Don’t Overlook the Human Factor When Addressing Consent Issues

There’s been lots of talk about how the clinical research enterprise will need to address new informed consent challenges raised in relation to eConsent, genomics, vulnerable populations, and more. Each issue requires new ways of guaranteeing everyone’s eyes are wide open during the conduct of informed consent.

Ultimately, however, it’s still the human factor that decides whether an informed consent program is up to standard, says Claudia Christy, an independent nurse consultant based in North Carolina. It takes time to build the relationships that are the foundation of properly performed informed consent, she says.

New hires and even relatively seasoned clinical research coordinators (CRCs) don’t always understand the why of what they’re being asked to do, Christy says. That’s problematic because it can result in sloppy work.

For example, Christy was a potential subject in a large study with no serious potential of danger. She was vetted by a young summer hire, a medical student probably looking for something good to put on his resume, she says, adding, “He told me to sign the form and then take it home and read it.”

Obviously, it should be the other way around, but the youngster didn’t know that was an issue. He treated the form as more of a pro forma. Another mistake: He didn’t read it closely and missed that the trial required a follow-up a year later.

Because of how easily misunderstandings and mistakes can occur, Christy urges clinical researchers to make sure a potential subject really understands what he or she is signing up for. Specifically, she recommends:

• Asking the subject to tell you how they’ll describe the trial to their family.
• Using short quizzes to double-check understanding.
• Ask the subject if they understand the basics of eConsent, if appropriate.

There’s another important human factor to consider, says Glenn Veit, JD, CIP, executive chair with the WIRB-Copernicus Group. “We need to make informed consent forms easier to read,” he says.

While the new reality might be 60-page forms mandated by legal and other departments, there are still opportunities to improve how that information is presented to prospective test subjects. Veit offers two practical suggestions:

• Simplify the language. “I’ve always thought a big pharma sponsor should bring in a 6th grade English teacher to vet the forms,” Veit says. The U.S. Food and Drug Administration mandates that consent forms be written at no higher than the 8th grade level. However, that’s often not the case.
• More white space. “Think of how USA Today changed the way we look at newspapers,” Veit explains as he calls for creative, user-friendly layouts.