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EXAMINING CORE ELEMENTS OF INTERNATIONAL RESEARCH COLLABORATION SUMMARY OF A WORKSHOP Susan Sauer Sloan and Tom Arrison, Rapporteurs Planning Committee for the Workshop on Examining Core Elements of International Collaboration Government-University-Industry Research Roundtable Policy and Global Affairs

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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. This study was supported by Contract/Grant No. FA9550-10-1-0041 between the Na- tional Academy of Sciences and the Air Force Office of Scientific Research, the Office of Naval Research, and the U.S. Army International Technology Center–Atlantic. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number-13: 978-0-309-21640-1 International Standard Book Number-10: 0-309-21640-0 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 Copyright 2011 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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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 man- date that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone 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. Charles M. Vest 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. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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PLANNING COMMITTEE FOR THE WORKSHOP ON EXAMINING CORE ELEMENTS OF INTERNATIONAL COLLABORATION JOHN M. CARFORA, (Co-Chair), Associate Vice President for Research Advancement and Compliance, Loyola Marymount University JAMES J. CASEY, JR., (Co-Chair), Executive Director, Office of Grants, Contracts and Industrial Agreements, The University of Texas at San Antonio KUNMO CHUNG, Advisor, Korea Electric Power Corporation, Seoul, Republic of Korea GIULIA DEL BRENNA, Head of Unit, Competitiveness in the Pharmaceuticals Industry and Biotechnology, European Commission, Brussels, Belgium CELIA MERZBACHER, Vice President for Innovative Partnerships, Semiconductor Research Corporation, Research Triangle Park, North Carolina BARBARA B. MITTLEMAN, Director, NIH Program on Public Private Partnerships, National Institutes of Health, Bethesda, Maryland Principal Project Staff SUSAN SAUER SLOAN, Rapporteur and Director, Government- University-Industry Research Roundtable TOM ARRISON, Rapporteur and Senior Staff Officer, Policy and Global Affairs Division DENISE GREENE, Administrative Coordinator, Government- University-Industry Research Roundtable (until July 2011) LAURENA MOSTELLA, Administrative Assistant, Government- University-Industry Research Roundtable CLAUDETTE K. BAYLOR-FLEMING, Administrative Coordinator, Federal Demonstration Partnership CHRIS VERHOFF, Financial Associate, Policy and Global Affairs Division v

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Preface and Acknowledgments Serving as co-chairs of the Planning Committee for the Workshop on Examining Core Elements of International Collaboration, we enjoyed an extraordinary opportunity to work with some of the world’s leading scholars, practitioners and global thinkers. Indeed, every workshop partici- pant played an integral role in making this GUIRR workshop a success. The Planning Committee worked collaboratively over several intense months to identify and secure internationally recognized experts who could come to Washington, D.C. to speak and share insights and experiences from their respective areas of expertise. An active GUIRR working group known as the “I-Group” supported the efforts of the Planning Committee and must be commended. Members of the I-Group include: Norka Ruiz Bravo (National Institutes of Health/ Pan American Health Organization), Susan Butts (The Dow Chemical Company), Brian Fitzgerald (Queensland University of Technology, School of Law – Australia), Wayne Johnson (Independent; formerly Hewlett- Packard Company), Maria Koszalka (Consultant; Northrop Grumman Corporation), Mark Maurice (Air Force Office of Scientific Research), Walter Schaffer (National Institutes of Health), Patrick Schlesinger (University of California, Berkeley), Robin Staffin (U.S. Department of Defense), Sandra Titus (Department of Health and Human Services-Office of Research Integrity), and Larry Weber (National Science Foundation). Planning Committee members were also part of I-Group. vii

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viii PREFACE AND ACKNOWLEDGMENTS Throughout this demanding planning process, we also drew energy from the leadership of Dr. C. D. (Dan) Mote, Jr., President of the Uni- versity of Maryland at College Park, and co-chair of the Government– University–Industry Research Roundtable (GUIRR). Similarly, the workshop could never have been realized without the skills and able assistance of Susan Sauer Sloan, Director of GUIRR, Denise Greene, Administrative Coordinator (GUIRR), Laurena Mostella, Administra- tive Assistant (GUIRR), Claudette K. Baylor-Fleming (FDP) and Chris Verhoff, Financial Associate, Policy and Global Affairs. Similarly, Tom Arrison, a Senior Staff Officer, Policy and Global Affairs, along with Bob Killoren, an I-Group member who had to withdraw for medical reasons, were also terrific resources throughout. We would also like to thank the workshop sponsors: the Air Force Office of Scientific Research, the Office of Naval Research, the U.S. Army International Technology Center–Atlantic, and the National Institutes of Health. This summary has been prepared by the rapporteurs as a factual sum- mary of what occurred at the workshop. The planning committee’s role was limited to planning and convening the workshop. The statements made in this volume do not necessarily represent positions of the planning committee, the workshop participants as a whole, GUIRR, or the National Academies. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with pro- cedures approved by the National Academies’ 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 quality and objectivity. 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 this report: Norman Hebert, Brown University; Ralph Kuncl, University of Rochester; Tembeka Mpako-Ntusi, Cape Peninsula University of Technol- ogy, South Africa; Neela Patel, Abbott Laboratories; and Anne Petersen, University of Michigan. Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the content of the report, nor did they see the final draft before its release. Responsibility

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ix PREFACE AND ACKNOWLEDGMENTS for the final content of this report rests entirely with the rapporteur(s) and the institution. John M. Carfora, Ed.D. James J. Casey, Jr., J.D. Co-Chair, Planning Committee Co-Chair, Planning Committee for the Workshop on Examining for the Workshop on Examining Core Elements of International Core Elements of International Research Collaboration Research Collaboration

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Contents 1 Introduction 1 1.1 Background and Context for the Activity, 3 1.2 Framing the Issues, 4 2 Creating an Environment for Productive International Collaboration 7 2.1 Research Collaboration, U.S. Foreign Policy, and the Global Context, 7 2.2 International Collaboration to Advance National Goals, 11 2.3 Clarifying Commonalities and Differences, 15 2.4 Examples of U.S. International Engagement in Science and Technology, 15 3 Cultural Differences and Nuances 19 3.1 The Impact of Culture on Research Collaborations, 19 3.2 Research Collaborations in a Global Organization, 22 3.3 Perspective of a South African Institution, 23 3.4 Perspective of a Publisher, 24 xi

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xii CONTENTS 4 Ethics 27 4.1 Ethical Issues in International Industry-University Research Collaboration, 27 4.2 Ethical Considerations Affecting Clinical Research Involving Children in the Developing World, 28 4.3 Ethical Considerations in Science and Engineering Practice, 30 4.4 Sample Perspectives from the Breakout Session on Ethics, 33 5 Research Integrity and the Responsible Conduct of Research 35 5.1 The Value of Written Agreements, 35 5.2 The Importance of Understanding Your Collaborator’s Context, 37 5.3 Research Integrity Issues in a Collaborative Project, 38 5.4 Sample Perspectives from the Breakout Session on Research Integrity and the Responsible Conduct of Research, 41 6 Risk Management 43 6.1 International Cooperation on Risk Management, 43 6.2 U.S. Federal Agency Approaches to Risk Management in Research, 44 6.3 Understanding Risk in International Partnerships, 45 6.4 Sample Perspectives from the Breakout Session on Risk Management, 47 7 Intellectual Property 49 7.1 IP Trends from a U.S. University Perspective, 49 7.2 International Cooperation in IP Issues, 51 7.3 Sample Perspectives from the Breakout Session on Intellectual Property, 53 8 Export Controls 57 8.1 The U.S. Policy Context for Export Controls, 57 8.2 University Perspective on Export Controls, 58 8.3 European Perspective on Export Controls, 60 8.4 Industry Perspective on Export Controls, 60 8.5 Sample Perspectives from the Breakout Session on Export Controls, 61

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xiii CONTENTS 9 Legal Issues and Agreements 63 9.1 Collaborative Mechanisms: Pros and Cons of Various Approaches for U.S. Universities, 63 9.2 Risk Areas and Key Contract Provisions in International Collaboration, 66 9.3 International Collaboration and the European Commission’s 7th Framework Program, 73 10 Summary Discussion 75 Appendixes A Workshop Agenda 77 B Workshop Participants 89 C Bios for Planning Committee, Agenda Speakers, and Staff 99

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