Who should review this material:
- PI
- Co-PI
- Personnel building project
- Personnel managing the project
- Regulatory personnel on the study team
Topics covered:
Regulatory Considerations
OCTRI's REDCap team does not prescribe the consent process.
Study teams are responsible for obtaining IRB approval for the consent process and building a REDCap consent/information sheet that is consistent with their IRB approval.
If you have a new study include the e-consent process in your protocol.
Additionally, it is strongly recommended to have a paper consent as a back-up.
If you have an existing paper consent process, you will need to submit a modification to the IRB to add or switch to an e-consent process.
IRB requirements for approval of an e-consent process include:
Submission of a paper (Word) consent document to facilitate the review process.
Describing the use of REDCap for consent included in the protocol/local conduct supplement/ or data security supplement for waived studies.
Describe the consent process – nature of consent discussion (phone, virtual, live or asynchronous opportunity to ask questions).
Indicate if you are obtaining signatures or requesting a waiver of written consent and waiver of HIPAA authorization signature.
How participants will be directed to REDCap (e.g. secure email with link to REDCap – indicate whether the link will be unique to the participant or generic).
Any revisions/additions to the consent language necessary to implement REDCap.
Consent introduction message/participant instructions.
A yes/no agreement to participate component.
Updated signature section.
Automated messages from REDCap.
The IRB must approve the final REDCap consent/information sheet prior to using it.
Is a signature required? Whether or not a signature is required is a key regulatory determinant that informs how to set up your project for consenting participants.
Planning: When to Contact REDCap Team
Additional help, for which there are charges, applies to implementing consents that involve:
- Re-consenting
- Consenting persons under 18
- Accommodating an LAR or a translator/interpreter
- Distributing the consent in a language other than English
- Adding consent to a project in production
Charges depend on the consent requirements and the personnel’s REDCap experience.
Contact the REDCap Team at redcap@ohsu.edu if your consent includes these requirements.
Reference: Materials
↓ Download PDF document Using REDCap for Consenting Research Participants
↓ Download (from IRB) IRB Use of Electronic Consent - Quick Guide
Regulatory Workflow Diagram for e-Consent
*Study teams will often require 2 submissions to get approval of the online consent. The first approval will finalize the content of the consent and the final IRB approval requires a PDF of the final consent in REDCap.
Regulatory Checklist
To implement an online consent, either a paper consent can be approved first (recommended so that the text of the consent is finalized before building the final e-consent) or the e-consent/paper consent (required to facilitate review) can be approved at the same time.
Any changes required by the IRB must be made to the online consent and the final online consent approved prior to launching it.
Submission to the IRB must include the following documents:
- Protocol with details about online consent process.
- Paper consent form (required for the review process and recommended to be available as a back-up to the e-consent process).
- Final PDF of REDCap online consent form.
- Survey invitation text including a subject line if email is used to distribute.
- Survey instructions.
Common Modifications Needed to Transform the Paper Consent into an E-Consent
- Adding a yes/no agree to participate component to capture the subject's consent decision.
- Example:
Select one of the following options to indicate if you want to participate in this study.
___ Yes, I agree to participate
___ No, I do not agree to participate
- Example:
- Modifying how the date of consent is captured to use the timestamp generated by REDCap when the e-consent form is submitted, instead of manually entering a date on a field on the form.
- When a participant's signature is required:
- Modifying how the participant's signature is captured.
- The subject "signs" the e-consent form by typing their first and last names into fields on the form, instead of adding an electronic signature to the form.
- Modifying the language of the consent statement that refers to the subjects statement.
Example:
On paper: Your signature below indicates that you have read this entire form and that you agree to be in this study.
In e-consent: Entering you first and last name indicates that you have read this entire form and that you agree to be in this study.
- Modifying how the participant's signature is captured.
- If you are not capturing a participant's signature:
Do not add any data capture fields that contain PHI to your consent form (e.g. participants’ name or email address fields)
- In order to collect any Personal Health Information or clinical data the e-consent must include HIPAA language and the IRB must have approved a waiver of the signature requirement (via a Waiver of Authorization form)
OCTRI's Model of Support
REDCap at OHSU is largely a self-service application. Personnel attend training, then build their projects, learning as they go. Help is provided at no cost, via email and through our 2 weekly drop-in sessions. There are charges for one-on-one consulting or additional help.
Our expectation is, in most cases, personnel who have completed Basics and Survey training and have experience building survey projects will be able to use this document to set up their REDCap project for consenting, getting help as needed, at no cost, via email and drop-ins.
We expect additional help will be needed: 1) for personnel who are new to REDCap and who have never built a survey project, and/or 2) when the consent process involves minors, involves re-consenting, needs to be distributed in multiple languages, needs to accommodate a legally acting representative (LAR), or needs other REDCap features to support the consent process. To utilize additional REDCap support beyond drop-ins, charges apply and vary depending on the study’s consent requirements and the personnel’s REDCap experience.
Preparing to Use REDCap
It's imperative for personnel building projects to understand both the REDCap skillset and the REDCap feature set involved in setting up a REDcap project for consenting. The project builder is responsible for addressing any gaps in training, skills or experience.
REDCap Features & Functionality
Required for All Projects
Survey functionality.
Adding Survey Settings to a form.
Determining the survey distribution method(s).
Managing users' survey related permissions.
Determined by Project & Consent Requirements
e-Consent framework.
Survey queue.
Automated Survey Invitations.
Alerts & Notifications.
- File Repository > PDF Archive.
REDCap e-Consent Framework
If your paper consent form requires a signature, the e-consent framework is required.
The e-Consent framework is a REDCap survey setting that adds the following components to the consent survey:
- A certification screen that prompts the participant to confirm the information entered in the consent survey and verifies the use of the electronic signature.
- Automatic storage of a PDF copy of the consent survey.
- Stores extra documentation of the identity of the person who consented, the version of the consent form and the date of the consent in the footer of the PDF copy
Required & Recommended Building Skills
Minimum Requirements
Basics training.
Survey training.
Experience building a survey project.
Recommended Skills
Using the Rich Text Editor to format a Descriptive Text field.
Using Action Tags.
Using piping.
Familiarity with Smart Variables.
Experience developing documentation for managing a REDCap project.
REDCap Training
The expectation is that all personnel involved in building and managing projects used for consenting participants will get training through the resources listed below.
- Watch the Training video (from August 2020 training session)
- Download Training Slide Deck