Limited health literacy is a pervasive and independent risk factor for poor health outcomes. Despite decades of reports exhibiting that the healthcare system is overly complex, unneeded complexity remains commonplace and endangers the lives of patients, especially those with limited health literacy. In this article, we define health literacy and describe the empirical evidence associating health literacy and poor health outcomes. We recast the issue of poor health literacy from within the ethical perspective of the least well-off and argue that (...) poor health outcomes deriving from limited health literacy ought to be understood as a fundamental injustice of the healthcare system. We offer three proposals that attempt to rectify this injustice, including: universal precautions that presume limited health literacy for all healthcare users; expanded use of technology supported communication; and clinical incentives that account for limited health literacy. (shrink)

Background:An ethical, informed consent process requires that potential participants understand the study, their rights, and the risks and benefits. Yet, despite strategies to improve communication, many participants still lack understanding of potential risks and benefits. Investigating attitudes and practices of research nurses can identify ways to improve the informed consent process.Research question:What are the attitudes, practices, and preparedness of nurses involved in the informed consent process regarding communication of risks and benefits?Research design:A survey was developed and administered online to a (...) national purposive sample of 107 research nurses with experience obtaining informed consent for clinical trials. Survey responses stratified by selected work-related characteristics were analyzed.Ethical considerations:Participants were instructed they need not answer each question and could stop at any time. They consented by clicking “accept” on the email which linked to the survey. The study was approved by the Northeastern University Institutional Review Board, Boston, Massachusetts.Findings:Most research nurses used a teach-back method to assess participant comprehension, while 72% relied on their intuition. About one-third did not feel prepared to communicate related statistics. About 20% did not feel prepared to tailor information, and half did not feel competent using supplemental materials to enhance risks and benefits comprehension. Only 70% had received training in the informed consent process which included in-person training, case studies, online courses, feedback during practice sessions, and simulation, such as role playing and viewing videos. Perceived preparedness was significantly associated with greater informed consent experience and training.Conclusion:Research nurses may have inadequate training to encourage, support, and reinforce communication of risks and benefits during the informed consent process. Relevant purposeful education and training should help to improve and standardize the ethical informed consent process. (shrink)