Informed consenting is process where someone interested in taking part in research learns important facts about the study before deciding whether or not to participate. To help the person decide, the consent document has information about what will happen during the study and any risks or possible benefits. Unfortunately, sometimes informed consent documents can be very long and use complicated language, which can make people feel uncomfortable asking questions or making the decision about participating.
Electronic Consent (eConsent) is a new way of helping patients consent for a research study online. Patients can sign an eConsent document on site or at home using a computer or tablet. eConsent may also use to help patients better understand what to expect from the study. The STRIDE intervention uses adapts eConsent, based in the REDCap platform, to be culturally sensitive to African American and Hispanic communities. REDCap is a secure, web application that lets researchers build and manage surveys and databases. REDCap meets standards for patient information security (HIPPA) and patients can access REDCap eConsent forms on a computer, smartphone, or tablet.
By moving consent online, we have the chance to include things like pictures, audio, and avatars to help participants feel more comfortable and have a better understanding of the risks and benefits of a study.
Use of eConsent also lets participants review information at their own pace, which may help participants to feel less anxious and less pressured to participate. The team created new tools/external modules that can be added to REDCap eConsent projects:
Patients can “sign” their consents by typing in their name, signing their name with a stylus/finger, or study coordinators may give a PIN number to people interested in participating.
After signing the consent document, participants can download a pdf copy of their signed consent document.
The team worked with physicians, researchers, and community experts to create a library of videos of medical procedures common in research studies. The videos can be placed inside an eConsent document and will hopefully help research participants to feel more comfortable and have a better idea of what to expect during the procedure.
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The Hover or Click/Popout feature lets participants decide how much information they need or want in the eConsent document. Participants can hover over or click key words/phrases to get pronunciations, images, or definitions without visiting another site.
Avatars are animated drawings of a person which can help define terms and walk someone through an eConsent document.
The Avatars can be customized to reflect a broad range of cultural identities.
To track all eConsents across all projects, the team created a document management system which will store full signed copies of eConsent documents which cannot be edited at a later time. This feature can be added by REDCap administrators by identifying any REDCap project as an “eConsent project.” Any time an eConsent is completed within an “eConsent project,” the full signed eConsent document is sent as a PDF to a centralized document repository, a secure space, housed within REDCap. These files are dated and timestamped, and provide a record of eConsent language and signature which cannot be changed. Metadata tags are also moved with the eConsent PDF file, allowing final eConsent documents in the document repository to be searched. This will allow participants to view all signed eConsent documents from a single location.
To see if the intervention is working as planned, the team will collect information about the ways participants are using and moving through eConsent documents. The team will look at demographics (age, race, gender) and which parts of the eConsent document the participants use.