Are Clinical Trial Sites Ready for Paperless Consent?

Cami Gearhart, CEO, Quorum Review IRB

Cami Gearhart, CEO, Quorum Review IRB

While some predict electronic consent (eConsent) systems will be the norm within five years, don’t tell that to the wide swath of sites that haven’t used the tools or, in some cases, don’t even understand eConsent.

“We find very few sites have used the tools yet, and some don’t even know what eConsent is,” says Cami Gearhart, CEO of Quorum Review IRB. It’s going to become increasingly challenging as more and more tools enter the marketplace, she adds.

However, it’s the human factor that will make or break ultimate adoption, Gearhart says. Training will be key. For starters, potential users must be dissuaded from some common misperceptions about eConsent. Example: It is only used in remote situations. That’s false, Gearhart says, but it will slow adoption until sites better understand how to leverage paperless consent in a variety of situations. “It can and should be used at the site,” she stresses.

Join site, industry, and IRB experts at the ACRP 2017 Meeting & Expo to discuss the variety of eConsent products becoming available and how eConsent tools can be used for in-office and remote consenting. Gearhart and colleagues from Yale University, Metadata Solutions, and Quorum Review IRB will present ACRP 2017 session, eConsent: Preparing for Paperless Consent, and provide practical tools for assessing your site’s readiness to use eConsent tools. View Program and Schedule

ACRP 2017 Meeting & Expo

Selecting the right technology is also critical, Gearhart says. When using an eConsent tool, site leaders must be clear about how they want to allow patient access before, during, and after the consent process. Do they want potential subjects to go over the form before the meeting? How long in advance should they have it? Should they be able to access it during the formal process? How often? These and other questions must be answered first in order to find the right eConsent suite of tools.

It’s also important to remember that no matter how widespread eConsent becomes, there will always be situations where it is not feasible (e.g., a patient cannot use a computer or flatly refuses out of concern over privacy).

Author: Michael Causey