As technology is becoming more prevalent, everything seems to be moving to an electronic format. For many years in the clinical research industry, informed consent forms (ICFs) were used. However, in recent years, electronic informed consent forms (eICFs) have made their way onto the scene, providing research staff an alternative way to educate potential participants about a trial.
Pfizer launched its pilot project, Research on Electronic Monitoring of Overactive-bladder Treatment Experience (REMOTE) in 2011, using electronic consent (eConsent) during recruitment. While the trial ultimately ended due to low enrollment, it began to pave the way for how eConsent is used today.
Benefits to eConsent
Oftentimes, traditional consent documents need multiple pages to include the information required for participants to make a fully informed decision on whether or not they want to participate. That leaves room for participants to get lost in the information and not fully understand what the trial entails.
Providing an eConsent option to participants gives research staff the opportunity to inform patients in ways that work for them. It’s important to remember that people learn in different styles – what works for one participant might not work for the next.
Not only does eConsent accommodate for different learning styles, but making the process interactive keeps participants engaged. Adding in assessments helps participants to understand the consent process in full. Studies using eConsent, like the All of Us Research Program, places tests throughout the process, aiding participants in understanding what the study is about and their role in it.
eConsent also accounts for real-time tracking, allowing for staff to document both the information provided and the participant’s understanding. Real-time tracking also makes remote monitoring and audit access easier.
Drawbacks to eConsent
Although eConsent helps research staff ensure their participants understand, retain and comprehend the eICF, there are concerns to performing eConsent rather than traditional consent. Common obstacles include verifying identification and ensuring comprehension.
To aid in identifying a participant, the electronic system needs to include a way to guarantee the person signing the eICF is actually the person participating in the study. A way to achieve this is using personal questions to verify the correct person.
Since eConsent is easily adaptable for multiple learning styles, participants can also move through the consent process at a quicker rate versus receiving the ICF from a clinical research staff. While this may seem like a benefit upfront, it also eliminates the reassurance that a participant completely understands the protocol. Through eConsent, participants wouldn’t have the opportunity to ask research staff for clarification, and staff don’t have the opportunity to test comprehension by asking participants to repeat information back in their own words.
eConsent also allows for participants to continue on with the study without re-consenting, even though the consent document has been updated. Research staff must be mindful of this challenge, making sure the system allows for re-consenting.
Ultimately, consent is a mandatory part of any clinical trial, and needs consistent approval as a trial moves through the phases. Regardless of the benefits or risks to eConsent, it’s an alternate way for research staff to recruit participants and ensure understanding of the trial. The more informed a participant feels throughout the trial, the less likely they are to withdraw.