by Crystal Stargell, Associate Product Manager for Florence and former Clinical Regulatory Coordinator
Informed consent is arguably the most important element of clinical research. It’s during the informed consent process that participants learn about their rights, what they’ll be asked to do during the trial, and how the clinical research team will protect their welfare.
Because the informed consent process is so important, Institutional Review Boards (IRBs) strictly enforce regulations around patient consent.
Institutional Review Boards and research sites often run into three major barriers when creating consent forms:
- Do the participants fully understand the informed consent document?
- Is the informed consent process accessible to all? Can the process accommodate participants who live with disabilities or who speak different languages?
- Do participants have a correct view of both the risks of the trial and the likelihood of each risk?
Electronic informed consent, or eConsent, has the potential to address many of these challenges in ways paper informed consent documents can’t.
If both your research team and your IRB understand eConsent software and choose the right platform, eConsent can improve your participants’ experiences and make your site more compliant with regulatory standards.
Here’s how eConsent addresses the challenges of informed consent documents and IRB approval.
Challenge 1: Does the participant fully understand the informed consent document?
The National Institutes of Health reports that over time, informed consent documents have grown longer and more complicated, often because of the IRB requesting more details.
There’s nothing wrong with a long, detailed consent document—unless that document confuses the participant. One recent study found that only 14.3% of patients demonstrated high comprehension of informed consent documents they’d read.
In my experience as a Clinical Regulatory Coordinator, I saw many IRBs ask for more details in the consent forms I submitted for research sites. The IRB often returned the consent form with a list of questions like: Can you explain why the investigator needs this many samples? What about describing why each visit is required?
It’s admirable that IRBs want to make sure participants fully understand the trial. But this often leads to very lengthy informed consent documents that can overwhelm the participant.
Federal regulations state the informed consent document must be written at an eighth-grade reading level. But with only 58.1% of patients achieving an intermediate understanding of informed consent documents and 27.6% showing a low understanding, it’s clear the reading level requirement alone isn’t enough.
How eConsent can help with participant understanding
With more people using electronic devices to read and retain information, it makes sense that 75% of research sites already use or are considering eConsent. When I worked as a clinical regulatory coordinator, I always knew an electronic process would one day eclipse the paper one.
The COVID pandemic accelerated the move to digital research. The number of sites interested in eConsent jumped 28% from December 2020 to June 2021.
But has this move to eConsent led to greater participant comprehension? Early evidence says yes.
A survey of 146 people from 100 biotech, pharmaceutical, CRO, and IRB organizations found that the number one reason sponsors and sites chose eConsent was to improve participant understanding.
eConsent gives participants more time to review and reread the informed consent documents. Participants often have to fill out paper forms at the site to prove that the correct person is signing them—but that may lead to participants feeling rushed and not reading as carefully as they should.
With eConsent, participants can sign on a tablet at the site or on another device at home, using a secure login that verifies their identity. When participants take their time reading and signing in a comfortable environment, they’re more likely to truly understand the informed consent document. This ensures that their consent is authentic.
eConsent and additional resources
I like to describe eConsent’s additional resources for participants as a braided cord. When working with a paper consent form, participants only have a single cord—reading the form and asking site staff questions. With eConsent, you can keep that cord, but you can also add others.
For example, eConsent could come with supplemental notes, videos, or interactive quizzes. Or participants and clinical research staff could engage in telehealth calls outside of the app.
If participants find the supplemental information overwhelming, the site can eliminate it with no harm to the core consent process. Participants can control which extra resources they’d like to see, which makes participants who crave information more likely to join without intimidating participants who like to stick to the essentials.
Challenge 2: Is the informed consent process accessible to all?
Participants could fail to fully understand the informed consent document because of language differences or a disability that affects their vision or comprehension.
Informed consent documents must be translated into a language the participants can understand, but this requirement doesn’t fully account for differences in proficiency. Just because a participant speaks a language fluently doesn’t mean they can understand medical or technical language in it.
Some participants with disabilities may also have trouble understanding the informed consent document quickly, either because it’s hard for them to see the text or because it’s hard for them to comprehend it immediately.
Studies have found that participants will occasionally sign documents they didn’t fully understand out of trust in the system or a desire to help others. But research sites and IRBs must ensure that participants know what they’re consenting to.
How eConsent can help with accessibility
eConsent platforms can offer services to make the informed consent document easier to understand. These accessibility features may include translations, screen readers, larger font, and different screen colors.
Accessibility features help people who are blind or have low vision, but they can also help people who have learning disabilities or who are neurodivergent focus on and understand longer documents.
It’s a good idea to ask vendors which patient-centric features are available or coming in the future when your site chooses an eConsent platform.
But eConsent can also help patients by providing more time to review the form and a chance to talk with friends and family. A participant can show the form to their loved ones and ask questions without being intimidated by the presence of research staff. They don’t have to feel alone or decide alone.
35% of participants who dropped out of a clinical trial thought the informed consent document was hard to understand, versus only 16% of participants who completed the trial. So having more time to understand the informed consent document doesn’t just make participants more likely to sign—the extra time also makes participants more understanding of trial protocols and more likely to stay in the trial.
Challenge 3: Do participants have a correct view of both the risks of the trial and the likelihood of each risk?
The informed consent document must help participants understand the risks of the trial. But what risks should be included, and how much detail should research sites go into?
Should a one-in-a-million risk be described? What about a one-in-five-hundred-thousand risk? How much detail should the document go into about the medical and technical details of the trial?
Research sites need to keep participants well-informed of the risks they might incur–but as the length and complexity of the consent document increases, patient comprehension falls.
IRBs wrestle with this tension between completeness and comprehension and often come to different conclusions. They must find the right balance of informing subjects of all risks versus the most important risks.
How eConsent can help participants understand risk
eConsent lets participants choose how much additional information about risks they want to receive. The informed consent document will include all of the risk information that IRBs decide is essential.
If participants want more detail on obscure risks or the underlying medical principles of the treatment, eConsent can include supplemental links or documents for participants to visit.
But eConsent also helps IRBs and research sites communicate risks more effectively. With eConsent, it’s much easier for sites to update the risks in the informed consent document as the trial goes on.
When research sites use paper consent forms, it’s hard to keep track of whether each participant has received the newest form of the document with all of the updated risks.
eConsent can help by providing version tracking and automatically sending each participant the newest version of the informed consent form. The participant can then sign a detailed, accurate, and comprehensible form at their own pace.
Choosing the right eConsent platform for your site
eConsent can only help research sites if the software also helps participants and the IRB. When you’re looking for an eConsent system, search for one that includes identity verification questions for compliant remote consent, easy navigation to help with participant comprehension, and the ability to update consent forms instantly.
The right eConsent program can make informed consent documents more comprehensible, more accessible, and more current. To learn more about the features you should look for in an eConsent program, check out our eConsent capability evaluation checklist.