Ink to Link: Understanding the Potential of eConsent

By Beau Bruneau, Senior Innovations Business Analyst, Florence Healthcare

The research technology landscape is evolving at a remarkable pace, driven by innovations that aim to streamline site, sponsor, and CRO processes while enhancing the participant experience. Among these innovations, electronic informed consent (eConsent) has the potential to be a transformative force. The FDA guidance on remote consent was released in 2013, and yet eConsent is still in the early phases of the technology adoption lifecycles.

The goal of Florence’s September Innovation Summit was to analyze the eConsent landscape and explore challenges and opportunities with the technology. Over 150 clinical trial professionals met for roundtable discussions on three aspects of eConsent: the pros and cons of mimicking paper processes for new software, site-sponsor collaboration and reporting, and video consenting. All attendees had a chance to weigh in on each topic. In this blog, we share the key findings from the discussions.

The transition to digital processes can be daunting, which is why many new software adopters attempt to mimic their familiar paper-based procedures with the software solution. While following the paper process is a safe and familiar option, this often means the advantages of the software are not fully leveraged. Software has the potential to remove steps impossible to remove in a paper world and to make the process more efficient.

This highlights the necessity for clinical trial software vendors to consider each new feature independently to determine which parts should mimic paper, and which can be reimagined. If successful, tools like eConsent allow sites to maintain a sense of continuity while embracing the transformative potential of digital workflows.

At the summit, we heard from a few attendees who had experience with sponsor/CRO-provided eConsent platforms for a single study and from other attendees who had experience with site-owned solutions, primarily RedCap and DocuSign. In both situations, the use of eConsent requires collaboration between sites and sponsors/CROs. All systems must be IRB-approved, and site-owned systems must be sponsor-approved. Sites need to adjust their SOPs to reflect the usage of the electronic system and reconcile if/how the process will be different than their paper process.

Site attendees shared their difficulties in having to use, manage, and train staff on sponsor/CRO-provided systems when they are provided for a single study and therefore different from their normal consenting process. Site attendees also cited issues with provided eConsent systems such as cumbersome workflows, software not adapting to their required processes, key features missing such as re-consenting, and the lack of ability to track all participants in a single system (both electronic consent participants and those who need to consent on paper).

In addition to the challenges with sponsor-supplied eConsent software, there are also many sponsors and CROs that not only prefer but require paper documentation. Attendees reported sponsors and CROs that would not approve the use of a site-owned eConsent solution, often without providing a compelling reason.

As the adoption of eConsent increases, there is a potential for the software to deliver another valuable advantage by simplifying the reporting of critical data to sponsors/CROs. A collaborative eConsent tool should enable the real-time collection and transmission of screening and consent data, reducing manual reporting work for sites and the information lag typically seen by sponsors.

One of the most exciting potential advancements in eConsent technology is the ability to reach patients in their homes remotely by utilizing video call technology. Traditional paper-based consent procedures often necessitate in-person meetings, which can be logistically challenging for both researchers and participants. However, eConsent paves the way for remote consenting, removing geographical barriers that once hindered participation.

While this adoption of technology sounds exciting, attendees discussed that the slow adoption of electronic consent means that many sites can’t even imagine using remote meeting technology. These advanced features are also difficult to prioritize when there are less advanced features that do not work consistently or reliably. The uncertainty of advanced features underscores the larger gap in basic electronic consent adoption compared to more established technologies such as eISF or CTMS.

While the transition to eConsent may present some initial challenges, attendees of the conference agreed on many of the potentials of eConsent. Here are some of the key benefits cited:

Increased Information Absorption: eConsent gives participants more time to absorb a large amount of information on the ICF. It also allows them to receive and review the consent without an in-person visit, in the comfort of their home, and with their loved ones. These benefits allow them to make an informed decision without feeling pressured.

Enhanced Accessibility: Remote consenting options remove geographic barriers, making clinical trials more accessible to a diverse range of participants, and sometimes removing an additional study visit.

Improved Efficiency: eConsent can streamline the consent process, making it quicker and more efficient, which, in turn, accelerates the pace of clinical trials.

Greater Transparency: Digital data collection and reporting enhance transparency, reducing manual work for site staff and ensuring that sponsors and CROs have access to up-to-date and accurate information.

To further understand how Florence’s eConsent solution can assist your clinical trials, schedule a demo today. We are committed to helping you make that first step towards enhanced, patient-centric clinical trials with confidence. Your journey to a more efficient and effective clinical trial system starts with eConsent, and we are here to guide you.