A legally authorized representative (LAR) has a vital role to play in clinical trials, yet clinical trial software vendors too often forget to think about LARs and their needs.
Most clinical research professionals have encountered patients who are in a coma or who have conditions like Alzheimer’s, dementia, serious mental illness, or developmental disabilities that prevent them from understanding and completing the informed consent process.
In these cases, a Legally Authorized Representative (LAR) can sign on the patients’ behalf, in accordance with FDA or other national regulations.
But in spite of how important LARs are to clinical trials, clinical trial software vendors often market their products exclusively to patients who can consent to and participate in trials themselves. Little or nothing is said about how the software can help Legally Authorized Representatives with informed consent.
With that in mind, we’ve put together this list of three ways eConsent can help LARs:
- Ensuring compliant signatures
- Increasing comprehension
- Improving accessibility and speed
If you’d like to learn more about the benefits of Florence eConsent for LARs at your site, keep reading!
eConsent Can Ensure Compliant Signatures for LARs
The FDA has approved the use of eConsent for both patients and Legally Authorized Representatives. But eConsent isn’t just compliant–it can actively help prevent compliance errors. eConsent can:
- Help LARs understand where and how to sign
- Comply with Part 11 regulations
- Make sure every LAR signs the correct form when the form is updated
Unlike paper forms, eConsent forms help prevent LARs from signing on the wrong line, skipping a signature, or writing down the wrong date. Some eConsent platforms, like Florence eConsent, even offer a “Next Field,” feature, which leads them through forms while pointing out each individual field they need to fill in.
This feature is valuable because LARs are often signing in high-stress situations. It’s difficult to focus on finding the correct line when your loved one is unconscious or unaware of what’s happening.
Of course, eConsent only helps with compliance when the eConsent solution follows 21 CFR Part 11 guidelines for electronic signatures. While eConsent software specifically designed for clinical trials is often Part 11-compliant, not all eSignature software is.
Popular services like REDCap require an extended process to make their software Part 11-compliant, and others, like DocuSign, charge extra for Part-11 compliance features. Software designed for clinical trials is more likely to have these features built in.
You can learn more about how to ensure software complies with these regulations in our 21 CFR Part 11 checklist.
Form updates and reconsenting
eConsent offers version control so sites can easily see whether Legally Authorized Representatives signed the most recent version of a consent form. If LARs need to sign an updated version of the form, they can do so via their computer, smartphone or tablet, without having to return to the site.
This advantage is especially important for LARs, who are often caregivers and have limited ability to quickly travel to the site.
In Florence eConsent, clinical staff can also control when a form becomes available for signing. For example, they could disable signing and put the form in “view-only” mode until they feel confident that the LAR has seen the updated form and has a full understanding of it. Then they can turn on signing capabilities.
Sometimes, when a LAR consents for a patient who was unconscious, the patient may also regain consciousness and be able to consent in their own right. When this happens, the eConsent platform can show an audit trail of when the LAR consented and when the patient submitted their updated consent for future inspections.
Increasing Comprehension for LARs in Clinical Trials
Informed consent isn’t just a form: it’s a process. Clinical research teams assume responsibility for helping Legally Authorized Representatives understand the form before they sign it.
But many people struggle to absorb all of the information in consent documents. The average eConsent form is now 15-20 pages long, and though it legally must be written at an eighth-grade level, that doesn’t always lead to high understanding.
When a survey asked people how well they understood an informed consent document they’d just read:
- 27.6% of people had a low understanding of the content
- 58.1% of people had an intermediate understanding of the content
- 14.3% had a high understanding of the content
Legally Authorized Representatives must deal with these often-confusing forms while also coping with the serious illness of someone they love. This combination of stressors can lead to low comprehension, especially when the LAR speaks English as a second language or has vision- or learning-related disabilities.
How eConsent Can Help with Comprehension of Informed Consent Forms
eConsent improves comprehension by:
- Giving Legally Authorized Representatives more time to review the form
- Letting LARs discuss the form with other loved ones
- Setting clear expectations for how long the consent process will take
- Providing supplemental information if desired
Mason McLellan, Clinical Research Coordinator at the Cancer Early Detection Advanced Research Center at OHSU, said in a recent interview that he uses eConsent at his site because it lets patients or LARs “get through the consent process with relative ease and really high understanding at the end.” He noted that they can go through the form “at (their) own pace, in (their) own home.”
eConsent is a two-step process: instead of just handing patients a form, the eConsent platform encourages LARs to read the form, then shows them exactly where they need to sign. This gives them plenty of time to process what they’re reading.
Discussions with Loved Ones and Extra Information
eConsent also gives LARs the chance to talk about an informed consent document with the patient’s other loved ones. For example, adult children could confer with one another or with their spouses before signing a consent form for their parent with Alzheimer’s. The LAR can even download PDFs to share with family members who aren’t the LAR. This lets the legally authorized representative make a more informed decision about whether they’ll enroll their loved one in the study.
eConsent platforms can also show LARs how many forms they’ll need to sign and how many pages each form consists of before they even begin reading. This lets the LAR know how long the consent process will take upfront.
Finally, eConsent programs can provide supplemental information like notes, videos, or quizzes. One study showed that participants were almost evenly split on whether they wanted extra information beyond the essential informed consent form. eConsent gives LARs the power to choose whether or not they want to receive additional information.
Improving Accessibility for LARs in Clinical Trials
Clinical research sites need to make clinical trials and the informed consent process easily accessible for Legally Authorized Representatives as well as patients.
Traveling to sites can be difficult for LARs who:
- Are caregivers (as many are)
- Have mobility-related disabilities
- Work strict hours
- Live long distances from the site
- Rely on public transportation
In a recent webinar, Catherine Gregor, Florence’s Chief Clinical Trials Officer, noted that during her time at Vanderbilt-Ingram Cancer Center, patients or LARs would often rush through forms to avoid returning to the site for a second visit.
With eConsent, LARs don’t have to drive back to the site just to return a form. They can view the informed consent form at home, complete it on their computer or tablet, and send it back to the site online.
Accessible Features for Informed Consent Forms
eConsent can also come with features to make documents more accessible. These features might include:
- Translations into other languages
- Compatibility with screen readers
- Ability to change font size
- Zoom in and zoom out
- Different screen colors
Accessibility features help LARs who have vision or learning disabilities as well as people who are neurodivergent. These features can even benefit people who are under severe emotional stress, as Legally Authorized Representatives often are.
Patient- and LAR-centric tools like eConsent can reduce recruitment times by up to 42%, leading to faster study start-up as well as a more welcoming experience for LARs.
How eConsent Can Benefit LARs in Clinical Trials
Clinical trials play a vital role in fighting serious neurological conditions like Alzheimer’s and schizophrenia. But many participants in these trials require consent from legally authorized representatives, and LARs are often under tremendous stress from coping with their loved ones’ illness.
eConsent can take some of this stress out of the informed consent process. LARs can take the consent form home and review it at their own pace, with supplemental information and accessible features immediately available.
Florence eConsent offers compliant LAR signatures, as well as features to make eConsent forms easier to read and understand. If you’d like to learn more about Florence eConsent, check out our eConsent capability checklist.