Electronic Informed Consent in Clinical Research

Medidata is conducting a study to understand the regulatory positions, adoption and the variability regarding electronic informed consent (eConsent) around the world. This exercise has come about due to the extensive number of regulatory relevant enquires Medidata gets from sponsors and organisations managing trials in research. These organisations are keen to have the option to leverage electronic means for consenting trial participants but are uncertain of the regulatory positions on the topic. The only way to seek clarity on this topic was to directly engage with the relevant bodies.

The study initially focused on the countries in the European geographic region countries but has evolved to other regions including Asia Pacific and the Americas. The study prioritized countries where there was an aspiration to run electronic informed consent by organisations running clinical trials.

Throughout the study, Medidata has directly engaged with regulators, health authorities and ethics groups to assess the eConsent landscape. Overall, the Medidata study team has collected meaningful feedback and engaged in positive and encouraging dialogues with these organisations. However, almost half of the bodies Medidata contacted have not responded or did not fully respond to the question being asked. We deduce this may be due to a lack time to consider the topic and/or a lack of general position.

The patient-centric benefits of electronic informed consent technologies have been well documented.1,2 Electronic informed consent has led to improved patient engagement and the ability to obtain trial patient signatures electronically whilst personally identifiable information (PII) remains safe and securely stored.

The US Food and Drug Administration (FDA) provides non binging recommendations on the subject and the US has seen accelerated adoption of eConsent solutions. Subsequently, the UK regulator, the MHRA (Medicines and Healthcare Regulatory Agency) has also issued a very comprehensive guidance and is exemplary in the thought leadership in terms of the interplay of eConsent and the consideration of the multiple EU regulations and UK laws.

The EU has seen variable adoption, mostly due to a lack of regulatory clarity and operational reasons. It is good to note that new EU eSystems guidance is being written to include electronic informed consent.