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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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OPTIMIZING THE
NATION’S INVESTMENT
IN ACADEMIC RESEARCH

A New Regulatory Framework for the 21st Century

Committee on Federal Research Regulations and
Reporting Requirements: A New Framework
for Research Universities in the 21st Century

Committee on Science, Technology, and Law

Board on Higher Education and Workforce

Policy and Global Affairs

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THE NATIONAL ACADEMIES PRESS

Washington, DC

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
×

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Ralph J. Cicerone is president.

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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COMMITTEE ON FEDERAL RESEARCH REGULATIONS AND REPORTING REQUIREMENTS: A NEW FRAMEWORK FOR RESEARCH UNIVERSITIES IN THE 21ST CENTURY

Chair

LARRY R. FAULKNER, President Emeritus, The University of Texas at Austin

Vice Chair

HARRIET RABB, Vice President and General Counsel, The Rockefeller University

Members

ILESANMI ADESIDA (NAE), Vice Chancellor for Academic Affairs and Provost, University of Illinois at Urbana-Champaign

ANN ARVIN (NAM), Lucile Salter Packard Professor of Pediatrics and Professor of Microbiology and Immunology, Stanford University School of Medicine and Vice Provost and Dean of Research, Stanford University

BARBARA E. BIERER, Professor of Medicine, Harvard Medical School and Brigham and Women’s Hospital and Faculty Co-chair, Multi-Regional Clinical Trials Center, Harvard University (Harvard MRCT)

JONATHAN D. BREUL, Adjunct Professor, McCourt School of Public Policy, Georgetown University

CLAUDE R. CANIZARES (NAS), Bruno Rossi Professor of Physics, Massachusetts Institute of Technology

ARTURO CASADEVALL (NAM), Professor and Chair, W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins University Bloomberg School of Public Health

JONATHAN R. COLE, John Mitchell Mason Professor of the University and Provost and Dean of Faculties (1989–2003), Columbia University

LEE ELLIS, Professor of Surgical Oncology and Molecular and Cellular Oncology and the William C. Liedtke, Jr. Chair in Cancer Research, The University of Texas MD Anderson Cancer Center

GEOFFREY E. GRANT, President, Research Advocates

JOSEPH R. HAYWOOD, Assistant Vice President for Regulatory Affairs and Professor of Pharmacology and Toxicology, Michigan State University

STEVEN JOFFE, Emanuel and Robert Hart Associate Professor of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine

DAVID KORN (NAM), Professor of Pathology, Massachusetts General Hospital and Harvard Medical School

CHARLES F. LOUIS, Professor of Cell Biology and Neuroscience Emeritus and former Vice Chancellor for Research, University of California, Riverside

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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DAVID W. ROBINSON, Professor and Executive Vice Provost, Oregon Health and Science University

THOMAS J. ROSOL, Professor, Veterinary Biosciences; Senior Advisor, Life Sciences, University Office of Technology Commercialization and Knowledge Transfer; and Special Assistant to the Vice President for Research, The Ohio State University

STUART SHAPIRO, Associate Professor and Director, Public Policy Program, Edward J. Bloustein School of Planning and Public Policy, Rutgers University

Staff

ANNE-MARIE MAZZA, Study Director and Senior Director, Committee on Science, Technology, and Law

THOMAS RUDIN, Director, Board on Higher Education and Workforce

ELIZABETH O’HARE, Program Officer, Board on Higher Education and Workforce (until January 2016)

STEVEN KENDALL, Program Officer, Committee on Science, Technology, and Law

NINA BOSTON, Senior Project Assistant, Board on Higher Education and Workforce (until September 2015)

KAROLINA KONARZEWSKA, Program Coordinator, Committee on Science, Technology, and Law

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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COMMITTEE ON SCIENCE, TECHNOLOGY, AND LAW

Co-Chairs

DAVID BALTIMORE (NAS/NAM), President Emeritus and Robert Andrews Millikan Professor of Biology, California Institute of Technology

DAVID S. TATEL, Judge, U.S. Court of Appeals for the District of Columbia Circuit

Members

THOMAS D. ALBRIGHT (NAS), Professor and Director, Vision Center Laboratory and Conrad T. Prebys Chair in Vision Research, Salk Institute for Biological Studies

ANN ARVIN (NAM), Lucile Salter Packard Professor of Pediatrics and Professor of Microbiology and Immunology, Stanford University School of Medicine and Vice Provost and Dean of Research, Stanford University

BARBARA E. BIERER, Professor of Medicine, Harvard Medical School and Brigham and Women’s Hospital and Faculty Co-chair, Multi-Regional Clinical Trials Center, Harvard University (Harvard MRCT)

CLAUDE R. CANIZARES (NAS), Bruno Rossi Professor of Physics, Massachusetts Institute of Technology

ARTURO CASADEVALL (NAM), Professor and Chair, W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins University Bloomberg School of Public Health

JOE S. CECIL, Project Director, Program on Scientific and Technical Evidence, Division of Research, Federal Judicial Center

R. ALTA CHARO (NAM), Warren P. Knowles Professor of Law and Bioethics, University of Wisconsin at Madison

HARRY T. EDWARDS, Judge, U.S. Court of Appeals for the District of Columbia Circuit

DREW ENDY, Associate Professor, Bioengineering, Stanford University and President, The BioBricks Foundation

MARCUS FELDMAN (NAS), Burnet C. and Mildred Wohlford Professor of Biological Sciences, Stanford University

JEREMY FOGEL, Director, The Federal Judicial Center

HENRY T. GREELY, Deane F. and Kate Edelman Johnson Professor of Law and Professor, by courtesy, of Genetics, Stanford University

MICHAEL GREENBERGER, Law School Professor and Director, Center for Health and Homeland Security, University of Maryland

MICHAEL IMPERIALE, Arthur F. Thurnau Professor of Microbiology and Immunology, University of Michigan

GREG KISOR, Chief Technologist, Intellectual Ventures

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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ROBERT S. LANGER (NAS/NAE/NAM), David H. Koch Institute Professor, Massachusetts Institute of Technology

GOODWIN LIU, Associate Justice, California Supreme Court

JENNIFER MNOOKIN, Dean and David G. Price and Dallas P. Price Professor of Law, University of California, Los Angeles School of Law

R. GREGORY MORGAN, Senior Vice President and Secretary of the Corporation, Massachusetts Institute of Technology

HARRIET RABB, Vice President and General Counsel, The Rockefeller University

DAVID RELMAN (NAM), Thomas C. and Joan M. Merigan Professor, Departments of Medicine and of Microbiology and Immunology, Stanford University and Chief, Infectious Disease Section, VA Palo Alto Health Care System

MARTINE A. ROTHBLATT, Chairman and Chief Executive Officer, United Therapeutics

DAVID VLADECK, Professor and Co-Director, Institute for Public Representation, Georgetown Law School

Staff

ANNE-MARIE MAZZA, Senior Director

STEVEN KENDALL, Program Officer

KAROLINA KONARZEWSKA, Program Coordinator

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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BOARD ON HIGHER EDUCATION AND WORKFORCE

Chair

WILLIAM E. KIRWAN, Chancellor Emeritus, University System of Maryland and Regents Professor on Mathematics, University of Maryland

Members

F. KING ALEXANDER, President and Chancellor, Louisiana State University (until December 2015)

LAWRENCE D. BOBO (NAS), W.E.B. Du Bois Professor of the Social Sciences, Harvard University

JOHN SEELY BROWN, Visiting Scholar, University of Southern California and former Chief Scientist at the Xerox Corporation and Director of its Palo Alto Research Center (until December 2015)

ANGELA BYARS-WINSTON, Associate Professor of Medicine, University of Wisconsin

JARED COHON (NAE), President Emeritus and University Professor of Civil and Environmental Engineering and Engineering and Public Policy, Carnegie Mellon University (until December 2015)

CARLOS CASTILLO-CHAVEZ, Regents and Joaquin Bustoz Professor of Mathematical Biology in the School of Human Evolution and Social Change and the School of Sustainability; and Director, Simon A Levin Mathematical, Computational and Modeling Sciences Center, Arizona State University (until December 2015)

RITA COLWELL (NAS), Distinguished University Professor, University of Maryland College Park and The Johns Hopkins University Bloomberg School of Public Health (until December 2015)

JAMIE L. CURTIS-FISK, Scientist and STEM Education Program Leader, The Dow Chemical Company

APRILLE ERICSSON, Aerospace Engineer, NASA Goddard Space Flight Center

RICHARD FREEMAN, Herbert Ascherman Professor of Economics, Harvard University

PAUL J. LEBLANC, President, Southern New Hampshire University

EARL LEWIS, President, Andrew W. Mellon Foundation (until December 2015)

SALLY MASON, President Emerita, University of Iowa

FRANCISCO RODRIGUEZ, Chancellor, Los Angeles Community College District

SUBHASH SINGHAL (NAE), Battelle Fellow Emeritus, Pacific Northwest National Laboratory

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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KUMBLE R. SUBBASWAMY, Chancellor, University of Massachusetts Amherst

SHELLEY WESTMAN, Vice President of Operations and Strategic Integration Initiatives, IBM Security

MARY WOOLLEY (NAM), President and Chief Operating Officer, Research! America

Staff

THOMAS RUDIN, Director

ASHLEY BEAR, Program Officer

ELIZABETH O’HARE, Program Officer (until January 2016)

NINA BOSTON, Senior Program Assistant (until September 2015)

IRENE NGUN, Research Associate

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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Preface

The United States maintains a research enterprise that is world renowned for its productivity, innovation, and dynamism. Forged during World War II, a collaboration between the federal government as funder and academic research institutions as hubs of discovery and invention created an enduring partnership. Trust and respectful gratitude bound the parties together in generating new discoveries and educating and training new scientists.

That partnership exists to this day, though recent decades have witnessed stress on the bond between the government and academic research institutions. The institutions, their faculties, and their staffs are now committing unprecedented time and resources to meeting a flow of new regulations and process requirements generated by the federal funding agencies. Though well-intended and undoubtedly appropriate, federal oversight and its accompanying burdens raise significant questions about whether the nation is optimizing its investment in our extraordinary research enterprise. This is the time to address and fully restore the foundation of our research enterprise partnership.

At the request of the United States Congress, the National Academies of Sciences, Engineering, and Medicine convened a Committee on Federal Research Regulations and Reporting Requirements and tasked the committee with creating A New Framework for the 21st Century. Committee members included university officers and administrators, prior government personnel, investigators, clinicians, ethicists, and public policy experts. The committee reviewed and analyzed previous reports and studies and heard presentations from representatives of federal research funding agencies, from university personnel whose institutions are the beneficiaries and stewards of that funding, and from organizations that work in this field. Having appreciated and considered the views we heard, the committee prepared this report of our findings and recommendations for rebuilding the nation’s research enterprise partnership.

Unlike most National Academies’ reports, this report has two parts. This is a consequence of a congressional request, made shortly after the committee had begun its work, that the committee issue an expedited report. In response, the committee in September 2015 issued Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century: Part 1. That report focused on those regulatory issues identified as of most pressing concern to the research community and upon which Congress might take immediate action. It forms the first part of this volume. Part 1 was issued with the

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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understanding that other significant issues would be addressed in a second report. Part 2 of this volume represents the completion of this process.

In Part 1, the committee addresses regulations along the continuum of research from proposal preparation and the conduct of research through to the final accounting of research funds and achievements. We offer concrete recommendations for Congress, federal agencies, inspectors general, and universities. The committee also articulates a new regulatory framework that includes the establishment of a Research Policy Board and the creation of a new position in the White House Office of Science and Technology Policy—Associate Director, Academic Research Enterprise. Further, the committee offers a set of operational principles to undergird the new regulatory framework.

The overarching message of Part 1 is that the continuing expansion of federal regulations and requirements is diminishing the effectiveness of the U.S. research enterprise and lowering the return on the federal investment in basic and applied research by diverting investigators’ time and institutional resources away from research and toward administrative and compliance matters. A new framework, the committee argues, is needed to ensure that regulatory requirements are justified, proportional to the problems being addressed, and harmonized across funding agencies so as to create a more effective and efficient partnership between funding agencies and research institutions.

In Part 2, the committee discusses the impact of federal regulations on university technology transfer, human subjects research, select agent research, and access to and use of technology (export controls). The committee believes that a consideration of regulations governing human subjects research is critically important. As Part 1 of the committee’s report was going to press, the Department of Health and Human Services issued a Notice of Proposed Rulemaking (NPRM) that seeks to revise the Common Rule governing human subjects research. The committee made initial comments on human subjects research regulations in Part 1, but it postponed additional analysis and recommendations so as to be able to incorporate a consideration of and response to the expected NPRM. It provides this analysis and additional recommendations in Part 2, Chapter 9.

In Part 2, the committee also illustrates how the new regulatory framework articulated in Part 1 might be operationalized in the future. Appendix B contains the committee’s recommendations from both parts of its report.

Having benefited from the opportunity to brief numerous groups on Part 1 of our report, the committee has become even more convinced that the nation is far from optimizing its investment in academic research. We continue to believe that the only clear path to strengthening the U.S. research enterprise and preparing it for continued leadership in the 21st century is through the creation of a Research Policy Board as an analytical, anticipatory, and coordinating forum on research regulatory policy. We continue to believe further that the health of the academic research enterprise requires creation of a permanent position within the White

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House Office of Science Technology Policy established for the primary purpose of maintaining strong links to the research community, the Office of Management and Budget, federal research agencies, inspectors general, and the United States Congress.

The members of the committee look forward to substantive consideration of the recommendations offered in both parts of our report.

We are grateful beyond measure to the committee for their tireless efforts, to the staff of the committee: Anne-Marie Mazza, Thomas Rudin, Steven Kendall, Elizabeth O’Hare, Nina Boston, and Karolina Konarzewska, for their dedication and superb work on this project, and to Rebecca Morgan of the National Academies’ Research Center, for her invaluable technical assistance.

Larry R. Faulkner, Chair

Harriet Rabb, Vice Chair

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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Acknowledgments

ACKNOWLEDGMENT OF PRESENTERS

The committee gratefully acknowledges the contributions of the following individuals:

Ann Bartuska, U.S. Department of Agriculture; Steven Beckwith, University of California; Laura Beskow, Duke University; Arthur I. Bienenstock, Stanford University; Linda Blevins, U.S. Department of Energy; Jeffrey R. Botkin, University of Utah; Richard Buckius, National Science Foundation; Thomas Burke, U.S. Environmental Protection Agency; Thomas Christian, Air Force Office of Scientific Research; John Cornwell, Rice University; Ellen Wright Clayton, Vanderbilt University; Gerald Epstein, U.S. Department of Homeland Security; Barbara Evans, University of Houston Law School; Jean Feldman, National Science Foundation; Jilda Garton, Georgia Institute of Technology; Howard Gobstein, Association of Public and Land-Grant Universities; Stephen J. Heinig, Association of American Medical Colleges; John Hemminger, University of California, Irvine; Cynthia Hope, The University of Alabama and Federal Demonstration Partnership; David Ivey, University of Texas, Austin; Walter Jones, Office of Naval Research; Cindy Kiel, University of California, Davis; William Kirwan, American Council on Education Task Force on Federal Regulation of Higher Education; Sarah Kiskaddon, Association for the Accreditation of Human Research Protection Programs; Paul Klotman, Baylor College of Medicine; Kei Koizumi, White House Office of Science and Technology Policy; Tejus Kothari, The Boston Consulting Group; Neal Lane, Rice University; James W. Le Duc, Galveston National Laboratory, University of Texas Medical Branch; David Leebron, Rice University; Allison Lerner, National Science Foundation; Mary Lidstrom, University of Washington; Randy Livingston, Stanford University; Patrick Mason, U.S. Department of Defense; Valerie McDevitt, University of South Florida; Amy McGuire, Baylor College of Medicine; Christian E. Newcomer, Association for the Assessment and Accreditation of Laboratory Animal Care; Lisa Nichols, Council on Governmental Relations; Kimberly Orr, U.S. Department of Commerce; Heather H. Pierce, Association of American Medical Colleges; Sally J. Rockey, National Institutes of Health; Marty Rubenstein, National Science Foundation; Patrick Schlesinger, University of California, Berkeley; Yvette R. Seger, Federation of American Societies for Experimental Biology; Richard Seligman, California Institute of Technology; Howard Shelanski, White House Office of Information and Regulatory Affairs; Tobin L. Smith, Association of American Universities; Robin Staffin, U.S. Department of Defense; Wendy Streitz, University of California Office of the President; Jamienne S. Studley, U.S.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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Department of Education; Brett Sweet, Vanderbilt University; Julie K. Taitsman, U.S. Department of Health and Human Services; Gil Tran, White House Office of Management and Budget; Frances Visco, National Brest Cancer Coalition; Daniel Werfel, The Boston Consulting Group; Keith Yamamoto, University of California, San Francisco; and Michael Zarkin, U.S. Department of Energy.

Finally, we would like to express our sincere thanks to the staff of the University of California, San Francisco and Rice University for facilitating our regional meetings at their campuses.

ACKNOWLEDGMENT OF 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 Academies of Sciences, Engineering, and Medicine’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 Part 1 of this report: Bonnie Beaver, Texas A&M University; Arthur Bienenstock, Stanford University; Charles Bowsher, former Comptroller General of the United States; Susan Fiske, Princeton University; John Graham, Indiana University; C.K. Gunsalus, University of Illinois at Urbana-Champaign; Sally Katzen, George Mason University; Michael Lairmore, University of California, Davis; Nancy Lane, University of California, Davis; Mary Lidstrom, University of Washington; Ken Mead, former Inspector General, U.S. Department of Transportation; Bradley Moore, University of California, Berkeley; George Stancel, University of Texas, Houston; and David Wynes, Emory University

We wish to thank the following individuals for their review of Part 2 of this report: Arthur Bienenstock, Stanford University; Alexander Capron, University of Southern California; Susan Fiske, Princeton University; Joe Gray, Oregon Health and Science University; C.K. Gunsalus, University of Illinois at Urban-Champaign; David Ivey, University of Texas, Austin; Katherine Ku, Stanford University; Nancy Lane, University of California, Davis; James LeDuc, Galveston National Laboratory, University of Texas Medical Branch; Mary Lidstrom, University of Washington; Theresa Koehler, University of Texas; Alan Morrison, The George Washington University; Heather Pierce, Association of American Medical Colleges; and David Wynes, Emory University.

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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 Charles Phelps, University of Rochester and Gordon England, V1 Analytical Solutions. Appointed by the Academies, 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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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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Page xxii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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Research universities are critical contributors to our national research enterprise. They are the principal source of a world-class labor force and fundamental discoveries that enhance our lives and the lives of others around the world. These institutions help to create an educated citizenry capable of making informed and crucial choices as participants in a democratic society. However many are concerned that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research.

Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. This review is critical to strengthen the partnership between the federal government and research institutions, to maximize the creation of new knowledge and products, to provide for the effective training and education of the next generation of scholars and workers, and to optimize the return on the federal investment in research for the benefit of the American people.

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