3 of the Biggest eConsent Myths – Busted!

In the dynamic realm of clinical research, staying ahead of technological advancements is paramount. Consent management, a critical aspect of research, has witnessed a transformative shift with the advent of eConsent solutions. Despite their potential to streamline processes and enhance compliance, pervasive myths surround their adoption. Florence experts, Amanda Kepshire, Keith Wright, and Melanie Palazzolo, and Radwa Aly, Chief & Executive Director at George Washington University School of Medicine, debunk three of the most common eConsent myths.

Dispelling the misconception that eConsent is a mere digital replica of paper processes, the truth is far more robust. Many people question whether eConsent adds value to a site, sponsor, CRO, and/or patient; However, modern eConsent solutions offer valuable functionalities such as:

• Access controls and validation procedures—make sure it’s CFR compliant
• Version control and built-in audit trails—maintain regulatory compliance leaving less room for error. You’ll never have to worry about losing or misplacing a paper consent form again.
• Stylus signatures—while the signature itself is out of scope for Part 11 compliance, utilizing it during the onsite consenting process is completed in a Part 11 compliant system.
• Integrations with existing systems—minimize anxiety and the burden of learning another system by integrating eConsent with tools your staff already uses like EMR and CTMS as well as the promise of integrate with future systems and workflows.

The misconception that certain demographics, such as the elderly or non-tech savvy, won’t adopt eConsent is debunked by recognizing the widespread use of smartphones and the increasing preference for everything to be digitized, especially medical records. We frequently underestimate the resilience and adaptability of people at large. You have an opportunity to tap into a group of people you wouldn’t have access to otherwise.

Aly emphasizes the hybrid approach adopted by GWU. While offering the convenience of electronic consent, they continue to accommodate those who prefer paper. In doing so, they empower patients to exercise autonomy and make choices that align with their best interests. Consideration extends beyond preference though; it’s crucial to be mindful of diverse participants and potential language barriers. Aly suggests opting for a user-friendly system, providing remote options and multiple languages to enhance inclusivity.

The reality is, when integrated effectively, it can reduce overheads and enhance efficiency, opening avenues for diverse recruitment and improved patient access to trials. Research sites, whether Academic Medical Centers or independent entities, often grapple with budget constraints, limiting room for technological advancements. Despite this, tech vendors provide guidance on seamlessly incorporating eConsent into study budgets through well-structured SOPs.

While sponsors value visibility and are open to reimbursing for such advancements, discussions may pose initial uneasiness due to the novelty of this approach for research sites. However, by embracing a sponsor-of-choice mentality, sites can assert their preferred approach, encouraging a collaborative middle ground for effective partnerships.

Aly shares GWU’s perspective, viewing eConsent as an investment in the future of research. Collaborating with sponsors and utilizing well-defined budgets ensures reimbursement and supports the paradigm shift toward technology in clinical trials.

In the wake of the technology boom, accelerated by the pandemic, the question arises: Could remote consenting through eConsent become a protocol requirement? Currently an option, the future may see it as a necessary component, ensuring accessibility for diverse populations, especially those facing transportation barriers.

From an implementation standpoint, sites increasingly request sponsors to consider eConsent costs in Clinical Trial Agreements (CTAs). Suggestions include breaking down fees into line items such as remote monitoring, document management, and archiving. Alternatively, incorporating sponsored startup bonuses into contracts can be a viable approach.

In the evolving landscape of clinical research, this discussion prompts consideration of eConsent as an indispensable mechanism, offering not just a streamlined process but also a patient-centric and technologically advanced future for clinical trials.

When considering eConsent solutions, four essential pillars stand out, ensuring a seamless and successful integration into the clinical research landscape.

1. Compliance is Paramount:
   At the forefront is compliance—the linchpin of any effective eConsent system. While user-friendliness is crucial, an accessible and easy-to-use system is rendered ineffective if it doesn’t meet regulatory standards.
2. Low-Risk System for Improved Enrollment:
   Beyond compliance, a low-risk system proves instrumental in elevating patient enrollment numbers. The integration capabilities with existing systems play a pivotal role here. A well-integrated eConsent system not only reduces risks but also ensures a smooth transition for research teams, contributing to enhanced efficiency and streamlined workflows.
3. Training: Simplifying Processes for Staff:
   Recognizing the significance of staff engagement, training becomes a critical aspect of eConsent implementation. The goal is to alleviate, not amplify, the staff burden. Implementation processes should provide a comprehensive dive into the system for staff, transforming them into super users even before institutional rollout. This ensures a confident and competent staff, well-equipped to navigate the digital environment seamlessly.
4. Exceptional Customer Service and Implementation Support:
   Central to success is exceptional customer service and a dedicated implementation team. Beyond just providing a tool, the eConsent system’s efficacy lies in how well it aligns with the operational needs and workflows of study teams. A supportive implementation team guides study teams through the digitization process, addressing variables and operationalizing workflows effectively. This level of engagement ensures not just adoption but optimal utilization of the eConsent system.

To tie these elements together, a well-defined rollout process is imperative. It begins with listening to study teams, understanding their current workflows, and identifying their goals. This empathetic approach allows for a customized implementation, filling in the gaps seamlessly between current practices and future aspirations.

During the webinar, we delved into GWU’s experience in adopting Florence’s eConsent. The decision to implement eConsent was driven by the need to improve patient recruitment numbers and address compliance issues. The implementation process involved engaging leadership early on, taking a pulse of the institution, and listening to the experiences of the research teams. To hear more about how GWU uses eConsent, watch the on-demand recording.

The adoption of eConsent signifies more than just a trend; it heralds a transformative era in clinical trials. For trial sites, sponsors, CROs, and participants alike, eConsent simplifies processes, enhances transparency, and revolutionizes the overall clinical trial experience. Florence Healthcare is at the forefront of this revolution, committed to making clinical trials efficient, transparent, and patient-friendly. To learn more about eConsent and how Florence Healthcare can support your clinical trials, reach out to us today. Embrace the future of clinical research with confidence and efficiency!