Informed consent forms are an essential aspect of conducting clinical trials, yet patients are often intimidated by the medical jargon and sheer length of the document.
What would happen if we could make the consent form more patient-friendly?
An electronic informed consent or eConsent form can allow for simplified language and a streamlined layout that is much easier for patients to comprehend. Its multimedia format can include anything from videos to galleries to a glossary or relevant hyperlinks.
Companies like Lilly are even taking things a step further by providing Tiered eConsent.
Tiered eConsent can help overcome the challenge of information overload. It’s divided into multiple sections, with the first section containing the most pertinent information. The second is a detailed reference section that provides additional facts.
Other companies are making noteworthy strides as well. Last year, Mytrus got approval from the Health Research Authority (HRA), a division of Britain’s National Health Service (NHS), to use their electronic consent forms for a clinical trial in England.
The Benefits of eConsent Forms
The medical community is paying close attention to the advancements of eConsent usage. Health professionals have noted the potential they have to remove a major roadblock to participation. As we strive to improve clinical trial recruitment and retention, listening to and addressing the needs of patients has become an essential requirement.
The eConsent form is appealing to a potential patient for a number of reasons:
- Convenience – The patient does not physically need to travel to a site.
- Intuitive Layout – Electronic consent forms can be formatted to relay information in a more intuitive way for readers. Potential participants can more easily identify the information that is most important to them within the consent form. Supplementary electronic technologies can help them better understand what they’re reading.
- Less Pressure – A patient can make a more informed decision when he or she reviews the consent form at his or her own pace. This can create a more relaxed environment than a clinical facility, and provides patients with the opportunity to discuss with family members.
- More Engaging – We live in a digital world, and many people have come to expect electronic and interactive technologies.
The multifaceted benefits of eConsent forms provide a strong argument for more widespread application.
The Limitations of eConsent Forms
As with all new technologies, the adoption of electronic informed consent forms come with challenges.
- Confidentiality – This is a recurring issue when it comes to the intersecting fields of medicine and technology. In the case of eConsent forms, the requirements of the FDA CRF part 11 compliance must be implemented.
- Cost – As one might predict, properly implementing multimedia eConsent forms at a research site or for a new clinical trial isn’t cheap. It requires more investment than simply printing additional copies. Some sites don’t have the infrastructure to justify these expenses at this time.
- Timelines – A new eConsent form also takes longer to develop (about 60 to 90 days) than drafting up a new written informed consent form. This is due to the development required to format electonic consent forms and to ensure that communication is possible between sponsors and eConsent vendors.
- Technical Issues – Sites use eConsent forms need to be wary of possible technical problems. Anything from software incompatibility to broadband connection issues and hacking vulnerabilities should be considered before implementing electronic informed consent forms.
Weighing the benefits and challenges, electronic consent forms may not be currently feasible for everyone. As a long-term investment, eConsent is one of the many digital tools with strong potential to help improve patient recruitment.
The Future of Electronic Consent Forms
Nichole Argo, a researcher at Carnegie Mellon University, summarized it this way:
“There is a broad consensus in the world of clinical trials that a more patient-centered informed consent process is needed. Our challenge was to create informed consent content and formatting that would be engaging and understandable to patients, but would at the same time not hinder or bias patient judgment and decision-making. We are now proposing a patient-centered informed consent process that seems to accomplish this goal.”
While the consent process still has some kinks that need to be ironed out, we expect that eConsent forms will become a critical part of the clinical research process in the near future.
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