Improve informed consent: Use teach-back to catch language problems
Expert offers suggestions to IRBs
One of the most important ways IRBs can improve the informed consent process is by encouraging investigators to confirm comprehension for their potential subjects, an expert suggests.
"A consistent trend across many studies is a shockingly high rate of potential subjects who don't understand key components of the research they're participating in," says Michael Paasche-Orlow, MD, MA, MPH, an assistant professor at Boston University School of Medicine. Paasche-Orlow has conducted research about the informed consent process.
For instance, research participants might understand the potential benefits and risks of a study if those are well-presented. But an informed consent form that includes boilerplate language about therapeutic misconception does not guarantee that subjects will understand the concept, Paasche-Orlow says.
"Similarly, using an informed consent form that includes language about conflicts of interest doesn't mean potential subjects will understand what conflicts of interest are," he adds.
Another common research term that is difficult for research participants to grasp is randomization.
"Potential subjects frequently will say things like, 'Yeah, well I know my doctor will give me the real stuff,'" Paasche-Orlow says. "Or they'll make comments, when you ask them in studies about comprehension that reveal they didn't really understand it."
One of the areas that people most often fail to understand involves the section that describes compensation for potential injury, he notes.
"I did a study that looked at the complexity of language and boilerplate sections and found that the most complicated subsection was on research-related injury," Paasche-Orlow says.
"We did some qualitative work where we presented different consent forms to subjects and asked them to talk about what these things meant," he recalls. "And even if the language was pretty clear, we'd often find that people kind of discounted it."
For example, a potential subject would comment, "Of course if I was injured they'd pay for it because why would I get stuck with the bill?" he says.
And potential participants would make these comments even when the informed consent form clearly said there would be no compensation for injuries, Paasche-Orlow adds.
"What this means to me is it would be cynical to not do our best with the language and the informed consent forms," he says. "But the forms themselves clearly cannot be seen as a stand-in for an adequate consent process."
The key is to develop a process that confirms comprehension, and Paasche-Orlow recommends the teach-back method.
"I say to subjects, 'Tell me in your own words what would happen if you joined this study,'" he explains. "I have subjects teach back to me information about the protocol."
The goal is not to have participants remember every detail, but to ensure they fully understand the key points.
"I say things like 'We've talked about a lot today, so tell me in your own words what would happen in this study if you got injured or if you got sick and went to the emergency room. What would happen then?'" Paasche-Orlow says.
"We walk through the process to see what they think would happen, how they would take care of that bill, and what randomization is about," he says.
The teach-back method also should focus on having participants explain how they can leave a study without compromising the care they receive from the provider, he adds.
Researchers should use the teach-back method for all of the key ethical components of informed consent.
IRBs can help improve the informed consent process by asking investigators of studies that deserve special scrutiny because of a vulnerable population or a higher risk to require a document trail showing participants' comprehension of informed consent, Paasche-Orlow says.
The person who provides informed consent might even have an informed consent certificate or authorization form that confirms through documentation that he or she reviewed comprehension of specific knowledge targets, he says.
"Another approach is to have an actual test," he adds. "In both cases, the potential subject should not be enrolled unless he or she can exhibit comprehension."
In all three methods of confirming comprehension, including teach-back, documentation, and a test, the goal would be to not enroll subjects who provided incorrect answers and did not correct these. "If they give a wrong answer you give them feedback that they have it wrong," Paasche-Orlow says. "Then you'll have to confirm that they have it right."
In a few cases, this won't work because the potential participant will hang onto the misconception.
It's Paasche-Orlow's view that research participants who have been through a more rigorous informed consent process will be better research participants.
"The better job you do, the fewer dropouts there will be in the study and the fewer disgruntled subjects," he says.
"Some people say that if you do this you'll scare some people away and have a lower enrollment rate," he adds. "But enrollment isn't the only goal: You want to enroll people who actually understand what they've gotten into."
One of the most important ways IRBs can improve the informed consent process is by encouraging investigators to confirm comprehension for their potential subjects, an expert suggests.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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