The value of deploying electronic informed consent (eConsent) technology is widely considered in terms of the comprehension, satisfaction, and retention of the clinical trial participants for whom consent documentation is a critical window on the complexities of trial-related processes and expectations. However, the authors of a forthcoming pair of ACRP Clinical Researcher articles whose lessons will be explored an ACRP Webinar this month say that a broader assessment of eConsent’s real-world impact is vital to ensuring that it delivers on its full promises for study sites and sponsors in addition to the participants signing the informed consent form’s bottom line.
“In the clinical trials industry, adoption of eConsent is often reported as being in the range of 50% to 75%,” says Andrea Bastek, PhD, Vice President for Market Strategy with Florence Healthcare. “The stated benefits of eConsent typically include improved patient engagement and operational efficiency. The eClinical technology landscape is both vast and complex, with more than 60 vendors offering solutions, which also suggests high adoption and a saturated market. However, anecdotal evidence suggests that these adoption numbers may be inflated, and that the rate of real-world experience with eConsent is actually very low.”
Bastek will serve as moderator with presenters Candida Barlow, PhD, MSN, CRN-BC, RN, Director of Clinical Research at Oklahoma State University, and Istvan Fekete, a Principal with Attain Partners, for the July 22 ACRP Webinar on “eConsent in Clinical Research: Bridging the Gap Between Promise and Reality.”
Along with Bastek, Barlow, and Fekete, the authors of the Clinical Researcher peer-reviewed articles on eConsent set to appear in the August 2026 issue (“Envisioning eConsent Success (Part I): Measuring Operational Impacts at Clinical Trial Sites” and “Envisioning eConsent Success (Part II): Laying Out a Global Interoperability Blueprint for eConsent,” available in a combined PDF preview) include Amanda Zenere (lead author); Amber N. Hood, DFS, MS, CPIA, CIP; Catherine Gregor, MBA, CCRP, CCRC; Kamila A. Novak, MSc; Katherine Leibowitz, JD; Megan Solomon, LPN; and Spencer Phelps.
The team’s publications are based on the efforts of an eConsent working group of The League, a Florence Healthcare initiative, which the authors say has developed a high-level framework for defining and measuring the impact of eConsent usage at study sites, especially in terms of the value of integrating eConsent systems with key eClinical technologies. They look at key success indicators, relevant metrics, and practical steps the industry can take to better understand how eConsent can function ideally for all of its stakeholders.
“Several large, multi-stakeholder eConsent initiatives highlight the limited guidance available for effective implementation of this technology, as well as misconceptions and disconnects in the industry, also suggesting that adoption is lower than reported,” Bastek notes. “However, there has been U.S. Food and Drug Administration support for eConsent usage since 2016, and more recent global regulatory guidance and support, so no obvious regulatory hurdle is preventing industry adoption.”
Sponsor eConsent usage and vendor selection vary by study phase, size, and geography, as well as sponsor/contract research organization (CRO) preference and various other factors, the authors say. Sites considering purchasing or using sponsor-provided eConsent must consider their existing technology infrastructure, staff experience, sponsor relationships, institutional review board policies, and evolving regulatory requirements, they add.
Meanwhile, “Sites also report that they sometimes receive sponsor-pushback on the use of eConsent,” Bastek explains. “All stakeholders face hurdles such as information technology review time, change management, platform cost, and concerns about integrating eConsent into existing workflows. Sponsors and CROs face similar challenges to adoption and implementation, and must consider global regulatory compliance to ensure consistency across study sites. These challenges have blunted eConsent adoption and implementation and resulted in fragmented usage of the many vendors across studies in the industry.”
Enroll in the July 22 webinar to gain actionable insights to reduce operational burden, improve compliance, and evaluate eConsent effectiveness in real-world settings. ACRP Members can sign on to attend for free without contact hours or for $15 to earn 1.0 contract hour; nonmembers can sign on for $75 for 1.0 contact hour.
Edited by Gary Cramer
