Literacy, Comprehension, and Informed Consent in Clinical Research

Abstract

Institutional review boards (IRBs) and informed consent have recently come under increasing scrutiny. The provision of appropriate and understandable information and its comprehension are key elements of the informed consent process. This article examines how literacy and other factors might impact on comprehension of the information provided. Better understanding of these issues and how to best address them are crucial to allowing clinical research subjects to participate as well-informed and willing partners in scientific inquiry.

Will the introduction of non-invasive prenatal diagnostic testing erode informed choices? An experimental study of health care professionals

“…Studies exploring written consent in the context of clinical research have generated mixed results with some showing no differences in comprehension between oral and written consent and others suggesting that written consent, in combination with an oral explanation, leads to better retention [19]. Whilst our results suggest that the information provided to individuals is likely to remain unaffected by whether testing is invasive or not, knowledge is only one component of an informed choice.…”

A study of the abilities in oral language comprehension of the Boston Diagnostic Aphasia Examination - Portuguese version: a reference guide for the Brazilian population

“…These questions refer to the influence of low education and lack of knowledge of the specific "health" lexicon on the ability of patients and their families to comprehend the diverse kinds of explanations and instructions given by health professionals. This lack of understanding may constitute an additional morbidity factor, especially in chronic diseases such as diabetes and systemic arterial hypertension (37)(38)(39)(40).…”

Health Literacy and Cancer Communication

“…For patients with limited health literacy, detailed factual information is often not relevant or useful. 6,48,49,58 Patients with low health literacy tend to be more responsive to information based on a health belief model where priority is given to patient action, motivation, and selfempowerment. Patients, especially those with low health literacy, are most interested in information that improves their sense of wellbeing and helps them resolve their immediate health problems.…”

“…58 In the last few years, Institutional Review Boards (IRBs) and the informed consent process have come under increasing scrutiny. Numerous studies have documented the high reading levels, length, and complexity of commonly used consent documents.…”