By Jim Gearhart
The use of electronic informed consent (eConsent) in clinical trials is on the rise. We have argued that widespread use of eConsent is an inevitable, natural progression away from paper-based informed consent forms, and from what we can see, its use is spreading. Not everyone agrees that the time is right, however, or that all eConsent programs offer the right solutions. Still, sponsors and sites are increasingly curious, and willing to give eConsent a try. As electronic alternatives to paper are taking over in other areas of medical research, such as Electronic Trial Master Files (eTMF) and Electronic Health Records (EHRs), the progress of eConsent continues, too.
The expansion of eConsent can raise a question for sponsor and investigative site alike: how can investigators be ready? What areas should a site concentrate on to prepare for an eConsent study? Based on our experience and on the 2016 FDA-OHRP guidance about eConsents (which the guidance calls eIC), here are five areas to investigate to determine whether your site is ready.