eConsent: Why the Content Matters as Much as the Tech
Insights from a conversation with Edwin Cohen, Principal Consultant at CM Flow Instrument Creation and Mark P Wade Global Practice Leader & COA SME, TransPerfect Life Sciences
For all the attention paid to the systems, platforms, and integrations behind electronic informed consent (eConsent), the real barrier to adoption may not be technical at all. It may be the words on the page.
That's the central argument from Edwin Cohen, whose research has examined how patients perceive electronic consent compared to traditional paper forms. His findings, published in the Journal of Medical Internet Research, confirmed something he and his co-researchers suspected going in: electronic delivery of consent information, especially when paired with accessible, animated content, is better received by patients than static paper documents. That evidence has become a foundation for continued advocacy of eConsent across clinical trials.
But better perception doesn't mean easy adoption. Cohen is candid about why eConsent still lags, and the reasons have less to do with what the technology can do and more to do with how the industry writes, structures, and manages consent content.
The Standardization Problem
One of the most common frustrations among clinical sites is the sheer number of eConsent technologies they’re expected to manage. Because eClinical providers often treat their platforms as proprietary technology, sites running multiple studies may also have to navigate multiple incompatible systems.
Cohen does not expect that fragmentation to disappear. But he suggests that the industry could do a much better job aligning these systems with actual site workflows. The core challenge is that the consenting process itself varies, not just from country to country, but from site to site. Technology needs to be flexible enough to support that variation rather than force sites into a rigid process. In principle, today's technology is capable of that kind of agnostic, adaptable design. In practice, it isn't happening.
The Real Bottleneck: Content, Not Code
If standardizing the technology is difficult, standardizing the content may be even more so. Consent forms have a well-documented reputation, echoed consistently by patient advocacy groups, for being too long, too dense, and too scientific. Simply moving a lengthy, jargon-heavy document from paper to a screen doesn't fix that problem. It just digitizes it.
Writing consent language that is genuinely accessible to patients is its own area of expertise. It requires meeting a relatively low reading grade level while still conveying everything patients need to understand before providing consent. Many people who draft these forms have not been trained in that specialized skill.
This is where visual content, particularly animation, comes in. Cohen has seen it used effectively in pediatric studies and sees no reason it could not extend to adult populations as well. Patients without scientific backgrounds often absorb visual information far more readily than dense text. The catch is that animation adds complexity, time, and cost to an already time-pressured startup process.
Why Reusability Is the Path Forward
If animation and better content design add time, how does the industry avoid blowing through enrollment timelines? Cohen's answer is reusability.
Many organizations still treat each clinical study as a one-off project, creating consent materials from scratch. A more sustainable model would draw from a repository of preapproved, proven content and reuse it where appropriate. This approach would reduce the time and cost that can make eConsent, particularly animated eConsent, feel like a “nice to have” rather than standard practice.
Global templates already exist at many companies, but they tend to stay high-level, often around nine or ten pages, and only address general study parameters. Once a Form? needs to become study-specific, it can stretch to twenty pages or more. Add country-specific templates into the mix, each requiring their own translation and localization, and the document balloons further. Every additional contributor tends to add their own language, their own interpretation, and their own layer, until the consent form becomes a sprawling document that a patient is still expected to fully absorb.
Cohen is mindful to note that this is not a matter of bad intentions. Everyone contributing to a consent form wants patients to be well informed. But without a smaller group of expert writers and a shared commitment to reusable content, the review cycle often produces longer documents, not clearer ones.
The is a correlation between multiple reviewers and lengthier Forms.
Reconsent: The Strongest Case for Going Digital
If there is one area where the case for eConsent is nearly airtight, it is reconsent. Most clinical trials go through several protocol amendments, with recent industry data putting the average at more than three per trial, and each one can trigger a requirement to reconsent participants.. Managing that process on paper is, in Cohen’s words, a nightmare. Should patients sign the full document again or just a summary of the changes? Practices vary widely, with no clear consensus.
Electronic delivery is a natural fit here. Updated consent forms can be instantly pushed to sites and patients through a platform or even email, helping trial teams meet regulatory timelines for informing patients of changes. That matters in practice: audit and monitoring findings still regularly uncover cases in which a patient wasn't properly reconsented at a visit, only to have the invitation lapse for months before the next appointment. That gap creates a genuine compliance and quality risk, and it's a solvable problem through appropriately timed digital delivery.
Cohen believes this could be one of the most effective on-ramps to broader eConsent adoption. Alongside reconsent, he sees particular promise in pediatric and rare disease studies. Families may be more receptive to visual, animated formats, while sponsors may be more willing to invest in better content for smaller, high-need patient populations. Success in these areas could build momentum for wider use across clinical trials.
What Cohen Would Change, If He Could
Asked what single change he'd make to the consent process if given the choice, Cohen didn't reach for a new platform or a new format. He pointed to the starting point: the document itself.
His hope is for an industry-wide standard defining the minimum and maximum amount of information a consent form should include to inform patients and satisfy protocol requirements. From there, he would give patients the freedom to receive that information in whatever format suits them best, whether paper, digital text, visual, or audio. Not every patient wants the same experience, and a truly patient-centered approach to consent would accommodate that range of preference rather than assuming one format fits all.
Getting there, he acknowledges, is a long road. But it starts with the industry making a collective decision that better, more accessible consent content is worth pursuing, then starting small, testing, learning, and scaling.
The Takeaway
Consent is not a one-time event. It’s an ongoing part of the patient relationship throughout a trial, with documents revised, reissued, and re-signed as protocols evolve. Managing consent electronically can produce better data and a smoother experience for sites and patients. But as Cohen’s research and experience make clear, technology is only half the equation. Without equal investment in clear, reusable, patient-centered content, eConsent risks becoming a digital version of the same overly complex documents it was meant to replace.
This post is based on a conversation with Edwin Cohen, Principal Consultant at CM Flow Instrument Creation, from the LifeSci Talks COA Series. Watch the full episode here.