your are using a form template, upload the zip file.
- If you started your project from one of content project templates, the consent form is included in your project.
- Click on the consent form to edit it.
| - Create a form for your consent document.
- Click on the form to edit it.
|
|
Edit the Version radio button field as follows:
- Edit the option
1, Version 1.0 to correspond to the version of your consent form. - A version can be either a date or a number (refer to Figure 1-T) or a combination of both, .i.e 1, V1-01.20.2021
Figure 1-T: radio button for versioning - Online Designer View
 | At the top of the form, add a radio button field to capture the consent form version, with a single option that corresponds to the version number of the consent form you are building.
- A version can be either a date or a number or a combination of both.
- Neither the study staff nor the participant will enter data in this field and the field will be hidden from the subject.
- Apply the following
Action Tags to this version field:
Figure 1-S: Adding the radio button for versioning  Figure 2-S: radio button for versioning - Online Designer view  |
|
Edit the ICF approval and expiration dates descriptive text field as follows:
- For
IRB Approved: replace MM-DD-YYYY with the date of your consent form's approval. - For
Approval Expires: replace MM-DD-YYYY with the date of your consent form's expiration.
Figure 2-T: descriptive text field for dates - Online Designer view
 | Add a Descriptive Text field for the approval and expiration dates of your consent form.
- Add the approval and expiration dates on separate lines as follows:
- IRB Approved: MM-DD-YYYY (where MM-DD-YYYY is the date of approval for your consent form).
- Approval Expires: MM-DD-YYYY (where MM-DD-YYYY is the date your consent form expires).
- Use the R
ich Text Editor to unbold the dates. - Set the text to
Align Right .
Figure 3-S: Adding the descriptive text field for the approval and expiration dates
 |
|
Edits are NOT needed to the descriptive text field for the logo. | Add a Descriptive Text field for OHSU logo.
- ↓ Download the OHSU logo (ohsu_logo_transparent.png) to your local machine.
- Do not enter a
Field Label . - For Attach an image, file, or embedded audio setting, click U
pload file .- ↑ Upload the OHSU logo (ohsu_logo_transparent.png) you downloaded to your machine.
- For
Display format of attachment on page setting , select Inline .
Figure 4-S: Adding the descriptive text field for the OHSU logo

Figure 5-S: descriptive text field OHSU logo - Online Designer view

|
1D - Form Fields for Text of the Consent Document |
Modify the multiple placeholder Descriptive Text fields to add the text/content of your consent document to the consent form.
Each template contains multiple placeholder Descriptive Text fields that are based on and consistent with the discrete sections laid out in the corresponding OHSU IRB approved consent Word template. - Copy and paste each discrete section of your consent document into the matching D
escriptive Text field. - Use the rich text editor for formatting.
- Transform any special formatting from the Word document into HTML, such as bulleted lists and tables.
- Remove any D
escriptive Text fields that are not pertinent to your consent document.
Figure 3-T: Example of place holder descriptive text fields - Online Designer view

| Create a Descriptive Text field for each discrete section of your consent form.
- Copy and paste each discrete section of your consent document into its own D
escriptive Text field. - Use the rich text editor for formatting.
- Transform any special formatting from the Word document into HTML, such as bulleted lists and tables.
Separating out each section of the consent document into individual fields is recommended to make the form easier to edit and maintain over time and to help manage versions. Making revisions to the consent form is reviewed later in these instructions. Figure 6-S: Adding a descriptive text field to add a content from the consent document to the consent form

Figure 7-S: Example of individual descriptive text fields with content from the consent document - Online Designer view

|
|
Edit the Consent radio button as needed to describe your process for collecting the subject's consent decision.
- Modify the language as needed to describe your process for collecting the subject's consent decision.
Each template contains a placeholder Consent(icf_consent) radio button field for capturing the subjects consent decision. Figure 4-T: Example of placeholder radio button for consent - Online Designer view | Add a radio button field radio button field with two options (an option to consent and an option to NOT consent) document the subject’s consent decision.
- Make this field required.
- Modify the language as needed to describe your process for collecting the subject's consent decision.
If a the subject's signature is required on the consent document, set up a Stop Action for the option you created for to capture a subject NOT participating, i.e. NO consent.
In Figure 8-S and Figure 9-S, we created the options 1, Yes, I agree to participate and 0, No, I do not wish to participate for capture the subject's consent decision. Figure 8-S: Adding a radio button field to capture the subject's consent decision

Figure 9-S: Example of the radio button for consent - Online Designer view

|
|
The subject signs the e-consent form by entering their first name and last name into text fields, instead of adding an electronic signature.
Optionally, edit the field labels of the First name and Last name text fields to meet your consent requirements.
In Figure 5-T we edited the First name field label to display Participant first name. Figure 5-T: Example text fields for subject's first and last names – Online Designer view

| Add text fields for the subject to enter their first and last name. In the e-consent form the subject types in their first name and last name instead of adding an electronic signature.
Figure 10-S: Adding a text field for the subject's first name
 Figure 11-S: Example of text fields for subject's first and last name - Online Designer view

|
|
|
|
Consent Form / Information Sheet (no subject signature)
Click on link to view screen shot
Consent Form / Information Sheet (subject signature required)
Click on link to view the screen shot
|
↑ top of the page
There are more than 20 elements that can be defined in the Survey Settings
. We cover a subset of those elements in our instructions, focusing on what's required to support consent and what's related to best practices, as well as highlighting the key decision points associated with consenting online.
If you started your project from one of the Project Templates, the consent form has already been enabled as a survey and only a few modifications will be required. However, you should still review the settings outlined below so you can support the consent process for the project.
Survey Settings |
---|
2A - Basic Options |
- Edit the
Survey Title to be unique.
- Edit the
Survey Instructions to include the contact information for the study team.- Additional instructions can help the subject understand how to interact with the consent survey AND this messaging will require IRB approval.
| Figure S-1: Survey title and instructions - Survey Settings view

|
2B - Survey Design Options |
| Figure S-2: Standard radios and checkboxes - Survey Settings view

|
2C - Survey Customizations |
If the subject signature is required on the consent form, select Yes for the setting: Allow participants to download a PDF of their responses at end of survey? - Accept the default selection,
Yes , for the setting: For 'Required' fields, display the red 'must provide value' text on the survey page?
| Figure S-3: PDF downloads and display must provide value for required fields - Survey Settings view

|
2D - Survey Access |
| Figure S-4: Save and Return disabled - Survey Settings view

|
2E - Survey Termination Options |
| Figure S-5: Auto-continue disabled and completion text - Survey Settings view

|
2F - e-Consent Framework and PDF Auto Archiver |
- For consent surveys that do not need the subjects signature select
Auto-Archiver enabled . If the subject signature is required on the consent form, select Auto-Archiver + e-Consent Framework .
| Figure S-6: Auto-Archiver enabled - Survey Settings view

|
2G - e-Consent Framework Options (subject signature required) |
- DO NOT check the box
Allow e-Consent responses to be edited by users? Enter your e-Consent version . For the First name field and Last name field , select the fields from the form that capture the subject’s first and last name. - The subject's first and last name is included in the footer of PDF copy of the completed consent survey.
- Any values entered in the
Optional fields will be included in the footer of PDF copy of the completed consent survey. Select the following signature settings for Force signature field(s) to be erased if participant clicks Previous Page button while on the certification page?
| Figure S-7: e-Consent configured - Survey Settings view

|
2H - PDF Copy Stored in File Repository |
A PDF copy of the submitted consent form is saved to File Repository > PDF Survey Archive . | Figure S-8: PDF copy of subject submitted consent form in the File Repository
 |
|
Information Sheet (subject signature required)
Click on the link to view the screen shot
e-Consent Added to End of Information Sheet (subject signature required)
Click on the link to view the screen shot
Information Sheet - Termination (subject signature required)
Click on the link to view the screen shot
e-Consent in PDF Footer of Information Sheet (subject signature required)
Click on the link to view the screen shot
|
↑ top of the page
BREAK - Decision Point
Skip Step 3 and Step 4?
If the following are true, skip Steps 3 and 4:
- Your consent form only requires the subject's signature.
- Your consent form DOES NOT require the signature of the study staff person obtaining consent.
This is typically true for minimal risk studies using the Information Sheet and Authorization consent form.
If your consent requirements meet the criteria above, skip ahead to the User Permissions section.
Complete Step 3 and Step 4?
If the following are true, complete Steps 4 and 5:
- Your consent form requires documenting the study staff obtaining consent.
- You're conducting real-time consent sessions with your subjects, over the phone, virtually, or in person.
This is typically true for more than minimal risk studies using the Consent & Authorization "full"consent form.
↑ top of the page
The consent survey completed and certified by the participant cannot be used to also capture documentation of the study staff obtaining consent. Editing a participant’s completed consent form for which the e-consent framework has been set up, to add the staff’s signature, would invalidate a participant’s consent, which is why we instruct you to configure the consent survey to be un-editable.
The solution is to build a separate form for documenting the study staff who obtained consent, enable that form to be a survey, configure the e-consent framework in the survey setting, and train study stuff to complete this form as a survey.
Modify a Template | Build from Scratch |
---|
- If your are using a form template, upload the Study Staff - Consent Attestation zip file.
- If you started your project from E. OCTRI Consent Template - Consent and Authorization, the Study Staff-Consent Attestation form is included in your project.
- Click on the Attestation form to edit it.
| - Create a new form, named Study Staff - Consent Attestation.
- Click on the form to edit it.
|
|
Edits are NOT needed to the descriptive text field for the instructions. | At the start of the form, add a descriptive text field with instructions for the study staff to open the form as a survey.
- Use the
Rich Text Editor to format the field - Add the following
Action Tags :- @HIDDEN-SURVEY to hide the field when the subject views the consent form as a survey.
- @HIDDEN-PDF to hide the field from being included in PDF copy/download.
Figure 12-S: descriptive test field for study staff instructions – Online Designer view

|
|
Edit the ICF approval and expiration dates descriptive text field as follows:
Figure 6-T: descriptive text field for dates - Online Designer view

| Add a Descriptive Text field for the approval and expiration dates of your consent form.
- Add the approval and expiration dates on separate lines.
- Use the R
ich Text Editor to unbold the dates. - Set the text to
Align Right .
Figure 13-S: Adding a descriptive text field for the approval and expiration dates
 |
|
Edits are NOT needed to the descriptive text field for verifying the subject name and date of consent, unless one of the following are true:
- Your project is set up as longitudinal.
- For piping the subject's last and first name, add the unique event name (of the event the consent form is assigned to) before the variable name.
- You modified the variable names of the subject first and last name fields on the consent form.
Figure 7-T: Descriptive text field to verify consent subject's name the date of consent edited to include an event name - Online Designer view*

*[unique_event_name] - replace unique_event_name with the name of your event | At the start of the form, add a descriptive text field with the subject's name and date of consent to make it easy for the study staff to verify they are completing the form for the correct participant.
- Pipe the subject's first and last names.
- Pipe the timestamp of when the consent form was submitted, using the smart variable: [survey-time-completed:instrument].
Figure 14-S: Adding a descriptive text field to verify the consent subject's name and the date of consent
 Figure 15-S: Descriptive text field to verify the consent subject's name and the date of consent - Online Designer view

|
|
Edits are NOT NEEDED to the Consent Attestation checkbox field unless one of the following are true:
- Your project is set up as longitudinal.
- For piping the subject's last and first name, add the unique event name (of the event the consent form is assigned to) before the variable name.
- You modified the variable names of the subject first and last name fields on the consent form.
Figure 7-T: Descriptive text field to confirm the subject consented edited to include an event name - Online Designer view* 
*[unique_event_name] - replace unique_event_name with the name of your event | Add a checkbox field with a single option for study staff to confirm they obtained consent for the participant.
Figure 16-S: Adding a checkbox field for confirming the subject consented

Figure 17-S: Checkbox field for confirming the subject consented - Online Designer view
 |
|
Edits are NOT NEEDED to the following fields:
Date of Consent Attestation text fieldStudy Staff First Name text fieldStudy Staff Last Name text field
| Add text fields for the study staff who obtained consent, to enter their first and last names, and the date they completed the attestation form.
Add a text field for capturing date of the staff complete this form Add a text field for the study staff’s first name. Add a text field for the study staff’s last name. Add a text field for the study staff’s last name.
Figure 18-S: Example of text fields for study staff's first and last names and date of completing form - Online Designer view

|
|
Study Staff - Consent Attestation
Click on the link to view the screen shot
|
↑ top of the page
There are more than 20 elements that can be defined in the Survey Settings
. We cover a subset of those elements in our instructions, focusing on what's required to support consent and what's related to best practices, as well as highlighting the key decision points associated with consenting online.
If you started your project from one of the Project Templates, the consent form has already been enabled as a survey and only a few modifications will be required. However, you should still review the settings outlined below so you can support the consent process for the project.
Survey Settings |
---|
4A - Basic Options |
- Edit the
Survey Title to be unique.
- Edit the
Survey Instructions to include the contact information for the study team.- Additional instructions can help the subject understand how to interact with the consent survey AND this messaging will require IRB approval.
| Figure S-8: Survey title and instructions - Survey Settings view

|
4B - Survey Design Options |
| Figure S-9: Standard radios and checkboxes - Survey Settings view

|
4C - Survey Customizations |
- Select
Custom Numbered for Question Numbering . - Select
Yes for the setting: Allow participants to download a PDF of their responses at end of survey? - Accept the default selection,
Yes , for the setting: For 'Required' fields, display the red 'must provide value' text on the survey page?
| Figure S-10: Custom numbered for Question numbering - Survey Settings view

Figure S-11: Allow PDF downloads - Survey Settings view
 Figure S-12: Display must provide value for required fields - Survey Settings view
|
Survey Access |
| Figure S-13: Save and Return disabled - Survey Settings view

|
Survey Termination Options |
- Edit the
Survey Completion Text to include instructions for the study staff about accessing the PDF.
| Figure S-14: Completion text - Survey Settings view

|
e-Consent Framework and PDF Auto Archiver |
- Select
Auto-Archiver + e-Consent Framework .
| Figure S-15: Auto-Archiver + e-Consent enabled - Survey Settings view

|
e-Consent Framework Options (subject signature required) |
- DO NOT check the box
Allow e-Consent responses to be edited by users? Enter your e-Consent version . For the First name field and Last name field , select the fields from the form that capture the study staff's first and last name. - The study staff's first and last names are included in the footer of PDF copy of the completed attestation survey.
- Under
Optional fields add Consent Attestation or Attestation for e-Consent Type . Select the following signature settings for Force signature field(s) to be erased if participant clicks Previous Page button while on the certification page?
| Figure S-16: e-Consent configured - Survey Settings view

|
PDF Copy Stored in File Repository |
PDF copies of the submitted consent and attestation forms are saved to File Repository > PDF Survey Archive . | Figure S-17: PDF copy of subject submitted consent survey and staff submitted attestation survey stored in the File Repository
 |
|
Open Attestation Form as Survey
Click on the link to view the screen shot
Attestation Survey
Click on the link to view the screen shot
e-Consent at the end of the Attestation Survey
Click on the link to view the screen shot
|
↑ top of the page
IRB approves the consent forms set up in REDCap.
Also include the following in your submission to the IRB
- The message the displayed to the participant when the consent survey is submitted.
- If you are emailing an invitation to the consent form, the subject line and message of the email.
If the consent form requires the participant to enter their first and last names, note you are using using e-Consent framework with the certification step for the participant.
↑ top of the page