The recent approval by Britain’s National Health Service (NHS) for the use of electronic informed consent in a clinical trial is a pivotal moment in the global expansion of a technology that benefits both patients and sponsors of clinical research.
Approval for the use of electronic informed consent from the California-based company, Mytrus, was granted by the Health Research Authority (HRA), a division of Britain’s NHS, established to promote and protect the interests of patients participating in research.  HRA oversees research ethics committees in England, as well as innovation in research, and the agency is interested in how eConsent technology impacts both trial efficiency and the ethical treatment of patients.
This is the first time eConsent has been approved in Britain. If the electronic enrolment process in England mirrors previous, positive experiences with eConsent, then we expect to see the use in British trials expand while regulatory authorities in other countries follow suit, reassured by the approval from a rigorous regulatory agency.  London is home to the European Union’s European Medicines Agency (EMA), which will undoubtedly be following trial progress.
[Read more…]