Advancing Clinical Research: Understanding eConsent

eConsent is a method of obtaining a patient’s consent digitally, rather than with traditional methods. This technology is becoming more common in many industries, and it’s beginning to take a hold in clinical research. In the research world, econsent is meant to provide subjects with sufficiently detailed information on the study so that they can make an informed, voluntary and rational decision to participate. Typically, patients would review:

  • Purpose of the study
  • Procedures/duration
  • Right to decline or withdraw
  • Risks
  • Benefits
  • Compensation
  • Resources for questions

eConsent is still a young technology in research, and there are several limitations that have contributed to the slow adoption in the industry, including:

  • Screen size (readability/font size)
  • Short existence of technology in the industry
  • HIPAA font size requirements
  • Hardware requirements
  • Signature capture technology limitations
  • Security considerations

Features of econsent

Organizations who use econsent incorporate a variety of features to effectively communicate. To start, some will use a video to lay out the econsent process to potential patients. Videos may also be used to cover procedures and visits in addition to the use of images and voice narrations. To capture patient signatures, organizations will employ electronic signature software. This software can be used on tablets, computers, PDF documents, and more. In order to enhance the informed consent process, some organizations may employ additional tools to improve their econsent process, including:

  • Webcams
  • Quizzes and assessments of understanding
  • IC data metrics

Benefits of econsent

For research sites, econsent can increase patient comprehension of study information, which can lead to a decrease in missed visits and other errors common throughout the study process. eConsent can also help minimize regulatory inspection findings, thanks to clearer documentation. What’s more, econsent software can integrate with other research technologies, eliminating duplicate data entry and improving real-time data transfer.

Managing organizations can also benefit from econsent. The clearly documented information paired with systems integrations allows sponsors, CROs and other managing entities to effectively monitor site activity in real time.

As technology becomes more integrated into the everyday processes of clinical research, make sure to stay on the lookout for even more crucial advancements to econsent technology in research.

Download the free webinar “Exploring eConsent Technologies” here.