eConsent

Introduction

eConsent refers to the process of obtaining informed consent from participants in clinical trials using electronic systems and processes. This method involves using electronic tools, such as tablets, computers, or smartphones, to present information about the trial and to collect signatures from participants.

Misconceptions

eConsent and remote consent are often confused, but they are distinct concepts. Remote consent refers to the participant and investigator being in different physical locations during the consent process. It can be done either on paper or through digital means. eConsent, on the other hand, specifically involves using electronic systems for the consent process, regardless of location.

The eConsent process needs to meet the same ethical and legal standards as traditional paper-based informed consent, ensuring that participants fully understand the trial’s risks, benefits, and their rights before agreeing to participate.¹ Some think participants may understand consent less thoroughly through digital means. However, eConsent can improve understanding by offering multimedia tools like videos, diagrams, and interactive features to clarify complex information. Many believe eConsent is only relevant for decentralized or virtual trials, but it can be used in both in-person and remote settings, offering benefits like streamlined documentation and tracking in any trial setting. Furthermore, eConsentelectronic systems often provide enhanced security features such as encryption, audit trails, and secure storage in comparison with paper-trail formats.

European Forum for Good Clinical Practice’s (EFGCP) eConsent Initiative

Due to such misconceptions, the European Forum for Good Clinical Practice’s (EFGCP) eConsent Initiative, involving over 50 companies, created the eConsent Fit-for-Purpose Study Framework to help stakeholders evaluate eConsent systems.^2,3 This framework provides sponsors (both commercial and non-commercial) with a structured and standardized approach to address potential issues. It may also benefit other stakeholders, including sites, ethics committees, health authorities, participants, vendors, and other partners involved in eConsent.

The eConsent Fit-for-Purpose Study Framework consists of five process steps and a Go/No Go decision point to design, measure and analyze the right eConsent for the clinical study and generate impactful study data on eConsent.^2,3

In Step 1, there is the definition the eConsent benefits and challenges for the study and stakeholders. ² Step 2 defines the best matching eConsent platform and operational aspects.² In Step 3, there is the evaluation of the study eConsent objectives and aspects upfront with selected stakeholders. ² Step 4 defines the eConsent metrics and measurements for the study and stakeholders. ² Finally, step 5 defines the eConsent analysis and reporting approach for the intended study. ²

Variations might exist in the overall process flow because the process steps might not be done at a study level but at the program level, or the Go/No Go decision point might not be applicable if the implementation of eConsent is mandatory within an organization. ²

Conclusions

Incorporating digital tools into the informed consent process (i.e., eConsent) can benefit all stakeholders and has the potential to address many of the common quality and compliance challenges associated with traditional paper-based consent methods. But successful eConsent adoption requires a fit-for-purpose approach and industry engagement because each study, each site, each participant might have their own needs. 

Associated Image

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