A study team should receive approval from COMIRB prior implementing Electronic Consent (e-Consent) in your project.
Jump to:
What is the e-Consent Framework?
The e-Consent Framework in REDCap is a tool that provides structure for maintaining and certifying consents. The study team will still be responsible for creating the e-Consent survey and the necessary fields therein (name, signature, etc.). The framework will add two main components.
- An additional page will be added to the end of the consent survey that will include an in-line PDF of the respondent's survey responses. The participant will be asked to review and certify that all information in the PDF is accurate before the survey can be marked as completed.
- A "PDF Snapshot" trigger, which will generate a static PDF of the responses as they were submitted when the consent was completed. This file will be saved to the File Repository.
Original e-Consent Framework
Some e-Consent designs are not conducive to the new versioning system that will be described later in this article. For example, consents which collect signatures at several different locations throughout the consent form may not be a good fit for the versioning system. In these cases, you may want to opt for an alternative method for consent versioning, such as creating new consent instruments for new versions. However, you can still take advantage of the original e-Consent Framework, providing you with the benefits described in What is the e-Consent Framework? above.
e-Consent Survey Design
If you have chosen to move forward with the original framework, start off by designing your consent survey. Our instance of REDCap offers a COMIRB eConsent Template during project creation, which is a template provided by COMIRB to guide study teams on appropriate verbiage and information to capture.
From a technical perspective, consent forms in REDCap can be built to represent your stamped consent. If you are concerned about what fields you may or may not capture in REDCap or if you may deviate from the template, please contact COMIRB (comirb@ucdenver.edu) to confirm whether you will need to adhere to the template.
e-Consent Survey-Level Settings
After you have finished designing your consent survey, navigate to the Designer home page and select "e-Consent".
From here, select "+ Enable the e-Consent Framework for a survey".
Select your e-Consent survey.
In "Primary settings", you can select whether users can edit e-Consent responses and designate the fields which collect first and last name. If your project is longitudinal, you will have an additional dropdown to select which event the consent is being collected in.
In "Additional settings", you can designate a date of birth field (if you are collecting one), custom text for the PDF footer (this should be static text), and custom text for the PDF header (this can include Smart Variables or Piping). Additionally, selecting the signature field will include an additional security step which will erase the signature if the respondent selects "Previous Page" on the final page of the survey, or if they use the "Save & Return" functionality.
In "Locations(s) to save the signed consent snapshot" you can make adjustments to where the consent PDF snapshot is saved. If you have a file upload field in your project where a copy of the consent should be saved, you can designate it in this step.
Finally, you can control the file naming convention of your e-Consent PDF snapshots by adding static or dynamic text using Smart Variables or Piping.
You may also add any notes for documentation or future reference.
When you are ready, select "Save Settings". You will then see your e-Consent survey marked as active.
If you are opting for the original e-Consent Framework without versioning, then you will not need to take any action with the "+ Add consent form" hyperlink.
If you create a new instrument later on to represent a new version, you can then follow the same steps as the above to enable the e-Consent Framework for that new instrument.
Versioning e-Consent Framework
As of August 30th, 2024, the e-Consent Framework is also equipped to manage version control. This feature was demonstrated in the 9/6/2024 User Meeting.
Here are some tips on how to take advantage of this new version control feature.
e-Consent Survey Design
With the e-Consent versioning system, the body of the consent (i.e., the language that may be changed from version to version) will be controlled within the e-Consent settings, as opposed to within the instrument itself.
The e-Consent settings will allow you to select a descriptive field where your consent language will be displayed. As an example in this article, I will create a descriptive field, [consent_form_language], that is completely empty.
At this point, it may be concerning to see your e-Consent instrument lack the body of your consent; however, hold on just a bit longer and we will configure that language to appear in the empty descriptive field in the following steps.
e-Consent Survey-Level Settings
Navigate back to the Designer home page and select "e-Consent".
From here, select "+ Enable the e-Consent Framework for a survey".
Select your e-Consent survey.
In "Primary settings", you can select whether users can edit e-Consent responses and designate the fields which collect first and last name. If your project is longitudinal, you will have an additional dropdown to select which event the consent is being collected in.
In "Additional settings", you can designate a date of birth field (if you are collecting one), custom text for the PDF footer (this should be static text), and custom text for the PDF header (this can include Smart Variables or Piping). Additionally, selecting the signature field will include an additional security step which will erase the signature if the respondent selects "Previous Page" on the final page of the survey, or if they use the "Save & Return" functionality.
In "Locations(s) to save the signed consent snapshot" you can make adjustments to where the consent PDF snapshot is saved. If you have a file upload field in your project where a copy of the consent should be saved, you can designate it in this step.
Finally, you can control the file naming convention of your e-Consent PDF snapshots by adding static or dynamic text using Smart Variables or Piping.
You may also add any notes for documentation or future reference.
When you are ready, select "Save Settings". You will then see your e-Consent survey marked as active.
e-Consent Version-Level Settings
To set up the first version of your e-Consent, select "+ Add consent form" below your e-Consent survey.
Now that we are working on a single version of this consent form, we will need to specify some version information.
Consent form version: First, establish a version naming convention that is appropriate for your team. Place an appropriate version in the "Consent form version" text box. In this example, I will use the version date.
Placement of consent form: This is where we will select the empty descriptive field, [consent_form_language], that we created earlier.
Display for specific DAG: An example of when you might use this option would be if you have a multi-site study that is split into Data Access Groups (DAGs) and those sites should have different consent language.
Display for specific language: You can manage language variations of your consent using this tool as well. You may want to use this option if you are utilizing language selection via the Multi-Language Management Tool (MLM).
Finally, select whether your consent language will be displayed as rich text or as an inline PDF. This is where you will place this version's consent language.
I will use placeholder text for this example.
My consent version is now listed under my e-Consent survey.
Even though the consent text is not in my instrument designer, and [consent_form_language] is still empty, my placeholder text is now visible when completing the consent survey.
Now, when I view the completed consent from the data entry view, I can see which consent form version this consent was completed under.
When I have multiple versions of the consent active, this "Consent form version" will save based on when the consent was completed. For example, when I introduce a new 2024-10-29 version to replace my 2024-10-11 version, Record ID 10007 above will still have Consent form version: 2024-10-11. However, new consents will now have the new consent form version with the new consent form language.
Viewing Consent Versions
When multiple consents have been used on your project, you may wish to view the previous and current versions. To do this, open the "View all versions" hyperlink.
A pop-up window will appear with a table of your consent versions. Notice that in the below screenshot, the 2024-10-11 version is blank in the "Active?" and "Set consent form as inactive" column.
The 2024-10-11 consent form was deactivated automatically when I introduced the 2024-10-29 version, the first row in the screenshot below, which was implemented with the same settings (replacing text in the same field, with no specification for Data Access Group or MLM Language). The three consent forms pictured below are now active, indicated by the checkmark in the "Active?" column and the option to Set as inactive. All three can be active at once because they each possess different settings (each has a different selection in the "MLM Language" column).
If I upload a new version at any point that has the same settings as one of the versions above, the existing consent form will become inactive automatically and the new form will be available for future participants.