Little research done for low literacy and consent
Little research done for low literacy and consent
Researcher argues that more studies are needed
While many IRBs complain about the quality of informed consent, there's been little substantive research into how to improve it, particularly for subjects with low literacy, says a researcher who has studied the issue.
Leonardo Tamariz, MD, MPH, associate professor of medicine at the University of Miami in Coral Gables, FL, says he and his colleagues found only a half dozen studies that tested an informed consent change to see if it improved comprehension in a low-literacy population.
"And of those six studies, none of them were specifically dedicated to patients with low literacy — they looked at a mixture of patients," Tamariz says. "I don't think many people are working on this, despite this being a big problem. The reason might be because there's not much funding out there to help start those studies."
His group's results were published recently in the Journal of General Internal Medicine.1
Of the studies his group looked at, only one was randomized and three did not look at informed consent in real research studies, but relied on hypothetical consents.
But even from this small group of imperfect studies, Tamariz says there were some useful insights.
Two of the more successful studies relied on so-called "teach-back" methods, in which a participant is required to verbalize his or her understanding of the informed consent information after receiving it.
"When an interviewer says something, the people being interviewed have to recall what was said in their own words — that's the purpose of teach-back," Tamariz says.
In one of those studies, an interviewer used a script to explain the consent and HIPAA privacy document for a medication adherence study and then had participants respond with information about study design, randomization, and disclosure of data. That study reported a comprehension level of 31% after one round of teach-back.
Teach to goal
The second study used a "teach-to-goal" method — several rounds of teach-back for the same participant — for the informed consent of an advance directive study.
"Teach-to-goal is doing [teach-back] multiple times — if they don't get it the first time, doing it a second time, doing it a third time or a fourth time or a fifth time or a sixth time, so you have a goal of making sure of comprehension," Tamariz says.
First, participants read along with a staff member, then they had to show their understanding of the tasks they'd be encountering in the study. The "first pass" comprehension level of participants was 33% — after three rounds, the comprehension level of those with marginal and inadequate health literacy was 90%.1
Tamariz's group notes that the best results came from a study team member speaking with a participant one-to-one. But he says there needs to be more research into this topic, asking participants themselves about what works.
He's currently planning a study that would ask participants who have gone through a consent process about their experience.
"We tend to do things — we physicians or regulators — without asking the key player in the informed consent process, the patient, so that they could give us some answers," Tamariz says. "So I'm planning a study asking what they feel we should do differently, incorporating all of those comments into a teach-back method and then trying to test it and see if that increases comprehension."
IRB interventions
Tamariz's interest in improving informed consent comes from his own experiences, both as a researcher and as IRB chair for Miami Veterans Affairs. In quizzing his own study participants, he learned that many didn't understand basic concepts such as voluntariness.
And he says his IRB routinely receives informed consent documents that are too long and complicated.
"[Participants] need to discuss the consent in its entirety and they need to be able to comprehend it," he says. "When you have a consent that's 25 pages, it's impossible to do. What I'm seeing right now is the consents that are coming from pharmaceutical studies that are sponsored by pharmaceutical companies, those consents are 25-30 pages long. We cannot work with that."
His IRB has sponsored educational sessions for research assistants and principal investigators ("From experience, I can tell you that we had a room full of research assistants and maybe two PIs"). They went through a mock consent process with the audience and showed them how the teach-back method works.
He says he'd also like to see more harmonization among the federal agencies — many of his studies must conform to informed consent requirements from the Office for Human Research Protections, the Food and Drug Administration and Veterans Affairs.
"We're dealing with three layers and some of those layers are different, so you have to have a longer, more difficult consent," he says. "I think we have to get everyone together — FDA, OHRP, VA, IRBs — in a room and come up with a way that we can trim this down."
Reference
- Tamariz L, Palacio A, Robert M, et al. Improving the Informed Consent Process for Research Subjects with Low Literacy: A Systematic Review. J Gen Intern Med. 2012 Jul 11 (Epub)
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