eConsent technology is often praised for its potential to revolutionize clinical trials, yet it remains underutilized. The promise is clear: better comprehension leads to better satisfaction, retention, and protocol adherence. But the reality is much bleaker. Many implementations fail to deliver on this promise because they treat eConsent as a digital version of paper forms rather than as a transformational tool. This article explores the barriers holding eConsent back, backed by evidence from scientific literature, and proposes actionable solutions.
Why eConsent Matters: The Evidence
Multiple studies have demonstrated that interactive eConsent tools enhance patient comprehension compared to traditional methods. Taylor et al. (2021) showed that video-based consent interventions significantly improved participants’ understanding of trial concepts compared to standard consent forms. Their randomized trial across six clinical studies found:
“Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process.” (p = 0.020).
Moreover, Glaser et al. (2020) highlight that 85% of interactive, teach-back-based digital interventions successfully improved comprehension outcomes. They concluded:
“Interactive interventions, particularly with test/feedback or teach-back components, appear superior.”
Retention is another critical metric tied to eConsent. Skea et al. (2019) emphasize that participants drop out when they don’t feel adequately informed or when trial demands are misaligned with their expectations:
“Initial decisions to participate may not have been fully informed, leading to mismatched expectations and eventual attrition.”
These findings align with broader educational research demonstrating that interactivity and multimedia boost knowledge retention. For example, multimedia learning theory shows that combining visuals, text, and interactivity engages multiple cognitive pathways, enhancing understanding.
The Catch-22: Barriers to eConsent Adoption
Despite these proven benefits, eConsent remains stuck in a vicious cycle:
- Weak Implementations Undermine ImpactMany eConsent platforms lack the interactivity needed to drive comprehension. Without videos, quizzes, or adaptive features, the technology becomes a glorified PDF viewer with signature capabilities. This contributes to skepticism among sites and study teams. As Vanaken et al. (2024) note:
“The term ‘eConsent’ is often misunderstood, with many platforms offering only weak ‘design’ functions, which do not fulfill the full promise of digital tools.”
- Resistance from Sites and Study Teams
Sites are critical stakeholders, yet many feel eConsent adds complexity rather than alleviating burdens. Glaser et al. (2020) reported that:
“Current practices often fail to define adequate patient comprehension and to ensure its assessment as part of the informed consent process, leading to frustration among sites.”
- Lack of Financial Justification
Sponsors are hesitant to invest in robust eConsent platforms without clear ROI metrics. Yet, these metrics often remain elusive because weak implementations fail to show measurable benefits in retention or compliance. This perpetuates a cycle where underinvestment leads to poor adoption and disappointing results.
Breaking the Cycle: Unlocking eConsent’s Full Potential
- Example 1: Incorporating Interactive Features
Taylor et al. (2021) demonstrated that video-based eConsent significantly improved satisfaction and understanding. If we give patients a short a video explaining key trial concepts, followed by an interactive quiz, we have already made real progress. This approach not only improves comprehension but also creates an audit trail for compliance. - Example 2: Leveraging Educational Theory
Studies on digital learning suggest that chunking information into bite-sized pieces and using visual aids enhances retention. A trial sponsor could use animated videos to explain randomization or potential side effects, coupled with glossary tools to define medical terms. Such tools could reduce dropout rates and enhance patient confidence. - Example 3: Quantifying ROI
Consider a large, global trial where dropout rates are reduced by just 5% through better eConsent. This could save millions in recruitment and operational costs. To encourage adoption, sponsors should calculate and share these savings, framing the initial investment as a long-term cost-saving measure.
Finally: just doing the right thing
Beyond the financial and operational arguments, eConsent represents an ethical obligation. As Pietrzykowski and Smilowska (2021) emphasize:
“The informed consent process actually leads to patients’ full comprehension of what they are consenting to. Unless this assumption is demonstrably true, the ethical viability of current medical experimentation practice is seriously flawed.”
This is also where I feel strongly. We are submitting patients to incomprehensibly long consent forms, knowing that comprehension will be low, but at least we’ve covered our legal bases.
Using multimedia and personalized tools isn’t just about better trials—it’s about respecting participants’ autonomy. When patients fully understand what they’re agreeing to, every stakeholder reaps the rewards.
To summarize, we must:
- Invest in “real eConsent”: Incorporate videos, quizzes, chatbots etc.
- Streamline Site Workflows: Simplify re-consenting and document retrieval processes.
- Measure What Matters: Track comprehension, satisfaction, retention, and ROI.
- Build Evidence: Publish success stories to showcase eConsent’s transformative potential.
It’s time to move beyond treating eConsent as a checkbox and realize its full potential. The technology is ready—now the industry must commit to using it to create better, more ethical, and more successful clinical trials. Let’s break the cycle.
References
- Taylor et al. (2021). Randomized comparison of two interventions to enhance understanding during the informed consent process for research. Clinical Trials, 18(4), 466–476. doi:10.1177/17407745211009529
- Glaser et al. (2020). Interventions to improve patient comprehension in informed consent for medical and surgical procedures: An updated systematic review. Medical Decision Making, 40(2), 119–143. doi:10.1177/0272989X19896348
- Skea et al. (2019). Exploring non-retention in clinical trials: A meta-ethnographic synthesis of studies reporting participant reasons for drop out. BMJ Open, 9(6), e021959. doi:10.1136/bmjopen-2018-021959
- Vanaken et al. (2024). Effective eConsent strategies for every study: Utilizing the eConsent fit-for-purpose study framework. Applied Clinical Trials. Available online.
- Pietrzykowski & Smilowska (2021). The reality of informed consent: Empirical studies on patient comprehension—Systematic review. Trials, 22(1), 57. doi:10.1186/s13063-020-04969-w