Rework informed consent to improve subjects' understanding

Ask thorough questions as part of IC

Research professionals increasingly are aware of how important it is to assess and anticipate research volunteers' comprehension before writing informed consent documents. Still, the industry is lagging behind the reality, an expert says.

"There are some very influential groups, including professional and nonprofessional groups, who are trying to raise the awareness," says Kris Walters, PhD, MSM, clinical research program coordinator at the University of North Carolina in Wilmington, NC.

"The other reason why I believe awareness of consent is an issue is because the FDA also is citing informed consent a little bit more, and they're looking into the clinical research (CR) processes more," she adds.

"The flip side is although I see a trend with clinical research sites being a little more aware of comprehension and consent, we're still very far away from sites really improving the informed consent process," Walters says.

Some nonprofit organizations have been working to raise overall public awareness of the CR process and patients' rights, she notes.

Theoretically this means when patients are approached about volunteering for a CR trial they'll have a better understanding of their alternatives and make a more educated or informed decision.

Yet there still are problems, especially in the areas of writing informed consent forms at a lower reading level and providing more time to allow patients to understand the forms, Walters says.

Too often CR sites follow this routine informed consent process: "They provide the patient with the informed consent form. Then they leave them in a room for a while to allow them time to read the consent form uninterrupted. When they return to the patient, they ask, 'So, do you have any questions about what you read?'" Walters says.

And that's where the informed consent process ends.

"They're not actually assessing whether the patient truly understands what he's read," she says.

"Some principal investigators (PIs) say, 'Well, we've given them that opportunity, and that's all we're supposed to do,'" she notes. "But it's also the PI's responsibility to assess the patient's ability to understand what he's volunteering for, and you do this by spending more time with the patient after the patient has read it."

Then the PI or CR coordinator should quiz the patient, asking pointed questions, Walters suggests:

They can say to the potential research participant: "Okay, we want to make sure you understand. Are you interested in this study?" Walters says. "If you are interested, we want to make sure you understand what you're volunteering for, and so I want to ask you a few questions about what you've read."

Key questions

These questions could be as follows:

  • Do you understand this is a research study?
  • Do you remember who to call if you have any questions about your rights as a volunteer for this study?
  • We want to make sure you understand more about some of the adverse reactions you might have by taking this investigational product. Can you name some of those that you read about in the consent form so we can be sure you understand that?
  • Did you read that there would be any benefit to you?

"If the patient says, 'yes,' while the informed consent form explicitly says there is absolutely no benefit, then the PI or coordinator should probe further, Walters says.

For instance, potential participants often think a benefit is that they'll be paid for participating in the study, and if they indicate that's the benefit they read about, the PI might ask, "Other than getting paid, do you remember if there's any benefit to you in participating in the trial?" Walters suggests.

"That's very important to ask because many people have a false hopes syndrome, especially if they're suffering from a serious disease," she explains. "So even if they're told there is no direct benefit from the study, they'll still believe they'll get a benefit from it because this is a new product."

Another area that needs improvement is the actual informed consent document's size and reading comprehension level, Walters says.

"The average American reads about two sentences before the attention span is diverted in some way," Walters says. "Informed consent forms still are seven to 10 pages long, so there's a disconnect between how people are communicating in the written form today."

With the popularity of Twitter and text messaging, there's a huge disconnect between the way people commonly receive information in the electronic information age and how information is conveyed in the standard informed consent form, she adds.

"So one way we can try to make that connection is to spend more time as clinical coordinators and researchers gently asking questions about what they've read," Walters says.

Research volunteers who understand the study and process more fully also are more likely to stay enrolled and stay adherent to the protocol regimen.

"The important reason why you want to do this is because the better the patient understands what the study is about and why they're a candidate," she says.