Miller School Researchers Identify Comprehension Gaps in Informed Consent Process
Miller School and Miami VA researchers are leading efforts to identify and close gaps in the process for informed consent, which often requires the completion of lengthy, jargon-laden forms. A study led by Leonardo Tamariz, M.D., M.P.H., associate professor of medicine, found the process to be particularly problematic for minority research participants who do not read above the eighth-grade level.
Published online in the July issue of the Journal of General Internal Medicine, the study, “Improving the Informed Consent Process for Research Subjects with Low Literacy: A Systematic Review,” noted that nearly half of the adult population in the United States is marginally health literate, yet few interventions exist to address this deficiency for those considering participation in research.
“There is clearly a need for new comparative and innovative studies that address this important gap in knowledge,” said Tamariz, principal investigator on the study.
Tamariz and his team were shocked when they began their systematic review of available interventions to help prospective study subjects with low health literacy understand research consent forms. None of the scant six studies the team found on the subject evaluated the efficacy of interventions exclusively in low literacy patients.
In their study of 1,620 research participants, they found one simple solution that could help address the multifaceted problem: Researchers should spend more time with potential research participants. Taking the time to talk one-on-one with study participants and using the teach-back method were the most effective strategies for improving informed consent comprehension in low literacy subjects.
Tamariz, who chairs the Institutional Review Board at the Miami VA, also hopes for more involvement from IRBs to practice evidence-based interventions and conduct quality improvement to correct the deficiency.
“The understanding of informed consent forms in low literacy populations needs to be addressed by all stakeholders,” said Tamariz.
Tamariz is planning future studies geared toward understanding the prevalence of low literacy volunteers in clinical research, patient-centered approaches to developing new interventions and comparative effectiveness of interventions in low literacy populations.
Other Miller School co-authors included health literacy expert Erin N. Marcus, M.D., M.P.H., associate professor of medicine in the Division of General Internal Medicine; health disparities expert Ana Palacio, M.D., M.P.H., associate professor of medicine, and Mauricio Robert, a Yale University pre-med student who worked with Tamariz as a summer intern.