Real World Evidence (RWE) 101 – eConsent

RWE 101 – eConsent

Electronic consent or eConsent refers to the process of using electronic systems and processes to convey information related to the study and to obtain and document participant consent. While eConsent brings numerous benefits to the table, such as improved participant comprehension, streamlined workflows, and easier tracking and managing of consent versions, it is not universally accepted in Real-World Evidence (RWE) studies due to several reasons:

[1] Regulatory Variations: Regulatory guidelines and requirements vary across different jurisdictions and countries. Some regions may not yet have clear guidance or regulations that specifically endorse eConsent, causing uncertainty about its legal validity.

[2] Digital Divide: While digital technologies are pervasive (increasingly accepted), access to and familiarity with these technologies is not universal. Some potential study participants may lack the technology needed for eConsent or may not be comfortable using it, which could potentially exclude certain populations from participation (introducing bias).

[3] Data Security and Privacy Concerns: As with any digital system, there are concerns related to data security and privacy. Participants may worry about their personal information being mishandled or leaked, especially given the sensitivity of health data.

[4] Implementation Costs: Setting up a secure, user-friendly eConsent system that can also meet all regulatory requirements is a significant investment. Small research entities or those in low-resource settings might find it challenging to bear these costs.

[5] Technical Hurdles: eConsent systems require a level of technical infrastructure and support to function effectively. This can include the need for reliable internet connectivity, ongoing technical support, regular software updates, and more.

Despite these challenges, the adoption of eConsent is increasing due to the evolution of technology, better regulatory support, and the COVID-19 pandemic necessitating remote study processes. As these challenges are addressed over time, it’s expected that eConsent will become a more universally accepted practice in RWE studies.


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