Author: Amanda Howley, Director of Services Delivery
Making informed consent more accessible and understandable for patients is a bedrock of ethical research. Lessons drawn from historical events—from the medical atrocities of Nazi Germany to the Tuskegee syphilis study—underscore the importance of patient autonomy, comprehension, and consent. Ensuring patients fully understand what they agree to is not merely for regulatory compliance; it is an essential step toward patient protection and empowerment. The recent FDA draft guidance on informed consent—which calls for concise, flexible, and user-friendly information in informed consent forms—further emphasizes the important role patient comprehension plays in supporting decision-making.
Bringing the consent process into the digital age has the potential to help improve patient understanding and empowerment. While many aspects of clinical trials have been digitized, the patient consent process has largely remained on paper. This preference persists due to several factors, including that paper-based consent forms are the default for on-site patients, concerns about technical issues with electronic systems, and the perception that paper is simpler.
Embracing eConsent: Are sites and sponsors keeping up with patients?
To evaluate the readiness of patients, sites, and sponsors to adopt eConsent, Suvoda conducted a global eConsent Market Survey with clinical trial sponsors and sites to explore the present state of electronic consent acceptance and the promising possibilities it offers for the future.
Our findings revealed a low eConsent adoption rate among sites and sponsors, with just 1/3 of sponsors and less than 1/5 of sites using the technology. While 40% of sites cited lack of provision by sponsors as their primary barrier to eConsent adoption, both sites and sponsors had other concerns about the transition as well. In the survey, almost half the sites and 1/3 of sponsors voiced concerns about patient accessibility, usability, or technical limitations for switching to eConsent.1
Although sponsors and sites have hesitations, over 70% of the US and UK population prefer electronically signing medical forms—signaling a readiness for digital adoption in the informed consent process.2 This gap points towards a significant opportunity: leveraging eConsent to enhance patient comprehension in clinical trials.
Comprehension as the foundation of informed consent
Enhancing comprehension not only significantly benefits patients and fulfills informed consent requirements, it also provides substantial advantages for trial sites and sponsors.
When patients fully understand their consent forms at the outset, the volume of follow-up questions can be reduced, eliminating delays in the consent process and potentially helping to retain patients. eConsent applications act as facilitators in this process, equipping patients with tools such as embedded videos, FAQs, and cross-linked glossaries to clarify their doubts. In the recent draft guidance, the FDA also suggested grouping key information in bubbles, with prompts for feedback to reinforce understanding in informed consent forms.
Improving patient comprehension can lead to better patient engagement, keep participants enrolled, and limit recruitment and re-enrollment tasks for trial sites. Interestingly, sites and sponsors acknowledge the potential of eConsent to streamline the consent process. In fact, 18% of sites and 27% of sponsors identify increased efficiency in the consent process as a primary benefit of eConsent.3
The digitization advantage
The digitization and interactivity of consent processes carry inherent benefits. For patients, it means a reduction in paper forms to manage and increased understanding. For sites, it results in decreased paperwork, less storage space requirements, and improved tracking. For sponsors, digital consent processes enhance data integrity, foster regulatory compliance, and reduce dependence on paper trails.
This is why Suvoda eConsent is designed to meet sponsors’, sites’, and patients’ needs. Built with patient comprehension in mind, Suvoda eConsent accommodates multiple consent types in various languages and on different devices. Further unified with IRT and eCOA, sponsors and sites have greater control over the entire process to minimize delays and reduce the risk of errors. For example, IRT will not allow drug dispensation if a participant has not signed the most current consent form.
However, it’s important to recognize that the shift to eConsent in clinical research goes beyond embracing digital tools—it’s about placing patient understanding at the forefront. Through the thoughtful application of eConsent and other digital technologies, sponsors can foster a more empathetic, patient-centric, and efficient landscape in clinical research.
References
- “eConsent Market Survey Results.” Suvoda, October 2023.
- “Survey From Suvoda Shows Comfort with Electronic Signatures is on the Rise, Yet Healthcare Consent Still Lags.” Suvoda, April 2023. https://www.suvoda.com/insights/all-news/survey-shows-comfort-with-electronic-signatures.
- “eConsent Market Survey Results.” Suvoda, October 2023.
Amanda Howley
Director of Services Delivery, Suvoda