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Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
×

CHALLENGES AND OPPORTUNITIES IN USING RESIDUAL NEWBORN SCREENING SAMPLES FOR TRANSLATIONAL RESEARCH

WORKSHOP SUMMARY

Steve Olson and Adam C. Berger, Rapporteurs

Roundtable on Translating Genomic-Based Research for Health

Board on Health Sciences Policy

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
×

THE NATIONAL ACADEMIES PRESS
500 Fifth St., N.W.
Washington, DC 20001

NOTICE: The project that is the subject of this report 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 project was supported by contracts between the National Academy of Sciences and the American College of Medical Genetics (unnumbered contract); American Medical Association (unnumbered contract); American Nurses Association (unnumbered contract); Blue Cross and Blue Shield Association (unnumbered contract); Centers for Disease Control and Prevention (Contract No. 200-2005-13434); College of American Pathologists (unnumbered contract); Department of Veterans Affairs (Contract No. V101(93) P-2238); Eli Lilly and Company (Contract No. LRL-0028-07); Genetic Alliance (unnumbered contract); Genomic Health, Inc. (unnumbered contract); Greenwall Foundation (unnumbered contract); Health Resources and Services Administration; Johnson & Johnson (unnumbered contract); Kaiser Permanente (unnumbered contract); March of Dimes Foundation (Contract No. 4-FY10-420); National Cancer Institute (Contract No. N01-OD-4-2139, TO#189); National Heart, Lung, and Blood Institute (Contract No. N01-OD-4-2139, TO#189); National Human Genome Research Institute (Contract No. N01-OD-4-2139, TO#189); National Institute of Child Health and Human Development (Contract No. N01-OD-4-2139, TO#189); National Society of Genetic Counselors (unnumbered contract); Pfizer Inc. (Contract No. 140-N-1818071); and the Secretary’s Advisory Committee on Genetics, Health, and Society (Contract No. N01-OD-4-2139, TO#189). Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project.

International Standard Book Number-13: 978-0-309-15954-8

International Standard Book Number-10: 0-309-15954-7

Additional copies of this report are available from

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

Copyright 2010 by the National Academy of Sciences. All rights reserved.

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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). 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
×

“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.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
×

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. Charles Vest 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. Harvey V. Fineberg 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. Charles Vest are chair and vice chair, respectively, of the National Research Council.


www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
×

PLANNING COMMITTEE*

WYLIE BURKE, Professor and Chair,

Department of Bioethics and Humanities, University of Washington, Seattle

ELLEN WRIGHT CLAYTON, Rosalind E. Franklin Professor of Genetics and Health Policy; Director of the Center for Biomedical Ethics and Society; Professor of Pediatrics and Law,

Vanderbilt University, Nashville, TN

SHARON LEE REILLY KARDIA, Professor and Chair of Epidemiology; Director,

Public Health Genetics Program;

Director,

Life Science and Society Program;

Co-Director,

Center for Genomics & Public Health, University of Michigan School of Public Health, Ann Arbor

MICHAEL KATZ, Senior Vice President for Research and Global Programs,

March of Dimes Birth Defects Foundation

ALLEN D. ROSES, Jefferson-Pilot Professor of Neurobiology and Genetics, Professor of Medicine (Neurology); Director,

Deane Drug Discovery Institute;

Senior Scholar,

Fuqua School of Business, R. David Thomas Executive Training Center, Duke University, Durham, NC

MARTHA TURNER, Assistant Director,

American Nurses Association Center for Ethics and Human Rights, Silver Spring, MD

IOM Staff

ADAM C. BERGER, Project Director

ALEX REPACE, Senior Project Assistant

*

Institute of Medicine (IOM) 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 rapporteurs and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
×

ROUNDTABLE ON TRANSLATING GENOMIC-BASED RESEARCH FOR HEALTH*

WYLIE BURKE (Chair), Professor and Chair,

Department of Bioethics and Humanities, University of Washington, Seattle

BRUCE BLUMBERG, Co-Chief of Medical Genetics,

Kaiser Permanente, and

Institutional Director of Graduate Medical Education,

Northern California Kaiser Permanente, The Permanente Medical Group, Oakland, CA

DENISE E. BONDS, Medical Officer,

Division of Prevention and Population Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD

C. THOMAS CASKEY, Director and Chief Executive Officer, The George & Cynthia Mitchell Distinguished Chair in Neurosciences, Executive Vice President of Molecular Medicine and Genetics,

University of Texas Health Science Center at Houston

STEPHEN ECK, Vice President,

Translational Medicine & Pharmacogenomics, Eli Lilly and Company, Indianapolis, IN

ANDREW N. FREEDMAN, Branch Chief,

Clinical and Translational Epidemiology Branch, Epidemiology and Genetics Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD

GEOFFREY GINSBURG, Director,

Center for Genomic Medicine, Institute for Genomic Sciences & Policy, Duke University, Durham, NC

R. RODNEY HOWELL, Special Assistant to the Director,

National Institute of Child Health and Human Development, Bethesda, MD

SHARON KARDIA, Professor and Chair of Epidemiology; Director,

Public Health Genetics Program;

Director,

Life Science and Society Program;

Co-Director,

Center for Genomics & Public Health, University of Michigan School of Public Health, Ann Arbor

MOHAMED KHAN, American Medical Association Representative; Associate Director of Translational Research,

Department of Radiation Medicine, Roswell Park Cancer Institute, Buffalo, NY

MUIN KHOURY, Director,

National Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, GA

*

IOM Forums and Roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
×

ALLAN KORN, Chief Medical Officer, Senior Vice President,

Clinical Affairs, Blue Cross and Blue Shield Association, Chicago, IL

DEBRA LEONARD,

College of American Pathologists Representative;

Professor and Vice Chair for Laboratory Medicine, Director of the Clinical Laboratories,

Weill Cornell Medical Center of Cornell University, New York

MICHELE LLOYD-PURYEAR, Chief,

Genetic Services Branch, Health Resources and Services Administration, Rockville, MD

ELIZABETH MANSFIELD, Director of Personalized Medicine,

Food and Drug Administration, Silver Spring, MD

GARRY NEIL, Corporate Vice President,

Corporate Office of Science and Technology, Johnson & Johnson, New Brunswick, NJ

ROBERT L. NUSSBAUM, Chief,

Division of Medical Genetics, Department of Medicine and Institute of Human Genetics, University of California–San Francisco School of Medicine

KIMBERLY POPOVITS, President and Chief Executive Officer,

Genomic Health, Inc., Redwood City, CA

AIDAN POWER, Vice President and Global Head of Molecular Medicine,

Pfizer Inc., New London, CT

RONALD PRZYGODZKI, Associate Director for Genomic Medicine,

Biomedical Laboratory Research and Development, Department of Veterans Affairs, Washington, DC

LAURA LYMAN RODRIGUEZ, Senior Advisor to the Director for Research Policy,

National Human Genome Research Institute, Bethesda, MD

ALLEN D. ROSES, Jefferson-Pilot Professor of Neurobiology and Genetics, Professor of Medicine (Neurology); Director,

Deane Drug Discovery Institute;

Senior Scholar,

Fuqua School of Business, R. David Thomas Executive Training Center, Duke University, Durham, NC

KEVIN A. SCHULMAN, Professor of Medicine and Business Administration; Director,

Center for Clinical and Genetic Economics;

Associate Director,

Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC

SHARON TERRY, President and Chief Executive Officer,

Genetic Alliance, Washington, DC

STEVEN TEUTSCH, Chair,

Secretary’s Advisory Committee on Genetics, Health and Society;

Chief Science Officer,

Los Angeles County Department of Public Health, Los Angeles, CA

MARTHA TURNER, Assistant Director,

American Nurses Association Center for Ethics and Human Rights, Silver Spring, MD

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
×

MICHAEL S. WATSON, Executive Director,

American College of Medical Genetics, Bethesda, MD

CATHERINE A. WICKLUND, Past President,

National Society of Genetic Counselors;

Director,

Graduate Program in Genetic Counseling;

Assistant Professor,

Department of Obstetrics and Gynecology, Northwestern University, Chicago, IL

IOM Staff

ADAM C. BERGER, Project Director

ALEX REPACE, Senior Project Assistant

ANDREW POPE, Director,

Board on Health Sciences Policy

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
×

Reviewers

This report 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 report as sound as possible and to ensure that the report 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 report:

Jeffrey R. Botkin, Professor of Pediatrics, Department of Pediatrics; Adjunct Professor of Medicine, Department of Internal Medicine Division of Medical Ethics and Humanities, University of Utah School of Medicine; Associate Vice President for Research Integrity, University of Utah, Salt Lake City

Michele Caggana, Deputy Director, Division of Genetics; Chief, Laboratory of Human Genetics; Director, Newborn Screening Program; Head, Genetic Testing Section, New York State Department of Health Wadsworth Center, Albany

Robert F. Vogt, Jr., Newborn Screening Branch, Division of Laboratory Sciences, Centers for Disease Control and Prevention, Atlanta, GA

Ann Waldo, Senior Counsel, Genetic Alliance, Washington, DC

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
×

Although the reviewers listed above have provided many constructive comments and suggestions, they did not endorse the final draft of the report before its release. The review of this report was overseen by Elena O. Nightingale, Scholar-In-Residence, Institute of Medicine, Washington, DC. Appointed by the Institute of Medicine, she was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the rapporteurs and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
×

Acknowledgments

The support of the sponsors of the Institute of Medicine Roundtable on Translating Genomic-Based Research for Health was crucial to the planning and conduct of the workshop, Challenges and Opportunities in Using Newborn Screening Samples for Translational Research. Federal sponsors are the Centers for Disease Control and Prevention; Department of Veterans Affairs; Health Resources and Services Administration; National Cancer Institute; National Heart, Lung, and Blood Institute; National Human Genome Research Institute; National Institute for Child Health and Human Development; and the Secretary’s Advisory Committee on Genetics, Health, and Society. Non-federal sponsorship was provided by the American College of Medical Genetics; the American Medical Association; the American Nurses Association; Blue Cross and Blue Shield Association; the College of American Pathologists; Eli Lilly and Company; Genetic Alliance; Genomic Health, Inc.; Greenwall Foundation; Johnson & Johnson; Kaiser Permanente; March of Dimes Foundation; the National Society of Genetic Counselors; and Pfizer Inc.

The Roundtable wishes to express its gratitude to the expert speakers whose presentations highlighted the challenges that need to be resolved in order to make newborn screening samples accessible for research without compromising the function of the newborn screening program. These speakers were Wylie Burke, Michele Caggana, Ellen Wright Clayton, Anne Comeau, Kelly Edwards, Alan Fleischman, Alissa Johnson, Sharon Kardia, Kenneth Pass, Sharon Terry, and Ann Waldo.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
×

The Roundtable also wishes to thank the members of the planning committee for their work in developing an excellent workshop agenda. Planning committee members were Wylie Burke, Ellen Wright Clayton, Sharon Kardia, Michael Katz, Allen Roses, and Martha Turner.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
×

FIGURES

2-1

 

The number of cases detected (169)/100,000 screened through the New England newborn screening program,

 

6

3-1

 

The CHI2 vision of integrating public health databases is juxtaposed with the current separated systems approach used in New York State,

 

16

BOXES

1-1

 

Definition,

 

1

3-1

 

A Use Case for Integrated Information,

 

17

4-1

 

Examples of Permitted Uses,

 

26

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
×

Abbreviations and Acronyms

CDC Centers for Disease Control and Prevention

CHI2 Child Health Information Integration

GINA Genetic Information Nondiscrimination Act

HIPAA Health Insurance Portability and Accountability Act

IRB institutional review board

PKU phenylketonuria

RHIO regional health information organization

SACHDNC Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children

SCID severe combined immunodeficiency

TIES Trust, Integrity, and Ethics in Science

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
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Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
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Suggested Citation:"Front Matter." Institute of Medicine. 2010. Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12981.
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Newborn screening samples are used to test more than 4 million infants each year for life-threatening diseases that are treatable if found at birth. These specimens also represent a potentially invaluable resource for public health and biomedical research. The IOM held a workshop to examine issues surrounding the use of residual specimens for translational research.

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