As defined by the Food and Drug Administration, eConsent refers to “the use of electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive and interactive Web sites, biological recognition devices, and card readers, to convey information related to the study and to obtain and document informed consent.” Within clinical trials, the Common Rule which was adopted in 1991, requires that people provide their consent before participating in clinical studies to ensure that they understand the purpose of the research and the possible associated risks and benefits. The adoption of eConsent transforms the clinical trial experience for both participants and researchers by removing accessibility and comprehension barriers, engaging participants, and increasing the efficiency of consent processes. 

Traditionally, consent was paper-based. Eligible participants would travel to a physician site to meet a healthcare professional who would relay the printed information, answer any questions, and request a signature. Time consuming and travel-dependent, the paper consent process also exacerbates comprehension and language barriers for participants belonging to minority groups. 

In fact, Chief Commons Officer at Sage Bionetworks, John Wilbanks describes the informed consent process as “a single-point transaction that must be completed to enroll participants [...] instead of a relationship” between participant and healthcare researcher. 

 

What are the benefits of eConsent? 

In March 2015, the FDA published multiple guidelines for the implementation of eConsent in clinical research. The COVID-19 pandemic and the rise of decentralized clinical studies quickened researchers’ acceptance for eConsent -- now a necessity and a complete paradigm shift.   

The use of eConsent increases patient access and diversity. In the past, researchers using traditional paper consent forms (PCFs) recruited people who had the means to spend money and time traveling to the research sites, which meant clinical trial samples were severely underrepresented. In fact, 70% of potential research participants live two or more hours away from the study location. With eConsent, researchers remove the participant's burden of visiting a research location, reducing accessibility obstacles and improving participation diversity. Patient-centric tools like eConsent improved the lengthy process of recruitment by 42%, according to a recent Biopharma Dive report

Additionally, eConsent enhances patient engagement. Through multimedia tools such as videos, images, and audio, this unique tool ensures that the participant fully understands the purpose of the research. It also facilitates the patient’s ease of experience which boosts retention, reduces dropout rates, and improves compliance.  

Finally, eConsent quickens the onboarding process and increases efficiencies within clinical workflows. During the remote recruitment process, this often multi-language tool limits the amount of lengthy paperwork and need for administrative overhead. While this tool remains an opportunity to provide consent in an easier, more affordable and convenient way, it does not eliminate participants’ ability to ask questions to clinicians, but rather it strengthens participant-researcher communications through alternative channels of communication. 

In conclusion, eConsent is not only about digitizing the traditional paper-based consent form; instead it’s about engaging the participants right off the bat, before even beginning the study. This essential step towards participating in a clinical trial ensures individuals are informed, engaged, retained, and empowered. 

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