Using teach back during consent
It's well known that informed consent forms (ICFs) often do not meet patient needs – being too long, too technical, and too contractual. ICF quality is associated both with participant experience scores and trial completion rates. This potentially implies that mismatched initial expectations are leading to dissatisfaction and withdrawal further down the line. If a patient doesn't know what the ICF means, how do they know exactly what they're agreeing to?
What site teams can do:
Treat consent as an opportunity to address individual concerns, questions, barriers, and motivators, instead of a legal obligation to read a document top to bottom. It's tempting to read through the ICF then ask a closed question like “Do you understand?”, but asking patients to explain the study back to you in their own words (“teach back”) helps to confirm they really are informed about what they are consenting to.
Some example questions to build around might include:
Can you talk me through why we're doing this study?
What do you think the potential benefits and risks of taking part might be?
How do you see this study comparing with your regular treatment?