Since it was first instituted in the 1960s, written consent to participate in research studies has undergone very little change other than tightening regulations and increased participant education of their rights. At that time, it was decided that for research to be considered ethical, participation must be done in a voluntary and informed manner. This decision resulted in an elaborate, paper-based consent process used in all studies until recently. Unfortunately, the goal of informed consent was not always met: to explain research to study volunteers so they could offer truly informed consent.
In March 2015, however, the FDA signaled a seismic shift when it proposed its first-ever guidelines for implementing eConsent and laid out an electronic consent meaning. The adoption of eConsent was slow, however, due to concerns of potential risks, longer timelines, and higher costs. There was an overall hesitancy from clinical researchers to embrace an entirely new approach to consent. As is true in all technology adoption life cycles, crossing the chasm to widespread adoption takes time.
eConsent has increasingly become more accepted over the years, however it wasn’t until the COVID-19 pandemic began that it was embraced on a worldwide scale as never before. As research centers closed down, teams working on in-progress studies needed a method to remotely re-consent participants due to protocol amendments. Previous objections to adopting remote consent were overcome by necessity. The industry is now seeking remote consent as a standard for trials instead of novel functionality—and they’ll have plenty of fresh evidence and case studies to back up their requests.
Castor’s remote eConsent solution is a powerful platform that puts the participant at the center of the consent process and reduces workload for site staff. Reach out to one of our friendly Castorians to find out how our remote eConsent solution can set up your next study for success.