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
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.
“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
—Goethe
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
Advising the Nation. Improving Health.
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.
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.
This page intentionally left blank.
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.
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
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.
This page intentionally left blank.
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.
This page intentionally left blank.
Contents
Federal Policy on Informed Consent
2 OVERVIEW OF THE KEY ISSUES INVOLVED IN INFORMED CONSENT
Informed Consent: Why Do We Care?
Best Practices and New Models of Health Literacy for Informed Consent
3 THE CURRENT STATE OF INFORMED CONSENT IN RESEARCH AND TREATMENT
The Impact of a Poor Informed Consent Process on Clinical Trials
Developing a Better Process for Informed Consent
Informed Consent and Patients with Limited English Proficiency
4 APPROACHES TO INFORMED CONSENT
The Importance of the Informed Consent Conversation in Addition to the Form
Establishing Harmony Between the Rules and Health Literacy
5 THE FUTURE OF INFORMED CONSENT
Informed Consent, Clinical Trials, and Information Technology
Initiating a Culture Change Around Informed Consent
B Biographical Sketches of Workshop Speakers and Planning Committee Members
Figures and Tables
FIGURES
2-1 Pros and cons of the effectiveness of multimedia and online approaches
2-2 A roadmap to health-literate informed consent
2-3 Situation risk model for communicating informed consent
3-1 Comparison of researchers’ methods to community member preferences
3-2 Comparison of formatting approaches that researchers use and community members’ preferences
3-3 Review of 44 trials indicating possibility of improving patient comprehension
3-4 Possible workflow for conducting meaningful informed consent for a high-risk surgical procedure
3-5 Aligning patient goals and outcomes
3-7 Hispanic or Latino population as a percentage of total population, by county, 2010
4-1 First page of the California’s advance health care directive
4-2 Medical intervention form offering patients three choices for care
4-4 The teach-back or teach-to-goal process
4-5 A colonoscopy consent form incorporating teach-back
5-1 Percentage of U.S. adults in each health-literacy level
5-2 Percentage of U.S. adults in each health-literacy level by highest educational attainment
5-3 Percentage of U.S. adults in each health-literacy level by race/ethnicity
5-4 Actual versus target readability scores for the 61 institutions with stated standards in 2003
5-5 Actual versus target readability scores for the 64 institutions with stated standards in 2013
TABLES
3-1 Demographic Distribution of Participants in a National Phone Survey About Informed Consent
3-3 Professional Interpreters Versus Bilingual Physicians
3-4 Suboptimal Communication Resulting from Language-Discordant Care
| 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 |
