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Suggested Citation:"Front Matter." 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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Informed Consent
and Health Literacy

Workshop Summary

Joe Alper, Rapporteur

Roundtable on Health Literacy

Board on Population Health and Public Health Practice

INSTITUTE OF MEDICINE
               OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu

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

THE NATIONAL ACADEMIES PRESS    500 Fifth Street, NW    Washington, DC 20001

NOTICE: The workshop that is the subject of this workshop summary was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

This activity was supported by contracts between the National Academy of Sciences and Aetna Foundation; the Agency for Healthcare Research and Quality (HHSP233200900537P); the California Dental Association; the East Bay Community Foundation (Kaiser Permanente); Eli Lilly and Company; Health Literacy Missouri; the Health Resources and Services Administration (HHSH25034004T); Humana; the Institute for Healthcare Advancement; Merck and Co., Inc.; the National Institutes of Health; North Shore–Long Island Jewish Health System; the Office of Disease Prevention and Health Promotion; and the UnitedHealth Group. The views presented in this publication are those of the rapporteur and do not necessarily reflect the views of the organizations or agencies that provided support for the activity.

International Standard Book Number-13: 978-0-309-31727-6
International Standard Book Number-10: 0-309-31727-4

Additional copies of this workshop summary are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2015 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

Suggested citation: IOM (Institute of Medicine). 2015. Informed consent and health literacy: Workshop summary. Washington, DC: The National Academies Press.

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

Knowing is not enough; we must apply.
Willing is not enough; we must do.
”      

                                                —Goethe

image

INSTITUTE OF MEDICINE
              OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

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

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.

The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. C. D. Mote, Jr., is president of the National Academy of Engineering.

The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Victor J. Dzau is president of the Institute of Medicine.

The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. C. D. Mote, Jr., are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

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

PLANNING COMMITTEE ON INFORMED
CONSENT AND HEALTH LITERACY1

LORI HALL, Consultant, Health Education, Eli Lilly and Company

LAURIE MYERS, Lead, Healthcare Disparities and Health Literacy Strategy, Merck & Co.

MICHAEL PAASCHE-ORLOW, Associate Professor of Medicine, Boston University School of Medicine

KIM PARSON, Consumer Experience Center of Excellence, Humana

CHRISTOPHER TRUDEAU, Associate Professor, Thomas M. Cooley Law School

_____________

1 Institute of Medicine planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteur and the institution.

Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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ROUNDTABLE ON HEALTH LITERACY1

GEORGE ISHAM (Chair), Senior Advisor, HealthPartners, Senior Fellow, HealthPartners Institute for Education and Research

WILMA ALVARADO-LITTLE, Director, Community Engagement/Outreach, University at Albany

CINDY BRACH, Senior Health Policy Researcher, Agency for Healthcare Research and Quality

GEM DAUS, Public Health Analyst, Health Resources and Services Administration

BENARD DREYER, Professor of Pediatrics, New York University School of Medicine

LAURIE FRANCIS, Senior Director of Clinic Operations and Quality, Oregon Primary Care Association

JILL GRIFFITHS, Vice President, Communications, Aetna

LORI HALL, Consultant, Health Education, Eli Lilly and Company

LINDA HARRIS, Team Leader, Health Communication and eHealth Team, U.S. Department of Health and Human Services

BETSY HUMPHREYS, Deputy Director, National Library of Medicine

MARGARET LOVELAND, Senior Director, Global Medical Affairs, Merck & Co.

LAURIE MYERS, Lead, Healthcare Disparities and Health Literacy Strategy, Merck & Co.

CATINA O’LEARY, President and Chief Executive Officer, Health Literacy Missouri

RUTH PARKER, Professor of Medicine, Pediatrics, and Public Health, Emory University School of Medicine

KIM PARSON, Consumer Experience Center of Excellence, Humana

KAVITA PATEL, Managing Director for Clinical Transformation and Delivery, The Brookings Institution

SUSAN PISANO, Vice President of Communications, America’s Health Insurance Plans

ANDREW PLEASANT, Senior Director for Health Literacy and Research, Canyon Ranch Institute

LINDSEY ROBINSON, President, California Dental Association

BERNARD ROSOF, Chief Executive Officer, Quality in Healthcare Advisory Group, LLC

RIMA RUDD, Senior Lecturer on Health Literacy, Education, and Policy, Harvard School of Public Health

_____________

1 Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteur and the institution.

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Suggested Citation:"Front Matter." 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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STEVEN RUSH, Director, Health Literacy Innovations, UnitedHealth Group

PAUL SCHYVE, Senior Advisor, Quality Improvement, The Joint Commission

MICHAEL VILLAIRE, Chief Executive Officer, Institute for Healthcare Advancement

PATRICK WAYTE, Vice President, Marketing and Health Education, American Heart Association

WINSTON WONG, Medical Director, Community Benefit Disparities Improvement and Quality Initiatives, Kaiser Permanente

IOM Staff

LYLA HERNANDEZ, Senior Program Officer

ANDREW LEMERISE, Research Associate

MELISSA FRENCH, Associate Program Officer

ANGELA MARTIN, Senior Program Assistant

ROSE MARIE MARTINEZ, Director, Board on Population Health and Public Health Practice

Suggested Citation:"Front Matter." 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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Reviewers

This workshop summary has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published workshop summary as sound as possible and to ensure that the workshop summary meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this workshop summary:

SUSAN M. ABDEL-RAHMAN, University of Missouri, Kansas City

JESSICA S. ANCKER, Weill Cornell Medical College

ROBERT LOGAN, National Library of Medicine

RICARDO WRAY, St. Louis University

Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop summary before its release. The review of this workshop summary was overseen by Hugh Tilson, University of North Carolina at Chapel Hill. Appointed by the Institute of Medicine, he was responsible for making certain that an independent examination of this workshop summary was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this workshop summary rests entirely with the rapporteur and the institution.

Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Acknowledgments

The sponsors of the Institute of Medicine Roundtable on Health Literacy made it possible to plan and conduct the workshop Informed Consent and Health Literacy. Sponsors from the U.S. Department of Health and Human Services are the Agency for Healthcare Research and Quality, the Health Resources and Services Administration, the National Institutes of Health, and the Office of Disease Prevention and Health Promotion. Non-federal sponsorship was provided by the Aetna Foundation; the California Dental Association; the East Bay Community Foundation (Kaiser Permanente); Eli Lilly and Company; Health Literacy Missouri; Humana; the Institute for Healthcare Advancement; Merck and Co., Inc.; North Shore–Long Island Jewish Health System; and the UnitedHealth Group.

The roundtable wishes to express its gratitude to the following speakers for their interesting and thoughtful presentations: Linda Aldoory, Alicia Fernandez, Sara Goldkind, Michael Paasche-Orlow, Sandra Crouse Quinn, Kenneth Saag, Yael Schenker, Rebecca Sudore, Jeremy Sugarman, and Christopher Trudeau. The roundtable also wishes to extend its appreciation to the planning committee members: Lori Hall, Laurie Myers, Michael Paasche-Orlow, Kim Parson, and Christopher Trudeau.

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Acronyms and Abbreviations

AHRQ Agency for Healthcare Research and Quality
AMA American Medical Association
   
CDC Centers for Disease Control and Prevention
CMS Centers for Medicare & Medicaid Services
CPR cardiopulmonary resuscitation
   
EDGE Effectiveness of Discontinuing Bisphosphonates trial
   
FDA U.S. Food and Drug Administration
   
HEW U.S. Department of Health, Education, and Welfare
HHS U.S. Department of Health and Human Services
HIPAA Health Insurance Portability and Accountability Act
   
IOM Institute of Medicine
IRB institutional review board
   
LVAD left ventricular assist device
   
NCI National Cancer Institute
NIH National Institutes of Health
   
PCORI Patient-Centered Outcomes Research Institute
POLST Physician’s Orders for Life-Sustaining Treatments
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Informed Consent and Health Literacy: Workshop Summary Get This Book
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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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