Electronic Consent Becomes Reality in England

Applied Clinical Trials

The U.K. National Health Service (NHS) has granted approval for what is thought to be the first use of electronic informed consent in England.

The U.K. National Health Service (NHS) has granted approval for what is thought to be the first use of electronic informed consent in England. The equipment for the trial will be provided by Mytrus, a California-based company.

The Health Research Authority (HRA), a division of the NHS, granted the approval to use e-Consent in a trial by a top-ten global pharmaceutical company, according to Mytrus. HRA, which oversees both research ethics committees and research innovation, was established to promote and protect the interests of patients participating in research. The plan is to use the results from the study to produce a paper that could serve as guidance for other national health authorities looking at ways to speed up the start of trials while assuring patients are at the center of decision-making.

Mytrus’ Enroll platform uses iPads to offer trial subjects an introductory overview and videos to reinforce key information. Potential trial subjects read the informed consent document, answer a set of questions to assess comprehension, and are prompted to review information they understand less well to help them make better, more informed decisions.

Research site staff can track patient metrics to determine where patients need counseling and dedicate time for each potential study participant to discuss the study with site staff before agreeing to give their consent. E-consent not only improves the patient experience, it also streamlines and speeds the costly enrollment process, according to the vendor.