Health Literacy and Informed Consent Materials: Designed for Documentation, Not Comprehension of Health Research

Abstract

Minority populations with health disparities are underrepresented in research designed to address those disparities. One way to improve minority representation is to use community-based participatory methods to overcome barriers to research participation, beginning with the informed consent process. Relevant barriers to participation include lack of individual or community awareness or acceptance of research processes and purposes. These barriers are associated with limited health literacy. To inform recommendations for an improved consent process, we examined 97 consent documents and 10 associated Institutional Review Board websites to determine their health literacy demands and degree of adherence to principles of community-based research. We assessed the reading level of consent documents and obtained global measures of their health literacy demand by using the Suitability and Comprehensibility Assessment of Materials instrument. Although these documents were deemed suitable as medical forms, their readability levels were inappropriate, and they were unsuitable for educating potential participants about research purposes. We also assessed consent forms and Institutional Review Board policies for endorsement of community-based participatory principles, finding that very few acknowledged or adhered to such principles. To improve comprehension of consent documents, we recommend restructuring them as educational materials that adhere to current health literacy guidelines.

A Proposed Approach for Implementing Genomics-Based Screening Programs for Healthy Adults

“…One obvious and refl exive approach to mitigating these is to embed them in informed consent documents. Unfortunately, consent forms are often poorly understood [31] and poorly recalled [32]; they can often appear to be exercises in liability mitigation rather than clear explanations of experimental procedures designed with the patient or research participant in mind [33,34,35]. Eff orts to optimize consent for genomics-based screening programs should be pursued, particularly if included alongside other routine health screenings.…”

Readability of consent forms in veterinary clinical research

“…A wealth of recent publications describing consent in human clinical trials has focused on readability and comprehension of medical consent forms . A survey conducted by the National Assessment of Adult Literacy concluded that approximately half of Americans have only basic literacy skills and that 14% have literacy skills that are less than basic .…”

<p>Health literacy and informed consent for clinical trials: a systematic review and implications for nurses</p>

“…23 Based on the evidence presented in this literature review, clinical trial consents are often written above the average health literacy level, prohibiting patients from being able to fully understand what they are signing. 21 Several of the articles presented the use of modified or simplified consents to aid in this process in order to attempt to increase comprehension levels among all patients. 7,14,13 Comprehension improved when information was simplified, increasing patients' satisfaction and confidence in their decisions.…”

“…Simonds et al 21 assessed 97 informed consent documents to determine readability, suitability, and comprehensibility. By using the Simple Measure of Gobbledygook, the results showed that the average reading level of the consents was grade 12.…”