Informed Consent and Health Literacy Workshop Summary (2015) / Chapter Skim
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1 Introduction
1 Introduction
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Regulations that govern the attainment of informed consent for treatment and research are crucial to ensuring that medical care and research are conducted in an ethical manner and with the utmost respect for individual preferences and dignity, Isham said. These regulations, however, often require -- or are perceived to require -- that informed consent documents and related materials contain language that is beyond the comprehension level of most patients and study participants, a fact recognized for decades (Fernandez, 2010; Herz et al., 1992; Howard and DeMets, 1981; Ingelfinger, 1972; Sharp, 2004)
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Examples of the topics covered in this workshop include an overview of the ethical imperative to gain informed consent from patients and research participants, a review of the current state and best practices for informed consent in research and treatment, the connection between poor informed consent processes and minority underrepresentation in research, new approaches to informed consent that reflect principles of health literacy, and the future of informed consent in the treatment and research settings. FEDERAL POLICY ON INFORMED CONSENT Isham explained that all 50 states have legislation that requires some level of informed consent for patients receiving medical care (Pape, 1997)
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Fourth, the informed consent process should ensure that all critical information about a study is completely disclosed and that prospective subjects or their legally authorized representatives adequately understand the research so that they can make informed choices. Fifth, the procedures used in seeking and obtaining informed consent should be designed to communicate with the subject population in terms that every individual in that population can understand.
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A paper commissioned by the roundtable on health literacy and informed consent is contained in Appendix C
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