OPTIMIZING THE NATION’S INVESTMENT IN ACADEMIC RESEARCH INVESTMENT IN ACADEMIC OPTIMIZING THE NATION’S 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 THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This activity was supported at least in part with federal funds from the U.S. Department of Education under Contract No. ED-OPE-14-C-0116 and under Contract No. HHSN26300067 with the National Institutes of Health of the U.S. Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations ex- pressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project, nor does mention of trade names, commer- cial products, or organizations imply endorsement by the United States Government. International Standard Book Number-13: 978-0-309-37948-9 International Standard Book Number-10: 0-309-37948-2 Digital Object Identifier: 10.17226/21824 Additional copies of this report are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334- 3313; http://www.nap.edu. Copyright 2016 by the National Academy of Sciences. All rights reserved. Printed in the United States of America 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. 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 na- tion on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Ralph J. Cicerone is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the na- tion. Members are elected by their peers for extraordinary contributions to engineering. Dr. C. D. Mote, Jr., is president. The National Academy of Medicine (formerly the Institute of Medicine) was estab- lished in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished con- tributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineer- ing, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy deci- sions. The Academies also encourage education and research, recognize outstanding con- tributions to knowledge, and increase public understanding in matters of science, engi- neering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.national-academies.org. 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 v 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 vi 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 vii 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 viii BOARD ON HIGHER EDUCATION AND WORKFORCE Chair WILLIAM