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With strengths in instrument engineering, signal processing, and pharmaceutical R&D, Perceptive Discovery consistently delivers successful imaging study designs and executions.
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What is eConsent?
eConsent is the process of obtaining digital consent from clinical trial participants. This digital approach is replacing traditional paper-based consent methods to streamline consent procedures. eConsent provides remote access to a convenient digital platform to obtain, document, and track participant consent.
In this article, we spotlight eConsent, considering its importance for clinical trial execution and weighing up the benefits of digitizing consent procedures in support of EU clinical trial regulations.
What does eConsent mean?
eConsent stands for electronic consent. eConsent is a digital process through which clinical trial participants can provide informed consent for clinical trial proceedings.
The process of electronic informed consent involves a consent discussion, either in-person or remote, in which information about the trial is presented, informing the candidate of the study requirements. This is followed by electronic consent documentation, whereby the participant indicates their agreement to participate through an electronic signature.
The importance of eConsent
Regulatory bodies around the world continue to emphasize the critical importance of informed consent as part of a legally valid and ethical clinical trial.
The EU Clinical Trial Regulation (EU No 536/2014) outlines specific requirements for informed consent, including the need for a written, signed, and dated consent form, including the right to withdraw.
Informed consent ensures participants are given sufficient information to understand and make an informed decision regarding their participation in a clinical trial. This not only protects the rights and safety of potential trial participants but also protects the validity of the study and builds trust between all stakeholders.
The Food and Drug Administration (FDA) supports the use of electronic processes to obtain informed consent, providing clear guidance for Institutional Review Boards, Investigators, and Sponsors on the use of electronic informed consent. The FDA considers electronic consent methods a convenient way to facilitate the participant’s ability to retain and comprehend trial information.
eConsent is quickly becoming a valid (and often preferable) method of obtaining participant consent when implemented correctly, considering ethical and data protection standards.
Key benefits of eConsent
Consent forms represent one of the earliest and most critical points of engagement in the participant’s journey. Traditional paper-based consent methods are rife with disadvantages, from human error and reduced efficiency to missing information and lack of sustainability. Electronic consent procedures provide a practical, participant-centric process that is easy to understand and use, whether in person or remotely.
The use of eConsent within clinical trials provides a whole range of benefits, including:
Not only is eConsent streamlining clinical trial procedures, but research suggests that participants actually prefer it, showing greater engagement, understanding, and preferring the usability of eConsent methods.
Flawed informed consent processes are listed within the top 10 cited regulatory deficiencies and audit findings and are the third highest reason for US Food and Drug Administration (FDA) warning letters to clinical investigators.
Poor understanding of the study requirements has been cited as a reason for early withdrawal from clinical trials. eConsent helps to create a smooth, streamlined trial journey right from the beginning of trial proceedings. eConsent in global, hybrid, or decentralized trials.
As the complexity of clinical trials continues to evolve, hybrid or decentralized trial designs are quickly becoming commonplace. To facilitate decentralized trials, digital technologies are being leveraged as a way to improve participant access and data quality and speed up clinical study timelines.
eConsent is no exception, facilitating decentralized trial designs with remote access to consent procedures around the world. By improving accessibility, eConsent is helping to make clinical trials more inclusive, breaking down geographic or time-related barriers to support broader and more diverse participation.
Challenges of using eConsent
While the use of eConsent offers clear benefits, some important considerations and challenges need to be addressed for successful implementation.
Conclusion
While eConsent was already gaining traction prior to COVID-19, the pandemic accelerated eConsent adoption significantly, improving participant access and enabling decentralized and remote trial designs. eConsent addresses many long-standing limitations of traditional consent methods, improving participant understanding and engagement and enhancing trial efficiency and regulatory compliance. With global regulatory support, it is rapidly becoming an integral part of clinical research studies around the world.
Learn more about Perceptive eClinical today, or contact an eClinical solutions specialist.
Resources
Central Committee on Research Involving Human Subjects. EU Clinical Trial Regulation (536/2014) – Informed Consent – https://health.ec.europa.eu/document/download/46519d8f-2ea7-49c2-9205-ca4d6400fea1_en
Food and Drug Administration. Informed Consent. https://www.fda.gov/media/88915/download
Cohen E, Byrom B, Becher A, Jörntén-Karlsson M, Mackenzie AK. Comparative Effectiveness of eConsent: Systematic Review. J Med Internet Res. 2023;25:e43883. doi: 10.2196/43883.
Bharucha AE, Rhodes CT, Boos CM, et al. Increased Utilization of Virtual Visits and Electronic Approaches in Clinical Research During the COVID-19 Pandemic and Thereafter. https://pubmed.ncbi.nlm.nih.gov/34481597/
