Implementing digital  informed consent (or eConsent) in clinical trials can be challenging and complex, but it doesn’t have to be!  One of the main reasons for this difficulty is the traditional mindset and habits of conducting clinical trials. Clinical trials have long relied on paper-based informed consent process, and making the switch to a digital solution requires a significant shift in mindset and approach. Additionally, different stakeholders, such as study sponsors, ethics committees, regulators, sites and patients, may have different expectations, perceptions and requirements for eConsent implementation, adding to the complexity of the process. Therefore, careful planning, communication, and a thoughtful execution are essential for the success of an eConsent implementation and adoption in studies.

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Obtaining approval of an electronic informed consent doesn’t have to be a complex and time-consuming process. While the review process involves multiple stakeholders,  including sites, sponsors, Ethics Committees (ECs), Institutional Review Boards (IRBs), and Health Authorities (HAs).  Researchers and study teams are constantly looking for ways to streamline their processes and improve efficiency. 

While the paper consent review process has remained the same, we have seenmany layers of improvements and efficiencies around electronic informed consent forms (eICFs). eICFs have emerged as a solution to help participant understanding and engagement, trials accessibility, and improve data quality. 

However many researchers still are hesitant to adopt due to concerns about the submission process, timelines, and regulatory compliance. In this blog, we will discuss how to overcome these obstacles and streamline the ethics review process by adopting eICFs.

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