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Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Informed Consent and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/19019.
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1

Introduction
1

George Isham,2 senior advisor at HealthPartners and roundtable chair, welcomed participants and provided an overview of the workshop topic. Informed consent—the process of communication between a patient or research subject and a physician or researcher that results in the explicit agreement to undergo a specific medical intervention—is an ethical concept based on the principle that all patients and research subjects should understand and agree to the potential consequences of the clinical care they receive. 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). To explore what actions can be taken to help close the gap between what is required in the informed consent process

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1 The planning committee’s role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteur as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or verified by the Institute of Medicine (IOM), and they should not be construed as reflecting any group consensus.

2 This section is based on the presentation by George Isham, senior advisor, HealthPartners, and senior fellow, HealthPartners Institute for Education and Research, and the statements are not endorsed or verified by the IOM.

Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Informed Consent and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/19019.
×

and communicating it in a health-literate and meaningful manner to individuals, the Institute of Medicine’s (IOM’S) Roundtable on Health Literacy convened this 1-day public workshop featuring presentations and discussions that examine the implications of health literacy for informed consent for both research involving human subjects and treatment of patients.

The Roundtable on Health Literacy brings together leaders from academia, industry, government, foundations and associations, and representatives of patient and consumer interests who work to improve health literacy. To achieve its mission, the roundtable discusses challenges facing health-literacy practice and research and identifies approaches to promote health literacy through mechanisms and partnerships in both the public and private sectors.

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), and although the details of these state laws vary, they all affirm that failure to obtain informed consent renders caregivers liable for negligence or battery and constitutes medical malpractice. The current U.S. system for protecting human research subjects is heavily influenced by the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (HEW, 1979). The current federal policy for the protection of human subjects is known as the “Common Rule” and is codified in separate regulations by 15 federal departments and agencies. The regulations of the U.S. Department of Health and Human Services (HHS), for example, are detailed in the Code of Federal Regulations, Title 45, Part 46 (HHS, 2009), and they spell out the basic provisions for institutional review boards (IRBs), informed consent, and assurances of compliance. According to HHS policy, the informed consent process involves three key features:

  1. Disclosing to potential research subjects information needed to make an informed decision,
  2. Facilitating the understanding of what has been disclosed, and
Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Informed Consent and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/19019.
×
  1. Promoting the voluntariness of the decision about whether to participate in the research.

HHS guidelines cover several elements of the informed consent process for research, explained Isham. First, the process should be an active one of sharing information between the investigator and the prospective subject. Second, prospective subjects should be provided with ample opportunity to ask questions and seek clarification from the investigator. Third, prospective subjects should be given the opportunity to decide freely whether to initially enroll in the research and, later, to withdraw or continue participating in the research. 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. Moreover, information about a research project must be presented in a way that enables each person to decide voluntarily whether to participate as a research subject. Thus, Isham said, the information must be conveyed in language understandable to those being asked to participate as subjects in the research.

For most research, informed consent is documented using a written document—the consent form—that provides key information regarding the research, Isham said. The consent form is intended, in part, to provide information for the potential subject’s current and future reference and to document the interaction between the subject and the investigator. However, even if a signed consent form is required, it alone does not constitute an adequate consent process, explained Isham. The informed consent process is an ongoing exchange of information between the investigator and the subject and could include, for example, use of question-and-answer sessions, community meetings, and videotape presentations.

ORGANIZATION OF THE SUMMARY

The workshop (see Appendix A for the agenda) was organized by an independent planning committee in accordance with the procedures of the National Academy of Sciences. The planning committee comprised Lori Hall, Laurie Myers, Michael Paasche-Orlow, Kim Parson, and Christopher Trudeau (see Appendix B for biographical information). This publication summarizes the presentations and discussions regarding what occurred throughout the workshop, highlighting the lessons presented, practical strategies, and needs and opportunities for improving discharge instructions. Chapter 2 provides an overview of why informed consent is important

Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Informed Consent and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/19019.
×

and reviews some of the best practices and new models that are influencing approaches to informed consent. Chapter 3 discusses the current state of informed consent and the relationship between informed consent and minority underrepresentation in clinical trials. Chapter 4 examines some new approaches to informed consent, and Chapter 5 looks at the future of informed consent. Chapter 6 recounts the discussion that the roundtable’s members and other participants had at the end of the workshop. A paper commissioned by the roundtable on health literacy and informed consent is contained in Appendix C.

Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Informed Consent and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/19019.
×
Page 1
Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Informed Consent and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/19019.
×
Page 2
Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Informed Consent and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/19019.
×
Page 3
Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Informed Consent and Health Literacy: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/19019.
×
Page 4
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Informed consent - the process of communication between a patient or research subject and a physician or researcher that results in the explicit agreement to undergo a specific medical intervention - is an ethical concept based on the principle that all patients and research subjects should understand and agree to the potential consequences of the clinical care they receive. 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. 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.

To explore what actions can be taken to help close the gap between what is required in the informed consent process and communicating it in a health-literate and meaningful manner to individuals, the Institute of Medicine's Roundtable on Health Literacy convened a one-day public workshop featuring presentations and discussions that examine the implications of health literacy for informed consent for both research involving human subjects and treatment of patients. Topics covered in this workshop included 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. Informed Consent and Health Literacy is the summary of the presentations and discussion of the workshop.

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