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

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 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 INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation THE NATIONAL ACADEMIES PRESS 500 Fifth Street, 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. 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) Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2004 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.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Adviser to the Nation to Improve Health

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 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. Bruce M. Alberts 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. Wm. A. Wulf 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. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 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

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 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

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 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

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 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.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 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-

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 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

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 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

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 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

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 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

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 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

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 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

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation Contents     EXECUTIVE SUMMARY   1 1   INTRODUCTION   15      Charge to the Committee,   21      Background on NIH,   23      Centers Today,   25      Context of this Study,   26      Methods of the Present IOM Study,   31      Organization of the Report,   32 2   CURRENT USE OF CENTER AWARDS   34      Overall Number, Cost, and Location of NIH Center Awards,   34      Trends by Institute,   36      Trends by Activity Code,   40      Summary of NIH Data on Number and Cost of Center Grants,   44      Comparison of Center Awards to Other Forms of Research Funding,   45      Alternative Research Models,   51      Problems with the Data on Centers,   55 3   INITIATION AND MANAGEMENT OF CENTER PROGRAMS   62      Initiation of Center Programs,   63      Origins,   63      NIH Program Planning Process,   77      Design and Management of Center Programs,   83      Findings and Recommendations,   88

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 4   CRITERIA FOR ESTABLISHING CENTER PROGRAMS   92      Implied Criteria for Center Program Establishment,   93      Findings and Recommendations,   101 5   EVALUATION OF CENTER PROGRAMS   106      Previous Evaluations of Center Programs,   108      Challenges in Evaluation of Center Programs,   110      Lessons from Other Agencies,   113      Possible Methodologies,   117 6   CLOSING COMMENTS AND THOUGHTS ABOUT THE FUTURE   124      The Future of Center Programs,   130     APPENDIXES     A   NIH Center Programs   137 B   Biographical Sketches of Committee and Staff   146 C   NIH Research Award Activity Codes and Their Definitions   159 D   NIH Program Planning Process   164 E   Justifications for Center Programs Used in Recent RFAs and PAs   182 F   Summary of Selected Center Program Evaluations Previously Conducted by NIH   195

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation Tables, Figures, and Boxes TABLES 2-1   NIH Budget by Mechanism (in millions of current dollars),   37 2-2   Number of Center Awards by Institute, FY1992-FY2001,   38 2-3   Funding of Center Awards, by Institute, FY1992-FY2001 (in millions of dollars),   40 2-4   NIH Extramural Research Mechanisms, FY2002,   46 3-1   Origins and Intended Purposes of Recent Center Programs,   66 FIGURES 2-1   Distribution of research center awards by state, FY2002,   35 2-2   Center and research project grant (RPG) funding as percentage of NIH budget, FY1992-FY2004,   36 2-3   Center funding as a percentage of the institute’s budget, FY2002,   39 2-4   Number of specialized, core, and comprehensive center awards, FY1992 and FY2001,   42 2-5   Funding of specialized, core, and comprehensive center awards, FY1992 and FY2001 (in constant dollars),   42 2-6   Average size of specialized, core, and comprehensive center awards, FY1992 and FY2001 (in constant dollars),   44

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation BOXES ES-1   Suggested Criteria for Initiation of Center Programs,   8 ES-2   Potential Indicators for Evaluating NIH Center Programs,   12 1-1   NIH Research Center Grants,   17 4-1   Suggested Criteria for Initiation of Center Programs,   102 5-1   Some Previous NIH Evaluations of Specific Center Programs,   109 5-2   Potential Indicators for Evaluating NIH Center Programs,   119