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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.
The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy’s 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine.
Support for this project was provided by funds from the National Institutes of Health (Contract No. N01-OD-4-2139). The views presented in this report are those of the Committee on the NIH Research Priority-Setting Process and are not necessarily those of the funding organization.
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Copyright 1998 by the National Academy of Sciences. All rights reserved.
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COMMITTEE ON THE NIH RESEARCH PRIORITY-SETTING PROCESS
LEON E. ROSENBERG* † (Chair), Professor,
Department of Molecular Biology, and Woodwork Wilson School of Public and International Affairs, Princeton University
JOHN ALDERETE, Professor,
Department of Microbiology, University of Texas Health Science Center at San Antonio
KENNETH B. CHANCE, Dean and Professor of Endodontics,
Meharry Medical College School of Dentistry
CARON CHESS, Director,
Center for Environmental Communication, Cook College, Reuters University
JAMES W. CURRAN,* Dean and Professor of Epidemiology,
The Rollin's School of Public Health, Emory University
DAVID CUTLER, Professor,
Department of Economics, Littauer Center, Harvard University
SUE DONALDSON,* Professor and Dean,
School of Nursing and Professor of Physiology, School of Medicine, Johns Hopkins University
BARUCH FISCHHOFF,* University Professor,
Department of Engineering and Public Policy, Department of Social and Decision Sciences, Carnegie Mellon University
SID GILMAN,* William J. Herdman Professor and Chair,
Department of Neurology, University of Michigan
ROBERT L. HILL,* † James B. Duke Professor,
Department of Biochemistry, Duke University Medical Center
RALPH HORWITZ,* † Chair and Professor,
Department of Internal Medicine, Yale University School of Medicine
THOMAS KELLY,† Boury Professor and Chairman,
Department of Molecular Biology and Genetics, Johns Hopkins University
ANNE PETERSEN, Senior Vice President,
Programs, W.K. Kellogg Foundation
SUSAN C. SCRIMSHAW,* Dean and Professor of Community Health Sciences,
School of Public Health, University of Illinois at Chicago
ROGER UNGER,† Professor of Internal Medicine,
Center for Diabetes Research, University of Texas Southwestern Medical Center
MYRL WEINBERG, President,
National Health Council
LINDA S. WILSON,* President,
Radcliffe College
ADAM YARMOLINSKY,* Regents Professor of Public Policy
in the University of Maryland System
Committee Liaisons
HARVEY R. COLTEN,* Dean and Vice President for Medical Affairs,
Northwestern University School of Medicine
JOSEPH T. COYLE,* Eben S. Draper Professor of Psychiatry and Neuroscience Chair,
Consolidated Department of Psychiatry, Harvard Medical School
JOHN D. STOBO,* President,
University of Texas Medical Branch
Study Staff
ANDREW POPE, Director,
Health Sciences Policy Program
GEOFFREY FRENCH, Research Associate
Consultants
KATHI HANNA
MICHAEL McGEARY
Copy Editor
MICHAEL HAYES
Section Staff
CHARLES H. EVANS, JR., Head,
Health Sciences Section
ROBERT COOK-DEEGAN, Director,
National Cancer Policy Board
LINDA DEPUGH, Administrative Assistant
JAMAINE TINKER, Financial Associate
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 Institute of Medicine in making the 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 content of the final report is the responsibility of the Institute of Medicine and the study committee and not the responsibility of the reviewers. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. The committee wishes to thank the following individuals, who are neither officials nor employees of the Institute of Medicine, for their participation in the review of this report:
JOHN ABELSON,† California Institute of Technology
DONALD D. BROWN,† Carnegie Institution of Washington
MICHAEL S. BROWN,* † University of Texas Southwestern Medical Center
JAMES EBERT,* † Marine Biological Laboratory, Woods Hole
ROBIN ELLIOTT, Parkinson's Disease Foundation
HARMON J. EYRE, American Cancer Society
MARC W. KIRSCHNER,† Harvard Medical School
S. ROBERT LEVINE, Juvenile Diabetes Foundation International
ROBERT LEVY,* American Home Products Corp.
MARSHALL LICHTMAN, Leukemia Society of America
DOROTHY RICE,* University of California, San Francisco
PAUL ROGERS,* Hogan & Hartson
CHARLES SANDERS,* Glaxo, Inc.
HOWARD K. SCHACHMAN,† University of California, Berkeley
MORTON N. SWARTZ,* Massachusetts General Hospital
SAMUEL THIER,* Partners Health Care System, Inc.
LOWELL WEICKER, University of Virginia
MYRON WEISFELDT,* Columbia University and past president, American Heart Association
While the individuals listed above have provided many constructive comments and suggestions, responsibility for the final content of this report rests solely with the authoring committee and the Institute of Medicine.
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Preface
The United States is preeminent in medical research. Since World War II this country has fashioned a medical research system—with government, academia, and industry at its core—that is a source of great national pride and the envy of the world. The federal government is the single largest sponsor of this research, committing more than $16 billion of public funds in the current fiscal year (1998). Of this total, the vast majority—$13.6 billion—is appropriated to the National Institutes of Health (NIH). Given the size of this public investment and the likelihood that it will be increased significantly in the immediate future and given the mission of NIH—"to uncover new knowledge that will lead to better health for everyone"—it should come as no surprise that there is intense interest in how NIH sets its priorities, that is, how it allocates its sizable budget. How could it be otherwise? Every one of us wants to live a long and healthy life. Every sick person—woman, man, or child—wants researchers to find new ways to make him or her well or to improve the quality of life for those who are disabled, regardless of whether the ailment is common or rare, acute or chronic, life-threatening or self-limiting.
We must acknowledge that setting priorities at NIH is an awesome task. Not only must the leadership of NIH answer to the executive branch and to the U.S. Congress, it must work with all of its constituencies—scientists, health care providers, patients, voluntary health groups and patient advocates, and industry executives—before making its fateful decisions. The quality and quantity of excellent science that it has supported, the widespread respect for it in and out of government, and its favored position in the annual congressional appropriations process signify that, over time, NIH must be doing many things right. Yet, we must also acknowledge that the recent request from Congress that the Institute
of Medicine conduct an independent assessment of research priority setting at NIH and that the evaluation be completed within 6 months signifies, just as clearly, that there is at least a perception that some things are not right. It is apparent that some segments of the public, in general, and its representatives in Congress, in particular, are dissatisfied enough to ask for ways to improve the current process.
This committee was charged with examining four issues related to setting priorities at NIH: allocation criteria, the decision-making process, mechanisms for public input, and the impact of congressional directives. Despite the nearly impossible constraints imposed by the study's time line, we took this broad charge seriously. To grasp the approach that NIH currently uses, we heard in person from the director of NIH, most of the institute directors, and many of the directors of offices housed within the director's office. To understand the tensions surrounding public input, we held a full-day public meeting at which we received verbal and written testimony from patients, advocacy and interest groups, foundations, and professional societies. To understand Congress's rationale for requesting the study, we interviewed legislative aides from key offices. To expand our collective knowledge base, we reviewed many current and past publications relevant to our charge.
As we listened and deliberated, several things became clear to me. First, the country has extraordinarily high expectations of NIH. To some, NIH has become a virtual surrogate for the U.S. Department of Health and Human Services, being encouraged to expand its purview well beyond research. We heard from no one who wants to dismantle NIH; we heard from many who wanted their "cause" to be embraced by NIH; we heard from all that NIH must excel at everything it does because what it does is so important to the hopes and aspirations of people everywhere.
Second, there is a sense that NIH has evolved mechanisms for judging scientific opportunity and merit that surpass its capabilities for assessing and being influenced by public health needs. Estimating research spending by disease and developing metrics for spending according to disease burden (e.g., incidence, mortality, disability, and cost) must be done more systematically and more thoroughly than they are currently done because not doing so leads some to conclude, incorrectly I believe, that NIH cares more about curiosity than cure, more about fundamental science than clinical application.
Third, there is frustration on the part of some groups about not being listened to and heard by NIH. We heard repeatedly that some institutes, and particularly the Office of the Director, lack mechanisms for orderly, regular public input and outreach. As the authority of the director over priority setting has increased, the demand to influence that office has become louder.
Fourth, there is a lack of understanding about how NIH priority setting "works." NIH has not crafted simple communications that make its priority-setting processes as transparent as possible to its many publics. NIH has not developed
sufficient communications tools to satisfy people that allocation decisions are made on the basis of equity and justice, as well as scientific opportunity.
Each of these observations has been converted to recommendations that reflect the committee's consensus. Our recommendations address each of the committee's charges, but there is a single theme that runs through them. It is that NIH must revamp its approach to public input and outreach—at every level—without delay. This will strengthen the priority-setting process in many ways. It will underscore that openness is as important to the process as such other valued qualities as expertise, innovation, and objectivity. It will provide NIH leaders more ways to demonstrate that they share the public's view that NIH exists to improve health through research. It will enhance the public's understanding of the complexities of decision making at NIH. Finally, it will give Congress additional confidence that it can delegate priority setting to NIH leadership knowing that a broader range of views will be sought and welcomed before decisions are made.
I would like to thank the many people who have made it possible for this report to be completed on schedule: first and foremost, the members of the committee who met and overcame the many challenges of our difficult task with a commendable blend of experience, energy, collegiality, and wisdom; second, the staff of the Institute of Medicine, without whom we would have foundered; third, the leadership of NIH, who educated us about this agency; and fourth, and perhaps most important, the public, who reminded us of the purpose of NIH and of the democratic ideals that must permeate effective stewardship of a federal agency.
Leon E. Rosenberg, M.D.
Chair
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Acronyms
ACD
Advisory Committee to the Director
DHHS
U.S. Department of Health and Human Services
FIC
John E. Fogarty International Center
FY
fiscal year
IOM
Institute of Medicine
NCI
National Cancer Institute, NIH
NCRR
National Center for Research Resources, NIH
NEI
National Eye Institute, NIH
NHGRI
National Human Genome Research Institute, NIH
NHLBI
National Heart, Lung, and Blood Institute, NIH
NIA
National Institute on Aging, NIH
NIAAA
National Institute on Alcohol Abuse and Alcoholism, NIH
NIAID
National Institute of Allergy and Infectious Diseases, NIH
NIAMS
National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH
NICHD
National Institute of Child Health and Human Development, NIH
NIDA
National Institute on Drug Abuse, NIH
NIDCD
National Institute on Deafness and Other Communication Disorders, NIH
NIDDK
National Institute of Diabetes and Digestive and Kidney Diseases, NIH
NIDR
National Institute of Dental Research, NIH
NIEHS
National Institute of Environmental Health Sciences, NIH
NIGMS
National Institute of General Medical Sciences, NIH
NIH
National Institutes of Health
NIMH
National Institute of Mental Health, NIH
NINDS
National Institute of Neurological Disorders and Stroke, NIH
NINR
National Institute of Nursing Research, NIH
NLM
National Library of Medicine, NIH
NSF
National Science Foundation
OMB
Office of Management and Budget
PHS
Public Health Service
R&D
research and development
RFA
request for application
RPG
research project grant
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