NIH EXTRAMURAL CENTER PROGRAMS
Criteria for Initiation and Evaluation
Frederick J. Manning, Michael McGeary, Ronald Estabrook, Editors
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
THE NATIONAL ACADEMIES PRESS
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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. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.
Support for this project was provided by the National Institutes of Health through Contract/Grant No. N01-OD-4-2139, TO#117. The views presented in this report are those of the Institute of Medicine Committee for Assessment of NIH Centers of Excellence Programs and are not necessarily those of the funding agencies.
Library of Congress Cataloging-in-Publication Data
NIH extramural center programs : criteria for initiation and evaluation / Committee for Assessment of NIH Centers of Excellence Programs, Board on Health Sciences Policy ; Frederick J. Manning, Michael McGeary, Ronald Estabrook, editors.
p. ; cm.
Includes bibliographical references.
ISBN 0-309-09152-7 (pbk.)
1. National Institutes of Health (U.S.) 2. Medicine—Research—Government policy—United States. 3. Medicine—Research—United States—Evaluation. 4. Medicine—Research—United States—Finance. 5. Federal aid to medical research—United States.
[DNLM: 1. Financing, Government—economics—United States. 2. Health Policy—United States. 3. Program Evaluation—United States. 4. Research Support—economics—United States. WA 540 AA1 N691 2004] I. Manning, Frederick J. II. McGeary, Michael G. H. III. Estabrook, Ronald W. IV. Institute of Medicine (U.S.). Committee for Assessment of NIH Centers of Excellence Programs.
R854.U5N535 2004
610′.72′073—dc22
2004004828
International Standard Book Number 0-309-53028-8 (PDF)
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COMMITTEE FOR ASSESSMENT OF NIH CENTERS OF EXCELLENCE PROGRAMS
RONALD ESTABROOK, (Chair), Professor of Biochemistry and Chair, Department of Biochemistry,
University of Texas Southwestern Medical Center at Dallas
SUSAN E. COZZENS, Professor and Chair,
School of Public Policy, Georgia Institute of Technology, Atlanta
IRWIN FELLER, Senior Visiting Scientist,
American Association for the Advancement of Science, and
Professor Emeritus of Economics,
Institute for Policy Research and Evaluation, Pennsylvania State University, University Park
CHARLES K. FRANCIS, President,
Charles R. Drew University of Medicine and Science, Los Angeles, California
RONALD G. GELLER, Senior Associate,
Health Research Associates, Gaithersburg, Maryland
DAVID G. KAUFMAN, Professor and Vice Chair of Pathology and Laboratory Medicine, Professor of Biochemistry and of Toxicology,
School of Medicine, University of North Carolina, Chapel Hill
J. RICHARD LANDIS, Director, Division of Biostatistics, Vice Chair,
Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia
STEPHEN MCCONNELL, Vice President,
Advocacy and Public Policy, Alzheimer’s Association, Washington, D.C.
RUTH MCCORKLE, Professor and Chair, Doctoral Program, and Director of the Center for Excellence in Chronic Illness Care,
Yale University School of Nursing, New Haven, Connecticut
NICOLA C. PARTRIDGE, Professor and Chair,
Department of Physiology and Biophysics, Robert Wood Johnson Medical School, Piscataway, New Jersey
MICHAEL SAAG, Professor of Medicine and Director,
1917 AIDS Outpatient Clinic, University of Alabama, Birmingham
S. LEONARD SYME, Emeritus Professor of Epidemiology,
Division of Public Health Biology and Epidemiology, University of California, Berkeley
MYRON L.WEISFELDT, Professor of Medicine and Director,
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
Board on Health Sciences Policy Liaison
MICHAEL LOCKSHIN, Director,
Barbara Volcker Center for Women and Rheumatic Disease, and
Co-Director,
Mary Kirkland Center for Lupus Research, Hospital for Special Surgery, New York, New York
Study Staff
FREDERICK J. MANNING, Study Director
NATASHA DICKSON, Senior Project Assistant
BENJAMIN HAMLIN, Research Assistant
Institute of Medicine Staff
ANDREW POPE, Director,
Board on Health Sciences Policy
MELVIN WORTH, Scholar-in-Residence
TROY PRINCE, Administrative Assistant,
Board on Health Sciences Policy
CARLOS GABRIEL, Financial Associate
Consultant
MICHAEL MCGEARY
Independent Report 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 NRC’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 deliberative process. We wish to thank the following individuals for their review of this report:
John S. Greenspan, University of California, San Francisco
Steven Hyman, Harvard University
David Korn, Association of American Medical Colleges
Edward D. Miller, The Johns Hopkins University
Jordan S. Pober, Yale University
David Roessner, SRI International
Joan L. Samuelson, Parkinson’s Action Network
Brian L. Strom, University of Pennsylvania
Terrie Wetle, Brown University
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions
or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by William N. Kelley, Professor of Medicine, Biochemistry, and Biophysics at the University of Pennsylvania Medical School, appointed by the Institute of Medicine, and Floyd E. Bloom, Chairman, Department of Neuropharmacology, The Scripps Research Institute, appointed by the NRC’s Report Review Committee. They were 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 authoring committee and the institution.
Preface
Research in the biomedical sciences in the United States is recognized to be at the pinnacle of success. This reputation is due in large part to the generous federal support for research provided by Congress, which appropriates the budget required to carry out the multitude of activities directed by the National Institutes of Health (NIH). This commitment by Congress over the last years is evidenced by ever increasing budgets for biomedical research. Increased funding has resulted in the ability of the scientific community to expand the portfolio of diseases studied while simultaneously developing and applying new techniques of experimentation. As a result, the biomedical sciences carried out in the United States are acknowledged to be at the forefront of major advances essential for extending the health and wellbeing of the general population.
NIH serves as the critical hub of this success. The wisdom and guidance of leaders at NIH together with the mechanisms developed over the years for selecting for support the very best ideas generated by scientists, principally in academic institutions, provide an unbeatable mix. The major share of support for research has been dedicated to funding ideas proposed by individual investigators and evaluated by a critical peer review system. However, biomedical science is changing. As our understanding of biology increases, the conduct of disease-oriented science is becoming more complex. Scientists with differing expertise and skills are now required to function as multidisciplinary teams to bring new approaches to solving complex issues. Further, the translation of basic science findings to clinical application requires unique settings where cross-disciplinary interactions and meth-
odological sharing can occur. It is this “team approach” to problem solving that one anticipates will dominate the future direction of biomedical research and thus lead to new discoveries and new therapies.
In the early 1960s the NIH established the General Clinical Research Centers program to provide loci for facilitating the cross-fertilization of scientists and clinicians that would foster the translation of fundamental science to patient care. As the years progressed the wisdom of this approach was evidenced by the establishment in the 1970s of Cancer Centers and Specialized Centers of Research for cardiovascular research. Today we note a multitude of centers that encompass a wide range of topics related to disease processes. However, support of centers is frequently expensive because of their multi-disciplinary structure and application to clinical care.
The success of centers supported by NIH has attracted the attention of members of Congress, many of whom have been urged by disease-oriented advocacy groups to seek similar funding for research in their special interests. This situation presents a dilemma for Congress and for NIH, because there is the temptation “to rob Peter to pay Paul” when dividing up the designated funding available for the support of biomedical research. Congress asked the Institute of Medicine (IOM) to carry out a study that would provide guidance to both Congress and the NIH in deciding which diseases warrant additional financial support by the establishment of new “Centers of Excellence” programs at NIH and which research areas are adequately supported by the present arrangements.
An excellent committee was established by the National Research Council and the IOM, and initial meetings revealed the large number (about 1,200) of centers that are now supported by NIH. The committee soon learned that the portfolio of centers supported by NIH is varied and the mechanisms of selection, evaluation, and initiation are not centralized at NIH. The size and funding for extramural centers supported by NIH are approximately equivalent to the size and funding of the intramural program at NIH. Likewise, the diversity of extramural centers equals the diversity of the intramural research programs supported by NIH. Much of the discussion of the committee at its five meetings was dedicated to understanding better the similarities and differences of the extramural centers supported by NIH. The committee decided at an early stage of its deliberations that a systematic approach was necessary in defining, establishing, and evaluating centers. The committee agreed that once the process of establishing new center programs is better defined and made more transparent, the joint efforts of Congress and NIH in debating the value of new center programs would be facilitated. The committee recognized the value of centers and never questioned the continued usage of this mechanism of support, in particular for translation research. Questions of the future role of centers and the shape and form into which centers will evolve in the next
decade, in particular in this period where “team research” is emphasized, remain unanswered. It is our hope that the enclosed report will continue to add to the strength and success of this multidisciplinary approach to research in the biomedical sciences.
Many individuals contributed valuable information and data to the committee through formal presentations, written submissions, or informal contacts with project staff. We are grateful to all of the following for their generous assistance: Paula Allen-Meares, James Anderson, Christine Bachrach, Kenneth Berns, Roger Bulger, Merry Bullock, Elaine Collier, Jacqueline Dunbar-Jacob, Steve Foote, Katy French, Myron Genel, John Haaga, E. Tessa Hedley-White, Kathie Hendrick, Anne Houser, Steven Hyman, Ruth Kirschstein, Steven Koslow, David Korn, Virginia Ladd, Anita Linde, Nita Maihle, Robert Moore, Creighton Phelps, Mona Rowe, John Schwab, Belinda Seto, Charles Sherman, Steven Teitelbaum, Judy Vaitukaitis, Marina Volkov, Gemma Weidlinger, Myrl Weinberg, Marion Zatz, Steven Zeisel, and Joan Levy Zlotnick.
As committee chair I am acutely aware of the contributions that the IOM staff has made to the success of the study. Special thanks and acknowledgment are due to project assistant Natasha Dickson, who made our meetings and travel as comfortable and convenient as possible, provided outstanding secretarial help throughout the study, and painstakingly copy-edited our final product. Michael Lockshin, liaison from the Board on Health Sciences Policy (BHSP), provided invaluable insight from his perspective as a former director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. IOM Scholar-in-Residence Mel Worth and BHSP director Andy Pope provided sage advice from start to finish. I am particularly grateful to study director Rick Manning and special consultant Mike McGeary for their skilled and professional support in shepherding the committee through its task. Finally, I want to acknowledge the individual and collective contributions of the committee members. They represent an admirable example of busy but unselfish professionals volunteering their limited time tending to the scientific “commons” on which we all depend. It was a special opportunity to have worked with this outstanding group.
Ronald Estabrook, Chair
Committee for Assessment of NIH Centers of Excellence Programs
Acronyms and Abbreviations
ACD
Advisory Committee to the Director
ADC
Alzheimer’s Disease Center
AIDS
acquired immune deficiency syndrome
ApoE4
apolipoprotein E4
BRIN
Biomedical Research Infrastructure Network
BSA
Board of Scientific Advisers
CAM
complementary and alternative medicine
CDC
Centers for Disease Control and Prevention
CFAR
Center for AIDS Research
CJ
Congressional Justification Budget
COBRE
Centers of Biomedical Research Excellence
COSEPUP
Committee on Science, Engineering, and Public Policy
CPEA
Collaborative Programs of Excellence in Autism
CRISP
Computer Retrieval of Information on Scientific Projects
CSR
Center for Scientific Review
DBSB
Demographic and Behavioral Sciences Branch
DHHS
Department of Health and Human Services
DMD
Duchenne muscular dystrophy
DNA
deoxyribonucleic acid
EEHSR
education, epidemiology, and health services research
ERC
Engineering Research Center
EXPORT
Excellence in Partnerships for Community Outreach, Research on Disparities in Health, and Training
FDA
Food and Drug Administration
FICC
federal interagency coordinating committee
FY
fiscal year
GDP
gross domestic product
GPRA
Government Performance and Results Act
HESC
human embryonic stem cell
HIV
human immunodeficiency virus
IBD
inflammatory bowel disease
IdeA
Institutional Development Award
IMPAC
Information for Management, Planning, Analysis, and Coordination
IOM
Institute of Medicine
IRPG
Interactive Research Project Grant
MAMDC
Multipurpose Arthritis and Musculoskeletal Disease Center
MDA
Muscular Dystrophy Association
MD-CARE Act
Muscular Dystrophy Community Assistance, Research and Education Amendments of 2001
MIT
Massachusetts Institute of Technology
NCAB
National Cancer Advisory Board
NCCAM
National Center for Complementary and Alternative Medicine
NCI
National Cancer Institute
NCMHD
National Center on Minority Health and Health Disparities
NCRR
National Center for Research Resources
NEI
National Eye Institute
NHGRI
National Human Genome Research Institute
NHLBI
National Heart, Lung, and Blood Institute
NIA
National Institute on Aging
NIAAA
National Institute on Alcohol Abuse and Alcoholism
NIAID
National Institute of Allergy and Infectious Diseases
NIAMS
National Institute of Arthritis and Musculoskeletal and Skin Diseases
NIBIB
National Institute of Biomedical Imaging and Bioengineering
NICHD
National Institute of Child Health and Human Development
NIDCD
National Institute on Deafness and Other Communication Disorders
NIDCR
National Institute of Dental and Craniofacial Research
NIDDK
National Institute of Diabetes and Digestive and Kidney Diseases
NIDA
National Institute on Drug Abuse
NIEHS
National Institute of Environmental Health Sciences
NIGMS
National Institute of General Medical Sciences
NIH
National Institutes of Health
NIMH
National Institute of Mental Health
NINDS
National Institute of Neurological Disorders and Stroke
NINR
National Institute of Nursing Research
NORD
National Organization for Rare Disorders
NPEBC
National Programs of Excellence in Biomedical Computing
NRC
National Research Council
NSF
National Science Foundation
OBSSR
Office of Behavioral and Social Sciences Research
OMB
Office of Management and Budget
ORD
Office of Rare Diseases
ORWH
Office of Research on Women’s Health
PA
Program Announcement
PAR
PA reviewed in an institute
PAS
PA with set-aside funds
Ph.D.
Doctor of Philosophy
PHS
Public Health Service
P.L.
Public Law
R&D
research and development
RCMI
Research Centers in Minority Institutions Program
RFA
Request for Applications
RFP
Request for Proposals
RIMI
Research Infrastructure in Minority Institutions Program
RNA
ribonucleic acid
RPG
Research Project Grant
SCCOR
Specialized Center of Clinically Oriented Research
SCOR
Specialized Center of Research
SIDS
sudden infant death syndrome
SPORE
Specialized Program of Research Excellence
STAART
Studies to Advance Autism Research and Treatment
STC
Science and Technology Center
STD
sexually transmitted disease
VHA
voluntary health association
Tables, Figures, and Boxes
TABLES
2-1 |
NIH Budget by Mechanism (in millions of current dollars), |
|||
2-2 |
Number of Center Awards by Institute, FY1992-FY2001, |
|||
2-3 |
Funding of Center Awards, by Institute, FY1992-FY2001 (in millions of dollars), |
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2-4 |
NIH Extramural Research Mechanisms, FY2002, |
|||
3-1 |
Origins and Intended Purposes of Recent Center Programs, |
FIGURES
2-1 |
Distribution of research center awards by state, FY2002, |
|||
2-2 |
Center and research project grant (RPG) funding as percentage of NIH budget, FY1992-FY2004, |
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2-3 |
Center funding as a percentage of the institute’s budget, FY2002, |
|||
2-4 |
Number of specialized, core, and comprehensive center awards, FY1992 and FY2001, |
|||
2-5 |
Funding of specialized, core, and comprehensive center awards, FY1992 and FY2001 (in constant dollars), |
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2-6 |
Average size of specialized, core, and comprehensive center awards, FY1992 and FY2001 (in constant dollars), |
BOXES
ES-1 |
Suggested Criteria for Initiation of Center Programs, |
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ES-2 |
Potential Indicators for Evaluating NIH Center Programs, |
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1-1 |
NIH Research Center Grants, |
|||
4-1 |
Suggested Criteria for Initiation of Center Programs, |
|||
5-1 |
Some Previous NIH Evaluations of Specific Center Programs, |
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5-2 |
Potential Indicators for Evaluating NIH Center Programs, |