Vo l u m e XXXVIII, Nu m b e r 2 Fa l l 2007 Cover Photo: This edition of the Journal of Research Administration is published as SRA International continues to celebrate its 40th anniversary. In this edition, the Journal celebrates the industry, craft and technology of the profession of research administration and its allied disciplines. Like the master woodworker carving instruments that will pluck at the raw center of human existence, the international service of research administrators is a masterful craft that makes possible the ways in which research touches the very core of what it means to be human.

The cover photo is used with permission from Fotosearch. Editorial Staff Editor Edward F. Gabriele, MDiv, DMin

Senior Associate Editor Bruce Steinert, PhD, CCRA

Associate Editors: Timothy Atkinson, EdD Frances Chandler, MA, PhD (cand) Bruce Elliott, PhD Lynda Hardy, PhD Cindy Kiel, JD David Langley, PhD Phillip E. Myers, PhD Mildred Ofosu, PhD Pam Vargas, MBA

Manuscript Editors Board Carol Fedor, ND, RN, CCRC John Gillon, JD, MPH Chair: Stephanie Hafner, MA Mary Adams, MTS Jim Hanlon, CHRP Members: Karen Hansen Paula Bistak, RN, MS, CIP Rene Hearns, MPA, CRA Douglas Carroll, MRE, MLIS Daniel Herr, MS, MD, FCCM Marie Cooper, IHM, EdD Elizabeth Holmes, PhD Nathalie Coté, PhD Martin Jamieson, MBA, ACMA John Gillon, JD, MPH Greg Koski, PhD, MD, CPI Darlene Gilson Barbara LoDico, CIP Anita Hartmann, PhD, CIP, CRA Michael McCallister, PhD Frances Jeffries, PhD Jessica Moise Elsa Nadler, EdD Sharon McCarl, MBA, CRA Michael Owen, PhD Sandra Nordahl, CRA Debra Schaller-Demers, MSOM Jennifer Morgan Shambrook, MHA Jackie Solberg, CRA J. Michael Slocum, JD Marianne Ward, CRA Timothy Sparklin, MSW, CIM Daniel Vasgird, PhD, CIP Journal Review Board Paul Waugaman, MPA Chair: “Voice of Experience” Authors Joseph Cosico, MA, CCRC, CRA Elliott Kulakowski, PhD 2007 Coordinator and Senior Writer Members: Lynne Chronister, MPA Rosemary Biscardi, MBA, CCRP Victoria Molfese, PhD Gary Chadwick, PharmD, MPH, CIP J. Michael Slocum, JD Jeffrey Cohen, PhD, CIP Cliff Studman, PhD Philip Cola, MA Paul Waugaman, MPA Sandra Crocker, MBA Erica Ellington, CRA Publishing Coordinator Marianne Elliott, MS, CIP Valerie J. Ducker

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 1 The Journal of Research Administration Journal Correspondence Manuscripts or letters to the editor should be submitted to the editor. Submission of a manuscript is considered to be a representation that it is not copyrighted, previously published, or concurrently under consideration for publishing in print or electronic form. Consult the journal web page (www.srainternational.org/journal) for specific information for authors, templates, and new material. The preferred communication route is through Email at [email protected] attention editor Subscriptions Subscriptions: $100 per year in the United States, Canada, and Mexico; $125 per year international.

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Subscriptions for SRA Members are included as part of an individual’s annual dues. All subscriptions are for two yearly editions. Send change-of-address notices (together with your address label) and all other correspondence regarding subscriptions and purchase of back issues to Society of Research Administrators International, Executive Office, 1901 North Moore Street, Suite 1004, Arlington, VA 22209 USA. Phone: +1-703-741-0140. Periodicals are postage paid at Arlington, VA and at an additional mailing office.

Copyright © 2007 by the Society of Research Administrators International (SRA).

All material subject to this copyright may be photocopied for limited non-commercial educational purposes with the written permission of the SRA and with appropriate credit. Opinions expressed in this Journal represent the opinions of the authors and do not reflect official policy of either the SRA or the author’s affiliated institution unless so noted in the author’s note portion of the specific article. Papers prepared by employees of the U.S. government as part of their official duties may not be copyrighted, but the Journal format is copyrighted and requires written permission of the Society of Research Administrators International, as outlined above. Copying for general distribution, resale, or other purposes may be authorized only with specific written permission from the Society of Research Administrators International. Requests for such permission must be made in writing to the Society of Research Administrators International, 1901 North Moore Street, Suite 1004, Arlington, Virginia 22209 USA or through Email at [email protected].

Officers Of The Society Of Research Administrators International President Philip Spina President - Elect Pamela Miller Past President Dorothy Yates Treasurer Frank Davis Secretary J. Terence Manns The Journal of Research Administration is published semi-annually by the Society of Research Administrators International, Arlington, Virginia 22209 USA. Founded in 1967, the Society of Research Administrators International is dedicated to the education and the professional development of research administrators and to enhance public understanding of research and its administration. Representing all disciplines and sectors in research administration, it serves as the international society to promote quality and innovation in research administration. USPS No. 008245. ISSN No. 1539-1590.

2 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Volume XXXVIII, Number 2

1. From the Editor’s Desk...... 5 Edward Gabriele, DMin

2. Contributors ...... 7

3. Articles Research Administration as a Living System...... 14 Sharon Stewart Cole, PhD

Institutional Challenges of Interdisciplinary Research Centers...... 28 Sherry Glied, PhD, Suzanne Bakken, DNSc, Allan Formicola, DDS, Cristine Gebbie, DrPH, Elaine L Larson, PhD

Why Academics Have a Hard Time Writing Good Grant Proposals ...... 37 Robert Porter, PhD

Internal Grant Competitions: A New Opportunity for Research Officers to Build Institutional Funding Portfolios ...... 44 Rengarajan V. Balaji, MS, MBA, CRA, Christine Knisely, MA, Jack Blazyk, PhD

Application of Standard Project Management Tools to Research – A Case Study from a Multi-national Clinical Trial...... 51 Peter Gist, PhD, David Langley, PhD

Customer-Supplier Roles and Relationships in the Management of Research Projects...... 59 Ian M. Carter, PhD

Implementing Ethics Policies in Developing Countries: Ploughing On Parched Ground?...... 67 Professor Isaac N. Mazonde, José Jackson-Malete, PhD, Jeremy Sugarman, MD, MPH, MA

Administration of an Innovative Program of International Cooperation: Success Across the Pond...... 78 Vincent S. Gallicchio, PhD, Dp (hon)

Book Review: Managing Scientists: Leadership Strategies in Scientific Research (2004) Alice Sapienza, Wiley-Liss, Inc., 246 pp...... 86 Frances Chandler, MA, PhD (cand)

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 3 Law Review: Recent Developments in Research Law...... 90 J. Michael Slocum, JD Eric Guttag, JD J. Mark Waxman, JD Jill Williamson, JD

Voice of Experience International Research Infrastructure and The Impact of Export Control Regulations...... 107 Elliott C. Kulakowski, PhD Lynne Chronister, MPA Victoria Molfese, PhD Michael Slocum, JD Cliff Studman, PhD Paul Waugaman, MPA

4 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration From the Editor’s Desk

Many times the most ordinary things present This edition of the us with the most extraordinary moments. Journal of Research That truth came home to me dynamically Administration occurs a short time ago. I was watching a as we draw to a close woodworker install hardwood floors in a the 40th anniversary home being remodeled. Part of the project of the Society of was the rebuilding of the main stairway. Research Administrators With sleeves rolled up for a long and steady International. It strikes stairway task, he singled out each piece me as important that this of solid oak and carefully reviewed every edition of the Journal line. Seasoned and calloused hands gently celebrates the craft, but definitely explored each inch of wood the technology and Dr. Edward Gabriele as if getting to know it personally. As he the industry that is our sawed and carved, it seemed nothing could profession. Our profession is the sometimes distract him. Carefully and with undoubted awkward conjoining of inspiration and knowledge, he cut each piece with exquisite perspiration. We sense the technology that is precision. He sanded over and over again, ours sometimes with that same bead of sweat and then stained each step with a red-gold that prisms the glint behind our eyes when we mastery as if burning the color into each have brought a tedious contract to fruition, piece. He cured each step and carefully or completed a critical proposal review, or fit each precisely into place. As wood is finalized a patent application. Regardless of one of my favorite media, I could not pull the specific task, our profession is itself a hard myself away but found myself drawn more hewn art that requires the masterful care of and more into the mastery that was taking building, and fitting, and staining, and curing. It place. As he began to put the finishing is a process. Sometimes it splinters. But if fired touches on his work, I caught a glimpse of with red-gold dedication, it is a fitting stairway something that arrested my attention. There, that facilitates the traffic of human ideas and while he was staining, sanding and curing, processes and invention. Indeed, ours is a craft I saw a single bead of perspiration catch that captures both industry and innovation. on the end of an eyelash. I thought I saw a flash, a glint. It seemed that for one brief In this edition, our craft, our industry, our second I was caught up in a fire that I never technology, and our innovation are celebrated expected. Something enduring swept open in special and unique ways. Dr. Sharon a path. Labor and passion met mastery and Stewart-Cole invites us to consider research brilliance. For one brief moment, it seemed administration as a systemic reality while I had left my own time and space and had Dr. Elaine Larson and colleagues complete journeyed back centuries to witness a lost professional analysis on interdisciplinarity in form of expression. I was watching a master. research first considered in the previous edition. This was no mere technician. This was no Dr. Robert Porter, and Mr. Remgarajan Balaji assembly line production. This was more and his colleagues explore various means of than just the remodeling of a set of stairs. bringing the service of research administrators This was art. Here was what the ancient most effectively to investigators and research Greeks would call “techne.” Craft. And communities. After these considerations, suddenly my definition of “technology” had various international authors present us with changed ­­– in the swift glint of a bead of provocative and important considerations sweat washing an eyelash of inspiration. concerning how our technologies serve researchers in diverse nations and cultures.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 5 Dr. Peter Gist and Dr. David Langley explore Sandburg uses the city of Chicago as a type of how programs of service can be enriched personification of the human spirit that rejoices by project management methods and in the buzz and hum of labor and industry and technologies. Noting the current debate in invention. He celebrates the “doing” that is research ethics concerning customer-service not just American, but that belongs to every terminology, Dr. Ian Carter discusses how culture, in every time, and in every place. these same concepts can be reinterpreted to highlight research administration as a service We indeed are a “Profession of the Big with important levels of accountability to Shoulders.” We bear up much. And we those who depend upon our efforts. In another know why. We know the stakes. Despite the vein, Dr. Isaac Mazonde and his colleagues challenges we may encounter and the set- reflect critically upon the challenges of backs that we may know occasionally, we research ethics in international cultures. To celebrate the inspiration and the perspiration complete our global reflections upon the craft that we expend on behalf of those we serve. and technology of research administration, Perhaps this is the image, the glint, of the Dr. Vincent Gallicchio reminds us that our art-form and the industry that we call research profession must truly be stretched —­­ never administration. As we celebrate an anniversary, tied to one place or one time — but ordered we look to the next generation that will to the common good that makes us truly continue to help build human progress through international. Our considerations are rounded research of every discipline. Perhaps the out by two insightful book and law reviews greatest gift we can give to those who will from Ms. Frances Chandler and Mr. J. Michael come after us is a wonderfully raucous spirit Slocum. The volume is then completed by bursting with pride-of-industry. Perhaps our another highly informative edition of Voice celebration this year is best capped by echoing of Experience as prepared by Dr. Elliott Sandburg’s words: Kulakowski and the VOE Co-Authors. “Under the terrible burden of destiny laughing The articles in this edition of the Journal as a young man laughs, are a point of unique pride for each of us in Laughing even as an ignorant fighter laughs research administration leadership. In 1916, who has never lost a battle, Carl Sandburg published his famous “Chicago Bragging and laughing that under his wrist is Poems.” Many of us are very familiar with the pulse. the central selection of that work. Seeming to and under his ribs the heart of the people, burst with Middle American pride, Sandburg Laughing! boasts Chicago as….. Laughing the stormy, husky, brawling laughter of Youth, “Hog Butcher for the World, half-naked, sweating, proud to be Tool Maker, Stacker of Wheat, Hog Butcher, Tool Maker, Stacker of Wheat, Player with Railroads and the Nation’s Freight Player with Railroads and Freight Handler to Handler; the Nation.” Stormy, husky, brawling, City of the Big Shoulders…..”

6 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Contributors

Rengarajan V. Balaji Dr. Ian Carter’s career is a Research Grants has spanned the capital Development Coordinator engineering industry, at the Office of Research an interdisciplinary and Grants at the Ohio research centre, and University College of university administration Osteopathic Medicine. and management. He Mr. Balaji has Masters is currently the Director degrees in Biological Sciences (focus on of Research at the University of Liverpool, Neuroscience) and Business Administration. where he is responsible for the research More recently, he also obtained the CRA portfolio, including the University’s research (Certified Research Administrator®) strategy and policy development, oversight certification. Mr. Balaji has over six years of all externally-funded research and of experience in various fields pertaining to knowledge transfer as Head of Research research and research administration. Over and Business Services. He is currently the last four years, he has focused more on playing a leading role in the introduction of grant writing and preparation of research full economic costing, and is also involved grant proposals. Mr. Balaji has seven peer- in the RAE processes. He sits on the UK reviewed publications (including the current Research Councils’ Joint Grants Processing one) in scholarly journals and four research Steering Group (under which he chairs the abstracts at scientific conferences. He is Research Organisation Consultation Group), well-versed with the grant administration and has been a member of various other processes (Pre-Award) at NIH and NSF. He Research Councils’ Boards. He is a member is an active member of NCURA and is part of the national Costing and Pricing Group, of their Pre-Award Neighborhood committee. and Technical Advisory Sub-Group. He is His other honors include, reviewing the Chair of the Association of Research responsibilities for three scholarly journals Managers and Administrators (UK), is a and a listing in Marquis Who’s Who (2008, leading member of the Brunswick Group, and USA). is a member of the International Committee of the Society of Research Administrators Dr. Jack Blazyk is International. His degrees are in Electrical Professor of Biochemistry and Electronic Engineering, and Engineering in the Department of Design & Management Systems. He is a Biomedical Sciences Chartered Engineer, and a member of the and Associate Dean for Institution of Electrical Engineers and the Research and Grants in Chartered Management Institute.He has the Office of Research authored more than 130 peer-reviewed and Grants at the Ohio University College journal articles, 45 book chapters and of Osteopathic Medicine. He received an 6 books. To date he has supervised 55 A.B. degree in Chemistry from Hamilton Masters and 23 Doctoral students. Among College and a Ph.D. in Biochemistry from his many honors and awards, Gallicchio Brown University. Blazyk’s laboratory has was recognized as the “Number One Rated developed a novel design for antimicrobial Scientist in Clinical Laboratory Science” peptides that may be effective against in the U.S. by Clinical Laboratory Science. antibiotic-resistant bacteria. This work has He was elected as a Fellow of the Royal been supported for the past eight years by the Society for the Encouragement of Arts, National Institutes of Health.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 7 Manufactures & Commerce and presented Writing Institute, and served as a mentor to to Queen Elizabeth II of England at faculty to assist them in producing a final Buckingham Palace in 2004. Currently grant proposal. he serves as President of Alpha Eta, the national honor society devoted to academic Dr. Vincent Gallicchio scholarship in the Allied Health Professions is Associate Vice and is President-elect of the International President of Research, Federation of Biomedical Laboratory Director of the Office Science (IFBLS). of Sponsored Programs, and Professor of Frances Chandler is Biological Sciences and currently the Associate Public Health Science Director of Research at Clemson University. He earned his Services at Brock B.A. in Biology and M.S. in Vertebrate University in Southern Physiology from Southern Connecticut Ontario where she has State University, M.T. from Yale University/ worked for six years. Hospital of St. Raphael School of Medical Prior to her employment Technology, Ph.D. with distinction in at the university she was engaged in Experimental Hematology from New York research, teaching, social work and University, Post Doctoral Appointments community development activities in China, at the University of Connecticut Health Ghana, and Northern and Southern Ontario. Center and Memorial Sloan-Kettering She has a Bachelor of Environmental Cancer Center, and an honorary diploma in Studies Degree in Urban and Regional Physiology and Medicine from Vasile Goldis Planning, a Bachelor of Education degree University in Arad, Romania. Gallicchio’s and a Master of Arts in Social Welfare research in AIDS and cancer has produced Policy. Currently Frances is a part time seven U.S. and one foreign patents and has PhD student in education with a focus on been supported by grants from NIH, HRSA, leadership. VA, NATO, U.S. Department of Education, European Union and various pharmaceutical Dr. Sharon Stewart companies. He has authored more than Cole is Contracts and 130 peer-reviewed journal articles, 45 Grants Administrator book chapters and 6 books. Among his with the Nevada many honors, Gallicchio was recognized Cancer Institute in Las as the “Number One Rated Scientist in Vegas, Nevada. Prior Clinical Laboratory Science” in the U.S. to joining the Nevada by Clinical Laboratory Science. He was Cancer Institute, she elected a Fellow of the Royal Society for was Director in the Office of Sponsored the Encouragement of Arts, Manufactures Programs and Adjunct Professor in the & Commerce and presented to Queen Department of Education at Oklahoma City Elizabeth II of England at Buckingham University. She received her doctorate from Palace in 2004. Capella University, College of Education, in Philosophy, Professional Studies in Education. She has also conducted workshops at the Oklahoma State Regents for Higher Education, Summer Grant

8 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Dr. Peter Gist is law experience on various aspects of Director, Ove Arup & patent, trademark, copyright, trade secret Partners Ltd. and unfair competition matters. He has Dr Gist has been a written or co-written over 30 articles on a consultant economist wide variety of intellectual property law since 1975, specialising subjects including patents, trademarks, in the application of trade dress, copyright, computer law, economics to business Y2K issues, and Internet law, as well as issues. He was a member of the economics conducted many presentations, including faculty of London Business School from “Does the Research in Motion (BlackBerry) 1981 to 1989 and an advisor to the UK Case Apply to You? The Extraterritorial Departments of Industry and Transport on Enforcement of Patents” presented at the liberalisation and privatisation during the 2006 SRA International Annual Meeting. 1980’s. He was involved in the privatisation He is registered to practice before the United of British Telecom including establishing States Patent and Trademark Office, the the first regulatory “price cap” in the UK. Court of Appeals for the Federal Circuit, the Dr. Gist joined the privatisation services Southern District of Ohio and the Court of department of Price Waterhouse London in Appeals for the 6th Circuit. He is a member 1989 and managed a series of assignments of the American Intellectual Property Law on privatisation and restructuring in sectors Association, the Cincinnati Intellectual including energy, telecommunications and Property Law Association and the Cincinnati transport for government and corporate Bar Association. He has a B.A. degree clients in the UK, Europe and South East (Magna Cum Laude, Phi Beta Kappa) in Asia. He was a founding Director of the chemistry from Carleton College, and a J.D. economics consultancy BMP International degree from T. C. Williams School of Law, in 1991 and joined Arup on its merger with University of Richmond. BMP in 1999. He is now a Director in the Arup Transactions Advice team, conducting Dr. José Jackson- commercial and technical due diligence Malete is the Deputy on mergers and acquisitions and providing Director of Research in business planning and strategic advice to the Office of Research Arup clients. He works extensively in the and Development at the education and health sectors as well as University of Botswana in infrastructure intensive industries, and (UB). She assists the recently implemented an activity based Director in the strategic costing system for research projects for management of research and directly Imperial College London. oversees the funding and quality aspects of research administration. She has conducted Eric Guttag is a partner research in the areas of responsible conduct in the Cincinnati, Ohio of research and evaluating the research office of the intellectual environment at UB. Jose is a food scientist property law firm of with Masters and PhD degrees from Cornell Jagtiani + Guttag. He University and Michigan State University, has over 30 years of respectively. In addition to her research corporate and private management duties, she also continues to do intellectual property research in her field in the area of the quality

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 9 and safety evaluation of under-utilized the full range of enterprise activities. He indigenous fruits and vegetables, as well as is a Board member of the Association of diet, nutrition and its relationship to health Research Managers and Administrators UK outcomes such as obesity and HIV/ AIDS. (ARMA) and on the Editorial Board for the Previously, she was Director of Research UK for Research Global, published by the at the National Food Technology Research Association of Commonwealth Universities. Centre in Botswana and Lecturer of Food Prior to his move to Bristol, he was Director Science at the University of the West Indies of Research Services at Imperial College in Jamaica. London (responsible for the management of a research grant portfolio of 5000+ Christine B. Knisely awards) and before that a senior manager is the Executive with the Medical Research Council, UK. Director of the Office Dr. Langley has worked in the private of Research and Grants sector (project management and finance in at Ohio University engineering), the National Health Service College of Osteopathic (in clinical oncology research) and was Medicine. She has a Fulbright Scholar where he undertook worked at the College postdoctoral at the NIH. He has a PhD in for over ten years in the areas of grants and neuropharmacology and is a Director and research administration and curriculum. Trustee of The British School of Osteopathy. Previous experience with grants includes He is an Associate Editor of the Journal of work in the Ohio University College of Research Administration. Education. Prior to Ohio University, Ms. Knisely was the Assistant Director of the Dr. Elaine Larson Ohio Humanities Council, a state-based is currently the agency of the National Endowment for the Associate Dean for Humanities. Other grants-related experience Research and Professor includes work with non-profit civic and arts of Pharmaceutical organizations. In 2005 she served on the and Therapeutic National Conference Planning Committee Research, Columbia for the Integrated Advanced Management University School of Information Systems. Nursing and Professor of Epidemiology, Columbia University Mailman School Dr. David Langley is of Public Health. From 1992-8, she was Director of Research and Dean, Georgetown University School Enterprise Development of Nursing, and Associate Director of at the University of Nursing, Georgetown Hospital. Dr. Bristol in the UK, Larson is currently a member of the which is internationally Board of Directors, National Foundation distinguished for Infectious Diseases and the Report for teaching and Review Committee, National Academy of research. He leads a professional team Sciences. She is the Director of an NIH- with varied roles including research funded center, Center for Interdisciplinary strategy and policy, research and business Research in Antimicrobial Resistance. Dr. development, relationship management, Larson has been Editor of the American project management, contracting, research Journal of Infection Control since 1994 governance, ethics and misconduct and and has published more than 200 journal

10 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration articles, four books and a number of book have won more than $5 million in awards chapters in the areas of infection prevention, from government agencies and private epidemiology, and clinical research. foundations. In addition to conducting workshops at universities and medical Professor Isaac schools nationally, he has presented award- Mazonde is Director winning papers at major conferences and has of Office of Research published articles in the Journal of Research and Development Administration. Dr. Porter has previously at the University of taught at Swarthmore College, Lewis and Botswana. Professor Clark College, and Susquehanna University. Mazonde obtained his He holds graduate degrees in Speech PhD from the University Communications from the University of of Manchester (UK) in 1987. Between Michigan. 1978 and 2000, he worked for the National Institute of Development Research and J. Michael Slocum is Documentation (NIR) within the University a senior member of the of Botswana, where he served as Research law firm of Slocum & Fellow, Senior Research Fellow, Associate Boddie, P.C. He has Professor and Acting Director. In June 2000 more than thirty years he was appointed Deputy Director of the of experience in grant Office of Research and Development of and contract law. He the University of Botswana, when the NIR is a Distinguished was phased out. In 2005, he was appointed Faculty member of the Society of Research Director of the Office of Research and Administrators, and has won the Excellence Development, the position he currently Award (2003) and the Hartford/Nicholson holds. Prof Mazonde’s research interests Award (1992) from that organization. Mr. include science and technology, social Slocum is an honor graduate of DePauw organization for economic production, and University, and received his J.D. with more recently, research management. He honors from George Washington University has published in all these areas. He has National Law Center. He is a member of had study tours to research management the Virginia State Bar, and is President of organizations in the United States, South Slocum & Boddie, PC in Springfield, VA. Africa and the United Kingdom. Todate, Prof Mazonde has attended three SRA Dr. Jeremy Sugarman is Annual General Meetings and this is his the Harvey M. Meyerhoff second article to be published by the SRA Professor of Bioethics Journal. From 2001 to 2007, he was a and Medicine, Professor member of the Southern African Research of Medicine, Professor and Innovation Management Association of Health Policy and (SARIMA), which is affiliated to the SRA. Management, and Deputy Director for Medicine Dr. Robert Porter is Director of the of the Berman Institute of Bioethics at the Proposal Development Team in the Johns Hopkins University. Dr. Sugarman Research Division at Virginia Tech. He conducts both theoretical and empirical has more than thirty years’ experience as research in medical ethics. His work a tenured professor, private consultant and concentrates on informed consent, research research administrator, and his proposals ethics, and the ethical issues associated

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 11 with emerging technologies. He is the Book Review Editor of the Ecology Law author of approximately 150 publications Quarterly, and the University of California, in peer-reviewed journals, in addition to San Diego (B.A., summa cum laude, 1970). multiple reviews and book chapters as He was admitted to the California Bar in well as editing or co-editing four books. 1973, and the Massachusetts Bar in 2001 Dr. Sugarman serves on the Scientific and and is admitted to practice before the United Research Advisory Board for the Canadian States District Court, Central, Southern, Blood Service and the Maryland Stem Cell Eastern and Northern Districts of California, Research Commission. He is currently the United States Court of Appeals, Eighth Chair for the Ethics Working Group of the and Ninth Circuits, the United States Claims HIV Prevention Trials Network, the Ethics Court and the United States Supreme Court. Officer for the Resuscitation Outcomes Consortium, and Co-Chair of the Johns Hopkins Embryonic Stem Cell Oversight Committee. Dr Sugarman is a member of the American Society of Clinical Investigation and a Fellow of the American Association for the Advancement of Science, the American College of Physicians, and the Hastings Center.

J. Mark Waxman is a partner with Foley & Lardner LLP, where he chairs the Health Care Industry Team and is a member of the White Collar Defense & Corporate Compliance Practice. Mr. Waxman’s focus on health care for providers and payers includes issues related to research and technology, integrated delivery systems, governance, strategic business counseling, the antitrust implications of mergers and acquisitions, federal program fraud and abuse, reimbursement and managed care contracting. Mr. Waxman writes and lectures extensively on various issues including medical research and technology, compliance, managed care, antitrust issues, and health care fraud and abuse. He is a graduate of Boalt Hall School of Law, University of California, Berkeley (J.D., 1973), where he was Articles and

12 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Voice of Experience

VOE advances the tradition and service of the Journal of Research Administration by fostering consideration of and reflection upon contemporary issues and concerns in research administration as they arise from professionals in the field of service. Dr. Elliott Kulakowski VOE is a celebrated feature column in each edition of the Journal. It is under the corporate authorship of some of the most distinguished and seasoned members of SRA International who lead research administration efforts around the globe. Our 2006 VOE Authors are: Lynne Chronister Ms. Lynne Chronister, Associate Vice Chancellor for Research , University of California, Davis, Dr. Elliott Kulakowski, President, Research Administration and Management Strategy Group (RAM), Dr. Victoria Molfese, Ashland/Nystrand

Chair in Early Childhood Education Dr. Victoria Molfese and Professor in the Department of Teaching and Learning, University of Louisville. Dr. Molfese is also Associate Editor, Developmental Neuropsychology Center for Research in Early Childhood, Mr. J. Michael Slocum, senior member of the law firm of Slocum & Boddie, P.C., Dr. Cliff Studman, Director, J. Michael Slocum Pie Squared Consultants, Mr. Paul Waugaman, Principal and co-founder of the Technology Commercialization Group (TGG). Dr. Kulakowski serves as the 2007 Senior Writer and Column Coordinator. The success of VOE for the profession depends directly on issues and emerging Dr. Cliff Studman topics of interest as they are articulated from our colleagues. If you wish to contribute, please contact the Journal Editor at [email protected].

Paul Waugaman

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 13 Research Administration as a Living System Sharon Stewart Cole, Ph.D. Nevada Cancer Institute One Breakthrough Way Las Vegas, NV 89135 Work: 702-822-5119 Home: 702-855-0396 Fax: 702-944-2379 E-mail: [email protected] Author’s Note Portions of the literature review were previously reported with the author’s dissertation research entitled, “Federal funding success factors: A replicated quantitative analysis.” The author received her Ph.D. in Education in December 2006. The Delphi study in this article is new research that was performed to expand the findings of the author’s dissertation research. The author has 20 years of experience in contracts and grants administration and has served as a director of sponsored programs. Abstract The purpose of this Delphi study was to gather expert opinions and recommendations for change in the research administration system to bring about growth and collaboration. This study was deemed important because at the heart of every system is the fact that individuals need each other to continue to exist. The results of the Delphi study give recommendations from the research faculty perspective for the improvement in the system of research administration and faculty relationships. Administrators and research faculty should view each other as team members whose objectives are to discover and understand how to achieve common goals. The recommendations suggested that change was needed by both faculty and research administrators to become a more unified, living system.

Keywords: Research administration, culture, grants, Delphi study, universities, research faculty, organization, principal investigator Introduction agencies support new research ideas and Imagine a university where faculty and new researchers? How could such a system research administrators work in harmony. be accomplished? Previous research Rather than strife, manipulation, placing explains how these circumstances evolved, blame, stress, and disallowances, a system and is addressed in the literature review. where research administrators are empathic and helpful and receive accolades and Literature Review recognition from faculty. Picture a system Publish or Perish Syndrome where faculty are supportive of research Faculty are faced with the need to publish administrators and share their objectives and journal articles and books, and to obtain needs openly. Can you envision a university grant funding. This publish or perish where faculty and research administrators syndrome is caused by universities using receive and accept constructive feedback? published research results to evaluate Systems where university business practices faculty for tenure, merit, funding, and salary support the research endeavor? Funding decisions (Hu & Gill, 2000). Hu and Gill (2000) developed the theory of faculty

14 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration productivity as a life-cycle model, which assigned with a weekly teaching load of states, “an individual engages in research more than 11 hours, [by taking] on many because of the perceived significant future academic service responsibilities, or financial reward for the research activity” (p. [having] been in the faculty position for 16). several years.

This theory suggests that productivity rises 4. Tenure status, academic rank, and sharply in the first stages of a career, peaks school type seemed to have no at the time of tenure, and then begins to significant correlation to faculty research decline. Hu and Gill (2000) found that the productivity. (p. 24) post-peak decline rate was slower for those in the high publication rate group compared The authors remarked that the life-cycle to those in the low publication rate group. model has potential limitations that might This finding followed the hypothesis that influence reliability because the data are self- research provides reputation capital, which reported, and the numbers may be inflated yields positive returns in subsequent years. for various reasons (Hu & Gill, 2000). What Hu and Gill reported that faculty who took is clear is that the ability to participate in administrative positions such as department grant-funded research can be critical to new head or dean showed a significant drop in faculty seeking tenure and to institutions research productivity compared to their seeking funding to support research academic colleagues, and that productivity activities. Participating in research projects, varied among institutions. preparing proposals, and publishing research results are traditionally considered activities Hu and Gill (2000) noted that institutions of scholarship. could help by providing graduate assistants and reducing teaching and administrative McMillin (2004) reported that becoming duties. Taking this previous research into a complete scholar was a process through consideration, Hu and Gill attempted to which junior faculty attempt to construct a “identify the set of variables that have professional identity: the most significant effect on the research [A senior faculty is] characterized as productivity of information systems faculty” [having] a thirty-five year career, [being] (p. 24). Results of their data analysis lead to an award-winning teacher, an effective the following conclusions: dean, and a well-respected historian. He has 1. Junior faculty may be productive because managed to constantly reinvent himself and of current technological skills, a strong adapt to changes in theory and methodology, reason that leads to longer working in pedagogy, student expectations, hours, more time allocated for research in institutional mission, and resource activities, and a light service load. availability—all with grace, wit and modesty. (p. 1) 2. Senior faculty may be productive because of favorable teaching loads, In contrast, junior faculty are characterized opportunities to work with several junior as being the lucky few survivors of a faculty and doctoral students, or more competitive job market, and technology time for research activities because of has shaped their work both in teaching fewer new classes requiring preparation. and research. They are beginning their careers at a time when the expectations of 3. Faculty were adversely affected when higher education are growing and societal

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 15 support for higher education institutions faced by research universities was not is declining. Many junior faculty are in the competition between faculty and struggling to develop a professional universities, but in the concentration identity, and new courses, and many are of government support to a few major stretched to participate in community universities. In support of this position, organizations. McMillin (2004) reported Stigler discussed changes that have occurred that participation in municipal projects, with the National Science Foundation social service agencies, and schools is often (NSF). He reported that around 1980, the part of the institutional mission. Many NSF came under political pressure that institutions protect junior faculty from this impaired its efficiency and threatened service mission and allow them to focus on injury to research universities. One of these traditional research. dangers, he said, was the congressional earmarking of funds for state projects and McMillin believed that if new faculty do not the political setting of research agendas. find ways to make their research accessible to students, serve the local community, The NSF has considerable power in setting and build interdisciplinary connections the direction of research and does not have before tenure, they most likely will not a serious competitor in the physical and do so afterward. McMillin noted that the mathematical sciences. This agency, Stigler challenge was to find the right balance said, has turned its focus on “cultivating the for new faculty so they could achieve a source of the funds, the Congress, and has supportive flexible work environment sought to structure its programs to increase in which to cultivate their academic its appeal to this source” (p. 7). Stigler professionalism. explained how this change contributed to increased competition among research The Competitive Nature of Federal universities: Funding Stigler (1993) reported that universities The National Science Foundation has found differ from businesses and athletics, which it easier to explain large-scale projects and promote competition as a positive. On research centers to Congress than to argue the other hand, a university, which views convincingly for the diffuse benefits of a competition as a threat, “fosters complaints, broad-based funding of individual research cries for support, pleads for exemption grants; as a consequence the NSF has from laws against collusion, and attempts promoted large projects. The scientists have to restrict new entries” (p. 1). Competition to a degree acquiesced in this shift, being does take place among research universities told that otherwise it would be impossible and faculty. The competition focuses on the to increase support to meet expanded need to increase the intellectual gains to challenges, and that the support for research students and for faculty to derive economic centers in fact permits at least a modest gain from new ideas that advance science growth of funding for other programs. and human well being (Stigler). Faculty But, that has not happened; instead, as compete for higher salaries, larger offices, might have been predicted, total budgets and recognition. Universities compete for have not grown in real terms, and since the prestige, students, and income; competition highly visible research centers have been determines who is successful. enthusiastically sold to Congress, the centers have of necessity been spared the worst of Stigler (1993) proposed that the difficulty the cuts. (p. 7)

16 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Stigler (1993) offered words of continuation of sufficient grant funding. It encouragement for the research university, is the mission of the university to serve saying that, although universities face the needs of society, and the government serious problems, they have already proven needs research to solve societal problems to be resilient and have emerged from these or concerns of national security. Society trials “changed and no less strong” (p. 9). benefits from university research, the university research infrastructure is University Perspective improved, new technologies are created, Boyer and Cockriel (1998) stated, “Research and the government agencies missions are universities [were] judged by others based supported (Federal Government and Higher on research productivity and the dollar Education, 1960). amount of acquired grants” (p. 61). Being “scholarly” was traditionally defined as Faculty Perspectives “engaging in research, writing articles for To better understand the faculty’s publication, and sharing research findings perspectives, Boyer and Cockriel (1998) with students” (p. 61). Writing proposals studied motivational factors and barriers and being successful in receiving federal associated with pursuing federal funding: funding helped scholarly development and Motivators: increased the opportunity for publication 1. Consideration for tenure or and recognition. promotion. Ikenberry and Hartle (2000) showed that 2. Building professional reputation as universities experienced a financial crisis a capable researcher or Principal as local government support for higher Investigator. education fell sharply in the 1990s. With 3. Strong commitment to federal an economy pulling out of a recession, great funding from the college president. pressure was placed on university budgets. Barriers: Kennedy (1993) stated that universities 1. Lack of training in grant seeking were facing a period of serious resource and grant writing. constraint, and that without an infusion of 2. Lack of knowledge of budget new resources, the future of basic research development. might resemble the biomedical sciences. 3. Lack of knowledge of funding sources. (1998, p. 61) Applications for grants [were] growing faster than the available resources, the Boyer and Cockriel showed that the key to success ratio [was] declining, unrealistic pursuing grant funding lies in discovering demands for university matching [were] the individual motivators that attract accompanied [by] reduced grant support, faculty. This helps to reduce the barriers good research [was] going un-funded, good in the most cost-effective manner and researchers [were] becoming frustrated, stimulates the faculty’s best work. McMillin young researchers [were] leaving the (2004) stressed that institutions can create field, infrastructure problems [were] being spaces where junior faculty can nurture deferred, and the price for it all [was] paid their professional goals. Many institutions by people who are not around to assert their make “investments in faculty research by interest. (pp. 2-3) providing funding for start-up costs, research grants, travel support, sabbaticals, and pre- Universities and the federal government tenure leaves [of absence]” (p. 2). Research share interest in research that supports the

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 17 universities’ reputation seemed to follow agencies caused problems for universities. research productivity, and such support was Policies, procedures, and federal regulations fair and needed (McMillin). This investment were extremely frustrating and confusing was supported by a “strong commitment and to applicants. It was necessary not only to obligation of higher education to put the best determine the proper rules to follow, but minds of our society to work on creating also to understand the sometimes unspoken new knowledge and its application to solve criteria for selection and management societal ills” (p. 2). of awards (Management Concepts Incorporated, 1995). Federal Government Porter (2004) reported that some new and Higher Education (1960) noted: faculty acknowledged their need for career advancement and a specialization. This Grants [were] made because of group recognized their need for training and proposals from individuals and groups, scholarly development. Porter observed that supported by their institutions. The size there seem to be few mentors available to of the grant [was] determined through help new faculty in becoming successful. estimated direct costs of time, materials, He further suggested that a series of training and services, frequently supplemented workshops with senior faculty serving as by funds to pay for needed special mentors would increase knowledge and skill equipment. A percentage fixed by law or and improve the attitudes of new faculty. regulation, of direct costs [was] applied Success in receiving federal funding would toward the institution’s indirect costs enhance the likelihood of achieving tenure, such as building maintenance and repair, promotion, and academic freedom (Porter). utilities, and other items of general administrative expense. (p.81) Research Administrator Perspective In the 1960s, the federal government started This system has grown so extensively many new programs that exploited the that universities have given research talents of faculty and the infrastructure of administrators the responsibility to carry American universities. Federal agencies out the required proposal submission and were established to manage these new grants administration operations in an initiatives through congressional budget efficient manner. The administration process allocations. Each agency independently is integral to the scholarly processes. The established federal mandates and designed focus of research administration has been its own processes for managing its programs on observing the laws, rules and regulations without coordination with other agencies imposed by funding agencies. This focus (Management Concepts Incorporated, 1995): has in many institutions been perceived as Dozens of different rules and procedures a barrier to faculty, who in many cases feel about how to deal with similar issues these requirements have been communicated appeared. Each grants office devised its in ways that are less than helpful. Research own standards, procedures, and forms administrators are frustrated by faculty’s for applying for federal funding. These seeming lack of interest in or concern [federal] institutions devised their own with their financial and compliance systems for determining how decisions responsibilities. would be made in awarding funding. Need for Change (pp. 1-2) Christopher and Gordon (1999) noted This great diversity created by the federal that systems form through collaboration and from a realization that we need one

18 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration another to maintain life. The recognition recognizes its weaknesses and cultivates that individuals need each other lies at the shared interests with research faculty. heart of every system. From that realization individuals reach out, and seemingly Study Methodology divergent self-interests develop into a Because there is so little systematic system of interdependency (Christopher and information about the working relationship Gordon). between research administrators and faculty, a Delphi study was undertaken to gauge Those of us have worked in universities for the opinions of faculty at several major many years know that we do not succeed research universities. Research faculty are nearly as often as we need to. We have the generators of the grants administration suffered from the unending changes that workload and recipient of services; overtake our universities, creating more therefore, their opinions and participation destruction than growth (Christopher and are deemed important to the improvements Gordon, 1999). So, what hope is left? of the system of research administration. Is there a way to create change in the This Delphi study was not designed to large, complex systems we have created? determine statistical significance, to involve The answer is yes — when something is busy experts in an approach similar to a impossible through one vision, it possible focus group. Unlike a focus group, the through another, as Christopher and Gordon Delphi participants did not meet physically. note: An online survey was prepared by the In a complex system it is possible to researcher and distributed through email find simple causes that explain our to individual participants. The researcher problems, or to know whom to blame. served as a clearinghouse through which A messy tangle of relationships has the survey responses of each panelist were given rise to those unending crises. We seen (Department of Sustainability and need a different worldview to guide us Environment, 2007). in this new world of continuous change The panelists were senior faculty at major and intimately connected systems that research universities that have received at reach around the globe…All living least $1 million in federal funding. A letter systems are webs of relationships spun was distributed to 287 possible panelists to into existence as individuals realize that confirm their willingness to participate. The there is more benefit available to them letter contained a description of the project, if they create relationships than if they its objectives, the time anticipated, and a stay locked in narrow boundaries of self- promise of anonymity. Of 34 senior faculty interest. These relationships of mutual researchers who agreed to participate, 32 benefit lead to creating systems that completed the two-step process. The four are more supportive and protective of open-ended questions posed are listed individuals. It’s important to remember below: that nothing living lives alone. Life Question 1: What support or services always and only organizes as systems of should research administrators give interdependency. (p. 2) faculty that are not offered?

When a system falls apart, it can see things Question 2: What should be the future differently and regenerate itself into a new goals and objectives of research way of living. Research administration administration? as a living system can reform itself as it

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 19 Question 3: What change is needed in experts who participated in the final round research administrators’ attitudes toward of surveys rated the significance the 40 working with faculty, and how should opinions or recommendations on a five-level the change be implemented? scale. Level 1 was given the highest priority rating and Level 5 was given the lowest. The Question 4: What change is needed in percent of faculty response to each of the 40 faculty attitudes toward working with questions was calculated. research administrators, and how should the change be implemented? Results The opinions were specific to how During the first round, the survey questions faculty perceived their interaction with generated 134 opinions. Similar opinions their respective research administration were offered by many participants and were offices and what they believed research later synthesized to delete duplicates and to administration should do to improve combine themes into 40 distinct opinions or services offered. A majority of the Delphi recommendations for change. Based on the panel agreed on several recommendations 40 opinions, a second and final survey was for change. Overall Level 1 responses to generated to assess the importance of each the 40 questions in the final survey averaged opinion regarding growth or change needed 45% of the total. The responses are shown in in research administration. The 32 faculty Table 1 below:

Table 1 Summary of Recommendations by Level of Significance (N=32) Question 1: What support or services should research administrators give to faculty that are not offered? 1. Assist with preparing proposals, prepare budgets and proposal forms, streamline procedures for timely proposal review; and provide mentoring and proposal critiquing as needed. Response Response Response Response Percent Count Percent Count Level 1 46.9% 15 Level 4 6.2% 2 Level 2 21.9% 7 Level 5 0.0% 0 Level 3 25.0% 8 2. Write the proposals if the university wants funding. Response Response Response Response Percent Count Percent Count Level 1 9.4% 3 Level 4 21.9% 7 Level 2 3.1% 1 Level 5 65.6% 21 Level 3 0.0% 0

20 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration 3. Change in services is not required. Faculty are being provided with all the help by Research Administrators that they need. Response Response Response Response Percent Count Percent Count Level 1 6.2% 2 Level 4 18.8% 6 Level 2 15.6% 5 Level 5 34.4% 11 Level 3 25.0% 8 4. Help more and become less of an enforcer. Response Response Response Response Percent Count Percent Count Level 1 58.1% 18 Level 4 0.0% 0 Level 2 19.4% 6 Level 5 6.4% 2 Level 3 16.1% 5 N/A 1 5. Develop better graduate student recruiting strategies. Response Response Response Response Percent Count Percent Count Level 1 21.9% 7 Level 4 9.4% 3 Level 2 37.5% 12 Level 5 12.4% 4 Level 3 18.8% 6 6. Reduce bottlenecks for better financial accounting, and reporting of grant funds, and timelier purchasing. Response Response Response Response Percent Count Percent Count Level 1 34.4% 11 Level 4 6.2% 2 Level 2 34.4% 11 Level 5 3.1% 1 Level 3 21.9% 7 7. Communicate the university research objectives to granting agencies. Response Response Response Response Percent Count Percent Count Level 1 15.6% 5 Level 4 25.0% 8 Level 2 9.4% 3 Level 5 18.8% 6 Level 3 31.2% 10 8. Work closely with faculty to plan a long-term university-wide research strategy. Response Response Response Response Percent Count Percent Count Level 1 21.9% 7 Level 4 12.5% 4 Level 2 25.0% 8 Level 5 6.2% 2 Level 3 34.4% 11

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 21 9. Encourage faculty to pursue research funding by offering awards, prizes, grant writing workshops; and recognition for outstanding research. Response Response Response Response Percent Count Percent Count Level 1 12.5% 4 Level 4 12.5% 4 Level 2 34.4% 11 Level 5 12.5% 4 Level 3 28.1% 9 10. Follow-up with notifications to faculty of progress reporting and renewal proposals deadlines. Response Response Response Response Percent Count Percent Count Level 1 25.0% 8 Level 4 12.5% 4 Level 2 43.7% 14 Level 5 9.4% 3 Level 3 9.4% 3 11. Return a significant part of the overhead or indirect cost to the college, department, and principal investigator. Response Response Response Response Percent Count Percent Count Level 1 67.8% 21 Level 4 0.0% 0 Level 2 25.8% 8 Level 5 3.2% 1 Level 3 3.2% 1 N/A 1 12. Add more research administration staff during times of peak proposal deadlines to overcome frustration and alleviate the increased workload. Response Response Response Response Percent Count Percent Count Level 1 31.3% 10 Level 4 6.2% 2 Level 2 46.9% 15 Level 5 6.2% 2 Level 3 9.4% 3 13. Facilitate institutional financial support (matching) for large scale-grant applications. Response Response Response Response Percent Count Percent Count Level 1 50.0% 16 Level 4 0.0% 0 Level 2 37.5% 12 Level 5 3.1% 1 Level 3 9.4% 3

22 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Question 2: What should be the future goals and objectives of research administration?

1. Identify proper funding agencies and programs beyond distribution of lists of announcements and web site links. Response Response Response Response Percent Count Percent Count Level 1 34.4% 11 Level 4 12.5% 4 Level 2 28.1% 9 Level 5 3.1% 1 Level 3 21.9% 7 2. Help develop inter-disciplinary or research clusters to facilitate large-scale university proposals. Response Response Response Response Percent Count Percent Count Level 1 25.0% 8 Level 4 15.6% 5 Level 2 40.6% 13 Level 5 0.0% 0 Level 3 18.8% 6 3. Encourage talented faculty members to achieve their full potential as researchers by standing behind faculty who are pursuing basic research. Response Response Response Response Percent Count Percent Count Level 1 46.9% 15 Level 4 6.2% 2 Level 2 31.3% 10 Level 5 9.4% 3 Level 3 6.2% 2 4. Visit researchers’ laboratories and open lines of effective communication by appreciating issues that the other person encounters. Response Response Response Response Percent Count Percent Count Level 1 9.4% 3 Level 4 18.8% 6 Level 2 28.0% 9 Level 5 18.8% 6 Level 3 25.0% 8 5. Reduce the time researchers spend with administrative and paper work duties. Response Response Response Response Percent Count Percent Count Level 1 68.8% 22 Level 4 0.0% 0 Level 2 25.0% 8 Level 5 3.1% 1 Level 3 3.1% 1

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 23 Question 3: What change is needed in research administrators’ attitudes toward working with faculty and how should the change be implemented? 1. Recognize common goals and essential service functions of research administration to help the faculty member succeed. Response Response Response Response Percent Count Percent Count Level 1 31.3% 10 Level 4 3.1% 1 Level 2 31.3% 10 Level 5 0.0% 0 Level 3 34.3% 11 2. Reduce arbitrarily implemented policies and be less rigid in their attitudes. Be more open to views of faculty. Response Response Response Response Percent Count Percent Count Level 1 38.7% 12 Level 4 6.4% 2 Level 2 35.5% 11 Level 5 0.0% 0 Level 3 19.4% 6 N/A 1 3. Try to understand the research before imposing restrictions on faculty’s ability to make program or budget decisions. Response Response Response Response Percent Count Percent Count Level 1 16.1% 5 Level 4 12.9% 4 Level 2 32.3% 10 Level 5 0.0% 0 Level 3 38.7% 12 N/A 1 4. Offer service as the greater purpose and not just attending to compliance. Response Response Response Response Percent Count Percent Count Level 1 53.1% 17 Level 4 6.3% 2 Level 2 25.0% 8 Level 5 0.0% 0 Level 3 15.6% 5 Question 4: What change is needed in faculty attitudes toward working with research administrators and how should the change be implemented?

1. Educate administrators of publication and grantsmanship relationship and requirements. Response Response Response Response Percent Count Percent Count Level 1 21.9% 7 Level 4 12.5% 4 Level 2 28.1% 9 Level 5 0.0% 0 Level 3 37.5% 12

24 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration 2. Send proposals with enough lead-time for the research administration office’s review and submission and not route at the last minute. Response Response Response Response Percent Count Percent Count Level 1 28.1% 9 Level 4 12.5% 4 Level 2 28.1% 9 Level 5 6.3% 2 Level 3 25.0% 8 3. Understand that administrators are trying to facilitate grant submission and administration and to treat administrators with mutual respect. Response Response Response Response Percent Count Percent Count Level 1 21.9% 7 Level 4 3.1% 1 Level 2 43.8% 14 Level 5 3.1% 1 Level 3 28.1% 9 4. Interact with research administrators to bring their research to the attention of funding agencies and the public and in finding industrial connections. Response Response Response Response Percent Count Percent Count Level 1 22.6% 7 Level 4 3.2% 1 Level 2 32.3% 10 Level 5 6.5% 2 Level 3 35.4% 11 N/A 1 5. Work as a team and show each other respect. Response Response Response Response Percent Count Percent Count Level 1 46.9% 15 Level 4 3.1% 1 Level 2 28.1% 9 Level 5 3.1% 1 Level 3 18.8% 6 6. Be more sensitive to the time of research administration personnel and their workload. Response Response Response Response Percent Count Percent Count Level 1 12.9% 4 Level 4 6.5% 2 Level 2 38.7% 12 Level 5 3.2% 1 Level 3 38.7% 12 N/A 1 7. Take a non-aggressive, open-minded approach toward research administrators. Response Response Response Response Percent Count Percent Count Level 1 34.4% 11 Level 4 6.3% 2 Level 2 37.4% 12 Level 5 3.1% 1 Level 3 18.8% 6

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 25 8. Learn to trust research administrators, appreciate their role in securing funding, see them as partners, and delegate. Response Response Response Response Percent Count Percent Count Level 1 25.8% 8 Level 4 3.2% 1 Level 2 48.4% 15 Level 5 9.7% 3 Level 3 12.9% 4 N/A 1 9. Explore the common interest of faculty and research administrators to reduce obstacles. Response Response Response Response Percent Count Percent Count Level 1 15.6% 5 Level 4 12.5% 4 Level 2 43.8% 14 Level 5 3.1% 1 Level 3 25.0% 8

Note. Responses were determined to have reoccurring themes and Table 1 is a representation of the responses received to the second and final survey.

Conclusions research in the form of assistance with There were recurring themes in the matching funds and a return of indirect significant responses. The first theme cost to the department and Principal addressed the system of research Investigators. administration. Faculty expressed a need for assistance with preparing proposals, Better communication and teamwork budgets and streaming procedures for timely between faculty and research administration proposal review. Such assistance could emerged as the third theme. Faculty felt that be in the form of mentoring or critiquing research administrators should encourage proposals. Faculty felt that research investigators pursuing basic research, and administrators should provide more help help them identify funding agencies and and be less focused on enforcing rules and programs beyond the basic distribution of regulations. Faculty believed that there lists of announcements and web site links. are bottlenecks in the financial accounting The fourth theme suggested that faculty and reporting of grants and that purchasing could assist research administration by services should be provided in a more showing respect and understanding. Faculty timely fashion. Faculty requested that expressed some need to submit proposals time required to spend on paper work be with adequate lead-time, and to work as a reduced. Faculty suggested that research team. administration should add more temporary staff to assist in times of peak proposal Some opinions that did not rate as submissions to alleviate the administrators’ highly significant in the final survey increased work loads. were: (a) faculty’s sensitivity to research administrators’ time and workload; (b) The second theme reflected a desire for exploring the common interest of faculty and additional financial support for faculty

26 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration research administrators to reduce obstacles; Christopher and Gordon Publishers. (1999). (c) faculty interacting with research Bringing schools back to life: Schools administrators to bring their research to the as living systems in creating successful attention of funding agencies;, (d) taking school systems. Retrieved January 21, a non-aggressive, open-minded approach 2004, from http://steen.acuvejle.dk/ic/ toward research administrators; (e) working pdf_filer/bringing_schools_back_to_life. with faculty to plan a long-term university- pdf wide research strategy; and (f) learning to Department of Sustainability and trust research administrators, appreciating Environment. (2007). Effective their role in securing funding, seeing them engagement: Delphi study. Retrieved as partners, and delegating. May 9, 2007, from http://www.dse.vic. gov.au/DSE/wcmn203.nsf/LinkView/D These opinions are from research 7B9E063A2B4FFAFCA25707E002488 faculty participating in this Delphi study, 22EBB2EB2F9035229BCA257091000 and are supported by their substantial BF7A6. number of years in research. Future Federal government and higher education. research will be conducted to obtain the (1960). Englewood Cliffs, NJ: Prentice- perspective of research administrators Hall. with substantial numbers of years of Hu, Q., & Gill, G. (2000). IS faculty experience. In this way viewpoints can be research productivity: Influential factors isolated and a determination made as to and implications. Information Resources collective concerns, points of agreement, Management Journal, 13(2). and disagreement. By then adding the Ikenberry, S.O. & Hartle, T.W. (2000). perspective of the university administration, Where we have been and where we are funding agency criteria for a model of a going: American higher education living system can be generated. and public policy. Washington, DC: The study provided both positive American Council on Education. recommendations as well as areas of Kennedy, D. (1993). Making choices in the organization and attitude of both faculty research university. Daedalus, 122(4). and research administrators needing Management Concepts Incorporated. (1995). improvement. There is still a great deal of Uniform administrative requirements effort required to bring about the desired for grants: OMB Circular A-102 and 2 changes. These recommendations are offered CFR parts 215. Vienna, VA: Author. as guidelines for both faculty and research McMillin, L. (2004). Creating the “complete administrators to consider in developing scholar”: Academic professionalism a vision for creating a living system of in the 21st century. Liberal Education, mutual goals and objectives, respect, and 90(2). cooperation. Porter, R. (2004). Off the launching pad: Stimulating proposal development by References junior faculty. The Journal of Research Boyer P., & Cockriel, I. (1998). Factors Administration, 31(1), 6-11. influencing grant writing: Perceptions Stigler, S.M. (1993). Competition and the of tenured and non-tenured faculty. The research universities. Daedalus, 122(4), Journal of Research Administration, 157. 29(3), 61-68.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 27 Institutional Challenges of Interdisciplinary Research Centers Sherry Glied, Ph.D. Professor and Chair, Department of Health Policy and Management Mailman School of Public Health

Suzanne Bakken, D.NSc. Alumni Professor of Nursing, School of Nursing Professor, Biomedical Informatics

Allan Formicola, D.D.S. Professor and Vice Dean, College of Dental Medicine

Kristine Gebbie, Dr.PH. Elizabeth Standish Gill Associate Professor, School of Nursing

Elaine L Larson, Ph.D. Professor and Associate Dean, School of Nursing Professor of Epidemiology, Mailman School of Public Health Columbia University School of Nursing 630 W. 168th Street New York, NY 10032 212-305-0723; FAX: 212-305-0722 [email protected] Authors’ Note Supported by The Center for Interdisciplinary Research on Antimicrobial Research, CIRAR, http://www.cumc.columbia.edu/dept/nursing/CIRAR/, funded by The National Center for Research Resources, P20 RR020616. We appreciate the input and feedback from Dr. Peter Bearman, Professor and Chair, Sociology Department, Columbia University.

Abstract Interdisciplinarity has become the model of scholarly inquiry generally espoused by many who seek federal research funding. Interdisciplinary research centers pose challenges to academic settings and to investigators. In a conference of directors of diverse research centers at a single research university we found that the challenges facing centers and their universities fell into three major categories: fiscal sustainability, recruiting and retaining faculty, and leadership sustainability. These challenges are discussed, and institutional recommendations are proposed to address these challenges.

Key Words: Academic Health Centers, Interdisciplinary Research, Research Centers

Introduction roadmapnewsecir.asp) on interdisciplinary Throughout the academic and research and translational sciences, interdisciplinarity community, interdisciplinary research has has become the model of scholarly inquiry become a catch phrase (Giacomini, 2004; generally espoused by many who seek and Robertson, Martin, & Singer, 2003). With receive federal research funding. Despite the recent emphasis in the NIH Roadmap this, there are major gaps in our general initiative (http://www.ncrr.nih.gov/ understanding of interdisciplinary research

28 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration and how it can be successfully integrated they can support research teams that cross and sustained in academic health science disciplinary and departmental lines and centers and universities (Mallon & Bunton, their members can conduct research that 2005). falls outside the established bounds of a disciplinary department. Finally, centers are Entities designated as interdisciplinary problem-responsive. They arise to confront research centers abound in large universities specific issues and concerns, drawing and academic health centers, but in many together faculty whose work addresses these settings the mantra of interdisciplinary problems. research may be no more than lip service. Such centers have been described as follows Interdisciplinarity, independence, and (Committee on Facilitating Interdisciplinary responsiveness are the principle strengths Research, 2004): and rationales for the existence of research Some are bigger and intellectually centers. At the same time, these features more influential than some academic present centers, and the universities that departments. Others are highly house them, with several distinct challenges. specialized and narrow. Some have In this paper, we report on the results of a existed for decades, others disappear conference of directors of diverse research after only a few years, and still others centers at a single research university that merge to create new units or emerge focused on the challenges facing centers and when one interdisciplinary unit is their universities and the factors predicting split. Some have retained their original their success. purpose throughout their lifetimes; others have substantially shifted their The Conference academic focus. (p. 20) In 2004, the National Institutes of Health allocated funds for exploratory centers Considerable ongoing resources and efforts in interdisciplinary research (http:// are being expended in these research centers. www.ncrr.nih.gov/roadmapnewsecir. Although they are highly variable in their asp). One of the 21 centers funded goals, administrative structure, funding, was the Center for Interdisciplinary and defined outcomes, it is likely that there Research on Antimicrobial Resistance are also many commonalities and potential interfaces or even overlaps among them. (CIRAR, http://www.cumc.columbia. Unfortunately, however, those characteristics edu/dept/nursing/CIRAR/). CIRAR’s that are predictive of success of such core research collaborative team centers have not been clearly articulated includes persons from the disciplines or codified. Research centers are different of epidemiology, microbiology, from other academic units, and are relatively pediatrics, infectious disease, nursing, independent of the existing structure of economics, health policy, education, a university. This means that they can statistics, economics, informatics, and undertake innovative research agendas public health. The goals of this Center free of the regulations of accrediting were not only to develop a research organizations, the routine activities inherent agenda that would have an impact on in administering educational programs, and the obligations of participation in university the global problem of antimicrobial administrative activities. They are – or are resistance, but also to establish a vital, intended to be – interdisciplinary, so that sustainable interdisciplinary research

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 29 process. Despite the recognized need for sustainability of centers (e.g. funding); for interdisciplinary collaboration in (d) increase networking and communication biomedical research, there are structural among interdisciplinary research centers; and cultural disincentives within the and (e) exchange successful strategies for academic setting that must be overcome. enhancing minority and gender balance Hence, we developed a series of strategic in interdisciplinary research centers, as initiatives to systematically examine well as the balance of junior and senior researchers. Because no list of such centers the structure, processes, and outcomes existed at the University, we searched necessary for an interdisciplinary websites and polled departments and research center to thrive. schools to identify relevant centers, using the following criteria: the center had to One of our first orders of business was be interdisciplinary with a major research to review bodies of literature from mission and have current external funding business, education and health care to from the government, foundations, and/or adapt and develop our own definition of professional organizations. We identified 65 interdisciplinarity which could then be centers across Columbia University that met used to identify the competencies needed these criteria and contacted directors either for successful interdisciplinary research directly by telephone or email. practice. From this literature review an initial definition was developed and small While there was some initial skepticism modifications were made after field testing. among directors and academic We defined interdisciplinary research as administrators about whether such a any study or group of studies undertaken meeting would yield a useful outcome, the by scholars from two or more distinct majority of center directors were enthused scientific disciplines. The research is and supportive, noting that there was little based upon a conceptual model that links opportunity for such interface. The forum or integrates theoretical frameworks from was convened in November 2005 with 59 those disciplines, uses study design and attendees from 29 different centers. Also methodology that is not limited to any one in attendance was a project officer from field, and requires the use of perspectives NIH, the vice president of the university, and skills of the involved disciplines and several deans. Eight center directors throughout multiple phases of the research and two moderators, who also serve as process. The process we used to address center directors, formed two panels to lead the definitional aspects of interdisciplinary discussions responsive to each of the aims of research has been described elsewhere the forum, and there was considerable input

(Aboelela et al., 2007). from the entire audience. Three professional staff members took extensive notes, panels Our second strategic initiative was were audiotaped, and consistent themes to convene a group of directors of were summarized at the end of the day by interdisciplinary research centers in a half- a skilled facilitator. Summarized below day symposium to accomplish five aims: are the thematic challenges identified (a) identify characteristics essential to by participants, discussion regarding successful interdisciplinary research centers; the interface of the centers and the (b) assess challenges in the operation of a university, and a summary of issues and research center and strategies to deal with recommendations that emerged from this these challenges; (c) discuss mechanisms conference.

30 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration The Challenges Identified facing research centers fall into 3 categories The following represents a qualitative (Table 1): fiscal sustainability, recruiting summary of the discussion that ensued. and retaining faculty, and leadership Our review of the conference proceedings sustainability. suggests that the challenges to success Table 1

Summary of Challenges Identified by Interdisciplinary Research Center Directors Challenge Specific Issues

Fiscal sustainability Need to continue seeking external funding; Loss of indirect cost recovery between grants or with some funding agencies; Extensive negotiations needed for new resources such as space, personnel, administrative support; Bridge funding during short unfunded intervals (i.e., between grants)

Recruiting and Some faculty do not fare well in an interdisciplinary environment; retaining faculty Willingness to learn new language and constructs of other disciplines; Need to satisfy disciplinary departmental promotion criteria; Changing faculty needs over the lifespan of a center; Providing incentives for faculty involvement (e.g., pilot funds); Varying expectations of roles across disciplines; No mechanism for hiring faculty outside an established department

Leadership Administrative demands interfere with time for science; sustainability Maintaining a center when a founding charismatic leader leaves or changes

Fiscal Sustainability or enlarge their research programs. These Many, but not all centers at the university new grants, however, often raised challenges began with a substantial research grant. A for the centers, especially when they small number began with funding from were written by faculty from disciplinary school or university administration or from departments who had joined the center. The an outside gift. This initial funding allowed new grants brought indirect cost recovery the centers to become established and to (ICR) funds, the distribution of which embark on their programs of research, and among the university, schools, departments, also financed or enabled a request for space and the center itself had not always been and other resources, such as administrative clearly contemplated at the establishment support. of the center. Centers often required new resources – space, faculty, or administrative Over time, center financing evolved. support – and center directors complained Successful centers generally obtained that obtaining these resources sometimes additional outside grant support to continue necessitated extensive negotiation.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 31 Policies with respect to the distribution of Challenges around faculty arose for ICR funds varied considerably across the three reasons. First, the center directors University. Center directors noted that the agreed, excellent disciplinary researchers ability to maintain control of some ICR committed to a problem area and excited funds facilitated the task of maintaining by the prospect of collaborating with the center over time. Centers with well- others may nonetheless fail to thrive in an established protocols for sharing ICR with interdisciplinary research environment. disciplinary departments also found that this Centers depend on faculty who are both practice brought them needed support from rigorous scholars and can function well in an the departments. Centers without access institutionally unusual environment. They to ICR funds, especially those without must be willing to learn the language and an outside endowment, had to develop constructs of other disciplines. They must strategies that would allow them to make have, as one center director put it, a high longer term commitments to participating level of intellectual curiosity, tolerance for faculty. ambiguity, and ability to play with others.

In some cases, centers experienced an Center directors struggled with identifying interval between grants when funding was such individuals and with the problems insufficient to maintain core resources. created by members who did not fit this Generally, centers did not have guaranteed bill. Some faculty members were simply sources of bridge funds for these not interested in spending the time necessary circumstances. Those larger centers that to work across disciplines or sharing their both held many grants simultaneously and perspectives and research interests with obtained a share of ICR funds sometimes others, i.e. they were not cut out for an had some wiggle room, but centers with interdisciplinary environment. Many found fewer grants found it difficult to set aside a that younger faculty members were more share of funds (from whatever source) and malleable and fit into the center better than had to negotiate bridge funding. Center did more established scholars. The need to directors agreed that reliance on direct satisfy disciplinary department promotion federal grant funding alone was problematic. criteria, however, can make participation in They noted that having a diversified an interdisciplinary center difficult for junior portfolio of financial supporters (including faculty. Moreover, centers cannot function a combination of government, industry, exclusively with young faculty. They need foundations, endowment, and university more senior faculty members to act as funds directly or through ICR) helped “heavy hitters” and obtain substantial grants, provide stability. as well as to manage the administrative tasks of the center even though some may be less Recruiting and Retaining Faculty accommodating than junior faculty. The initial development of a center generally required identifying faculty across Second, centers needed to retain and disciplines with an interest in a topic area. replenish the ranks of their faculty over Successful centers had identified research time. Center directors needed strategies for areas where there was a widely shared sense faculty recruitment and retention throughout of need for more collaborative work. Several the life of a center. They reported that the center directors remarked that they had been establishment of core facilities often acted flooded with requests to participate when the as a magnet that drew and held faculty to the center was first developed. center. Many centers offered pilot grants and seed money to investigators.

32 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Moving beyond pilot projects required new The center may saturate a department with kinds of collaboration and communication faculty. In these situations, the boundaries among center members. Conference between the department and the center participants pointed out that such may disappear altogether. One university communication can be difficult. For administrator noted that in this situation it example, the culture of the private sector might make more sense to convert the center where interdisciplinary collaboration has into a department of its own. been most successful emphasizes discovery and application of profitable products, Leadership Sustainability while academics may be more interested in The final set of challenges facing centers mechanisms and new discoveries. In other concerned leadership. Center directors cases, collaborators may have very different must be charismatic advocates for their styles of communication, as well as different research areas and for the enterprise of perspectives on sharing and ownership. interdisciplinary research. They must be Because of the nature of the work, some able negotiators, finessing arrangements disciplines may have varying vocabularies with university administrators, department and methods, expectations about the pace chairs, and both accommodating and less or hours to be worked and standards of accommodating center members. The proof. Some investigators favor rapid nature of interdisciplinary work means publication of each new finding; others that they must do all this in a collaborative prefer to amass a body of work for a single rather than a dictatorial style. Finally, they large publication. Some are open to large must be skilled administrators. Several teams and data sharing while others prefer to directors understandably complained that minimize interactions. Thus, working and the administrative demands of managing a communication styles played important roles center were very time consuming. in attracting or failing to attract and retain Centers are generally developed because faculty over time. an individual with this rare combination The need to recruit new faculty often of qualities initiates them. Problems may generated a third problem. At this arise over time, however, when these university, as at most others, only pioneering leaders seek to share the burden disciplinary departments may make faculty of management or leave their positions. appointments and promotions. In some Center directors noted that new leadership cases, centers may appoint researchers was likely to be drawn from the ranks of using non-professorial titles. Several center senior center members who viewed this role directors noted that these titles were less as a professional obligation. valued in the university than traditional Centers and the Institution titles. Center directors often needed All three of the challenges we identified to work with disciplinary department arise from the problem of establishing the leadership to recruit faculty who were natural lifecycle of a center. Problem- expected to participate exclusively in center responsive centers are fundamentally activities. One center director suggested different from existing university that permitting joint appointments between a institutions. They occupy a place between department and a center might facilitate such academic departments and individual recruitments. grant-funded projects, both institutional In some cases, centers draw in most of the forms with well-understood lifecycles. Our faculty of a given disciplinary department. university, and we suspect most others, does

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 33 not have established criteria for defining committees. Universities also have when centers should be established, how procedures for recruiting departmental they should be sustained, and when they leadership, whether through a system should be closed. Individual grants are of rotation or a search process. Finally, initiated by faculty and usually managed most universities have formal systems in the context of an academic department. of departmental review, during which They begin on the funding date and end outside committees periodically assess the (usually) when the grant expires. Financing, performance of each department. personnel, and leadership throughout the grant period are clearly specified in the grant Centers fall somewhere between individual proposal and funding statements. grants and departments. They begin with much more university buy-in than would an Departments are developed very slowly. individual faculty member’s grant proposal. Generally, the formation of a department Since interdisciplinary research centers exist requires several layers of academic to address a new area of research, they do approval from the school, the university not require all the steps needed to establish administration, the faculty senate, the board a department. Centers generally have a of trustees, and sometimes the State. To specific mission statement and aims defining initiate a department, a school must clearly the proposed scope of the center. Unlike define the discipline represented, the the case of a grant, however, this statement teaching need and academic mission, and generally does not specify when the work availability of appropriate resources to meet of the center will be completed or what the the articulated needs. Once established, criteria would be to close the center. a department is built on the financial and scholarly bedrock of its teaching mission. Research centers, unlike academic Sufficient faculty must, at the very least, departments, often do not collect teaching be retained to teach courses required by revenue. Most depend on the school or accrediting agencies. These agencies, in university administration to help them turn, provide an outside force prompting maintain fiscal sustainability, either through the university to maintain the viability of ICR sharing or direct commitments. the department. Teaching revenue, while Without pre-specified guidelines about often limited, provides a stable backstop what constitutes center success and what against volatile outside “soft money” the university’s commitment to the center funding. Closing a department, a very rare will be, center directors cannot always rely event, likewise requires a series of steps, upon these potential funds. This lack of and the academic institution usually remains dependable funding leads center directors to responsible for compensating any tenured seek independent endowment support. This, faculty in a department that is closed. in turn, can pose challenges to the university if the rationale for the existence of the Demands from students, accrediting center no longer exists or if centers compete agencies, and others, and the existence of with other university priorities for outside teaching revenues, require that universities funding. have well-established procedures for evaluating and maintaining their academic Further, centers usually do not have a departments. Procedures exist to recruit natural constituency, unlike departments, faculty when positions become available, which can depend on their current students and to promote faculty through promotions and alumni, as well as accrediting agencies,

34 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration to advocate on their behalf. Several of the to govern ownership of work products center directors at our conference spoke and data, material transfer, and academic- of their efforts to develop a constituency industrial agreements. In general, external in the outside community to provide them collaboration cannot proceed without with leverage as they built their centers. involving the institution. Although An outside constituency relieves some of guidelines or regulations do not explicitly a center director’s burden to continuously cover many aspects of collaboration, justify the university’s commitment. the goal should be communication that clarifies expectations of all parties involved. There is generally no established procedure For these reasons, policies, procedures for sustaining leadership in centers. In and principles for management of the case of a single grant, the life of the interdisciplinary research centers need to be grant is coincident with the participation explicit. of the lead investigator. In the case of a department, the existence of the department The challenges of interdisciplinary research is independent of the present leadership. centers highlighted by participants in In the case of a center, leadership and this conference—fiscal sustainability, existence are intertwined. If a university recruiting and retaining faculty, and has no systematic procedures for deciding leadership—have been recently summarized when a center is successful or should in a report published by the National be perpetuated, the decision to maintain Academy of Sciences (2004). To our leadership for a center is made separately in knowledge, however, our symposium was each case. the first formal meeting of a large cadre of research center directors to address the Centers should not be departments. They aims we articulated. While there remain should come into and out of existence at many universities structural challenges more easily and fulfill missions that to interdisciplinary research (e.g. policies departments cannot. But as centers become and processes for sharing of ICR funds), an increasingly important component of we recognized that the major challenges as the university’s institutional life, more well as the major sources of gratification formal procedures are needed to monitor associated with research centers are their establishment, continuation, and interpersonal as well as institutional. termination. These procedures will help the university control its overall operations This conference served to facilitate and and ensure the quality of the centers. It support an institutional shift towards an will also help center directors, who will be environment in which interdisciplinary able to rely on a set of defined privileges efforts thrive. This is well within the ethos and obligations as they strive to build their of the university whose faculty strive to faculties and research programs. work in collaboration with those outside of their own disciplines. Following this Summary and Recommendations conference, a senior staff member was The process of collaboration requires hired by the university to focus on the institutional and individual commitment, but development and support of interdisciplinary formal partnerships such as research centers research. Based on the proceedings of are regulated primarily at the institutional the conference, we make the following level. Nearly all institutions have rules and recommendations for institutions in guidelines for interdisciplinary research which interdisciplinary research centers

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 35 are housed:(a) maintain a database of References interdisciplinary research centers within a Aboelela, S., Larson, E., Bakken, S., centralized office (e.g. grants and contracts Carrasquillo, O., Formicola, A., or research office) for the purposes of Glied, S., et al. (2007). Defining networking and tracking; (b) provide interdisciplinary research: Conclusions an ongoing forum for interaction among from a critical review of the literature. directors and members of interdisciplinary Health Services Research, 42 (1Part 1), research centers; (c) establish criteria for 329-346. defining when centers should be established, Committee on Facilitating Interdisciplinary how they should be sustained, and when Research, National Academy of they should be closed (i.e., what the natural Sciences, National Academy of lifecycle of a center should look like); (d) Engineering, Institute of Medicine. clearly identify individuals/offices within Andreasen, N.C., & Brown, T.L. the institution that are responsible for (2004). Committee on facilitating policies regarding issues such as indirect interdisciplinary research. In cost sharing, faculty recruitment into Facilitating interdisciplinary research centers and/or departments, and other (p. 20). Washington, D.C.: The administrative policies that influence National Academies Press. center operations and success; (e) provide Giacomini, M. (2004). Interdisciplinarity support for development of interdisciplinary in health services research: Dreams leadership skills; (f) develop formalized and nightmares, maladies and remedies. mechanisms to assure that interdisciplinary Journal of Health Services Research activities are acknowledged and rewarded Policy, 9, 177-183. in the faculty promotion and tenure process; Mallon, W.T., & Bunton, S.A. (2005). and (g) explore the role of interdisciplinary Research centers and institutes in U.S. centers in developing and contributing to medical schools: A descriptive analysis. coursework designed to prepare researchers Academic Medicine, 80, 1005-1011. with interdisciplinary expertise. Robertson, D.W., Martin, D.K., & Singer, P.A. (2003). Interdisciplinary research: Putting the methods under a microscope. BMC Medical Research Methodology, 3, 1-5.

36 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Why Academics Have a Hard Time Writing Good Grant Proposals Robert Porter, Ph. D. Program Development Manager, Research Division Virginia Tech 340 Burruss Hall, MC0244 Blacksburg, VA 24060 (540) 231-6747 [email protected] Author’s Note This paper was presented as part of the 2006 Symposium at the annual October meeting of the Society of Research Administrators International in Quebec City, where it was awarded Best Paper of the Year. Abstract This paper discusses the contrasting perspectives of academic prose versus grant writing, and lists strategies grant specialists can use to help researchers break old habits and replace them with techniques better suited to the world of competitive grant proposals.

Introduction the relationship between workplace When they are new to the grant game, experiences and supervisor-targeted even scholars with fine publishing records aggression. Indeed, despite the can struggle with proposal writing. Many differential effects of situational are surprised to find that the writing style and individual difference factors that made them successful as academics on aggression, it is notable that the is not well suited to crafting a winning individual difference factors exerted proposal. To succeed at grant writing, a consistent but relatively low-level most researchers need to learn a new set of effect on aggression across contexts, writing skills. whereas the more salient situational experiences exerted context-specific Academic Writing effects. (Inness, Barling, and Turner, For purposes of this discussion “academic 2005) writing” is defined as that style commonly adopted for scholarly papers, essays, and Look at the Difference journal articles. The following is a typical To start, glance at the first pages in any example: sampling of winning grant proposals. The Taken together with the findings from first thing you notice is that they look the present study that (a) workplace different from pages in typical academic aggression in the primary job was more journals. Sentences are shorter, with key closely associated with negative work phrases underlined or bolded to make them experiences and (b) both situational stand out. Lists are printed bullet style. and individual characteristics played Graphs, tables and drawings abound. Now a role in aggression in the secondary read the pages more carefully. The writing job, future research might benefit is more energetic, direct and concise. The from a greater focus on the subjective subject matter is easy to understand, as salience of the job as a moderator of there are fewer highly technical terms.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 37 Each time you learn something about incomplete. The evaluation methods might a subject entirely new to you. You are be inadequate. The researchers may not be intrigued by exciting new ideas that have qualified to carry out the work. But all too a good chance for success. In short, you often, the core problem in a failed proposal quickly agree that the review panels made lies in the writing itself, which bears too the right choices in funding these proposals. many characteristics of academic prose. (A baffled professor once came to my office The lesson here is a hard one for beginners: bearing the written critiques he had received Success in grant writing is a matter of style from reviewers of a failed proposal. One of and format as much as content. Make no them included this killer remark: “Reads mistake—the best written proposal will not like a journal article.”) win money for a weak idea. But it is also true that many good ideas are not funded Contrasting Perspectives because the proposal is poorly written (New To understand the dimensions of the & Quick, 1998; Steiner, 1988). Sometimes overall problem, consider the contrasting the failure is due to a weak or missing perspectives of academic writing versus component that is key to a good proposal. grant writing: The research plan may be flawed or Table 1 Academic Writing versus Grant Writing: Contrasting Perspectives Academic Writing Grant Writing

Scholarly pursuit: Sponsor goals: Individual passion Service attitude Past oriented: Future oriented: Work that has been done Work that should be done Theme-centered: Project-centered: Theory and thesis Objectives and activities Expository rhetoric: Persuasive rhetoric: Explaining to reader “Selling” the reader Impersonal tone: Personal tone: Objective, dispassionate Conveys excitement Individualistic: Team-focused: Primarily a solo activity Feedback needed Few length constraints: Strict length constraints: Verbosity rewarded Brevity rewarded Specialized terminology: Accessible language: “Insider jargon” Easily understood

38 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Scholarly Pursuit versus Sponsor Goals in perspective that seasoned scholars find Driven to make unique contributions to their difficult when starting to write proposals. chosen fields, scholars habitually pursue their individual interests, often with a good Theme-Centered versus Project-Centered deal of passion. When seeking financial Scholarly writers are prone to dwell on support for these endeavors, however, theme, thesis and theory. Essays and books many find that potential sponsors simply can be devoted to the authors’ original do not share their enthusiasm. “A sound thinking, contributions of past and present concept, but it does not fit our current scholars, or the evolution of entire schools funding priorities,” or similar phrases, of thought. They draw us into the realm of are commonly found in letters that deny ideas. Grant writers, however, draw us into funding. With the exception of a few career a world of action. They start by sketching development programs, funding agencies out an important problem, then they move have little interest in advancing the careers quickly to describing a creative approach of ambitious academics. Sponsors will, to addressing that problem with a set of however, fund projects that have a good activities that will accomplish specific chance of achieving their goals. This is why goals and objectives. The overall project is seasoned grant writers devote a good deal of designed to make a significant contribution time parsing grant program announcements, to a discipline or to a society as a whole. highlighting passages that express what Academic writers often seek funding to the sponsors want to accomplish, and what “study,” “examine,” or “explore” some kind of projects they will pay for. Then theme or issue. But this can be deadly, as the writers adopt a service attitude, finding sponsors rarely spend money on intellectual ways to adapt their expertise to match the exploration. They will, however, consider sponsor’s objectives. Finally, they test their funding activities to accomplish goals that ideas with grant program officers before are important to them. It is the project that deciding to write a proposal. As one of our interests them, not just the thinking of the university’s consistently successful grant investigator. Finally, academic essays end writers put it: “My epiphany came when I with their authors’ final conclusions, while realized that grant programs do not exist to grant proposals end with their projects’ make me successful, but rather my job is to expected outcomes. make those programs successful.” Expository versus Persuasive Rhetoric Past versus Future Orientation The academic writer uses language to In academic writing, the researcher is explain ideas, issues and events to the describing work that has already been done: reader. The aim is to build a logical Literature has been reviewed, an issue progression of thought, helping the reader to examined, a thesis presented, a discovery share the writer’s intellectual journey and to made, a conclusion drawn. Grant writers, agree with the core themes of the piece. But by contrast, describe in detail work that they the language in a grant has to be stronger; it wish to do. For some disciplines, good grant must sell a nonexistent project to the reader. writing can be viewed as science fiction, The writer has to convince the reviewer that i.e., it must be grounded in solid science, the proposed research is uniquely deserving. but the research design itself is a set of The whole effort is geared toward building logical yet imagined activities that have yet a winning argument, a compelling case to take place. This in itself is a major shift that scarce dollars should be spent on a

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 39 truly exceptional idea that has an excellent Perched at a desk, in the library or at home chance for success. Grant reviewers are in the den, the solitary scholar fills page a notoriously skeptical lot who reject a after page with stolid academic prose. When majority of proposals, so writers must the paper or book chapter is completed, it use language strong enough to win their may be passed to one or two readers for reluctant support. In effect, a good proposal final proofing, but the overall endeavor is is an elegant sales pitch. highly individualistic. Good grant writing, however, requires teamwork from the outset. Impersonal versus Personal Tone Because their ultimate success depends upon From their undergraduate term papers to nearly unanimous approval from a sizeable their doctoral dissertations and numerous group of reviewers, grant writers place high papers that followed, scholars have been value on feedback at every phase of proposal conditioned to generate prose in proper writing. Before the first draft, a thumbnail academic style—cautious, objective and sketch of the basic concept will be sounded dispassionate, exclusively focused on the out with colleagues before sending it on to topic, with all evidence of the writer’s a grant program officer to test whether the persona hidden from view. Grant writers, idea is a good fit. Large multi-investigator however, seek the reviewers’ enthusiastic proposals are typically broken into sections endorsement; they want readers to be to be written and rewritten by several excited about their exemplary projects, so researchers, then compiled and edited by they strive to convey their own excitement. the lead writer. Many large proposals are They do this by using active voice, strong, submitted to a “red team” for internal review energetic phrasing, and direct references to before sending them out to the funding themselves in the first person. Here are some agencies. Even single investigator proposals examples: have been combed over repeatedly as the Our aim with this innovative curriculum documents move from first draft to the final is to improve the supply of exceptionally product. Proposals that bypass this essential skilled paramedics with National process have a much greater chance of Registry certification. failure.

This project will provide your grant Length versus Brevity program with a powerful combination Verbosity is rewarded in academe. From of cutting edge nanoscale science extended lectures to journals without page and frontier research in applied limits, academics are encouraged to expound geochemistry. at great length. A quick scan of any issue of Though we launched this large and The Chronicle of Higher Education reveals ambitious program just two years ago, the degree to which simple ideas can be we are gratified by the regional and expanded to multiple pages. A common national awards it has garnered. technique is to stretch sentences and paragraphs to extreme lengths. Consider Sentences like these violate editorial rules of the following example, which won a Bad many scholarly journals. Writing Contest sponsored by the journal Philosophy and Literature: Solo Scholarship versus Teamwork The move from a structuralist account in With the exception of co-authored work, which capital is understood to structure academic writing is mostly a solo activity. social relations in relatively homologous

40 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration ways to a view of hegemony in which over us when we know our writing will power relations are subject to repetition, be evaluated, either by editors or by grant convergence, and rearticulation brought reviewers: We want our work to appear the question of temporality into the scholarly, so we habitually inflate our prose thinking of structure, and marked a shift with large words and complicated sentences from a form of althusserian theory that to achieve the effect of serious thinking. takes structural totalities as theoretical Unfortunately, such tactics have the opposite objects to one in which the insights into effect on readers. Alley (1996) shows the contingent possibility of structure how too many big words and convoluted inaugurate a renewed conception expressions can result in muddled jargon: of hegemony as bound up with the The objective of this study is to contingent sites and strategies of the develop an effective commercialization rearticulation of power. (Butler, 1997) strategy for solar energy systems by analyzing the factors that are impeding An extreme example perhaps, but its commercial projects and by prioritizing characteristics can be seen in many scholarly the potential government and industry essays. actions that can facilitate the viability of Grant reviewers are impatient readers. the projects. Busy people with limited time, they look A sentence like this could kill a grant for any excuse to stop reading. They are proposal on the first page. Grant writers quickly annoyed if they must struggle to cannot afford to lose even one reviewer in understand the writer or learn what the a barrage of obtuse phrasing. They must project is all about. Worse, if the proposal use language that can be understood by a does not intrigue them by the very first page, diverse group of readers, some of whom they will not read any further (unless they may be as highly specialized as the writer, must submit a written critique, in which but most will be generalists. Reworking the case they immediately start looking for cumbersome structure above, Alley comes reasons to justify why the proposal should up with simpler, more accessible language: not be funded). When asked to describe the This study will consider why current characteristics of good grant writing, senior solar energy systems have not yet reviewers put qualities such as “clear” and reached the commercial stage and will “concise” at the top of the list (Porter, 2005). evaluate the steps that industry and Brevity is not only the soul of wit; it is the government can take to make these essence of grantsmanship. Or, to cite Mies systems commercial. van der Rohe’s famous dictum about modern architecture: “Less is more.” Fewer words with greater clarity—a tradeoff that will improve the score of any grant Specialized Terminology versus Accessible proposal. But how can one consistently Language strike a balance between scholarly precision Every discipline uses specialized and meaning that is clear to a mixed terminology, much of it dictated by the audience? One NIH web site on grant need to convey precise meaning. But there writing advises writers to study articles reaches a point where specialized words published in Scientific American (National become needlessly complex and the reader Institute of Allergy and Infectious Diseases becomes lost in a tangle of dense verbiage. [NIAID], 2006). Here world class scientists As Henson (2004) points out, a spell comes use accessible language to teach a general

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 41 readership about complex subjects while those focusing on specific funding agencies. simultaneously informing them of cutting Especially popular are presentations by edge developments. Good proposals do the successful grant writers and copies of same. The following excerpt is from a recent winning proposals (Porter, 2004). Scientific American article on stem cells and cancer research: 2. Reading Successful Proposals Conventional wisdom has long held that Winning grants teach by example. By any tumor cell remaining in the body perusing several, the new grant writer could potentially reignite the disease. will note some common differences from Current treatments therefore, focus on accepted academic style, and can be killing the greatest number of cancer encouraged to mimic them. Successful cells. Successes with this approach are proposals from one’s own institution still very much hit-or-miss, however, can be put online, with access limited to and for patients with advanced cases internal researchers. Copies of winning of the most common solid tumor proposals can also be purchased from The malignancies, the prognosis remains Grant Center at reasonable rates: www. poor. (Clarke & Becker, 2006) tgcigrantproposals.com. Finally, successful proposals can be obtained directly from Clinically accurate yet easily federal agencies under the Freedom of understandable, this would be a fine Information Act, but be prepared to wait introduction to a grant proposal. several months for the documents to arrive, with sensitive information deleted. Remedial strategies Given the contrasting perspectives listed 3. Editing by a Grants Specialist above, what can the university research While no amount of editorial polishing office do to help academics adapt to the can save a weak idea, a seasoned grant unfamiliar standards of grant writing? First, writer can add value to a sound concept by recognize that no one likes to be told they judicious editing. This is labor intensive at do not write well, especially highly educated first but once the writer catches on to the folk who are justly proud of their intellectual simpler, livelier style of grant writing, the achievements. Nevertheless, proactive and need for personal attention drops off rapidly. tactful research administrators can do much to help instill good proposal writing habits. 4. Red Team Reviews Here are five remedial strategies that instruct Writing a strong proposal for a major without offending. multidisciplinary grant is a challenging project all by itself, one that can overwhelm 1. Home-Grown Workshops the researchers, for whom grant writing For young investigators, grant writing is often an additional chore on top of full workshops are an effective way to learn workloads. One effective tool is to form good writing techniques. Home-grown an internal review team consisting of workshops, taught by any combination of experienced senior colleagues. If carefully research office personnel and grant-savvy selected for their expertise and reputations, faculty, can yield positive returns at a very their written comments can have great low cost. Beginning workshops on basic impact. Be warned, however: A considerable grant writing skills should be offered on a degree of gentle but persistent nagging regular basis, supplemented periodically by is required for the writers to have the

42 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration document ready for internal review with References sufficient lead time before the sponsor’s Alley, M. (1996). The craft of scientific deadline. writing (3rd ed.). New York: Springer. Butler, J. (1997). Further reflections on the 5. Writing Tips conversations of our time. Diacritics, Finally, the research office should post a set 27(1), 13-15. Cited in Dutton, D. of simple writing tips on its web site. These (1998). Philosophy and Literature are most helpful if examples of bad writing announces winners of the fourth bad are contrasted with effective revisions. writing contest. Retrieved June 5, 2006, Seeing them side by side, readers will from http://www.aldaily.com/bwc.htm quickly spot which bad characteristics are Clarke, M., & Becker, M. (2006). Stem their own, and will note how they can craft cells: The real culprits in cancer? better versions. Alley’s work, in particular, Scientific American, 295(1), 53-59. is peppered with numerous examples of Henson, K. (2004). Grant writing in higher weak composition contrasted with more education. Boston: Allyn & Bacon. effective phrasing. A truly time tested source Inness, M., Barling, J., & Turner, N. is Strunk and White’s familiar Elements (2005). Understanding supervisor- of Style (2000). Versions of this concise, targeted aggression: A within-person, lively handbook have been popular for between-jobs design. Journal of Applied nearly half a century, and its instructions for Psychology, 90(4), 731-739. crisp and vigorous writing will give heart National Institute of Allergy and Infectious to academics who are trying to break old Diseases. (2006). How to write a grant habits. application. Retrieved June 20, 2006, Conclusions from www.niaid.nih.gove/ncn/grants/ As competition intensifies for limited write/index.htm research dollars, proposal success rates New, C. C., & Quick, J. A. (1998). for most agencies are declining. To be Grantseeker’s toolkit. New York: Wiley. successful in this environment, proposals Porter, R. (2004). Off the launching pad: must be written in a strong, persuasive Stimulating proposal development by style, and academic writers accustomed to junior faculty. The Journal of Research a different style need help to develop more Administration, 35(1), 6-11. effective writing habits. Such leadership can Porter, R. (2005). What do grant reviewers be provided by a proactive research office really want, anyway? The Journal of that is sensitive to this pervasive need. Research Administration, 36(2), 47-55. Steiner, R. (1998). Total proposal building. Albany, N.Y.: Trestletree. Strunk, W., & White, E. B. (2000). Elements of style (4th ed.). New York: Longman.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 43 Internal Grant Competitions: A New Opportunity for Research Officers to Build Institutional Funding Portfolios Rengarajan V. Balaji, MS, MBA, CRA, Research Grants Development Coordinator 232 Grosvenor Hall Ohio University College of Osteopathic Medicine Athens, OH 45701 Phone: 740-593-2304 Fax: 740-593-2320 E-mail: [email protected]

Christine Knisely, MA Executive Director Office of Research and Grants

Jack Blazyk, PhD Associate Dean for Research and Grants Office of Research and Grants Ohio University College of Osteopathic Medicine, Athens, OH 45701 Authors’ Note The material presented in this manuscript is not based on any presentation or dissertation. To the authors’ best knowledge, no financial or other conflicts of interest exist, including specific financial interests and relationships and affiliations relevant to the subject of their manuscript. The competitive grant program described in this article was funded by the College of Osteopathic Medicine at Ohio University. The authors wish to thank Dean Jack Brose, D.O., and the College’s Research and Scholarly Affairs Committee for their strong support in implementing this program. The authors also wish to thank Jessica Wingett and Suzanne Vazzano for their administrative support. Abstract The Ohio University College of Osteopathic Medicine in 2005 created an innovative competitive grant program aimed at stimulating faculty to submit more and better NIH research proposals, thereby increasing the probability of success. In this internal competition, three experienced external reviewers critique each proposal and assign a priority score, mirroring the NIH review process. An internal panel then selects the two to three best proposals to receive $20,000 awards, contingent upon submission to NIH of a revised proposal that incorporates the comments and suggestions of the reviewers. Thus, the awardees receive additional resources to move their project forward. Moreover, all participants benefit from the constructive reviews, the “free” review cycle (in addition to the NIH “three- strike” system), and the excellent learning experience in grant preparation, revision and submission of competitive proposals. Academic researchers and administrators, particularly at smaller, less research-intensive institutions, today face a challenging environment with increased competition for a limited funding pool. Under such circumstances, an internal grant development program may be a great avenue for mentoring and education for faculty, and

44 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration also serve as a cost-effective investment for research officers to increase external research funding as well as enhance the research skills of faculty.

Key Words: Grant, NIH, research administration, mentoring program, seed money Introduction cycle, it is not uncommon for applicants The National Institutes of Health (NIH), the to spend up to two years revising and predominant funding agency for biomedical resubmitting their proposals before receiving research in the United States, was allocated a final decision on funding. In the absence $29.24 billion for its fiscal year 2007 budget, of sufficient institutional support, this time an inflation-adjusted decrease of 1.2% lapse can significantly hinder a research from the previous year (National Institutes project. of Health, 2007). At the same time, NIH expects the number of grant proposals Sufficient preliminary data to demonstrate to increase by 6.5% in 2007 (Zerhouni, the feasibility of the applicant’s hypothesis 2006). This is compounded by the decline is one of the key factors that increase in success rates for new NIH R01 research reviewers’ enthusiasm for a grant proposal. grants from about 25% in 1998 to 16.3% in In a proverbial Catch-22, however, 2006 (NIH, n.d.). At the same time, many limited resources can delay or prevent the academic institutions are attempting to generation of preliminary data required for increase federal research grant funding. For a successful proposal. Hence, it would be smaller, less research-intensive institutions, helpful to have a targeted source of funding the situation is even more challenging if they for a promising proposal that may not be are to compete with their more research- funded in the first submission. intensive counterparts. This article describes a novel Funding decisions at NIH are based competitive grant program that we believe primarily on the critiques provided by the can help address some of the problems reviewers who serve on study sections. discussed above. Faculty compete for While this system is necessary to ensure that $20,000 awards by submitting NIH research only the best and most worthy proposals grant proposals for internal review. Our are funded, it can be a slow process. With program is intended to increase both the the Roadmap program, NIH is streamlining quantity and quality of grant proposals the application process and encouraging submitted to NIH and to provide incentives more applicants by revising the review to enhance chances of funding in a timely criteria, transitioning to the electronic manner. Similar programs can be adapted grant application system and introducing and further customized to meet the needs a new award mechanism targeted toward and objectives of individual institutions. beginning investigators (NIH, 2004, NIH, The Program at OU-COM 2006 & NIH, n.d.). Despite these efforts, The Office of Research and Grants at the the average turnaround time between Ohio University College of Osteopathic grant submission and receipt of scores and Medicine (OU-COM) initiated a program reviews is still five to seven months (NIH, to stimulate the submission of competitive n.d.). Typically, NIH grant programs permit NIH proposals. The aim of this new a maximum of two resubmissions. Because mechanism is to support selected faculty in the overwhelming majority of new proposals continuing their research and gathering more do not get funded during the first review

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 45 preliminary data while their proposals are range), but were not funded and one was under review. unscored, ranking in the bottom half of the applications. Participating faculty are required to complete a full research grant proposal In 2006, the number of applications using the NIH application format. These increased to 12, and two were selected for proposals are then sent to qualified external the award. These applications were revised reviewers from across the nation. Reviewers and submitted to NIH for grant deadlines in are recruited with not only the necessary early 2007; NIH review of these proposals is expertise in the scientific area of the grant pending. We strongly encourage the faculty proposal, but also with a track record of NIH who did not receive internal college funding funding and experience with the NIH review to use the reviewers’ critiques to strengthen system. The reviewers, who are paid a their proposals prior to submission to NIH. modest honorarium, are instructed to critique the proposals based on NIH’s standard Discussion review criteria and to assign a priority More and more faculty at smaller academic score, just as they would do as part of an institutions are abandoning efforts to NIH study section. The call for proposals secure federal research funding because of is sent to faculty during the summer (July/ increased teaching loads, stark competition August), with milestones and deadlines set for an ever-diminishing pool of grant in such a way that the applicant will be able monies, and lack of resources to generate to complete a significantly revised version of the strong preliminary data required to the proposal for submission to NIH during produce competitive grant proposals. It is, the February/March cycle of the following therefore, important to provide assistance year. and incentives to faculty, so they can focus and refine their research efforts, and increase Based on the critiques provided by the their chances for success in securing external reviewers, an internal panel of NIH- external research grant funding. Institutions funded faculty members at Ohio University faced with this situation may be well- recommends up to three proposals for advised to consider a competitive internal $20,000 awards, using funds allocated by the grant program, such as the one described College. Because this award is restricted to here. OU-COM’s faculty members, any potential conflicts of interest were minimized by Why is this Program Important for recruiting panel members from outside the Research Offices and Administrators? college. The $20,000 awards, coupled with The basic concept of internal grant funding the prospect of receiving expert reviews opportunities to help investigators garner prior to submission to NIH, provide a strong preliminary data is not unique. Many incentive for faculty members to take part in universities and medical schools (including the program. University of Iowa Medical School, University of Minnesota Medical School, When the competition was initiated in 2005, Georgia State University, University eight applications were received, of which of Mississippi, Auburn University and three were selected for the internal award. University of Texas) have similar programs. Of these three, two proposals received However, there are certain important respectable priority scores at NIH (160-175 distinctions between existing programs

46 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration and OU-COM’s. The key innovations of between proposal submission and our program are: (a) by mirroring NIH’s applicants’ receipt of critiques from requirements, duplication of efforts during external reviewers through this program grant submission is avoided, making the was only two months, which is a grant review and submission process more 60-70% reduction in the average review efficient for both the research office and time at NIH. The program is designed the researcher; (b) of the internal funding so that proposals can be revised based mechanisms that were identified, none had a upon the reviews received in December requirement of an external grant submission and submitted to NIH for the February/ tied to the program, nor did the proposals go March deadline dates. through a rigorous external review process; 3. Improvement in quantity and quality and, (c) the scope of many of these funding of proposals: A competitive grant mechanisms was limited, e.g., some were program, coupled with institutional restricted to a particular research topic or to expectations, can provide the necessary junior faculty members. incentive for faculty to apply for more grants (quantity). With critiques from Additionally, our experience shows that qualified and experienced reviewers, there are a few overarching advantages to faculty can revise their proposals prior conducting such a program: to submission for external funding and 1. Opportunity for mentoring and greatly improve their chances of funding education: One of the primary by submitting a better proposal (quality). functions of research/grant offices is to educate and mentor investigators 4. The “fourth strike”: Many funding in grant submission and compliance agencies have restrictions on the number with sponsors’ regulatory, scientific of times an application can be submitted. and administrative requirements. At NIH, a research grant application can A competitive grant program can be revised only twice. If the application serve as a good “dry run” for novice is unsuccessful after three attempts, investigators who do not have significant NIH requires applicants to submit a new NIH grant writing experience. This grant (making major changes in specific allows them to experience all of the aims and research plans) for future elements of the grant application applications. Given NIH’s “three-strike” process — preparing biosketches, system, this grant competition program formulating a budget, following the provides one additional review cycle sponsor’s guidelines, assembling the (the “fourth strike”) to improve the various sections of the grant, honing chances of funding. writing and communication skills, and developing proficiency in using the 5. Resources to advance the research electronic grant application system. project: Participants who receive Finally, the reviewers’ critiques are also $20,000 awards through the grant a key part of this education because they competition are able to advance their examine the soundness and value of the projects and gather more preliminary fundamental hypotheses, and the aims data, serving to jumpstart the project and methods of the project. if funded by NIH or further strengthen a resubmission if the proposal is 2. Reduced review turnaround time and not funded. For example, one of the greater efficiency: The elapsed time researchers selected for the award was

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 47 able to obtain enough preliminary data NIH for 2006 are 7.9%, 27.7% and 46.9%, (using the awarded funds) to publish the respectively (Figure 1) (Bleakley, personal results in a peer-reviewed publication, communication, 2007). These data clearly thus further strengthening his NIH grant show that subjecting a grant to a thorough application. review and revision, and subsequently resubmitting it considerably increases one’s The success rates for new, first amendment chances of being funded. and second amendment R01 proposals at Figure 1. Overall Success Rates for New and Amended R01 Proposals at NIH.

60.0%

50.0% A2 A2 40.0%

30.0% A1

A1 Success rate 20.0%

10.0% New

New 0.0% 2006 2005 A1: Firs t Am endm ent (R evis ion) A2: S ec ond Am endm ent

The key to the success of the grant technical and administrative aspects of the competition lies in the ability to recruit grants, but also showed a strong sense of qualified reviewers who can provide a collegiality and responsibility – a genuine thorough critique of the grant proposals; desire to do a thorough job and provide only then can the program truly simulate the valuable input for the benefit of their fellow stringent review process at NIH. Reviewers, junior researchers. This was well- received who can comment not only on the technical and appreciated by the applicants of the aspects of the proposal but also provide grant competition; the high-quality reviews valuable insight from a study section’s proved to be just as valuable an incentive standpoint, can significantly increase the as the $20,000 award, as indicated by the likelihood of funding. In this regard, our strong increase in the number of submitted program has been fortunate. The external proposals in the second year of the reviewers who participated in this program competitive program. were not only well-qualified to review the

48 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Process identity of the reviewers was not disclosed Creation and Implementation to the applicants. The proposals were The OU-COM grant competition sent to reviewers after obtaining a signed was created in 2005, shortly after the confidentiality agreement. All reviewers announcement of an institution-wide were instructed to prepare a detailed critique initiative for enhanced national prominence of the proposal, conforming to NIH’s review in the areas of research and grant funding. criteria. A modest honorarium was paid While there was strong administrative to reviewers for these services. This grant support for the program, the faculty were competition program was developed and initially less enthusiastic, but have shown administered by the Office of Research and increasing support since the first funding Grants at OU-COM. cycle. The goal of this program is to Timeline stimulate productivity and to provide a A call for proposals was sent during the last process through which faculty members week of July or the first week of August (see improve the quality of their grant proposals. Figure 2 for complete timeline). All faculty As mentioned earlier, the key to the success members interested in responding to the of this program was the quality of the call were instructed to provide some basic external reviewers who had the required information pertaining to their proposal (i.e., scientific background and also understood topic of research; tentative title; program the NIH review process. Significant time announcement number, if applicable; and effort were spent in recruiting at least NIH grant mechanism; etc.). Using this two qualified reviewers per proposal. For information, suitable reviewers were more broadly -defined research topics, recruited. The deadline for faculty to submit three reviewers were recruited for each proposals was the second week of October, proposal. Online web resources such as with reviews completed by early December. PubMed, CRISP database and NIH Study Thus, the applicants had sufficient time to Section rosters were used to identify and revise their proposals and submit them to recruit potential reviewers. To maintain NIH for the February/March deadlines. anonymity and to make the process fair, the Figure 2. Timeline for the OU-COM Grant Competition.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 49 Reflections Conclusion The most valuable product of the grant A competitive internal grant program such competition was the high-quality of the as the one started at OU-COM can help reviews, which provided thorough and to enhance the research climate within constructive suggestions for strengthening an institution, stimulate faculty morale, the proposals. It was impressive to find and encourage friendly competition and that most reviewers were willing to devote productive collaboration among faculty time from their busy schedules, to prepare members. Our experience with this program detailed critiques and to provide pointers has been encouraging, as evinced by the for their fellow researchers’ benefits. In 50% increase in the number of applications fact, a few reviewers even volunteered over the last two years. While supporting to provide additional assistance to the such a program requires a significant applicant beyond the scope of this program. institutional commitment in terms of Such a conscientious effort on the part of both time and money, we believe that this the reviewers was a major contribution to investment will prove to be worthwhile the success of this program, and, in many because of the potential to increase both the cases, was more valuable than the monetary research skills of our faculty and the level of awards. external research funding.

Based upon our experience over the last few References years, we believe that this grant competition NIH establishes website for new program could be further improved in investigators. (2004). Retrieved several ways. First, we could perform a December 25, 2006 from http:/www.nih. preliminary review of the proposals before gov NOT-OD-05-014. they are submitted to the external reviewers. NIH Extramural Nexus. (2007, Through this process, proposals could be March). Retrieved May 15, 2007 screened for completeness, for adherence from http://grants.nih.gov/grants/ to NIH’s guidelines (i.e., page limitation; partners/0307Nexus.htm font size and type; biosketches; introduction NIH Office of Extramural Research. section; budget justification; human subjects (n.d.). Submission dates for competing and animal sections; etc.), and for formatting applications. Retrieved January 10, and grammatical errors. Correcting such 2007 from http://grants1.nih.gov/grants/ errors before sending out the proposals funding/submissionschedule.htm. will allow the reviewers to focus on Standard postmark/ scientific merit with fewer distractions, NIH successfully receives grant applications thereby resulting in more useful comments. electronically through GRANTS.GOV. Secondly, a more rigorous follow-up process (2006, January). NIH Extramural Nexus. is required. To gain the greatest value from NIH success rates by type and activity. the reviewers’ comments, faculty should (n.d.). Retrieved August 29, 2007 from have the opportunity to work closely with http://grants.nih.gov/grants/award/ the research office staff during the revision success/Success_ByActivity.cfm process. Faculty whose proposals were not Zerhouni, E.A. (2006). Research funding. selected for an award should also be urged NIH in the post-doubling era: Realities to make revisions. After revision, these and strategies. Science, 314(5802), proposals may be as competitive in the NIH 1088-1090. review process as those selected for the internal awards.

50 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Application of Standard Project Management Tools to Research – A Case Study from a Multi-national Clinical Trial Peter Gist, Ph.D. Ove Arup & Partners Ltd, UK [email protected] Ove Arup & Partners Ltd 13 Fitzroy Street London W1T 4BQ, UK

David Langley, Ph.D. Director of Research and Enterprise Development, University of Bristol, UK Authors’ Note We recognise the contribution and efforts of a number of key individuals whose work on MDP ensures it is such a well-managed study and who were intimately involved in the development of the tools and reports described in this paper: Dr. Sheena McCormack (MDP Chief Investigator), Professor Janet Darbyshire, Emmanuel Harding, Terry Kenvyn, Clare Rutterford (all from Medical Research Council Clinical Trials Unit, UK), Professor Jonathon Weber, Dr. Lorna Colquhoun, Kathryn Taylor, Ruth Tipples, Claire Puddephatt (all from Imperial College London, UK), Professor Helen Rees (Reproductive Health and HIV Research Unit, University of Witwatersrand, South Africa), Professor Heiner Grosskruth (MRC/Uganda Virus Research Institute, Uganda), Stephen Phillips, Andrew Butt (both from Ove Arup & Partners Ltd, UK), investigators and staff at the trial sites in Africa too numerous to mention by name. MDP is jointly funded by the UK Department for International Development and Medical Research Council, UK. David Langley was previously Director of Research Services, Imperial College London, UK. Abstract PRINCE2, which stands for Projects in Controlled Environments, is a project management method covering the organisation, management, and control of projects and is widely used in both government and commercial IT and building projects in the UK. This paper describes the application of PRINCE2 to the management of large clinical trials (specifically, of a Phase III trial of a candidate microbicide to prevent vaginally acquired HIV infection). It reviews the challenge of ensuring that the project management tools add value to the project overall and are not perceived as an overly administrative burden. It reviews the requirement for high level summary reports for use by an executive committee and funding bodies, highlighting the reasons for taking this approach — in particular, not only to manage the science, but to link expenditure to activities at geographically separate trial sites and to key performance indicators, and to provide tools for monitoring risks and possible re-alignment of budgets to reflect changing activities and outputs by collaborators. The paper considers the wider costs and benefits to researchers and funders of taking this approach and explores implications for research administrators and managers at institutions involved in large, complex collaborative research projects, whether clinical or not.

Key Words: Project management tools, PRINCE2, clinical trial, microbicide, Microbicides Development Programme (MDP), financial controls

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 51 Introduction transmission, funded by the UK Department Although the pharmaceutical industry for International Development (DFID) has well-developed project management and the UK Medical Research Council, methodologies for research, it is unusual and coordinated by the Medical Research for academic researchers working in the Council Clinical Trials Unit, UK and education and public sectors to do so. The Imperial College London, UK. The central discipline that these tools impose can appear goal of the Partnership is to complete a alien initially and often require cultural Phase III trial of candidate microbicides change for the potential value they can bring in Africa. Phase III trials are randomised to be recognised. controlled trials on large patient/healthy volunteer groups (often enrolling several This paper examines the experience of thousand individuals), and are aimed at introducing a standard project management definitively assessing the efficacy of a new tool, PRINCE2, to the management therapy or prevention. Phase III trials are of a large Phase III clinical trial, the invariably expensive, time-consuming and Microbicides Development Programme complex to design and run. These trials look (MDP). Phase III clinical trials are usually at whether the new treatment works and at undertaken by the pharmaceutical industry. any side effects it may cause. Somewhat unusually, the MDP is publicly funded and managed by a partnership of The MDP budget is GBP 42M (USD 75M) academic bodies. Funding is provided and involves thirteen principal scientific by the UK Department for International partner institutions, six of which are African. Development (DFID) and the programme A large number of scientists and clinicians is coordinated by the Medical Research are involved in programme management Council Clinical Trials Unit, UK and functions in addition to their own areas of Imperial College London, UK. The trial sites particular expertise. There are also a number themselves are in Africa. of people focusing on specific areas, such as trial management and communication. The complexity of this particular trial, and the need to communicate and monitor Given the size of the management “burden” progress against budget in a standard format of a Phase III clinical trial and the need to to the funder, DFID, prompted senior communicate progress in a standard format academic staff to modify their approach to to the funder, DFID, in a way that would management and reporting through adopting reflect both the customary approaches elements of PRINCE2. This has proved to trial management and DFID’s usual beneficial for both the trial team and DFID. approach to reporting on projects (not designed specifically for clinical trials), The paper describes what was done in senior academic staff opted to adopt an the MDP case and discusses the costs and approach to project management based on benefits of adopting a similar approach more PRINCE2 methodology. widely in conducting academic-led clinical trials. Features of PRINCE2 PRINCE is a structured method for The Microbicides Development Programme achieving effective project management The Microbicides Development Programme that has evolved in the UK. It was first (MDP) is a partnership to develop vaginal established in 1989 by the UK Central microbicides for the prevention of HIV

52 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Computer and Telecommunications Agency 3) defined resources linked to activities; and as a standard to be used for all government 4) an organisational structure, with defined IT projects, and was subsequently developed responsibilities to manage the project (UK as an approach to project management for all Office of Government Commerce) (Figure 1). projects. Since 1996 it has been a standard requirement that UK public sector projects Typically, these features are captured in a are run using this version of the approach, set of project documents against which aims PRINCE2. and progress are monitored, risks identified and managed, and changes to aims or Key features of the PRINCE2 approach activities controlled. The set of documents include: 1) a clear business case, which sets includes a project initiation document (PID), out the aims of the project; 2) a defined and risk register, issues log, project plan and measurable set of “products” or results, statement of success criteria. together with the activities to achieve them; Figure 1. The Main Components of the PRINCE2 Approach.

C hange C ontrol Business C ase

D irecting a Project C onfiguration Organisation M anagem ent Starting up Initiating C ontrolling M anaging C losing a Project a Project a Stage Stage a Project Boundaries M anaging Plans Quality in a Project Product D elivery Environm ent Planning

M anagem ent of R isk C ontrols

The PRINCE2 approach is not intended to PRINCE2 requires the production of a cover all aspects of management for every summary reporting document to a steering project, and the techniques and tools may group and a related set of supporting vary according to the type of project and documents and processes. The set of organisation carrying it out. Some aspects documents that were considered most of project management are well covered by appropriate for use in the MDP case included other well-proven methods, including people the following: management techniques, generic planning 1. A Project Initiation Document (PID) — approaches (e.g., Gantt charts, critical to summarise in one place the aims of path analysis) and methods for controlling the project, an outline project plan for all budgets. PRINCE2 is a coherent set of project activities and deliverables by all parties, management concepts and processes that resources and budgets, key project provides a minimum set of requirements dependencies (including critical external for a properly run project. But the approach dependencies, e.g., supply of the gel and fully recognises that each project may vary ethics committee approvals), reporting substantially, and that the particular approach processes and governance structure, risks, to effective project management will require and change control procedures. tailoring of the overall method.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 53 2. Detailed Project Plan — a consolidated summaries for use by the project team overall plan of key deliverables, and in reporting to DFID (Figure 2). milestones and timescales. 4. Risk Register – the majority of risks 3. Financial Controls and Reporting in the MDP case were already being Procedures - these include financial anticipated and recorded by the trial profiles that link budgets and management team, but not easily expenditures to activities, as well as the communicated to DFID. This document associated monitoring and corrective collated this information according to action procedures. In the MDP case the groups of activities. Probability the approach that was already being and severity of risks were also noted taken was modified to provide clearer so that priorities could be determined. reporting on progress with the trials A “traffic light” warning system was (e.g., recruiting trial participants at the employed to readily prioritise any risks. trial sites), and matching this progress against proportion of budget used. 5. Issues Log – to record risks that have Financial spreadsheets were adapted become reality and identify what is to produce automatically graphical being done to address them and by whom. Figure 2. Activity and Expenditure Data.

% of Tot a l Budge t Spe nt a nd Ta r ge t A ct iv it y A chie v e d (ba se d on columns D a nd E)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Total Spend

Spend on Diagnostics

Spend on Participant Reimbursement

Enrolment

Total Target Budgeted Actual

As the PRINCE2 approach was being Costs: The MDP Case applied to a project that had already started, In the MDP case an existing approach to it was decided not to create the PID (as the project management was modified. The relevant documentation already existed, information required was already being albeit not in one single document). Emphasis collected and, to a large extent, all of the was therefore placed on modifying the project management functions implied approach to financial monitoring and by PRINCE2 were being implemented. reporting, and on identifying and reporting However, these were not organised in a way risks and issues. that lent itself readily to linking progress and

54 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration planning of expenditures to activities, or to Table 1 summarises the costs associated with reporting in a transparent way that could modifying the existing project management be easily communicated to the funder in a approach for MDP. standard format.

Table 1 Indicative Costs to Modify Project Office Documents and Processes on MDP Activity USD

Review of modifications to project office documents 15,000 • Review current project office documents against PRINCE2 standard • Discussions with PI, MRC Clinical Trials Unit (CTU) • Note to PI, MRC recommending changes to documents • Note to steering committee and DFID on recommended changes Implementation of changes to project office documents 20,000 Note on current process for financial reporting and recommendation on • changes Production of worked example of modified quarterly financial reports (linking • expenditures to activities) • Preparation of outline overall project plan Adjustments to MRC CTU financial reporting spreadsheets to automate • production of quarterly reports Modifications to clinical site financial reporting templates and automation of • data transfer to CTU reports Additional time for project office to implement changes (“one-off costs” only) 40,000

Total additional cost (USD) 75,000

It is likely that these costs would have been Although these benefits are qualitative lower had a PRINCE2 (or similar) approach (we do not attempt to put a financial been adopted at the outset. But this is with measure against them), we believe the most the benefit of hindsight, and it must be important of these will result from more recognised that even for the funder there effective project management and from the was limited familiarity with this approach enhanced relationship with the funding body and hence an iterative process of learning rather than from quantifiable cost savings. and familiarisation. Nevertheless, one of the consequences of Benefits: The MDP Case streamlining the quarterly reports to the The benefits of adopting the PRINCE2 steering committee and funder (DFID) has approach in the MDP case are summarised been that the time required to produce these in Table 2. Some of these are prospective, reports has been reduced. as the trial is still in progress and some of the modifications have yet to be fully implemented.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 55 Table 2 Benefits to MDP from Modified Project Management Improved understanding of the trial process at the funding body (DFID) and confidence • in financial management Ongoing savings in time for team members through standardisation of site reporting and • automatic flagging of variances (for monitoring) between actual and forecast/budgeted expenditures Improvements to project management effectiveness through explicit linking of activities • and expenditure (objective measures aiding process of making future revisions to budgets) Improvements in risk management from modifications to the risk register, and linking of • the risk register to the high level reports Ongoing savings in team project management time from streamlining and automating • financial reports

Wider Benefits managers, and research teams as a whole In the MDP case, a primary reason for if project management is recognised as an reviewing the project office documents was explicit cost item at the project proposal the request from DFID to improve the link stage and project management approaches between expenditure and activities in high are then adopted at the outset of a project. level reporting. As the modifications to the reports were explored, wider benefits to the Table 3 suggests where the main benefits project managers and the team as a whole might arise. The list of benefits reflects to a from the proposed modifications became large extent what has already been shown in apparent. MDP. We also add potential benefits to the research team itself. Our view is that there are substantial potential benefits for funding bodies, project

56 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Table 3 Wider Benefits of Project Management in Research Funder Researchers Research Managers • Provides assurance of value • Improves research team • Improves management of for money through: chances of winning research relationship with funders. • Clear reports of progress funds. • Clarifies the plan, roles and and plans for the next • Aids knowledge transfer responsibilities – reduces period. between team members ambiguity in the project • Clear governance structure (standard reporting and data management task. for decision making accessibility). • Assists with budgetary and for assignment of • Reduces time and risk control (e.g. requires responsibilities. in conveying knowledge academics to engage • Improving confidence between team members. more closely with the link that expenditure is well • Potentially influences between activities and managed (i.e. tied to scientific outcomes by resources). activities – milestones and providing objective criteria • Provides audit trail. deliverables). for targeting efforts/ • Improving confidence that avoiding or managing risks. any risks to milestones or deliverables will be mitigated.

Wider Costs Clearly, in assessing costs adjustments, While the ratios are not rigid, a common one needs to account for: (a) Scope – what rule of thumb in management consulting is will be included in project management, that project management costs represent on e.g., which of the PRINCE2 documents average 3% of total fees. Typically a full- and processes are considered appropriate time project manager is required on projects in each case; (b) Geographical spread of of £3m and over per year. In construction sites (consultant or client) and number of projects a common expectation is that different parties involved (entities/team project management will require 1.5% - 3% size); (c) Number of key decision points of the capital costs, but much depends on envisaged (need to take stock of progress size and complexity and on which functions and adjust plan); (d) Number of different are included in project management. disciplines (or work-streams) involved in the project; and (e) Size and duration of the As in the MDP case, it can be expected that project cost will be lower if a coherent approach is built in from the beginning (from the Conclusion proposal stage). The use of PRINCE2 to help manage MDP and use it to report back to DFID was loaded on projects. Once the PID and project fairly novel for all concerned — scientists, documents are set up, their maintenance clinicians, and administrators alike. by team members who understand the Indeed, Ove Arup and Partners Ltd. was process is relatively economical. Properly commissioned to work with the team to administered, they also save administrative develop the tools and techniques needed. time on other tasks. The approach adopted gave a transparent

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 57 and robust tool for managing risks and particularly for the researchers. Whether budgets that enabled DFID to readily review this achievement can always be proven is a a number of key performance indicators moot point. The mandates of Good Clinical relevant to the trial and thereby obtain Practice (GCP), FDA and other authorities assurance about programme management require that data collection and storage, trial and trial progress. management, and processes per se must be of the highest quality. Project management, The tools and terminology were alien to the however, is less well defined - the majority majority of those involved and therefore of researchers, quite rightly, need to be required overcoming a steep learning convinced of the merit and benefit of curve. It was also resource-intensive for a incorporating these tools in order to accept number of key staff as changes were made the costs and resource implications of to the existing approach. Familiarising the doing so. We suspect, however, that as the consultants on clinical trial methodologies, number, size, and complexity of research on MDP itself and how the new tools projects continue to increase, the need for should be scoped, developed, and managed formal project management will become required a significant amount of time from more critical. It is likely that as research key MDP staff members. This was essential managers, we will be required to undertake to download structure and intelligence to the necessary training to support and work ensure the tools were accurate and fit for closely with our academic colleagues. purpose. It is doubly essential, therefore, that tools and templates provide obvious Reference efficiencies in the medium to long term. UK Office of Government Commerce. It is important that techniques and tools (Third edition Crown copyright 2002, Managing of this kind are seen as adding value in Twelfth Impression 2005). successful projects with PRINCE2 terms of oversight and scrutiny rather than . becoming an additional bureaucratic burden,

58 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Customer-Supplier Roles and Relationships in the Management of Research Projects Dr. Ian M. Carter Director of Research Research and Business Services University of Liverpool Foresight Building 3 Brownlow Street Liverpool L69 3GL UK +44 151 794 8723 +44 151 794 8728 (fax) [email protected] Author’s Note This article derives its inspiration from a conversation between the author (when he was at the University of Glasgow) and staff at the then UK Office of Science and Technology about how Government approaches the commissioning of research. The matrix derived from that conversation has subsequently been used to help understand and tease out quality and process issues. Abstract Recognising the existence of customer-supplier roles and relationships in the performance of research can lead to an improvement in the management, and hence delivery, of research. Research, especially university-based research, is often managed with a light touch, with the researchers operating independently, and neither their institution nor their funder intervening to a great extent. Whilst this has significant advantages, the explicit understanding and execution of specific roles will enhance the research performance for both those undertaking research and those using its results. This paper presents a simple matrix to help explore the customer-supplier relationship, and to identify some key activities of each during different stages of the research process. Three stages are identified, relating to the commissioning and winning of funding, undertaking the research, and reporting and using the results. Each of these provides a focus for a set of roles, which might be the responsibility of different individuals or organisations. The role of the research administrator in this model is also explored, to show how it is an integral part.

Key Words: Research management, customer-supplier relationships Introduction questions; recording and reporting the Undertaking research involves a range results; and making use of the results of activities: generating the idea for in both specific and broader contexts. the research, refining it and identifying All of this involves a number of roles the relevant hypotheses and questions; and responsibilities, including those of a developing the method; generating the customer-supplier nature. In some cases, necessary funding; undertaking the studies the customer-supplier relationship is clearer to test the hypotheses and answer the (e.g. contract research) than in others (e.g.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 59 grant-funded and institutionally-funded to their customers, typically taken to be research). In institutionally-funded research, their institutional academic community. and in some types of externally grant-funded Even in this context, the recognition of the work, the institution may be acting as both alternative customer bases of the institution customer and supplier (e.g. where the idea and the external funder are important to for the content of the research comes from recognise, in the knowledge that they the researcher themselves). This paper require a different service from that of the explores these roles with the aid of a simple academic researcher. A later section of this matrix, and aims to show how performance paper discusses the role of the research can be improved with only a little additional administrator in the customer-supplier conscious effort. interaction.

A reflection on customer-supplier Whilst recognising the sensitivities that relationships does not mean that one is might exist about the terminology, the operating a commercial model, or that it terms customer and supplier are used in reduces the effectiveness of the research this paper to reflect the roles of individuals process, or academic freedom to investigate or organisations in being the recipients or and express. Being well-organised, and providers of research, respectively, and not understanding and responding to the in other, potentially more pejorative, ways. person or organisation that is paying for the research, can only have beneficial effects The Customer-Supplier Research in terms of making a case, winning funding Matrix and producing interesting results. Indeed, in Table 1 presents a simple matrix of customer the vast majority of academic applications and supplier roles during a three stage for funding, those making the decisions research process. The stages represent the are other academics. This does not reduce major phases of determining what research the need to understand what those other is to be done and who is to do it, undertaking academics will be looking for, and what they the research, and using the results. The believe to be a good outcome. relevant tasks, processes, activities and decisions do not, of course, fall neatly into There are a number of other issues about the six boxes, but the broad distinctions are customer-supplier relationships, in terms sufficient to support the discussion of the of the fundamental role of research support different roles undertaking the stages. functions, and their provision of service Table 1 The Customer-Supplier Research Matrix Stage Customer Supplier 1 Commissioning Winning the Business 2 Monitoring Progress Doing the Research 3 Using the Results Reporting the Results

Stage 1 department might commission a piece The commissioning of research will take of contract research to meet a specific different forms, typically dependent on the need, relating to their strategic objectives. type of funder. A company or government A Research Council or Federal research

60 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration funder1, on the other hand, may make a objectives. Submitting a standard grant call for proposals in a broad area, with less proposal to a call for tenders3 is not likely to prescription of what should be delivered, be successful. In some cases, suppliers will or may have an open call for “responsive have to be on an agreed/accredited list of mode” applications in their subject area2. suppliers. In between these two is investigator-led contract research, in which the researcher An extension of contract research is service provides the hypothesis. The activity of provision: the use of existing knowledge commissioning is therefore different. to the benefit of the customer, for payment, without the generation of new knowledge Contract Research (i.e., the activity does not meet the Frascati Funders at the contractual end of the definition of research (HEFCE, 1995)). In spectrum would tend to determine the this type of activity, a standard purchaser hypothesis and research question that they – supplier relationship is more likely to wish to have answered, and in trying to apply, whereas research relationships will win the business, the supplier will try to tend to have more dialogue and iterative show that they have the capability, capacity participation between the parties. and track record to do so, as well as demonstrating value for money. A variation Grant Research on this may be that the customer will A large proportion (and in some universities define the issue to be addressed, with the the vast majority) of research is closer expectation that the supplier will be able to to the grant-funded end of the spectrum, define the research hypothesis. The nature in which the details of the hypothesis, of contract research varies, but it is often questions, method, etc. are determined by focused on problem-solving, rather than the academic researcher, to be evaluated by blue skies knowledge generation, and hence the funder on the quality of the research. In the commissioning process may be more this case, the commissioner of the research, constrained. and hence one of the customers, is the researcher him- or herself, along with the Suppliers will be best placed to respond, institution. Many, if not most, institutions and hence to aid the customer’s business, if require grant applications to be approved they have an understanding of the needs of by a researcher’s head of department and/or the customer, including the uses to which Dean, plus institutional authority. Doing so the research results will be put, so that they is a form of commissioning process: “Yes, can demonstrate a good match with and this project fits with the institutional/faculty/ understanding of the customer’s underlying departmental strategy.” This is becoming a more conscious process than it has in the 1 The author is writing from a UK perspective, in which past, although it is unlikely that the Head the Research Councils are the UK Government’s research of Department and the Dean, let alone the agencies, akin to the US National Science Foundation and National Institutes of Health, whilst individual Government researcher, is thinking of themselves as a departments commission specific research either directly “customer.” Perhaps they should. This is or through a tendering process. References to Federal throughout the paper therefore relate to U.S. Federal already relatively common in the context agencies. of the resources required for the projects,

2 Responsive Mode refers to a mechanism used by a funder 3 A Call for Tenders is the formal contractual process used in which proposals may be submitted at any time, or against to elicit offers against a specification of work, and is used for specified deadlines, within a general area of interest, as a significant proportion of Government department-funded opposed to Managed or Directed Mode, in which the funder research defines more precisely the required research topics.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 61 where the department head or Dean is being In terms of winning the business, the grant asked to confirm that there is space available, process requires the supplier to understand technical support, and so on. It is starting the customer’s needs, too. It will often be to become more explicit, as more countries the case that certain areas or techniques are move to or consider a full economic cost favoured or even in fashion. Understanding basis for their research (HEFCE, 2005). A what has been funded recently can help. consequence is that the researcher needs to Equally, being in a position to influence show more explicitly why the research is (appropriately!) the interests, policies, worth supporting. Although this makes sound objectives, and targets of the funder can be management sense, there will be arguments beneficial. This takes multiple streams of that this sort of approach is a restriction of activity, including institutional interactions academic freedom. Understanding that there with the funder at senior levels, involvement is a form of customer-supplier relationship of researchers on the funder’s committees, within the institution (as well as what is and interactions of the individual researcher the true, legal nature of academic freedom with the funder’s staff, to talk through (SURPC, 1997)) can help us to work through specific proposals. Those researchers who are these issues. more actively involved in the wider research community (e.g., reviewing proposals and This shift of focus of the responsibility publications, being members of decision- for defining the research is interesting and making committees) tend to have better important. It underlies the nature of academic success rates because they understand their freedom – to be able to ask questions – and subject and its funding environment; i.e., is relevant to the increased emphasis on they understand their customer (which universities undertaking more research with particularly includes their peer community) industry, on a contractual basis; i.e. is it as (Viner, Powell, & Green, 2004). reasonable in a research contract to modify the hypothesis as the work progresses The role of the university’s research as it might be in a research grant? The support office (or equivalent) will also vary, relationship between customer and supplier depending upon the customer, and also on in terms of the work to be done is much more the researcher(s) involved. A support office tightly bound in a research contract situation should be researching the market needs, than in a research grant. Although this could whether that is Government or Federal be considered as an issue for Stage 2, it funders’ objective areas, or the commercial merits attention at this stage, as the freedom market for research outputs or products. Both for manoeuvre will be determined by the markets, but particularly the commercial agreement reached during Stage 1. market, require the ability to understand the institution’s own expertise and capability, Some customers may be happy for and how to package the range of options to divergence from the original goals to occur. best effect. However, they are likely to want to know, and to be part of the decisions to allow Stage 2 redirection and replanning. Understanding Having won the research grant or contract and enabling this partnership is important, funding, the researcher then needs to get on and the means of doing so need to be and do the research. In a significant number addressed at the start, rather than half-way of contexts, this is all that happens in this through, when the need arises. stage: the customer (internal or external) may have little contact and no involvement in the

62 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration progress of the research. This may or may not may enable the customer to make use of key be reasonable, depending on the scope and results without having to wait until the formal timescale of the project. Longer-term grants completion of the work and its final report. will often require annual or intermediate This can also apply where the researcher progress reports, and some may involve a is the customer, and may take the form of mid-stage review, to confirm continuance. patenting and/or publishing results during the Contracts will often require regular reporting course of the work. Thus, in both these cases, or monitoring, which can come as a bit of a elements of Stage 3 are taking place whilst shock to a researcher more used to grant or the research is on-going during Stage 2. Federal funding. Stage 3 There are particular challenges at this stage. Once the research is complete, the researcher From the supplier’s/researcher’s position, will have to report the results. This may be maintaining contact with the customer a formality, or the payment for the work and making regular reports can be highly may rest on the quality and suitability of valuable. Not only does it help to meet any the report or other research product. In the specific reporting requirements, it can also institutional context, we might consider how help to give the customer confidence in much attention we pay to this, to ensure the researcher, hence possibly allow some that all possible outputs are identified. For flexibility in the current work, as well as example, do we ensure final reports are of a strengthening the researcher’s position for suitable quality, make explicit links between extension or follow-on work. If this sounds outputs and the work that produced them, as though it’s only relevant to contractual and maximise publicity for the findings? situations, consider for a moment the position The customer, having received the results, of a researcher running a Research Council should ensure that they answer the original or Federally-funded project. The funder will questions, and act accordingly – depending be keen to hear of successful progress, so that on what their objectives were for the they can use that information in their own research. However, they should also look for processes of seeking and allocating funds tangential or secondary uses for the results: between programmes, and in demonstrating for example, could they be used by someone beneficial research outputs and outcomes to else in the organisation. This is especially their own paymasters. Equally, the researcher relevant to grant-funded research in which providing progress reports to his or her one of the customers is the researcher’s department/faculty will help to disseminate own institution: as well as other researchers the research results, and help to demonstrate potentially using the results, they should their competence up their management line. inform or feed directly into the institution’s research-based teaching. Results may be For the customer, active engagement with the used, directly or in modified form, to count research can help to ensure that the desired for the knowledge transfer metrics against objectives are met, and importantly that the which many of us are now measured.4 subsequent transfer of the results to their Similarly, whilst the results (hopefully) target is achieved more successfully. The customer will need to be careful to balance 4 The UK uses metrics of knowledge transfer activity their involvement and need for reports, to to demonstrate levels of activity and by implication be sure that such activities do not become the socio-economic effects. Some of these metrics are detrimental to the research itself or be used directly in allocation of core Government funding to universities to support knowledge transfer: e.g. the perceived to bias or influence the outcomes. Higher Education Innovation Fund in England, and the However, maintaining a suitable oversight Knowledge Transfer Grant in Scotland.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 63 answer the original questions, they may lead to the customer missing a critical prompt additional issues to explore, or the opportunity for their research to be done, methodology used might be applicable to with competitive / market implications. For another problem area. This discussion is also an institution, being aware of the range of relevant to Government-funded research: the research being undertaken for a specific findings in one Department’s research may customer is necessary so that issues (such be usable by another Department, which will as slippage) can be headed off before they require transparency of the activities and become crises, and new opportunities are good communication links, for example via identified and pursued (especially those in the departmental Chief Scientific Advisors.5 which several different researchers/groups are needed). All of these comments apply equally where the institution or the researcher is The original matrix can be expanded, as in the customer: Where does this lead next? Table 2, to include a number of activities Can the methodology be extended? Can it that can be associated with each role and be applied elsewhere (e.g. on a different stage. As already observed, the appropriate topic, or the same topic for a different agent to fulfil each role might vary between customer)? Should this area of research still projects. Thus an organisation or individual be a focus? Answering these questions will needs to understand when it or they be part of the process of commissioning should fulfil a particular role, and hence is the next piece of research, and may happen responsible for certain activities. The actions explicitly or implicitly. Within a university, within the roles might vary depending aside from further research, the results on whether it is an internal or external could be relevant for development into an customer. This can cause issues within an exploitable technique or product, or creation institution, such as a researcher negotiating of a Continuing Professional Development contractual details rather than an authorised course, as well as becoming incorporated institutional official, or an administrator into mainstream learning and teaching. pursuing a commercialisation route that does not fit with the researcher’s plans for the Expanding the Matrix work. This description of the research process, and the perspectives of both customer and The Role of Research Administrators supplier, necessarily suggests a linearity in Customer-Supplier Relationships that does not generally exist. Stages 1, 2 The discussion so far has tended to and 3 overlap, and blur into each other, concentrate on the academic researchers both for the single piece of research, and and their role in these relationships, between different pieces of research. This and particularly noting that they might makes understanding the roles even more be their own customer. A couple of important: not providing reports to the observations have been made about research customer might lead to the supplier missing administrative support staff, and it is worth a second piece of work that the customer some more thought on this area. intends to commission; not being aware of the supplier’s capacity constraints may Aside from the support role, in helping researchers to apply for, win, and operate 5 Many UK Government Departments have a Chief research and related activities, in which the Scientific Advisor; they interact under the auspices of administrator is providing a service to the the Government’s Chief Scientific Advisor, who is the researchers, support staff are also crucial head of the Office of Government Science.

64 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Table 2 The Expanded Customer-Supplier Research Matrix Stage Customer Supplier 1 Commissioning Winning the Business • Define objectives, targets, and real • Understand customer and their objectives. needs of the research. • Interact formally and informally at all levels • Understand suppliers (capability and with customer to understand and influence. capacity). • Know own (individual, group, institution) capabilities and capacity. • Understand the brief; pre-qualify. • Apply/tender/propose work to meet objectives. 2 Monitoring Progress Doing the Research • Keep watching brief. • Report regularly, to self, internally and to • Provide assistance where appropriate. external customers. • Look for further opportunities. • Check customer is happy with progress. • Identify protectable IP • Look for “spin-off”, other opportunities. 3 Using the Results Reporting the Results • Read the final report! • Produce final report – ensure it meets the • Use the results, against original customer’s objectives. objectives. • Follow up to check it is OK, enquire about • Look for other uses of results. or suggest follow-on. • Consider follow-on research/other • Publish the results (if permitted) research. • Exploit the results. to the wider customer-supplier relationship We are now seeing more opportunities that is being discussed in this paper. The for key account relationships, in which administrator, whether centrally or locally- a range of research and related activities based, can have a role in understanding the are provided for a customer (typically a external opportunities and market for their larger organisation, but can be both public researchers’ skills, might be responsible for and private sector); e.g. research projects, elements of market analysis and promotion, studentships, placements, consultancy, and may be significantly involved in secondments, and training. Managing the preparing the proposal for funding. All relationship across these activities becomes of these need attention to the customer necessary, with a level of complexity in requirements of the research. In some most universities because they are supported cases, the administrator will have a more by different parts of the administration (as established relationship with the funder than well as probably being delivered by different the researcher does, which can be used to parts of the academic structure, to reflect good effect. Equally, the administrator may the skills and subject mix). The role of the understand the institution’s own workings research administrator can then be to help to better, and hence enable their researchers to form internal consortia, construct packages have their proposals approved and enhance of products, and act as the bridge to the their internal profile. customer.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 65 This change in approach may appear and organisations are already doing this. antagonistic to some researchers, and However, many of us may not be, and hence hence the administrator will also need to have opportunity for improvement. That provide reassurance, for example about the begins by asking a critical question: Do you researcher’s freedom to undertake research. really know your customers and suppliers? Research administrators can thus take active roles within the customer-supplier References relationship, as well as supporting their HEFCE (1995). Generic research: Method researchers in fulfilling their roles. and data collection. Circular Letter 10/95, Annex B. http://www.hefce.ac.uk/ Conclusions pubs/hefce/1995/c10_95.htm The customer-supplier relationship is HEFCE (2005). Transparent approach to simple, but is also very accessible, and costing. http://www.jcpsg/guidance/ helps us to understand the roles in the about.htm commissioning and delivery of research, HM Treasury (2004). 10-year science and roles that may not have been particularly innovation framework. http://www. well explored in the past. In the context of hm-treasury.gov.uk./spending_review/ governmental pressures for universities to spend_sr04/associated_documents/ assume responsibility for contributing a spending_sr04_science.cfm greater, even significant, part in the future SURPC (1997). Academic freedom and economy (HM Treasury, 2004), there will research. In Scottish Universities be more need for the explicit management Research Policy Consortium University of customer-supplier relationships. This research in Scotland: Developing a will be best achieved where there is a policy framework. (pp. 91-98). balance between the researcher’s freedom to Viner, N., Powell, P., & Green, R. (2004). explore an issue or hypothesis and sufficient Institutionalised biases in the award of communication to ensure that the customer research grants: A preliminary analysis can be reassured about progress and revisiting the principle of accumulative outcomes. Customer-supplier relationships advantage. Research Policy, 33, may currently be most often considered 443-454. in the context of a contractual relationship with an external organisation, and hence possibly are already being managed appropriately. The benefits for a research organisation may therefore be in considering the internal customer-supplier interactions, and those involved in grant-funded research work. Much of what has been presented is intuitive; however, a more conscious approach could bring benefits to the individual researcher and to their institution.

Those who perform best will fulfil their own responsibilities, but will also be aware of others’ responsibilities and support them where appropriate. Some individuals

66 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Implementing Ethics Policies in Developing Countries: Ploughing On Parched Ground? Professor Isaac N. Mazonde Office of Research and Development University of Botswana Corner Nyerere / Notwane Road Gaborone, Botswana [email protected]

Dr. José Jackson-Malete Deputy Director Office of Research and Development 149 Centre for Continuing Education Building P.O. Box UB 00708 University of Botswana Gaborone, Botswana

Jeremy Sugarman, M.D., M.P.H., M.A. Harvey M. Meyerhoff Professor of Bioethics and Medicine Phoebe R. Berman Bioethics Institute Johns Hopkins University Hampton House 351 624 N. Broadway Baltimore, Maryland 21205 USA Authors’ Note The ideas for this paper originated from experiences gathered during the implementation of the Ethics Policy at the University of Botswana beginning in May 2005, and the deliberations of an international ethics conference held in Durban, South Africa in October 2006. The ideas were further developed from discussions during the Southern African Research Innovation and Management Association (SARIMA) conference held in Pretoria, South Africa, in May 2006. Abstract It is globally expected that universities will ensure that policies guiding researchers’ conduct are in place and adhered to. This expectation is not waived in developing countries. Successful implementation of an ethics policy is facilitated by an appropriate national regulatory framework on which to base the argument for compliance. However, it is possible to implement such policies even when a regulatory framework is absent. The University of Botswana implemented a program to increase awareness of research ethics and to manage allegations of research misconduct through a needs assessment and seminars on the Responsible Conduct of Research (RCR). This paper describes this problem, and the success of the program initiated to address it. This program serves as a model for other research institutions in the developing world that may encounter similar challenges.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 67 Introduction Much of the recently published literature Research integrity is a global concern. concerning research ethics, integrity, When research lacks integrity, it destroys and compliance comes from Northern public trust in the academic and scientific and Western nations. Nevertheless, community (The National Academies Press, internationally collaborative research has 2002). While this issue is important for all become more commonplace in locations research institutions, it becomes increasingly that may have fewer financial resources to complex in the setting of internationally develop ethics and compliance programs. collaborative research, in which local Yet constructing such programs is possible. standards vary despite considerable global In this paper we discuss some of the consensus regarding many aspects of difficulties inherent to setting up these research integrity and ethics. programs in the developing world and describe one program that may serve as a International interest in research ethics model. became pronounced following World War II (Deyhle, Hess & LeCompte, 1992). Difficulties with setting up ethics structures This interest resulted from the inhumane in developing countries treatment of human beings by Nazi Perlman (2005) maintains that, in the United physicians (Crigger, 1992). Subsequently, States, reliance on regulations to enforce numerous bodies offered standards to help ethics requirements has resulted in a focus ensure the ethical conduct of research on compliance with requirements rather than (CIOMS; Declaration of Helsinki). While the ethical principles that underpin them there are some differences among these (National Commission, 1979). Despite this policies, most support the prospective shortcoming, the U.S. approach helps to review of research and informed consent. ensure that vulnerable subjects are protected In addition, every profession is governed by and that their rights, safety and welfare take implicit or explicit standards of competence priority over the interests of science. and conduct (Bayles, 1988). These The situation in many developing countries standards help to ensure that professionals is very different due to a lack of national perform as expected and that the profession legislation that would form the required itself maintains quality and integrity. umbrella for ethics policies. In Botswana, Accordingly, institutions are concerned for example, there is no national legislation with both the review and the responsible on ethics. In particular, although the country conduct of research. Because allegations has for years depended upon South Africa of misconduct tend to be unique rather for specialized medical services, there is than routine at most institutions around the no tissue act to regulate the movement of globe, few have extensive experience in human tissues across national borders, nor responding to allegations. The uniqueness of to oversee their disposal once laboratory allegations of misconduct makes it difficult procedures are completed. The Ministry for an institution to develop expertise in of Health is the only ministry with an conducting inquiries and investigations active ethics body. Its institutional review (Rhoades, 2000; Lock, 1995; Husemeyer, board (IRB) ensures adherence to standard 1995). However, a research misconduct international ethics. The lack of a national allegation has the potential for a high legislative framework is not unique to impact, both on the individuals involved and Botswana, but common across the sub- the institution (Rhoades, 2000). Saharan region.

68 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration This situation – like ploughing on parched the implementation of the ethics policy ground — makes it very difficult for an represents another step toward handling of academic institution to formulate and cases of academic misconduct and helping effectively enforce an ethics policy. More the university achieve its vision as a leading importantly, this explains in part why so academic centre of excellence in Africa and many university faculty members and the world. students lack awareness of the responsible conduct of research. It is not always clear The ethics policy at UB was approved whether faculty members flout the rules in 2004. The Director of the Office of for responsible ethical conduct deliberately Research and Development (ORD) or out of ignorance. Although the scale implements the policy through the Research of academic misconduct by staff at the Risks Committee (RRC). The RRC and University of Botswana (UB) is not well its associated committees, including the documented, cases involving both students IRB, the Animal Use and Care Committee and staff have occurred (Moahi et al., 2005). (AUCC) and the Chemicals and other Some of these cases have involved both Hazardous Materials Committee (CHMC), intellectual and financial misconduct and were established in April 2005. The ORD are usually handled confidentially within the Director is therefore responsible for university. Some cases, however, some cases ensuring that all research at UB follows have also reached the public media, putting both the ethical principles that have been the university’s integrity at stake (Odubeng, set by the university and the laws and 2004). regulations governing research in Botswana. The Director also is responsible for University of Botswana Ethics Policy fostering a culture of respect for research The objective of the ethics policy at integrity; for ensuring the education of the the UB is to ensure that research is ethics committees, researchers and staff conducted according to internationally on the ethical conduct of research; and for recognized ethical standards. Further, monitoring UB’s ethics program. Figure 1. Reporting Structure for UB Human Subjects Institutional Review Board

University Research Advisory Committee (URAC)

Research Risks Committee

Human Subjects Institutional Review Board (IRB)

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 69 The organization and administration of human subjects with whom UB investigators research ethics is demonstrated in Figure 1, interact or about whom they obtain private which illustrates the relationship between information. When there is a question the URAC, the RRC, and the IRB. about whether an activity constitutes human subject research, the UB requires “a The University Research Advisory qualified person or persons other than the Committee (URAC), established in investigator or research team” to verify that November 2002, advises the ORD on the activity requires IRB review (Protection implementation of policy. The URAC of Human Subjects). consists of the Deans of each Faculty, the Director and Deputy Director of the IRB review is also extended to student ORD, the Dean of the School of Graduate research activities. In some courses, Studies, the Faculty Research Committee students collect data by using professional Chairpersons, one person appointed by the research methods, even though the work is Deputy Vice-Chancellor (Academic Affairs) not expected to contribute to generalizable to represent support staff, and the Manager knowledge. Because some methods involve of Special Projects from the Office of human subjects, and in some instances Financial Planning and Control. place these subjects at risk, student research projects are reviewed and approved prior The RRC has two primary roles: to initiation to assure that the rights and 1. To provide guidance in research welfare of human subjects are protected. ethics to the UB community, including, questions about misconduct To direct its operations, the UB IRB has (falsification, plagiarism, or established guidelines used by staff and misrepresentation of data), the level of students in both courses and research, and contribution that warrants inclusion as it has the authority to require adherence an author on a publication, or ownership to these practices. Deviation from these of a research idea. The RRC promotes standards is usually reported to the Director awareness and compliance with the UB of ORD, who then takes further action Policy on Ethics and Ethical Conduct as recommended by the RRC. The IRB of Research through periodic release of also reviews all research protocols of staff information to staff and students. and students in which human subjects are used. The committee is authorized to 2. To review and make recommendations communicate approval and disapproval about all research proposed by UB actions to those submitting the proposal, and staff or students. This responsibility is required to report all review outcomes to is delegated to the three committees the RRC. for which the RRC has oversight: the AUCC, the CHMC, and the IRB. The IRB consists of 12 members appointed by the Director, ORD. Membership includes The UB Institutional Review Board for knowledgeable individuals from the local Protection of Human Subjects community, the Government, and UB. The UB IRB is responsible for review of all Additional individuals with special expertise human subject research activities consistent may from time to time be designated as with U.S. federal regulations (Protection ad hoc members to assist the IRB. The of Human Subjects, 2005). These broader committee is chaired by a member of the UB definitions are critical to protecting the staff.

70 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration The IRB review process requires researchers e. Some researchers have the habit of to submit 12 copies each of the entire commencing research work before academic proposal, the completed UB IRB approval is given. In view of application for Approval of Human that, the IRB will not accept requests Research, instructions to participants, the for approval of research that is consent form, any questionnaires (translated ongoing or completed and has not as appropriate), and the curriculum vitae of had prior approval. the Principal Investigator(s). The IRB is scheduled to meet at least The review process of the IRB consists of: quarterly, but may meet monthly if the 1. Discussion of any policy issues, conflict protocols received for review call for that. of interest or procedural matters. The IRB chair reports all board actions 2. Review of protocols. to the RRC, and communicates with the Chair of the RRC when conflicts of interest a. The IRB will establish and publicize arise that affect the rights and welfare of to UB staff and students deadlines for participants. Conflicts may exist among IRB submission of research projects for members and consultants, investigators, review. students, sponsors or administrators. Any b. Each protocol is assigned to a case of research misconduct or serious or member of the IRB for review. continuing noncompliance with regulations When additional expertise is pertaining to research and/or university required, the protocol may be policy may be reported to the RRC as an assigned to an ad hoc member for allegation of misconduct by the IRB chair, review and presentation to the IRB. any member of the IRB, human subjects or any other individual. c. Review criteria are provided to the researcher and to the reviewer. A UB IRB pilot review of proposals. short, formal review with written The UB IRB began reviewing university comments is completed by the research in November 2005 on a pilot basis member to whom the review is for those researchers who received funding assigned (see 2 b above) before the from URAC. The outcome of this first round meeting, and will form the basis of of reviews is shown in Table 1. None of the the discussion during the meeting. proposals was deemed exempt from review; Researchers may be asked to provide 20% qualified for expedited review and clarification or additional information 80% were assigned to the full board. None to assist the deliberations of the IRB. of the proposals was approved on the first review, as all had both methodological and d. The IRB acts on each research ethical issues that needed to be addressed. project it receives, and advises the Sixty percent were approved on the researcher of the outcome. No second review; the IRB requested that two research may be started until a researchers attend a meeting to discuss and research permit has been issued by clarify their proposals. Four proposals are the Ministry of Health. still pending.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 71 Table 1 Statistics on Review of Research Proposals Status of proposals Number Proposals received for review 10 Proposals exempted from review 0 Proposals for expedited review 2 Proposals for full board review 8 Proposals approved at 1st review 0 Proposals approved at 2nd review 6 Researchers invited to IRB meeting 2 Proposals pending 4

Among the challenges in operating the board left to the IRB to clarify. are the following: 1. Time constraints – committee members 4. Monitoring of researcher compliance often have limited time to dedicate to – continuous checking of projects to the IRB because of conflicting activities ensure that researchers are adhering involved in teaching, research and other to the regulations is impossible at this committee memberships. As a result, time, given the staffing situation. This members who attend often do not form a problem is expected to become even quorum, which makes decision making more difficult once this pilot phase difficult. is over and review of all university research begins. 2. Administrative constraints – No staff member is dedicated solely To alleviate some of these problems and to administration of the IRB. This improve operations, the UB IRB has made responsibility was added to a staff specific suggestions to the ORD. First, it member’s already full work load. has requested a dedicated staff member, However, it soon became obvious that trained in research ethics, to serve as the IRB administration itself is a full-time IRB Administrator. This will provide for job, in terms of coordinating meetings, smoother operation of the IRB and faster the protocol reviews, organizing communication to researchers. The IRB also paperwork, and communicating with recommended that the committee allocating researchers (even for this pilot project, research funding conduct more thorough which did not include all the research reviews to ensure that proposals approved conducted by the University). for funding have sound methodologies that do not require further exhaustive review 3. Ethical versus methodological review by the IRB. This has been addressed by – while it is widely known that the IRB revising the tools that the peer review panel may review both the research and ethical uses to allocate funding. A more thorough considerations of a protocol, most of methodological review may also alleviate the methodological issues should be the time commitment of IRB members, who addressed by the committee allocating could concentrate on ethical, rather than research funding. However, many methodological, issues. questions regarding methodology were

72 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Responsible Conduct of Research Seminar teaching resources, formats and methods, Series and strategies for increasing awareness Researchers in many institutions globally about RCR. must receive instruction in nine core areas of responsible conduct of research (RCR) A majority of the respondents considered to be eligible to receive public funding for RCR training as useful primarily for research (ORI, 2005). These core areas and graduate and undergraduate students, other relevant topics have been adopted researchers, research assistants, training and by UB into a seminar series available development officers, Ethics Committee throughout the academic year and targeted members, and financial project officers. A at increasing the awareness of researchers total of 82.1% of respondents considered on issues related to RCR. The series focuses seminars an appropriate format for on aspects of planning, conducting and delivering instructions in RCR; 59.5% cited reviewing and reporting on research, as a manual on RCR; 52.4% preferred Web- follows: Planning research: (a) research Based Modules and only 11.9% preferred involving human subjects, (b) research audio tapes. involving animals, (c) research involving The topics recommended for RCR training the use of chemicals, (d) management programs are shown in Table 2. The main of research funds, and (e) conflict of topics of interest for researchers were interest and commitment; Conducting collaborative research and misconduct in research: (a) data acquisition, management, research (78.6% in each case), authorship/ sharing, and ownership, (b) mentor/trainee publication (75%) and intellectual property responsibilities; Reviewing and reporting (71.4%). For graduate students, the topics research: (a) research collaboration, (b) recommended were education in research publication practices and responsible misconduct (76.2%), research design (69%), authorship, and (c) peer review. intellectual property (63.1%) and scientific An RCR training needs survey was record keeping (61.9). For undergraduate administered to 300 academic staff members students, misconduct in research (60.7%) simultaneously with the seminar series to was identified as a crucial topic, as well assess the educational needs at UB in RCR as research design (52.4%). The majority and the handling of allegations of scientific of researchers felt that more adequate misconduct. Responses from 115 individuals instructional materials were needed for were received, which represented a selected RCR topics. The primary topics 38% response rate. It was designed to included research design (71.1%), penalties identify who should receive training, what for misconduct in research (57.9%), lab instructional materials were needed, the safety (53.5%), and misconduct in research topics the training should address, useful (51.8%).

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 73 Table 2 RCR Topics that Training should Address and that Require Additional Instructional Materials RCR Topics Responses for research group (%) Researcher Researchers Grad students Undergrad responses for students instructional materials (%) Research Design 69.0 69.0 52.4 71.1 Scientific record keeping 54.8 61.9 46.4 39.5 Human/Animal subjects 48.8 46.4 39.3 46.5 Lab safety 28.6 38.1 28.6 53.5 Funds management 61.9 41.7 27.4 35.1 Mentoring 63.1 28.6 20.2 34.2 Collaborative research 78.6 44.0 26.2 32.5 Authorship/Publication 75.0 59.5 32.1 37.7 Authorship of student work 56.0 53.0 46.4 22.8 Peer review 63.1 44.0 28.6 43.0 Intellectual property 71.4 63.1 45.2 48.2 Conflicts of interest and 59.5 36.9 21.4 36.0 conflicts of commitment Misconduct in research 78.6 76.2 60.7 51.8 Penalties for misconduct in 60.7 60.7 46.4 57.9 research Institutional policies on 53.6 48.8 34.5 25.4 research misconduct Whistle blower and / or 53.6 48.8 34.5 3.5 reporting misconduct

Administrators at UB were also asked reporting to the UB community and the about the management of issues related public media (62.5%), restoring reputation to research misconduct. The Deputy Vice (58.3%), and treatment of respondents Chancellor of Academic Affairs, all Deans and whistle blowers (54.2%) were the and Heads of Departments were identified primary ones identified. For research as the administrators most needing training integrity officials, important topics included in this area (Table 3). However, it must developing investigation plans (54.2%), be noted that some respondents suggested handling evidence and sequestering of that all researchers needed training in the data (54.2%), interviewing (50%), and management of allegations of misconduct. responding to retaliation complaints (50.0%). For researchers, the important The specific topics in terms of the topics were conflicts of interest (50%), management of allegations are shown maintaining confidentiality (48.5%) and in Table 4. Among the topics for developing investigation plans (45.8%). In administrators, policy requirements (62.5%), terms of the format of the training program,

74 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Table 3 Type of Staff to Receive Training on Managing Allegations Staff Positive response (%) University Administrators Vice Chancellor (VC) 58.3 Deputy VC Academic Affairs 70.8 Deputy VC Financial Affairs 45.8 Deputy VC Students’ Affairs 45.8 Deans 87.5 Heads of Departments 83.3 Directors of Centers 66.7 Public Affairs staff 44.1 Research Integrity Officials Chair, research risks committee 54.2 Members, Research Risks Committees 45.8 Members, Research Ethics Committees 66.7 Researchers Academic staff 79.2 Others Faculty Research and Publication Committee 58.3 Others 25.0 the majority (69.6%) felt that the most appropriate resources for the management of effective format was within a leadership allegations of misconduct. training program or an Administrators Annual Retreat organized jointly by ORD Ploughing On Parched Ground? and the Centre for Academic Development This paper highlights the limitations within (CAD). Over half (52.6%) also felt that RCR which developing country institutions training should be included in the induction such as the University of Botswana work. program for Heads of Departments. While the ethical principles outlined in the Belmont Report seem to have broad reach, The majority of administrators felt it was an emphasis on compliance rather than important that feedback on allegations of ethics may lead to untenable approaches misconduct at UB be provided to university in the developing world. Throughout staff, but less so to the press and the general Southern Africa, problems with ascertaining public. The data showed that 90.9% wanted compliance may in part be due to the lack feedback on publicly reported cases while of a national framework to support relevant 69.6% wanted such cases to be publicized policies relating to ethics and associated by the press. Administrators also suggested legislation such as intellectual property and that guidelines, examples of best practices data management. Notwithstanding the and case studies, as well as a dedicated shortage of overarching ethics legislation, research integrity officer, were the most however, the University of Botswana has

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 75 Table 4 Topics Training should Address Positive response (%) Topics UB Admin RI Officials Researchers Others Policy requirements 62.5 37.5 37.5 8.3 Maintaining confidentiality 45.8 41.7 48.5 8.3 Protection against conflicts of interests 33.3 37.5 50.0 4.2 Assuring appropriate expertise 29.2 29.2 25.0 4.2 Treatment of respondents & whistle 54.2 45.8 25.0 4.2 blowers Developing investigation plans 29.2 54.2 45.8 4.2 Handling evidence and sequestering 25.0 54.2 33.3 8.3 of data Requirement of proof 37.5 45.8 20.8 4.2 Interviewing 20.8 50.0 41.7 8.3 Preparing reports 16.7 41.7 25.0 8.3 Responding to retaliation complaints 41.7 50.0 25.0 8.3 Restoring reputation 58.3 37.5 16.7 8.3 Reporting to UB community 62.5 29.2 25.0 8.3 Reporting to public media 62.5 20.8 12.5 8.3 Departmental/Faculty Appeals 25.0 29.2 29.2 12.5 Research Risks Appeals 29.2 41.7 25.0 4.2 Committee hearings 20.8 45.8 16.7 8.3 Others 4.2 4.2 4.2 4.2

been able to achieve a culture of responsible ethical conduct among its researchers. While a lack of support from above and complimentarity with others addressing the same problems may be likened to ploughing on parched ground, the success of the University of Botswana can be replicated by institutions in similar settings.

76 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration References Belmont Report: Ethical principles and Bayles, M. (1988). Professional ethics (2nd guidelines for the protection of human ed.). Belmont, CA: Wadsworth. subjects. Washington, DC: Department Crigger, B. (1992). Twenty years after: the of Health, Education and Welfare. legacy of the Tuskegee syphilis study. Odubeng, M. (2004, February). UB exam Hastings Center Report, 22(6), 29. papers disappear. Mmegi Online Deyhle, D.L., Hess, G.A., Jr., & LeCompte, Newspaper, 21(24). Retrieved M.D. (1992). Approaching ethical issues February 16, 2006 from http:// for qualitative researches in education. www.mmegi.bw/2004/February/ In M.D. LeCompte, W.L. Millroy, & Monday16/10584761891225.html J. Preissle (Eds.), The handbook of Office of Research Integrity. (2005, qualitative research in education (pp. October). Teaching tools for responsible 597-643). Toronto: Academic Press Inc. conduct of research. Presented at Doberneck, D. (Ed.). (2004, Spring). the annual meeting of the Society of Research Mentoring. Michigan Research Administrators International, State University Research Integrity Milwaukee, WI. Newsletter, 7(4). Retrieved February 14, Perlman, D. (2005). Putting the ethics 2006 from www.msu.edu/user/gradschl/ back into research ethics: A process for all/ris04.pdf ethical reflection for human research Husemeyer, R.P. (1995). Handling scientific protection. The Journal of Research fraud. British Medical Journal, 311, Administration, 37(1), 13-22. 261-262. Protection of Human Research Subjects, 45 Lock, S. (1995). Lessons from the Pearce C.F.R. § 46 (2005). affair: Handling scientific fraud.British Rhoades, L.J. (2000).The American Medical Journal, 310, 1547-8. experience: Lessons learned. Science Moahi, K., Becker, C, Lee, M., Kuruba, and Engineering Ethics, 6(1), 95-107. G., Jackson-Malete, J., Masupo, S., et The National Academies Press. (2002). al. (2005). Report of the task group on Integrity in scientific research: academic dishonesty in the University of Creating an environment that promotes Botswana. University of Botswana. responsible conduct. Retrieved February National Commission for the Protection 16, 2006 from http://www.nap.edu/ of Human Subjects in Biomedical catalog/10430.html and Behavioral Research (1979). The

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 77 Administration of an Innovative Program of International Cooperation: Success Across the Pond Vincent S. Gallicchio, Ph.D., Dp (hon) Associate Vice President of Research Professor, Biological Sciences and Public Health Sciences Research Division Clemson University 301A Brackett Hall Clemson, SC 29634-5701, USA 864-656-1643 (office); 864-656-0881 (fax) [email protected] Author’s Note The author acknowledges Ms. Lynn Kunkle, Grants Administrator, and Ms. Emily Land, Office of Sponsored Programs, Clemson University for their thoughtful and helpful discussions. This project was supported in part by grants from the U.S. Department of Education; Funding for the Improvement of Postsecondary Education (FIPSE), Washington, D.C. (P116J050001), awarded to Clemson University, Clemson, SC and from the European Union (2003-4033-CPTUSA), Brussels, Belgium. Abstract The world continues to change rapidly and globalization is fostering common social, economic, and political agreements among countries. Agreements by governments have created opportunities to enhance educational and research endeavors that, by design, will remove barriers that previously have limited the flow of students, educators, researchers, and professionals across borders. Global access has opened the door to mobility in higher education, encouraging the development of educational standards and mutual mechanisms of recognition. Three years ago an eight-institution consortium comprised of four American and four European institutions of higher learning came together in a partnership to provide opportunities for students and faculty to share the educational and research experience internationally. A partnership of this magnitude was constructed despite barriers that were both administrative and cultural in origin. Through a positive approach, a framework for a transatlantic program of educational and research cooperation was developed. A significant level of mutual cooperation effectively solved the administrative hurdles initially encountered in the realm of research. We believe a model has been created that fosters the development of international programs to benefit faculty, students, and research administrators as they work to effectively interact in the global environment.

Key Words: Research administration, international education, study abroad Introduction between the United States, Canada, and The world is rapidly changing, and Mexico. These agreements provide the globalization is helping to establish common context and rationale for government social, economic, and political agreements involvement in enhancing educational between countries, as evidenced by the opportunities and removing barriers that 1993 Maastricht Agreement that created limit the flow of students, educators, the European Union (EU) and the 1994 professionals, practices, and projects across North American Free Trade Agreement borders. Having opened the doors to North

78 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration American and European mobility in higher — not just to the academics in a particular education, this increased global activity has curriculum, but more importantly to help encouraged the development of common facilitate a better understanding in culture education standards and mechanisms for among the peoples of these countries. mutual recognition, and liberated processes by which professionals are permitted to An integrated effort to help promote practice. For example, the educational the joint collaboration between higher ministries within the EU have mandated educational institutions within the United through the Bologna Declaration that by States and the EU has been in place for 2010 all educational curricula, course several years based upon a treaty of mutual syllabi, textbooks, and related materials cooperation. The origin of this cooperation must be identical within the EU countries. in education and training dates from the This means that whether an institution is Transatlantic Declaration on EU-U.S. educating an architect or a zoologist, the relations adopted in November 1990. educational methodology will be identical In 1993, a two-year exploratory phase to its counterpart institutions’ programs of cooperation was launched, and the throughout the EU. Therefore, this experience gained provided the basis for a Declaration has been designed not just to formal EU-U.S. Cooperation Agreement lower barriers, but to remove them entirely. signed in June 1993. Since that time a total of 107 transatlantic consortia have These barriers also exist in the U. S. They been funded involving 726 European and are generated by responding to the criteria U.S. institutions of higher education and for specific academic curricula that in vocational training. More than 4,000 U.S. many cases are imposed, or at the very and EU students have completed portions of least influenced by accreditation agencies, their programs of study abroad within these certification bodies, ministries of education consortia projects. and health, and licensure laws, because education and training can differ from state To enhance the cultural awareness of to state and country to country. These students while removing their academic, barriers will create unique challenges for research and practice differences across higher education in the U.S. as our graduates borders, three years ago an international try to stay competitive in the global consortium comprised of four American economy. Thus, global mobility of students and four European institutions of higher has now been recognized as an important learning united to establish a mutual student component of the educational experience to exchange program (Table 1). help address concerns related to differences

Table 1 Institutions Comprising the Transatlantic Health Science Consortium United States of America European Union Clemson University, U.S., Lead University of Central Lancashire, UK, Lead University of Alabama, Birmingham University of Wolverhampton, UK University of Kansas Jönköping University, Sweden University of Puerto Rico University of Cadiz, Spain

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 79 The integration of the eight institutions is matriculation of the consortium program. diagrammed in Figure 1.The Consortium This partnership has now been extended agreed to target biomedical science as the to programs in behavioral science and initial academic area of focus, with interest business. in other areas to be identified following the Figure 1. Illustration of the Transatlantic Model for Clinical/Biomedical Sciences.

UCLAN UK EU Lead U of Jönköping Kansas U USA

U of U of EU/USA Cadiz Alabama Partners Spain USA

UWV U of UK Puerto Rico CU USA Lead

From the perspective of the research changes, by no means complete, gives us an administration office, a program of this idea of their scope and effect on our daily scope focusing on international cooperation lives. Changes to our economy, education, creates unique challenges. Obligatory environment, livelihood, health, natural and components such as memoranda of non-renewable resources, nations and people understanding (MOU) and sub-contractual are profound in their impact on how we will agreements are potential hurdles that must live in the future. be overcome to provide the necessary instruments for the ultimate success of We in higher education are not immune to the project. There is also the potential these changes. In representing institutions challenge of overcoming language barriers. of higher learning, we have been governed This article describes those challenges by the simple fact that our role and and how they were addressed to best responsibility is to educate students. This serve both the individual institutions and, remains the basic core value in our mission importantly, the students who participated statements; however, what has changed in the international study abroad exchange and will continue to change is the climate program. and environment within which our students will enter the job force of the future. The Importance of International Education challenge of higher education today and These are challenging times in which tomorrow is to make sure that our graduates we live. We have embarked on the 21st leave our institutions not just with the century like no other time in human history. necessary knowledge in their respective Life changes almost daily, as reading the disciplines required to become successful, newspaper or listening to the evening but more importantly, the necessary skills to network news can attest. A list of these live and work in a global economy.

80 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration To achieve this combined success, groups, all of which share a strong belief educational institutions will need to change in blending the international education the way they meet their mission. To address experience into their educational programs. this challenge, we must ensure that our Administrators, faculty and, most important curricula become internationalized, thus of all, students are the essential components providing our students all the necessary for success of any such program. skills to become as marketable as possible as they seek to enter the international work Focus on the Academics—Role of force. Research in International Education Over the years, the role of research and How can this be accomplished? We scholarly activity has been a hallmark of must internationalize the curriculum to American higher education, in many cases emphasize the importance of the study attracting foreign students to study in the abroad experience for our students. This U.S. However, in several areas of U.S. valuable experience allows students to higher education, especially within the learn a portion of their area of study health professions, a focus on conducting while sitting next to their host country research has not been emphasized. In several classmates in the foreign site. This allows areas, specifically clinical laboratory and our students to hone the skills necessary to biomedical science, an increase in the survive in the international setting, whether performance of research by faculty over survival is defined as simply being able to the last decades has gained significant communicate or, more complexly, to sustain importance (Covey & Burke, 1987; Bruhn, a livelihood. Importantly, these interactions 1987). This increased effort arose in reaction allow the visiting student the opportunity to criticism that academic programs within to learn more about the history, culture, and the health professions have been deficient in language of the host country. their commitment to conduct scientific and scholarly activities. It also has been noted International education and the opportunity that those few programs conducting research to study abroad allow students to broaden or sponsored activity received little or no their horizons and think beyond their recognition. (Karni & Waller, 1999) It is own individual area of influence. For the essential in today’s health care environment institution, internationally focused education that health professions’ faculty initiate and and curriculum bring added value to the conduct research and scholarly activity. In overall experience (Gallicchio, 1993). addition to their mission of contributing We must provide the best education and to the improvement and delivery of health training possible for our students if they care, research and scholarly activity fulfills are to become successful competitors in the the responsibility of building the knowledge global community. If we fail, we will have base of the individual academic disciplines negatively impacted our graduates’ ability to (Syed, 1991). The criteria to evaluate be the best possible adults. colleges and schools of health professions International experience as part of an have for too long highlighted the following educational system is imperative – deficiencies: (a) historically, members program by program — to the interest and of health professions’ faculty/staff have commitment of participating institutions. To achieved academic ranks and tenure without be successful, there must be adequate and the rigors of having to demonstrate scholarly effective communication among specific productivity on a level with what is expected of faculty/staff members in other schools

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 81 and colleges on the same campus; (b) the Focus on Faculty majority of the faculty/staff within these The importance of international units have a weak track-record of capturing opportunities for academic faculty and staff external grant funding for research; and (c) can be significant. International programs the school or college does not have graduate can provide faculty with access to students programs. (Kraemer & Lyons, 1989; Waller, capable of conducting research, who would et al., 1988) The important points to not otherwise have been available within the emphasize in the performance of scholarly program, department, school, or college. . activity are research, graduate education, The faculty member also gains skills in the and the provision of research opportunities supervision of sponsored student research to faculty and students. Academic programs programs, skills they may not have had that incorporate international collaborations previously. This aspect of the program is have been effective instruments in achieving important because it allows for the direct research excellence (Gallicchio, Kirk & interaction of the faculty member in the Birch, 1998). supervision of students.

Focus on Administrators The criteria to evaluate health professions’ Leadership is the key role for administrators faculty for too long have focused on in programs incorporating international the following issues: (a) historically, collaborations. Opportunities for the health professions’ faculty have achieved promotion of collaboration can be either academic ranks and tenure without having interdisciplinary or inter-institutional. When to demonstrate scholarly productivity on the possibilities to develop programs of this a level comparable with other university nature are identified, it is critically important faculty; (b) the majority of health to have administrators in place who both professions’ faculty within these units support and believe in what is trying to be historically had a weak track-record accomplished. Without the cooperation and of capturing external grant funding for advocacy of the appropriate administrators, research; and (c) there existed a lack of more often than not, such projects become graduate programs within the schools or very difficult, if not impossible, to colleges of health professions; therefore, implement. It is particularly important for a climate that fosters the development of the appropriate administrators to view first- researchers performed by researchers was hand the international site, including the absent. These issues have clearly re-defined classrooms, laboratories, clinical facilities, the academic role of health professionals’ and dormitory facilities where students faculty in today’s academic environment will be housed. Administrators must also that clearly demonstrates the performance make sure programmatic areas of emphasis of scholarly activity as defined by research, are within the overall institutional goals graduate education, and the provision and objectives. In some cases this can be of research opportunities to faculty and referred to as a strategic plan. Because students. (Kraemer & Lyons, 1989; Waller, administrators are required to sign off on et al., 1988) documents essential to implementing study abroad programs, e.g., memoranda of One method to increase research and understanding (MOU), having them in the scholarly collaborative activity is through loop as early as possible can avoid delays at the use of cooperative interactions between best and rejection at worst when review of faculty from different schools or colleges. these programs becomes necessary. This collaboration can be regional, national

82 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration or international. Collaborative research are usually performed under sub-recipient incorporates the use and participation of agreements that require careful preparation multiple investigators, usually each with a and review by a skilled grant administrator. defined role and purpose in the objectives These agreements must cover the objectives of the project. An additional advantage of the project while following the sponsored of collaborative efforts is that they can be agency and institutional guidelines. either interdisciplinary or multidisciplinary. The Transatlantic Health Science Focus on Students Consortium Experience The opportunities for students, whether The Transatlantic Health Science undergraduate or graduate, to engage in Consortium (THSC) has succeeded by generating scholarly activity in health overcoming several initial obstacles that, professions have been limited or non- if not resolved, would have made its existent. An international consortium implementation difficult if not impossible. to promote the exchange of students in clinical laboratory and biomedical science First, the MOU was an important document was organized to provide educational required by the sponsoring agency and opportunities to advance the knowledge the participating institutions. The MOU base of participating students. This program determined the exact conditions under afforded students the opportunity to both which the program was to be conducted. exchange ideas and become involved in It specified such terms as academic credit, educational partnerships and research accommodation/housing, tuition, and collaborations (Hope-Kearns, Gallicchio & general rules pertaining to the conduct and Ward-Cook, 2004). performance of the international student enrolled in the host country institution. Each The Role of the Research Administrator institutional grant researcher had input in the The performance of sponsored research formation of the MOU, and the role of the requires the cooperation of a team of skilled grant administrator was critical. individuals. The obvious lead member of this team is the principal investigator (PI). The MOU also highlighted language Not so obvious are research administrators, differences among the collaborators. One who typically work behind the scenes, of the EU partners, the University of Cadiz, often hidden from the limelight. . mandated that the document be translated Research administrators are responsible in Spanish. Another EU partner, Jönköping for reviewing and processing pre-award University, did not require a Swedish proposals, maintaining post-award research translation because all of its administration accounts, and overseeing various aspects of and faculty were fluent in English. In fact, compliance (e.g., research involving the use Jönköping University’s biomedical science of human subjects, animals, and biological curriculum is taught in English. or chemical hazardous agents). Second, the sub-recipient agreement served Often collaborative projects among faculties to describe the project in terms of funding of different institutions (whether they are and implementation. Each lead institution focused or involved in research and/or by definition of the sponsoring agency education) are conducted under complex was the recipient of the total funding, arrangements. When conducted under respectively. However, in the absence of a sponsored research, these collaborations sub-recipient agreement, the allocation of funds for each of the participating partner

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 83 institutions could not be provided. The experience by making active contributions research administrator was instrumental to their respected field of study. Many of in ensuring the success of the project by the best and brightest international students incorporating specific institutional policy who were once totally committed to study into these agreements. in the U.S. are now studying elsewhere or staying at home. This change has evolved Third, the project required a renewal sub- in part since 9/11. Changes in policy recipient agreement for each of the three mandated by the Departments of Education, years the grant was funded. Each year Homeland Security, and State have altered submission of a project scope list was the ability of international students and required. This was a list provided by each scholars to pursue the opportunity to study of the project site institutions detailing in the U.S. Although the circumstances that what they planned to accomplish over the created these changes are understandable, next 12 months and how their funding the overall long-term consequences and would accomplish these goals. Research eventual impact on the ability of the U.S. to administration viewed this list as mandatory; maintain its leadership in many academic otherwise the sub-recipient agreement for areas and research are now in jeopardy. that particular institution would not be A concerted effort must be made by both validated for that year, resulting in a lack of policy makers and educators to work funds. together to re-establish the U.S. as the place Fourth, the project required an annual for international students to be educated. In progress assessment, which also included so doing, important contributions are made a financial statement pertaining to the to American society as these students go allocation of funding for the previous year on to become active members of the global and how this funding was spent. Research community. administration facilitated the process of Thus, it will continue to be through collecting and validating this information to education and research that we will be the sponsor’s satisfaction. allowed to return to the forefront in In the final analysis, research administrators providing opportunities for international played a critical role in the overall grant students. The consortium described in this process. In addition to providing the report is an example of a new strategy proper project oversight required by the for international program development. sponsoring agency, they also ensured that The focus for the future pursues a more institutional policies and procedures were ambitious aim of implementing joint or dual followed during the performance of the transatlantic undergraduate degrees within project. As more of their time became a smaller consortium. This is based on the devoted to compliance issues such as these, rationale that the growing pace of global research administrators continued to serve as interconnectedness in virtually all aspects important members of the team. of human life means our post-secondary institutions must rethink how best to The Future prepare students for a lifetime of work in an The United States has long been engaged in international environment, i.e., “the world an aggressive competition for international is getting flat” (Friedman, 2005). In doing students. For years, international students so, the EU and U.S. governments intend came to the U.S. to be educated and to gain to support collaborative projects that can

84 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration contribute to innovation and the acquisition cooperative exchange program for of skills required for meeting the challenges faculty and students in allied health of the global knowledge-based economy. emphasizing academic and research Those most successful colleges and initiatives. Journal of Allied Health, 22, universities in the future will increasingly 439-445. define themselves as truly international in Gallicchio, V. S., Kirk, P., & Birch, N. J. terms of their educational activities and the (1998). Use of an international faculty/ demographic profile of their faculty and student exchange program as a process students. While the research community to establish and improve graduate has to a larger extent embraced the global education and research within an allied dimension, as reflected in broad and health discipline. Journal of Allied intensive international collaborative activity, Health, 27, 31-34. the study and teaching dimensions of higher Hope-Kearns, E., Gallicchio, V. S., & Ward- education still have to address this challenge Cook, K. (2004). International survey of in a truly international perspective. In program directors opens doors toward the EU-U.S. context the next aim is to ASCP globalization: An innovative address this challenge by developing and transatlantic student exchange program. testing a new and more integrated form of Laboratory Medicine, 35, 466-469. international education: transatlantic joint Karni, K. R., & Waller, K. V. (1999). degrees. This innovative initiative will Comparing CLS faculty and allied undoubtedly create new challenges for health deans and directors: Time spent research administration in order to allow the in academic activities and perceptions colleges and universities that select this high of the research environment. Clinical ground to succeed. Laboratory Science, 12(6), 332-335. Kraemer, L. G., & Lyons, K. J. (1989). References Research productivity of allied health Bruhn, J. G. (1987). The changing limits of faculty in academic health science professionalism in allied health. Journal centers. Journal of Allied Health, 18(4), of Allied Health, 16, 111-118. 349-359. Covey, P. C., & Burke, J. E. (1987). Syed, H. (1991). Collaborative research. Research and the mission of schools in Journal of Allied Health, 20, 69-73. allied health. Journal of Allied Health, Waller, K. V., Jordan, L., Gierhart, J., 16, 1-5. Brodnik, M. P., Schiller, M. R., Friedman, Thomas L. (2005). The world is Flanigan, et al. (1988). Research flat — A brief history of the twenty-first skills and the research environment: century. New York: Farrar, Stratus and A needs assessment of allied health Giroux. faculty. Journal of Allied Health, 17(2), Gallicchio, V. S. (1993). Process 101-113. development of an international

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 85 Book Review: Managing Scientists: Leadership Strategies in Scientific Research (2004) Alice Sapienza, Wiley-Liss, Inc., 246 pp. Frances Chandler, M.A., Ph.D. (cand.) Associate Director Office of Research Services Brock University St. Catharines, Ontario, Canada Managing Scientists: Leadership Strategies in Scientific Research is the kind of book that researchers in all disciplines, not just the sciences, will want to read in their capacities as Principal Investigators (PIs), collaborators or team members. It is equally useful to research administrators charged with the responsibility of assisting scholars who may benefit from help in leading, managing, and collaborating with peers, students, post doctoral fellows, and bureaucrats. Alice Sapienza believes this second edition further illuminates those consequences that arise when PIs are unable to mediate, mentor, or manage their projects. Like others who write in her field, Sapienza notes that “poor leadership results almost invariably in poor productivity and a lack of creativity” (Preface, p. x), and that emerging theories, polices, and practices need to be easily accessed and implemented to ensure maximum output from the research project and its participants. She suggests that “the journey from occupying a managerial/leadership role to being an effective leader sometimes begins with a book” (Preface, p. x), and this book is one that she feels will provide researchers with context-specific examples of the joys and challenges of leading and managing in an academic milieu. I am not a scientist, but in my capacity as a Alice Sapienza also supports this assertion, university administrator I offer assistance and as a professor of leadership, she is in managing scientific research projects. uniquely situated to study and appreciate the Over time I have come to understand that issues articulated to her by individuals who many of the challenges researchers face take part in scientific research. Over a three- are not unique to their discipline. I also year period she and a colleague conducted a understand that, while they are cognizant study of scientists engaged in research; the of the latest scientific studies in their fields, results of her findings are published in this they typically are not aware of emerging book. Encouraged by her reflections, new leadership literature. As a result, my role as theories of management and leadership, and an administrator involves apprising them of a renewed enthusiasm for the topic area, those theories, models, and practices that she has written a book that is an excellent will have an impact on their work. This role resource for research administrators, PIs, is one that we, as research administrators, and others engaged in scientific research. are called upon to assume in our capacities as managers, leaders, planners, counselors, What makes this book of interest to conciliators, and compliance officers, so we members of SRA is the author’s unique need to be aware of these new and emerging perspective – one that is familiar to us. theories and tools. Sapienza knows that, based in a setting

86 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration where the main activity “occurs between The approaches I choose are based on what I the ears of scientists” (p.168), it is difficult read in journals and books such as this one, to adapt management strategies from and what I hear from researchers when they the private sector to academia, as there “find themselves leading other scientists and is a difference between a “discovery technical personnel” (Preface, p. xi). I am organization” and “development particularly drawn to Sapienza’s chapter on organization” (p.168-169) in regards to the organizational structure, as it is beneficial expectations related to output. to all of us in the business of supporting researchers as they design and create a She suggests that we need to be cognizant practical and operational organization for of the differing purposes of discovery and their new or floundering projects. Chapter development organizations, as well as the Nine is devoted to this discussion and the project management language used in each. unique culture within which we develop For example, there is a marked difference these structures. between the traditional definitions of project management and those used in discovery A chapter entitled Being Different refers organizations. Words such as develop, to the cultural, ethnic, age, educational, construct, and implement are widely used and gender diversity found within in development organizations, while collaborative research teams. Comprised of explore and discover (p. 168) are used in individuals from different disciplines and research settings. These differences need to backgrounds, these team members need be understood by research administrators to sort out divergent views on appropriate who are disseminating information on methodologies, philosophical approaches, new approaches to leadership and project power, equality, role differentiation and the management. We need to be selective as sharing of intellectual property rights. to what theories or models will be most useful to our cohort prior to addressing These divergent viewpoints may also affect their questions and concerns about the how a collaborative is managed. In Chapter management of their research projects. Seven, Sapienza addresses the issue of project management and the important role Unfortunately, there is a lack of research it can play in developing creativity and on this differentiation that Sapienza writes respect among members. PIs need to think about. This dearth of information is both about designing a management structure what compelled her to conduct research and developing a leadership style that best on this topic and what has encouraged me meets the needs of the participants, while to undertake doctoral studies in project research administrators have an obligation management and leadership within a to assist them by reading, deciphering, and knowledge-based university environment. retrofitting current theories to their unique environment. We both know that discovery organizations are unique in their development and This sentiment is echoed by Sapienza structure, but as an emerging scholar, I do in Chapter Three, where she discusses not have the breadth of experience that the definition of motivation and theories Sapienza possesses. Therefore, I refer to related to it. She writes that, to be her book, among others, when deciding on proficient at motivating employees, a fit an approach I might suggest to researchers must occur when balancing job demands, starting a new project or revamping an personal competencies, and organizational existing one. characteristics. Her diagram depicting three

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 87 intersecting circles provides the reader with articulate our needs to ensure the a visual representation of how important it achievement of personal and group is to balance these three spheres to create goals. These skills are not innate, so an optimum environment for creativity and it is imperative that we, as research knowledge creation. She also notes that administrators, are aware of the latest there are human and technical aspects within theories and tools that will assist researchers, each circle that must be considered. For then package the material and deliver it in example, education, skills, and training are a timely and accessible format to our target found within the technical aspects, while audience. work, motivation needs and leadership style are considered human characteristics. For example, contrary to what classical scholars believed, it is now widely held The latter is what Sapienza suggests is the that the contingency model of leadership most difficult, and I am sure that most of effectiveness is the best. Sapienza discusses us in our roles as research administrators this model in the fourth chapter by referring would agree, based on what we hear from to Fred Fiedler’s assertion that proficient researchers. In my capacity as an Associate leaders emerge only as a result of a good Director of Research Services I cannot fit between leadership style and three other recall more than a handful of questions from elements: 1) leader-member relations, 2) faculty members regarding the research task structure, and 3) power position (p. process, but in relation to human resource 73). It is this model that she introduces as and management issues, the queries are a basis for her discussion on the need to numerous. change one’s leadership style to suit unstable environments and the ever-changing It is precisely for this reason that books situations that emerge from within and such as this one are important for us to read, outside of them. understand, and relay to our constituents. Easy to follow, it combines a how-to She also suggests that we need to employ all approach while interweaving context– the resources we have at our disposal when specific, new and established theories on dealing with conflict, as well as individual, leadership and project management. organizational, and power differences. For example, I rely on my skills as a social Divided into 10 chapters, Managing worker when acting as a mediator between Scientists: Leadership Strategies in researchers who may not agree on the Scientific Research outlines issues related to direction of the research, my planning skills effective communication, conflict resolution, when assisting them with their management assessment of the working culture, and structure, and my teaching skills when leading change. It includes examples from relaying new information to them that I have within the research environment and results learned as a result of my doctoral studies. from the three-year research project that I know that I need to keep abreast of the formed the basis for the book. It lists new changes in my environment, so continue to understandings that the author has acquired read, study, and disseminate my knowledge as a result of her research, indicating the to those I serve within my institution. ongoing personal growth that she says is so important when managing or leading people. Sapienza’s book has provided me with some excellent ideas about what researchers might She writes that we all need to understand find useful, and although her focus is on ourselves, and in so doing, respectfully

88 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration a scientific lab setting, she outlines some excellent strategies that are transferable to researchers in other disciplines. At the very least, we should all read this book so that we can better understand that the challenges researchers articulate to us on regular basis are not specific to one individual, project, university, laboratory, or country, but are universal.

As the Society of Research Administrators International approaches its 40th anniversary and expands its reach to more locations than ever before, it behooves us to stay current, share our new and evolving insights with others, and maintain an active role in the research enterprise as well as its administration. This book will assist us in this endeavour.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 89 Law Review: Recent Developments in Research Law J. Michael Slocum Slocum & Boddie, PC 6225 Brandon Ave. Suite 310Springfield, VA 22150 (703) 451-9001, Fax: (703) 451-8557 [email protected]

Eric Guttag Jagtiani + Guttag Cincinnati, OH

J. Mark Waxman Foley & Lardner Boston, MA

Jill Williamson Alston & Bird LLP Washington, DC Authors’ Note Over the past year there have been important developments in the law related to research and research administration. Some of these changes are outlined in this article, which was conceived and written by a group of attorneys with expertise in topics of particular importance to the research institution. Many of the issues addressed are related to intellectual property, but there are important developments in other areas of the law as well, including new and proposed changes to export regulations and exciting new developments in research collaborations. The authors would like to give a special thanks to Amanda Boddie, a summer intern at Slocum & Boddie, PC, and a new law student at the Catholic University of America in Washington, for her efforts to pull the various topics together and to assure some level of continuity and consistency in the language in this article.

An Overview of Export Law and Export Administration Regulations Regulations The responsibility of the Bureau of Industry Current federal export laws control a wide and Security (BIS) in the U.S. Department range of technologies and some of the of Commerce is to apply and enforce the regulations outlined in them can have a Export Administration Regulations (EAR) substantial impact on research. These laws (15 CFR chapter VII, subchapter C). The control the conditions under which certain EAR is responsible for regulating the export information, technologies, and commodities and re-export of numerous commercial can be transmitted overseas to anyone items, including those that have dual-use (including U.S. citizens) or to foreign applications, which means that they may be nationals (even if in the U.S.), and some used in both the military and commercial of these regulations will be outlined in this realms. Other government agencies, such section. as the U.S. Department of State, regulate defense items.

90 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration A small percentage of U.S. exports and As one would expect, items such as re-exports regulated by the EAR require weapons, chemical and biological agents, a license from BIS. To obtain a license, military vehicles, and equipment all have a information must be provided regarding the military use according to ITAR. However, item that is being exported, its anticipated all satellites and related technology and use, and the recipient and final destination data are now added to this list. Both the of the item. There are 10 specific categories ITAR and the EAR are now subsuming that require a license: nuclear materials; control over applied research such chemicals, microorganisms, toxins; as satellite technology, that was once materials processing; electronics; computers; considered to be of a non-military nature. telecommunications; lasers and sensors; In spite of a longstanding official policy avionics; marine; and propulsion systems that exempted fundamental research from (See §734.2(a) of the EAR for items that are the export regimes, these organizations subject to the EAR). have increasingly been expanding their jurisdictional reach to include items such as International Traffic in Arms Regulations satellites (22 CFR § 121.1 Category VIII). The U.S strictly regulates exports and re- exports of defense items and technologies Office of Foreign Assets Control to protect its national interests in peace and The Office of Foreign Assets Control, security. The Directorate of Defense Trade or OFAC (2002 CFR Title 31, Volume 2 Controls (DDTC), Bureau of Political- Chapter V), is part of the U.S. Department Military Affairs, Department of State, in of Treasury and is the organization accordance with 22 U.S.C. 2778-2780 of the responsible for administering and enforcing Arms Export Control Act (AECA) and the economic and trade sanctions. OFAC has International Traffic in Arms Regulations the authority to impose comprehensive or (ITAR) (22 CFR Parts 120-130), is charged selective control over transactions between with controlling the export and temporary the U.S. and other countries and to freeze import of defense articles and defense foreign assets. This role is mandated by services covered by the United States American foreign policy related to national Munitions List (USML). (22 CFR § 121.1) security concerns such as terrorism and the proliferation of weapons of mass The purpose of ITAR is the control of destruction. arms sales to foreign parties to protect U.S. national security and to further U.S. foreign OFAC also has the power to provide general policies. The Core of the ITAR is the United licenses authorizing the performance of States Munitions List (USML). Items certain categories of transactions and to included on this list are those that are deemed provide restricted licenses on a case-by- to have a military use or one that allows case basis subject to specific conditions. Americans in military situations to defend These particular transactions, which OFAC themselves by disarming or eliminating is empowered to oversee, are referred to as their adversaries. The ITAR governs license prohibited transactions and may include applications for exports dealing with matters trade or financial embargos between and related to defense trade compliance and among U.S. citizens and foreigners. Unless enforcement, and also assumes responsibility expressly authorized by OFAC or exempted for the creation of defense trade reports to by statute, prohibited transactions are to Congress and the public (Defense Trade be adhered to by the parties involved. Function Overview, n.d.) However, each program, such as the Anti-

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 91 Terrorism program and the Anti-Drug have full-time employee status or the foreign program, is based upon different foreign visa holder who is required to maintain a policy and national security goals so the foreign residence. prohibitions may differ. In some cases, a license is needed to undertake almost any The National Policy on the Transfer of transaction involving a citizen of a targeted Scientific, Technical, and Engineering country while in other cases only specified Information, or NSDD 189, generally individuals or companies are subject to provides that products of fundamental restriction or prohibition. research are to continue to be unrestricted. This policy, created under President Reagan The National Policy on the Transfer of in 1981 (NSDD 189, 1985), states that: Scientific, Technical, and Engineering Fundamental research in this sense is Information, NSDD 189 defined as the basic and applied research There has been a longstanding tension in science and engineering, the results between the perceived need to protect of which ordinarily are published and national security through the control of shared broadly within the scientific technical information while at the same community, as distinguished from time providing an environment that allows proprietary research and from industrial for free and open scientific discourse to development, design, production, and take place to advance scientific knowledge. product utilization, the results of which This tension has been balanced through a ordinarily are restricted for proprietary carefully negotiated Fundamental Research or national security reasons. Exclusion policy that allows published research that is already in the public domain For national security reasons, there may to be excluded from licensing such as that be instances when control of information overseen by OFAC. This exclusion applies is necessary and data that are generated only to disclosures in the U.S. at accredited during federally funded research in science, institutions of higher learning and may be technology, and engineering at colleges, reversed if these institutions accept federal universities, and laboratories are subject funding for projects that are subject to to review. Various federal agencies use specific national security controls. a form of classification to determine the level of control of this information. These Bona-fide, U.S. citizens employed full agencies are responsible for: (a) determining time at American universities are allowed, whether classification is appropriate prior under ITAR, to share unclassified technical to the award of a research grant, contract, data with foreign nationals who are also or cooperative agreement and, if so, employees of American universities and controlling the research results through who reside in America. This exemption standard classification procedures; and (b) may only be applied when the employee periodically reviewing all research grants, is not a national of an embargoed country contracts, or cooperative agreements for and upon receipt of a signed agreement potential classification. No restrictions may that disallows the sharing of information be placed upon the conduct or reporting with other foreign nationals without prior of federally funded fundamental research government approval. There are limitations that has not received national security to this exemption however, as in the case of classification, except as provided in graduate or doctoral students who may not applicable U.S. statutes.

92 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration The expansive definition of export we are pleased that the proposed continues to be a problem in research even requirement for unique badging and with the exemption provided by NSDD segregated work areas for foreign 189. In situations where export controls nationals has been removed. We also stipulate that a license is required but no appreciate that the new proposed rule exemption is available, a license must be addresses the concern raised by AAU obtained before export-controlled items or about the “flow-down” of export-control information can be shared abroad or with contract clauses from commercial foreign nationals participating in research entities to university subcontractors. on U.S. campuses. For example, restrictions Finally, AAU appreciates that this new exist for dissemination of information at proposal more explicitly references conferences where unpublished research is National Security Decision Directive to be presented and when assisting foreign 189 (NSDD 189). collaborators with understanding how to use items in research (defense service) or AAU continues to maintain that transfers of research equipment abroad. DOD clauses pertaining to export Finally, no licenses at all are available for controls should place the burden of exports to embargoed countries and those export controls compliance on the countries designated as supporting terrorist contractor. DOD should avoid turning activities (15 CFR chapter VII Part 764, its contracting and program officers Supplement 3; See also 15 CFR chapter VII into export control compliance officers. Section 744.1(c)). The only instances in which contracting officers should be involved in export The NSDD 189 and other legislation control determinations are when such as the Bayh-Dole Act (PL 96-517, the research to be performed is not Patent and Trademark Act Amendments fundamental and when the information of 1980), have an impact on every area required to conduct the research, or of research. For example, current export the research results, are known at the laws control a wide range of technologies outset to require security controls or including those created by researchers classification. at educational institutions or by medical personnel. Most recently the Association Deemed Exports, Immigration Policy, and of American Universities (AAU) has taken Universities the lead in protecting principles outlined There are some key issues associated with in NSDD 189. On October 16, 2006 the the proposed rules on export from the AAU commented on the newest draft of the so-called deemed export rules. Institutions proposed Department of Defense (DOD) of higher education have a responsibility rules concerning export controls as follows to make certain that any and all research (DFARS Case, AAU comments, 2-3 2006): conducted under their sponsorship protects In terms of specific improvements, we the national security of the U.S. and are pleased that the new rule has been complies with export rules and regulations. modified to eliminate overly prescriptive However, with the current rules in place at provisions that went far beyond existing universities, progression within the scientific Export Administration Regulations community and the conduct of research can (EAR) and the International Traffic in be seriously hindered. Stringent guidelines Arms Regulations (ITAR). In particular, related to how researchers undertake

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 93 their work, has meant that the progress of residency in another country that would collaborative science may be impeded. not require a license to obtain access to controlled information. The deemed export rule (See §734.2(b) (2)(ii) of the Export Administration The initiatives posed by OIG could have a Regulations ) has been set in place to chilling effect on the research community. protect U.S, national security, and applies For example, an academic institution when “an export of technology or source might be required to identify the country code (except encryption source code) is of origin of students, researchers, or others deemed to take place when it is released to at the institution to determine whether a foreign national within the United States” they would need an export license to gain (Deemed Export FAQ’s). Thus, under this access to controlled information. The AAU rule, an export is considered to take place (Revision and Clarification, 2005) made when covered information is disclosed to note of this concern by suggesting that “the a non-citizen even though the disclosure reality is that the largest fraction of the happens inside the United States (persons best and brightest students that America’s with permanent resident status are often research universities attract comes from exempt from the restrictions). Universities what the Department refers to as ‘countries and companies that have foreign nationals of concern,’ especially China, India, Russia, as students or employees must comply Pakistan and Israel.” Apprehension about with these rules when access to controlled export controls could lead to situations technology is granted to them. However, if a in which research is governed by these foreign national has been granted permanent concerns rather than scientific expertise of a residence, U.S. citizenship, or considered a researcher when assigning certain projects protected person, he or she may be exempt or taking on new research ideas. from the deemed export rule. The concern regarding federal laws that The Department of Commerce Office of has been expressed by the AAU relates to Inspector General (OIG) (The Inspector state law as well. As of April 2007, 50 state General Act of 1978, 5 U.S.C.A. legislatures, and even some counties, had Appendix 3) has expressed concerns over introduced over 1,200 bills and resolutions certain existing policies of the Export related to immigration. The Immigration Administration Regulations (EAR). The and Compliance Act (06 SB529/AP, 2006), OIG takes the position that a loophole which went into effect in Georgia on July exists in export licensing related to the 1, 2007, is one such law. This law affects current policy of using a person’s country any entity that contracts or subcontracts of residency, rather than citizenship, in with the state of Georgia, is a Georgia State determining whether an export license is entity, has any 1099 employees in Georgia, required. The OIG outlined its concerns or provides state benefits to Georgians. in a report to the Bureau of Industry and Obviously this legislation encompasses Security entitled Deemed Export Controls most universities and many other research May Not Stop the Transfer of Sensitive organizations. Some key provisions of the Technology to Foreign Nationals in the U.S. Act are included below: (Final Inspection Report, 2004). This report 1. Affected contractors and suggested that foreign nationals, originally subcontractors with over 500 from a country of concern, could maintain employees are required to register

94 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration and use BASIC, the federal electronic In addition to Georgia other states across employment verification system, and the nation are continuing to take matters submit an affidavit of compliance; into their own hands when it comes to 2. Affected contractors and immigration policies. While Congress and subcontractors with 100 or more the White House continue to have heated employees will have to register and debates over immigration policies, more use BASIC beginning July 2008; than 57 new statutes have been enacted in over 18 states including Oklahoma, 3. All other affected contractors and Maryland, and Arkansas (Prah, 2007). subcontractors must register and use BASIC by July 2009; Oklahoma’s new immigration law allows police to arrest illegal immigrants, restrict 4. All state entities will be required to their benefits, and makes it against the law use BASIC for all new hires; to harbor illegal immigrants. In addition, 5. State income tax deductions for the new Oklahoma law requires companies business expenses related to to verify that new employees they hire are employment of employees for whom legal U.S. citizens (Prah, 2007). Following the employer has not properly verified suit, Arkansas has enacted laws that bar any residency status, are disallowed; and state agencies from working with companies hiring illegal immigrants (Prah, 2007). 6. Tax for payments amounting to 6%, made via 1099, will be withheld if However, not all new immigration laws are the recipient has not provided a valid focused on barring and excluding illegal taxpayer identification number (06 immigrants. Although Oklahoma is moving SB529/AP, 2006). toward a tougher stance on immigration, in-state tuition and aid to students of illegal This new law is worth the attention of all immigrants is still allowed, provided they universities and research organizations not begin the U.S. citizen process within one just those physically located within the state year of beginning their college education of Georgia. It is not clear what the impact (Prah, 2007). Among Maryland’s new of the law will be outside of the state or policies are programs designed to persuade even internationally but several provisions immigrants to learn English and encourage may result in unintended complications. them to begin the process of becoming a For example, the Act has an impact on the U.S. citizen (Prah, 2007). salaries of both regular and 1099 employees within the state (i.e., consultants, part- The export and immigration issues timers who are not on the regular payroll, continue to be controversial and fluid. Any and “independent contractors” who are organizations that are comprised of foreign providing personal services to the company students, professors, or researchers, should or institution), regardless of where the remain alert to the potentially crippling employer is located (06 SB529/AP, 2006). effect of national security concerns on Additionally, the Act applies to contractors fundamental research. and subcontractors providing services Intellectual Property Issues and Patent in Georgia, regardless of where they are Rights located. Contractors and subcontractors Many cases in the past several years have located outside the U.S. are not eligible to clearly indicated that the impact of these use BASIC. laws is significant in relation to intellectual

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 95 property. In Madey v. Duke University (307 Duke’s research was irrelevant to whether F.3d 1351, 2002 U.S. App. LEXIS 20823) the experimental use defense applied (Fed. Cir., 2002) (Madey), for example, (Madey, at 1363). the Federal Circuit took a stand against the experimental use defense and several The outcome of this trial could have institutions have turned to the Supreme damaging effects on the scientific Court for help arguing that the effects of this community. Many academic and other decision against experimental use could set research institutions have weighed in as the up harmful roadblocks to the progression of case goes to the Supreme Court for further science. Some of these decisions are noted appellate review, arguing that the effects of in this section. this decision against experimental use could establish almost insurmountable roadblocks The Experimental Use Defense to Patent to the progression of science. Now when Infringement: Madey v. Duke University research institutions want to further their In Madey v. Duke University, the Court of research agendas they will be faced with Appeals for the Federal Circuit overturned additional costs due to delays caused by the the decision made by the District Court. Dr. time spent on researching patents or dealing Madey, former head of Duke’s free electron with difficult patent holders. laser (FEL) research lab, filed suit against Duke for patent infringement. Madey While the Federal Circuit, after the Madey claimed that three pieces of equipment that case, may have left the experimental were in Duke’s FEL lab were covered by use defense with little remaining value, one or both of his patents and that Duke was universities and other non-profit research unauthorized to use them. institutions are not without other viable options for immunizing their research from In District Court, Duke University was patent infringement. In fact, there are at least granted a partial summary judgment (no three potential safe harbors that universities trial was necessary) on the grounds of an and other non-profit research institutions can experimental use defense. The District Court and should consider: (a) for state entities’ acknowledged that this defense applied immunity under the Eleventh Amendment; to uses “solely for research, academic or (b) immunity under the Hatch-Waxman experimental purposes” (Madey, at 1355). Act; and (c) immunity under the federal The District Court also recognized “the contractor’s defense of 28 U.S.C. §1498(a). debate over the scope of the experimental use defense,” but held that this defense The Washington University v. Catalona et al. was “viable for experimental non-profit In another case involving a university purposes” (Madey, at 1355). and a former employee, The Washington University v. William J. Catalona, et al. The Federal Circuit, however, viewed the (U.S. App. LEXIS 14442 (8th Cir. Mo., experimental use defense as too broadly June 20, 2007)), the court ruled in favor applied in this case holding that the research of the university. Unlike the Madey case, projects carried out by Duke “unmistakably there was no dispute in Catalona involving further the institution’s legitimate patent rights or violations but the Court’s business objectives, including educating ruling could have major implications for and enlightening students and faculty intellectual property ownership disputes. participating in these projects” (Madey, at 1362). As far as the Federal Circuit was In Catalona, Judge Stephen Limbaugh concerned, the profit or non-profit status of heard arguments regarding the ownership

96 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration of patient-donated biological samples. After their right to remove themselves from the the proceedings Judge Limbaugh ruled in research study gave them the additional right favor of Washington University at Saint to determine where and how their samples Louis (WU), granting it sole ownership were to be used. of all biological samples donated for research purposes to its bio-repository. The There were two cases used as guidance Judge further ruled that the researchers in Catalona: Greenberg, et. al. v. Miami and research participants (RPs) had no Children’s Hospital Research Institute, Inc., legal claims to ownership of any donated et. al. (2003) and Moore v. The Regents of biological samples. the University of California, et. al. (1990).

Dr. Catalona, a researcher and urologist, In Greenberg, the plaintiffs argued they was employed by WU from July 1976 until had property interest in their donated body February 2003 when he left WU to pursue tissue and genetic information, but the court a job at Northwestern University. Upon declined to support this argument, noting his departure from WU, Catalona mailed that donations to research are made without letters to those who had donated samples any expectations of return of the body tissue to the bio-repository at WU, asking them and genetic samples. In Moore, a patient to authorize the release of their samples to undergoing treatment for hairy-cell leukemia him so he could continue his research at had his biological materials, portions of Northwestern. Six thousand donors signed his spleen, and blood samples used in and returned their release forms to Catalona. medical research without his knowledge or Nevertheless, WU refused to release the consent. The research conducted with his samples and filed suit to determine their biological materials resulted in a cell line ownership. that was patented by the defendants who entered into agreements for the commercial WU believed it owned the samples because development of the cell line and the they were donated as gifts to the university resulting products. The patient-plaintiff to use in research and maintained it was brought suit alleging conversion and breach in exclusive ownership of the samples of physician’s disclosure obligations, but throughout the entire period of Catalona’s the court ruled against the patient. It stated employment. It entered into evidence forms that the defendants had a right to use the that Catalona had signed that clearly stated plaintiff’s cells in medical research, without WU was the owner of all biological samples permission, since there was no ownership donated for research purposes. interest in cells after they left his body.

The basis of Catalona’s argument was The Catalona court followed these two cases that no gift was made to WU. The defense entirely. It declared that WU had maintained asserted that because of exculpatory and financed the bio-repository, bore language (i.e., language that purported the risks of the research, and asserted its to excuse the university from liability) ownership interests through its intellectual contained in the informed consent forms, property policy. Catalona appealed this no gift could have been made to WU. Dr. decision by the Federal Circuit and took the Catalona also argued that the RPs made case to the 8th Circuit Court of Appeals. On donations with the intention that their June 20, 2007, the 8th Circuit affirmed the samples be given to Catalona to further District Court of Missouri decision that WU his research. Furthermore, Dr. Catalona’s owned the disputed biological materials in attorneys asserted that the RPs believed the tissue bank, and that Dr. Catalona and

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 97 the contributing individuals (RPs) had no rights to license the invention (i.e., the right ownership or proprietary interest in those to take over exploitation of the invention biological materials (Supra 1002). where it determines it is not being made available to the public) to a third party, th It is important to note that the 8 Circuit without the consent of the patent holder or affirmed this decision solely on the narrow original licensee. state law ground (under Missouri law) that the RPs donated their biological materials Most research institutions are aware to WU as inter vivos gifts. The 8th Circuit that Bayh-Dole allows them to retain made no mention of the earlier Moore title to patent rights in federally funded and Greenberg cases, of the Common research. However, they may not know Rule under Title 45 of the CFR, or any that patent rights can also be lost if the other federal regulation relating to tissue subject invention is not disclosed to the donations or research that the District Court federal funding agency in a timely fashion used to reach its decision. Since the opinion and pursuant to Bayh-Dole. The case of was based strictly upon state law grounds, Campbell Plastics Engineering & Mfg., Inc. it could be deemed of minimal precedential v. Brownlee deals with this patent issue and value outside the 8th Circuit and possibly involves a federal defense contractor who even outside Missouri. Alternatively, it forfeited his patent rights based on a failure could also stand for the proposition that to disclose in a timely manner. tissue donation is a state law question that could create 50 different state laws on the During the time period between September subject and potentially set up a state-federal 1992 and September 1994, the contractor law pre-emption issue that might have to be filed three reports with the army on form resolved by the Supreme Court if the circuits DD 882. In these forms he did not mention split on this issue. his invention, the sonic welding of mask components. From September 1994 through Campbell Plastics Engineering & Mfg., Inc. August 1997, the contractor contacted v. Brownlee and the Bayh-Dole Act its patent attorney about drafting a patent The law continues to develop in the area of application on the subject invention; while balancing Federal rights with those of the in the process, he no longer filed reports inventors of technology under government with the army. contracts or grants. The case of Campbell Plastics Engineering & MFG., Inc. v In June 1997, the army published a Brownlee (2004) turned on the application report (the June 1997 report) on research of the Bayh-Dole Act. conducted by the army from October 1991 through July 1995, including research on The Bayh-Dole Act allows for the transfer sonic welding of mask components. This of exclusive control over many government- report formed the basis for the army’s funded inventions to universities and subsequent joint ownership claim, even businesses operating with federal contracts though the contractor submitted at least 16 for the purpose of further development progress reports and drawings to the army and commercialization. The contracting on his invention. These reports, however, universities and businesses are then were not submitted on form DD 882. permitted to exclusively license the inventions to other parties. The federal Over time an exchange of letters took government, however, retains march-in place between the contractor and the

98 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration army regarding joint ownership of the on forfeiture and remain within the bounds invention, and eventually the Administrative of sound discretion” (Campbell Plastics, Contracting Officer (ACO) for the army 1250). concluded that the contractor had forfeited title to the particular patent because of In Campbell Plastics, the Federal Circuit its failure to comply with the patent sent several very clear warnings about rights clause by not disclosing the subject complying with contractual obligations invention to the army in a timely fashion. based upon the Bayh-Dole Act. For example, loss of patent rights is an appropriate The contractor appealed the ACO’s consequence when the contractor fails decision to the Armed Services Board of to disclose the subject invention to the Contract Appeals. The Board denied the funding agency and the funding agency can contractor’s appeal, ruling: (a) the contractor dictate, within reason at least, the form of failed to satisfy its contractual obligation compliance to inform the Army that it considered the sonic welding of mask components to be KSR v. Teleflex an invention; (b) any information that the After a long absence from significant Army learned from its January 1998 review activity, the Supreme Court has also returned of the subject patent application for its to delivering important rulings concerning secrecy determination, as well as from its intellectual property (IP). In KSR Int’l Co. own June 1997 report, was not provided v. Teleflex Inc. (127 S. Ct. 30; 165 L. Ed. 2d by the contractor, and, thus, forfeiture of 1009; 2006 U.S. LEXIS 5385; 75 U.S.L.W. title to the patent was appropriate under the 3094 (2006)), the Supreme Court used the circumstances; and (c) while the Army had obviousness test to overturn a decision made some discretion in determining whether to by the U.S. Court of Appeals for the Federal take title, it did not abuse that discretion. Circuit. The Supreme Court ruled that the Federal Circuit had applied the obviousness In affirming the Board’s decision, the test too narrowly, and reversed the ruling Federal Circuit was unsympathetic to the holding that it was inconsistent with 35 contractor’s plea that it had “continually U.S.C.S. §103. disclosed all features” (Campbell Plastics, 1249) of the subject invention to the army KSR designed a gas pedal with an electronic throughout the agreement period. Instead, sensor designed to automatically adjust to the Federal Circuit said the agreement’s the height of the driver. Teleflex sued KSR requirement “of a single, easily identified for patent infringement. KSR argued that form on which to disclose [subject] it was obvious to look into new methods to inventions is sound and needs to be strictly make the pedal electronic and use a sensor, enforced” (Campbell Plastics, 1249). and asserted that, because this technology was obvious, the Teleflex patent in question As it had argued to the Board, the contractor should be invalid. also argued to the Federal Circuit that the ACO abused his discretion by demanding The U.S. Supreme Court unanimously held title because the federal government had that the patent claim was invalid as obvious allegedly suffered no harm. The Federal since mounting an available sensor on a Circuit rejected this argument, holding fixed pivot point of the competitor’s pedal that “harm to the government is not a was a design step well within the grasp of a requirement in order for the ACO to insist person of ordinary skill in the relevant art, and the benefit of doing so was obvious.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 99 This decision by the court comes at a time as malaria, tuberculosis, and HIV. when many commentators are asserting that Complementary research is being the U.S. patent system is in need of major undertaken on plans and processes that changes. Currently, new legislation is being would make current health methods more reviewed in Congress that could drastically affordable and accessible for those who are change the process through which patents in need, especially in developing countries. are obtained – among other things adopting a first inventor to filesystem rather than the The NCI is another organization dedicated current first to inventsystem, and changing to helping research move from discovery the ease with which patents are granted. to delivery by “expanding and facilitating researcher access to resources and new New Legal Models for Research Activity technologies” (Enhancing Investigator, 76, Beyond the seemingly perennial issues of 2004). This institution believes that “the importance to research, such as control increasing complexity of research projects and ownership of information, several demands that researchers work in an new topics are creating a buzz in the interdisciplinary team environment, rather legal community and in the management than in isolated laboratories with occasional offices of research institutions. One of the collaborators” (Enhancing Investigator, 73, topics receiving the most commentary is 2005). the increasing prevalence of collaborative research, especially internationally. Being able to collaborate with others on issues of global importance, especially Research Collaborations in the medical arena, enhances resource Researchers and the funding agencies that sharing, innovation, and the promotion support them are making headlines with of translational research and intervention the collaborative work they are engaged development. The NCI supports a wide in. The Bill & Melinda Gates Foundation array of research that will further develop and the National Cancer Institute (NCI), “scientific discovery at the molecular and for example, are two leading groups that cellular level” (National Cancer Institute, fund collaborative projects designed to n.d.). enhance the health and well being of people all over the globe. The former, with its Agricultural Research Collaborations Global Access Strategy, has focused its Collaborations in agricultural research research funding on projects that “create and are essential to protect the environment improve health interventions and strategies while ensuring a supply of food to all the to make these interventions accessible to populations in the world. Universities, the people who need them most” through in conjunction with government and the development of “vaccines, drugs, and grass roots organizations, are developing diagnostics, including basic research, agricultural practices that improve the product development, clinical trials, and quality of food products while enhancing operations research” (Priority Health the yield and addressing the environmental Strategies, n.d.). impact. Groups such as the Agricultural Research Organization (ARO), International Currently the foundation is conducting Center for Agricultural Research in the Dry research related to the creation of new Areas (ICARDA), and the Agricultural methods for treating health problems Experiment Station (AES) at the University for which there is no known cure, such of California, Davis are a few of the

100 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration organizations leading the way in agricultural work. International activities are considered research. an integral part of the NSF’s mission to sustain and strengthen the nation’s science, The ARO and ICARDA ensure that mathematics, and engineering capabilities, representatives from a variety of ethnic and to promote the use of those capabilities groups are able to work together to better in service to society. NSF makes grants develop agriculture methods. For example, available to promote the development the ARO is working in collaboration with of international collaborations. Grants groups such as Commonwealth Scientific & from the Office of International Science Industrial Research Organization (CSIRO), and Engineering (OISE) also support Indian Council of Agriculture Research meritorious, collaborative research and (ICAR), and The Russian Academy educational activities that offer potentially of Agricultural Sciences on numerous great benefit because of the vital and integral research projects based upon shared goals. nature of the foreign collaboration. ICARDA “seeks to improve and integrate the management of soil, water, nutrients, Individual universities and research plants and animals in ways that optimize institutions are also promoting collaborative sustainable agricultural production” (Annex research. For example, the Agricultural 2, n.d.). ICARDA is collaborating with Department of the University of California, The Arab Center for the Studies of Arid Davis, Agricultural Experiment Station Zones and Dry Lands (ACSAD), Arab (AES) supports multiple collaborations Organization for Agricultural Development involving both the U.S. and other (AOAD), and the Centro Internacional de governments, universities and commercial Agricultura Tropical (CIAT). organizations. These programs and others undertaken by research entities across the The Agricultural Research Services Office of world are contributing to new bi- or multi- International Research Programs (OIRP) is lateral agreements, and even more complex another group using research collaboration interpretations of the law as it relates to in the agricultural field. Its projects are ownership and control of the new and designed to “enhance the effectiveness and emerging technology. impact of U.S. agriculture” (ARS, 2006) by: 1. Extending the capacity of national Cooperative Research and Development programs to address problems Agreement (CRADA) confronting U.S. agriculture; The Cooperative Research and Development Agreement (CRADA) is a legal agreement 2. Promoting the participation of those between a private company and one or engaged in the scientific community to more non-federal parties. The CRADA expedite the exchange of innovations, was “created as a result of the Stevenson- data and germplasm; and Wydler Technology Innovation Act of 1980, 3. Facilitating international cooperation as amended by the Federal Technology and collaboration on mutually Transfer Act of 1986” (Cooperative beneficial, high priority, agricultural Research, n.d.). The CRADA allows for research. “the Federal government and non-Federal partners to optimize their resources, In the U.S., governmental organizations share technical expertise in a protected such as the National Science Foundation environment, share intellectual property (NSF) are concentrating on collaborative emerging from the effort, and speed the

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 101 commercialization of federally developed all parties to realize their objectives while technology” (Cooperative Research). It serving veterans and the American public also makes possible the protection of by fostering translation of discoveries into background inventions, trade secrets, and medical practice. It allows access to VA confidential information, and provides for research resources including personnel, the establishment of intellectual property services and property. ownership and licensing options in advance of an invention. The CRADA assists with Informed Consent leveraging federal expertise to develop With all of the important developments in products with commercialization potential the law related to research and research and has the power to enforce agreements it administration over the last year, the Office is involved in creating. for Human Research Protections (OHRP) has released updated information pertaining A CRADA agreement is used when a to the rules and regulations governing the “government laboratory and the industry use of informed consent in research studies. partner collaborate on the development and design of a clinical trial to assess the safety OHRP recently published an updated set of and effectiveness of a study agent (e.g., a Frequently Asked Questions and Answers drug, medical device, or dietary supplement) (FAQs) on the subject of informed consent. for a specific indication” (Cooperative These guidelines include both regulatory Research, n.d.). Known as a Clinical Trial requirements and recommendations. 45 CRADA agreement or CT-CRADA, this CFR Part 46 states the following general is used when the collaborator designs the requirements for informed consent: protocol, funds the project and is a holder of Except as provided elsewhere in this an investigational new drug (IND). policy, no investigator may involve a human being as a subject in research CRADAs are being used at Department of covered by this policy unless the Veterans Affairs (VA) research facilities investigator has obtained the legally located at VA medical centers throughout effective informed consent of the subject the country. CRADAs establish the terms of or the subject’s legally authorized sponsored collaborative research, generally representative. An investigator shall seek with non-federal industry partners, and such consent only under circumstances are specifically designed to protect the that provide the prospective subject or parties’ prior inventions while allowing the representative sufficient opportunity the government and private sector research to consider whether or not to participate partner(s) to negotiate management of any and that minimize the possibility of new discovery or intellectual property that coercion or undue influence. The may result from the collaboration. information that is given to the subject or the representative shall be in language The VA highly values its Partnerships for understandable to the subject or the Effective Research for Veterans Health. representative. No informed consent, Whether the collaboration is initiated by whether oral or written, may include any VA, a VA principal investigator (PI) or exculpatory language through which the private sector, a CRADA is a very the subject or the representative is made effective and unique tool. VA’s CT-CRADA to waive or appear to waive any of the is the federal government equivalent to a subject’s legal rights, or releases or clinical trial agreement (CTA), and allows appears to release the investigator, the

102 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration sponsor, the institution or its agents from an electronic signature may, under liability for negligence (OHRP, 2005). certain circumstances, be accepted as documentation of informed consent. The In its FAQ, OHRP notes that informed investigator and the institutional review consent is legally effective if it is obtained board (IRB) need to be aware of laws from the subject or the subject’s legally governing electronic signatures in the authorized representative and documented jurisdiction where the research is being in a manner that is consistent with both conducted. OHRP will allow electronic the HHS protection of human subjects signatures of the consent if such signatures regulations and applicable laws of the are legally valid within the jurisdiction of jurisdiction in which the research is the research and if the signature is properly conducted. obtained. In the university setting it is In response to a related question, OHRP important to know the rules governing the holds that it is possible, under the use of electronic signatures for consent, as circumstances noted below, to obtain legally many studies these days are available to effective informed consent to research in students to complete online. an urgent or emergency care setting. In an In addition to the use of electronic urgent or emergency care setting, the answer signatures, university researchers need to be would depend upon: (a) the expected aware of the numerous rules governing the medical condition of the prospective subject participation of student subjects in research population, (b) the nature of the research, (c) studies. When enrolling students into the time allowed for the potential subjects research studies the amount of coercion or or their legally authorized representatives undue influence must be kept to a minimum. to consider participation, and (d) the OHRP recommends that universities have circumstances for obtaining informed policies that clarify for students and faculty consent appropriately minimize the that any participation by students in research possibility of coercion or undue influence must be voluntary. Reasonable levels of (Human Research Questions, n.d.). extra credit or rewards may be offered for It is also possible to waive consent in an participating in research. If extra credit emergency care setting. Under 45 CFR or rewards are offered, or if participation 46.101(i) (and consistent with FDA 21 CFR is a course requirement, students must be 50.24), OHRP has authorized a waiver of the given the option of pursuing non-research requirement for obtaining and documenting alternatives involving comparable time and informed consent for research that may be effort so that undue influence is minimized. carried out in human subjects who are in An important rule is that students (indeed, need of emergency therapy and for whom, all research subjects) must not be penalized because of the subjects’ medical condition for refusing to participate in research (45 and the unavailability of legally authorized CFR 46.116(a)(8) OHRP, n.d.). representatives of the subjects, no legally Guidelines governing the enrollment of effective informed consent can be obtained. employees in research are similar to those As the world continues to advance governing the enrollment of students. technologically, the question of whether or According to OHRP, he investigators and not informed consent can be documented IRBs must be cautious about the potential by an electronic signature has also been for coercion or undue influence and the raised. According to the updated FAQs, need to protect confidentiality. Freedom

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 103 of choice may be undermined when would agree that national security is of employees are faced with deciding whether the utmost importance. Nevertheless, “the or not to participate, particularly when defense authorities have very good reason that decision could affect performance to know that the scientific community has evaluations or job advancement. Employees proved its respect for the national security may experience coercion if they feel that through three hot wars and a long cold one. refusal to participate could lead to a loss of That respect must be reciprocated” (Carey, benefits, or undue influence if a decision to 1982). Given the positive impact that participate could result in a job promotion. research has had on the health of Americans, Both employers and researchers must ensure their economy, and their safety and security, that the decision to participate or not has no legislators must carefully weigh the effect on the employees’ jobs. consequences of policies that reduce the ability of researchers to conduct their work. The information listed here is just a brief introduction into OHRP’s FAQs Ever-changing legislation and regulations regarding informed consent. For additional governing how research is handled information, these and more FAQs may be are certainly a challenge for today’s accessed at: http://www.hhs.gov/ohrp/faq. researchers and research administrators. By html. understanding the changes in laws related to data collection and dissemination, through Conclusion the sharing of information such as what has President Harry Truman (1948) once said been included in this article, The Society of that: Research Administrators International will Continuous research by our best continue to help research administrators scientists is the key to American keep abreast of these developments. leadership and true national security. This work may be made impossible by References the creation of an atmosphere in which 15 CFR chapter VII, subchapter C. Export no man feels safe against the public Administration Regulations (EAR). airing of unfounded rumors, gossip and 15 CFR chapter VII Part 764, Supplement vilification. 3; See also 15 CFR chapter VII Section 744.1(c). His comments resonate even today as noted 22 CFR Parts 120-130. International Traffic by the AAU (Ehringhaus, Owens, Smith, & in Arms Regulations (ITAR). Turman, 2003), which suggests that: 22 CFR § 121.1. United States Munitions Increasing restrictions on the List (USML). communication of and participation 22 CFR § 121.1 Category VIII. in research, including agency efforts 45 CFR 46.116(a)(8) “OHRP - Code of to create new categories of sensitive Federal Regulations” but unclassified research and to insert 2002 CFR Title 31, Volume 2 Chapter restrictions through regulations and V. Office of Foreign Assets Control through clauses in contracts, threaten (OFAC). the core university value of openness in §734.2(b)(2)(ii) of the Export scientific research. Administration Regulations. “Deemed This openness may be at risk of being Export Rule”. compromised even though most Americans PL 96-517, Patent and Trademark Act Amendments of 1980. Bayh-Dole Act.

104 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Annex 2: ICARDA Regional Networks. (2005). Retrieved August 1, 2007 from Retrieved August 1, 2007 from http:// http://plan2005.cancer.gov/investigator. www.icarda.org/CWANA+Partnership/ html. CWANA+SSP.html “Final Inspection Report No. IPE-16176- ARS Office of International Research March 2004”. (2004). Office of Programs (OIRP). (2006). Retrieved Inspector General. Retrieved August 1, August 1, 2007 from http://www.ars. 2007 from http://www.oig.doc.gov/oig/ usda.gov/research/docs.htm?docid=1428 reports/2004/BIS-IPE-16176-03-2004. Campbell Plastics Engineering 7 Mfg., Inc. pdf. v. Brownlee, 389 F.3d 1243 (Fed. Cir. Greenberg, et. al. v. Miami Children’s 2004) Hospital Research Institute, Inc., et. al., Carey, William D. (1982) Handcuffing 264 F. Supp. 2d 1064 (S.D. Fla. 2003) Science. Science Magazine. Volume Human Research Questions & Answers: 217, Issue 4566. Informed Consent, Question 1, 9. (2007) Clinical Technology Transfer Group, Retrieved August 1, 2007 from http:// P.L.L.C. (CTTG). “Cooperative answers.ohrp.hhs.gov/cgibin/answers_ Research and Development Agreement ohrp.cfg/php/enduser/std_alp.php (CRADA)”. Retrieved August 1, 2007 KSR Int’l Co. v. Teleflex Inc.127 S. Ct. 30; from http://cttg-law.com/cradas.shtml. 165 L. Ed. 2d 1009; 2006 U.S. LEXIS Cooperative Research and Development 5385; 75 U.S.L.W. 3094 Agreement (CRADA). Retrieved August Madey v. Duke Univ., 307 F.3d 1351, 2002 1, 2007 from.http://www.usgs.gov/tech- U.S. App. LEXIS 20823 (Fed. Cir., transfer/what-crada.html. 2002), overturning Madey v. Duke Univ., Deemed Export FAQ’s. Retrieved August 1999 U.S. Dist. LEXIS 21379 (MDNC 1, 2007 from http://www.bis.doc.gov/ 1999) deemedexports/deemedexportsfaqs. Moore v. The Regents of the University of html#1. California, et. al., 51 Cal.3d. 120, 793 Defense Trade Function Overview. (no date) P.2d. 479, 271 Cal.Rptr. 146 (CA. 1990). Retrieved August 1, 2007 from http:// National Cancer Institute Mission. Retrieved www.pmddtc.state.gov/ August 1, 2007 from DFARS Case 2004-D010. (2006), AAU http://www.nih.gov/about/almanac/ Comments. Retrieved August 1, 2007 archive/2002/organization/NCI.htm from http://www.aau.edu/research/Ltr_ National Security Decision Directives AAU_DFARS_10-13-06.pdf. (NSDD). (1985). Retrieved August Ehringhaus, S., Owens, M., Smith, T., & 1, 2007 from http://www.fas.org/irp/ Turman, R. (2003). AAU Memorandum: offdocs/nsdd/. Homeland Security Workshop- OHRP - Code of Federal Regulations. Summary and Action Steps. Association Retrieved August 1, 2007 from http:// of American Universities. Retrieved www.hhs.gov/ohrp/humansubjects/ August 1, 2007 from http://www.ncsu. guidance/45cfr46.htm edu/sparcs/export/aau_workshop.doc . Prah, Pamela. Oklahoma cracks down on Enhancing Investigator Initiated Research. illegal immigrants. (2007). Retrieved (2004). Retrieved August 1, 2007 from August 1, 2007 from http://archive. http://plan2004.cancer.gov/capacity/ stateline.org/flash-data/blurbs.html#OK investigator.htm. Prah, Pamela. State legislatures reflect Enhancing Investigator-Initiated Research. election changeover. (2007).

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 105 Retrieved August 1, 2007 from http:// of Inspector General (OIG). Retrieved www.stateline.org/live/printable/ August 1, 2007 from http://www.aau. story?contentId=214708 edu/research/AAU_Comments_on_ Priority Health Strategies. Retrieved Export_Controls-06-27-05.pdf. August 1, 2007 from http://www. The Immigration and Compliance Act 06 gatesfoundation.org/GlobalHealth/ SB529/AP. (2006). Retrieved August 1, Grantseekers/GH_Strategy/Strategy_ 2007 from http://www.legis.state.ga.us/ Grantmaking.htm legis/2005_06/fulltext/sb529.htm. Revision and Clarification of Deemed Truman, President Harry S. (1948) Address Export Related Regulatory to the Centennial Anniversary AAAS Requirements Bureau of Industry Annual Meeting. Retrieved July 18, and Security, Commerce, 15 CFR 2007 from http://www.aaas.org/spp/ Parts 734 and 772 (RIN 0694-AD29). yearbook/chap2.htm. (2005). Retrieved August 1, 2007 Wash. Univ. v. Catalona, 437 F. Supp. 2d from http://www.aau.edu/research/ 985, 2006 U.S. Dist. LEXIS 22969 (ED AAU_Comments_on_Export_ Mo., 2006), overturning Wash. Univ. v. Controls-06-27-05.pdf Catalona, 2007 U.S. App. LEXIS 14442 The Inspector General Act of 1978, 5 (8th Cir. Mo., June 20, 2007) (1978). U.S.C.A. Appendix 3. Office

106 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Voice of Experience International Research Infrastructure and The Impact of Export Control Regulations 2007 Coordinator and Senior Writer Elliott C. Kulakowski, Ph.D. 2007 Authors/Contributors Lynne Chronister, MPA Victoria Molfese, Ph.D. Michael Slocum Cliff Studman, Ph.D. Paul Waugaman Authors’ Note The authors wish to thank Ms. Amanda Boddie for her assistance in preparation of this article. Abstract Research today has become very complex, often involving international collaborations among multidisciplinary teams. Many institutions, especially those in less economically developed countries, have a great deal of expertise to contribute to these collaborations, but often lack the instrumentation, training, and research management infrastructure needed to support their endeavors. While non-profit organizations provide assistance with instrumentation and training to support the research infrastructure, efforts from the United States are hampered by Export Control Regulations. An appropriate balance is needed to develop research collaborations with universities in other countries while protecting United States security interests. Introduction The face of research, too, has changed over Administrators International (SRA) the years. Seldom is research confined to celebrates its 40th anniversary. Originally a single team working at one laboratory. founded as a North American organization, As research has become more complex, with four sections in the United States sub-specialties have developed in scientific and one in Canada, SRA has grown into disciplines, and special expertise in a truly international society. To reflect its using complex research procedures and growing global membership, SRA added instrumentation is critically important. the term “International” to its name in 2000. Not every institution can afford the Members today come from nearly every increasing cost of highly sophisticated part of the world (Table1). As SRA has instrumentation, such as nuclear magnetic increased its international membership and resonance spectroscopy (which can reach diversity of research management interests, hundreds of thousands of dollars, even it has remained dedicated to its mission of before maintenance and personnel costs), training and career development for research and funding sources are not able to pay managers and administrators through formal such costs. This has led to the growth of educational offerings, exchange of best multidisciplinary, collaborative research that practices and continual networking among is no longer confined to a single laboratory members. or nation, but involves multiple institutions internationally.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 107 Table 1 Countries with Representation in Society of Research Administrators International Algeria Georgia Moldova Spain Armenia Germany Netherlands Sweden Australia Ghana New Zealand Tanzania Azerbaijan Hong Kong Nigeria Thailand Botswana India Pakistan Ukraine Brazil Ireland Republic of South Africa Uganda Cambodia Israel Russia United Arab Emirates Canada Jamaica Scotland United Kingdom Denmark Japan Senegal United States Egypt Kazakhstan South Korea Uzbekistan England Kenya Southwest Africa Virgin Islands Finland

As the complexity and globalization of of research management infrastructure at research have grown, regulations governing universities and other organizations needed research also have become more complex. for international collaborations. Other Institutions in the United States and U.S.-based foundations, such as the Bill & elsewhere have learned to deal with the Melinda Gates Foundation, the Rockefeller regulatory and policy differences attendant Foundation, and the Ford Foundation, with the globalization of research. To have invested heavily in developing local meet the needs of universities and other solutions to local and global problems organizations engaged in research, SRA through research. has provided training and professional development opportunities to improve the Despite the continued efforts of these groups research management infrastructure of and others to support research organizations institutions throughout the world. and researchers, United States Export Control Regulations can be a barrier to It has been said that the path to economic collaborations between scientists in the U.S. and human development in a global and around the world. Understanding these knowledge economy is through increased restrictions is critical if we are to engage in education. Organizations such as the global research. U.S. Civilian Research and Development Foundation (CRDF), the Carnegie This article describes United States Corporation, and the John D. and Catherine Export Control Regulations and the needs T. MacArthur Foundation support efforts of international researchers for access to increase the capacity for higher to training, the latest technologies, and education and research in Africa, states of the infrastructure support of their home the former Soviet Union, and elsewhere. institutions. Examples of the needs of These groups support the research efforts, universities in Africa, Russia, and states complex equipment, and the development of the former Soviet Union are presented.

108 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration An appropriate balance must exist among computers; telecommunications; lasers the U.S. need for national security, and sensors; avionics; marine; propulsion support for educational advances in other systems. The requirements for a license countries, and advances in research that depend on, among other things, what item can only be achieved through international is being exported, where it is going, who is collaborations. going to receive it, and how will it be used.

An Overview of Export Control Laws International Traffic of Arms Regulations and Regulations The mission of the International Traffic of Current U.S. export laws control Arms Regulations, or ITAR, is the control dissemination of a wide range of of arms sales to foreign parties to protect technologies in a way that may have an U.S. national security and to further U.S. adverse impact on research and the ability foreign policies (22CFR120 – 130). The of international researchers to perform regulations of defense items are overseen competitively. U.S. laws and regulations by the U.S. Department of State. ITAR is control the conditions under which certain responsible for regulating export and import information, technologies, and commodities of defense items that the United States can be transmitted overseas to anyone, Munitions List (USML) covers, or items that including U.S. citizens working overseas, are inherently military in nature (designed or to a foreign national, even if he or she is to kill/defend against death in a military working in the U.S. situation). ITAR also serves as a judge for license applications for exports, dealing with Export Administration Regulations matters related to defense trade compliance The responsibility of the Bureau of Industry and enforcement, and making reports on and Security (BIS) in the Department of defense trade available to Congress and the Commerce is to apply and enforce the public. Export Administration Regulations (EAR), which implement the Export Administration ITAR has 21 categories that require a Act of 1979 (Export Administration license, including weapons, chemical Regulations Database). The EAR is and biological agents, vehicles, missiles, responsible for regulating the export and re- equipment, and all satellites. Among the export of many commercial items, including problems ITAR can create for research those often referred to as “dual-use.” Dual- organizations includes the expansion of its use items have both military and commercial jurisdiction to research satellites, related applications. Some examples of these items technology and data. Universities that had are software, chemicals, and technologies been developing their own research satellite such as aircraft power transmission systems. capabilities now must deal with an export A list of these items can be found on the regime applied to spy satellites and military BIS webpage (Export Administration rocketry. Regulations Database). A second issue for research organizations A small percentage of U.S. exports and is the increasing application of ITAR to re-exports that the EAR regulates require the life sciences. For instance, after 9/11 a license from BIS. There are 10 specific applications of export control regulations to categories that require a license: nuclear research quantities of bacterial specimens materials; chemicals, microorganisms, were considerably stricter due to heightened toxins; materials processing; electronics; national security.

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 109 Office of Foreign Assets Control to continue to be unrestricted. This policy, The Office of Foreign Assets Control, created under the Reagan administration in or OFAC, is part of the Department 1981, defines fundamental research as: “the of Treasury. OFAC is responsible for basic and applied research in science and administering and enforcing economic engineering, the results of which ordinarily and trade sanctions. These sanctions are are published and shared broadly within the governed by U.S. foreign policy and national scientific community, as distinguished from security goals in defense against terrorists, proprietary research and from industrial drug traffickers, and the proliferation of development, design, production, and weapons of mass destruction. OFAC has the product utilization, the results of which authority to impose controls on transactions ordinarily are restricted for proprietary or and to freeze foreign assets; these controls national security reasons.” can be either comprehensive or selective. The NSDD 189 provides that: OFAC regulations often provide general Where the national security requires licenses authorizing the performance of control, the mechanism for control of certain categories of transactions (Foreign information generated during federally- Assets Control Regulations). OFAC also funded fundamental research in issues specific licenses on a case-by-case science, technology and engineering at basis under certain limited conditions. colleges, universities and laboratories is OFAC oversees limited transactions referred classification. Each federal government to as “prohibited transactions,” which agency is responsible for: a) determining are trade, financial and other dealings in whether classification is appropriate which U.S. persons may not engage unless prior to the award of a research grant, authorized by OFAC or expressly exempted contract, or cooperative agreement by statute. However, each program is based and, if so, controlling the research on different foreign policy and national results through standard classification security goals, so the prohibitions may procedures; b) periodically reviewing all differ between various programs. Generally, research grants, contracts, or cooperative a license may be required any time a agreements for potential classification. research collaboration involves a person No restrictions may be placed upon the with citizenship in, or institution located conduct or reporting of federally-funded in, one of several countries (e.g., various fundamental research that has not countries in the Balkans, Belarus, Burma, received national security classification, Cote d’Ivoire, Cuba, Democratic Republic except as provided in applicable U.S. of the Congo, Iran, Liberia, North Korea, Statutes. (National Policy on the Sudan, Syria, and Zimbabwe), and there are Transfer of Scientific, Technical, and contractual or financial dealings. Engineering Information)

The National Policy on the Transfer of This clause from the NSDD 189 is important Scientific, Technical, and Engineering because it maintains that fundamental Information - NSDD 189 research that has not been classified as The National Policy on the Transfer of important to national security must remain Scientific, Technical, and Engineering free and unrestricted. If the national security Information, or the National Security interest is important enough to trump the Decision Directive (NSDD) 189, holds that need for open transfer of information in the products of fundamental research are support of research, the Directive requires

110 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration that the information be protected under the applied when the employee is a national National Security Classification system. of an embargoed country. Some of ITAR’s embargoed countries include Afghanistan, Federal Research Exclusion Belarus, Cuba, Iran, Libya, North Korea, In response to academic concerns that Syria, and Vietnam. In addition, ITAR export control regimes would stifle basic allows the employee exemption only when research, the Federal government created the the university informs the employee in Fundamental Research Exclusion to allow writing that data may not be transferred to free transmission of solely fundamental other foreign nationals without government research information that is already approval. There are additional limitations. available in the public domain to full-time Some researchers, such as graduate or employees of an institution or university for doctoral students, may not have full-time educational instruction. This exception to employee status, and some types of visas the application of the various export control may require holders to maintain foreign regimes applies only to information that is residence. published and in the public domain, and only in the U.S. at accredited institutions of National Security in Conflict with Global higher learning. According to Eric Iverson Interests at a Public Policy Colloquium in 2002, “In The problem for researchers and research the absence of this policy, universities would administrators that arises from regulations need an export license for each foreign such as the EAR and ITAR is the expansive student matriculated, each foreign researcher definition of “export.” Understanding when invited, and each collaboration with a export controls apply, when a license is foreign institution.” (Iverson, E., 2002). required, and when there are no exemptions available is problematic because of the The Fundamental Research Exclusion can complexities of agencies, policies, and be lost in a federally funded project where a range of covered activities and materials. university accepts specific national security To engage in non-fundamental research controls. Under the EAR, as opposed to the collaborations, institutions must obtain ITAR, the exclusion may not be lost even if a license before export-controlled items a university accepts greater restrictions on or information can be shared abroad or its rights to disclose. However, the scope on a U.S. campus with foreign nationals of pre-emption of the regulatory exclusion participating in the research. When restricted is not clear, and universities should never countries are involved, there may be no accept contract or grant language that licenses available at all. The destinations purports to override the Fundamental most often subject to restriction include both Research Exclusion. major powers such as China, India, Israel, The Fundamental Research Exclusion Pakistan, Russia, and countries that are also applies to full-time employees often the site of international collaborations: under ITAR. This allows disclosures of various countries in the Balkans, Belarus, unclassified technical data in the U.S. by Burma, Cote d’Ivoire, Cuba, Democratic U.S. universities to foreign nationals who Republic of the Congo, Iran, Liberia, North are bona fide, full-time regular university Korea, Sudan, Syria, and Zimbabwe. Other employees whose permanent residence restrictions apply to conferences only where throughout the period of employment is in unpublished research is presented, such as U.S. However, this exemption may not be who can attend or co-sponsor the meeting. Institutions will face even more restrictions

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 111 when the activities involve teaching foreign additional training, availability of the latest collaborators how to use items in research technologies, the opportunity to collaborate (“defense service”) or when transfers of with investigators in the United States and research equipment abroad is proposed. elsewhere, and support for their research programs. The following examples describe In his 1948 address to the Centennial some international efforts that have yielded Anniversary of the American Association successes, the greater challenges ahead, and for the Advancement of Science Annual the need for additional collaborations and Meeting, President Truman said, support for research, its infrastructure and its Continuous research by our best management. scientists is the key to American leadership and true national security. African Experience This work may be made impossible by The Association of Commonwealth the creation of an atmosphere in which Universities has reported in a survey of no man feels safe against the public African universities that only one reported airing of unfounded rumors, gossip and submitting between 250 and 500 proposals vilification. (Truman, 1948) annually, low by American standards for a research institution (Kirkland, J. To bring these issues all into perspective, 2005). However, universities in Africa are the following quote from the Association very interested in building their research of American Universities, made during a programs and research management homeland security workshop, conveys the infrastructure (Stackhouse, J. Sultan, J., impact of the above mentioned policies and and Kirkland, J. 2001). In particular, the regulations. Carnegie Corporation provided support Increasing restrictions on the for SRA International to bring six chief communication of and participation executive officers from universities in in research, including agency efforts Ghana, Nigeria, Tanzania, and Uganda to to create new categories of ‘sensitive’ the United States in the spring of 2003 to but unclassified research and to insert learn about research management and meet restrictions through regulations and with U.S. federal research funding agencies. through clauses in contracts, threaten The goal was to enable all participants to the core university value of openness in learn more about the American research scientific research. (Ehringhaus, Owens, management system and to begin to build Smith, and Turman, 2003) collaborations between American and African universities. These meetings, What Is Being Done held at the Northeast Section of SRA, at There is a considerable need for education universities in the United States, and at and the development of international federal agencies in Washington, D.C., were research collaborations by economically followed by week-long training workshops less-developed countries. Some successes in research management at the six Carnegie have been achieved, but there is a partner universities between June, 2004 and tremendous opportunity to do considerably March, 2006. Workshops were organized more. There are many challenges facing and presented by SRA members. An research faculty and administrators from example of the building of the research less developed countries as they try to management infrastructure in Nigeria is build and sustain world-class research discussed below. programs. This includes the need for

112 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration In another program, the Carnegie Corporation. These funds partially support Corporation is supporting a project faculty development, the purchase of new that aligns SRA with the Association equipment, and the development of research of Commonwealth Universities and the infrastructure, such as information and Southern African Research and Innovation communications technology networks and Management Association to engage a improved reference libraries. For instance, number of universities in a year-long needs at Ahmadu Bello University, there is a assessment and planning exercise to develop thriving nuclear energy research program a comprehensive plan for staff development supported by the government that may one and education in research management for day enable the country to provide reliable universities across the African Continent. power throughout the region.

Nigerian Experience The virology research program at the Nigeria is the most populous nation in University of Ibadan is focusing on HIV Africa, and has a system of over 80 national and malaria research in very sophisticated universities, many of which were established biosafety level II and III laboratories with at the time the country became independent modern equipment provided by the Bill & in 1961. The Nigerian national universities Melinda Gates Foundation. This lab and are awakening from nearly 20 years of others at the university medical center have neglect by their federal government. Once continuous electrical power supported by a thriving research centers such as Ahmadu grant from the World Health Organization. Bello University, Bayero University and the University of Ibadan, have an aging faculty, The Nigerian universities are establishing a outdated equipment for which parts are no number of collaborations with institutions in longer available, and decaying laboratories. the United States and Europe. In particular, Some faculty and students conduct manual the University of Ibadan has about 40 experiments, much as they did in the 1960s. international collaborations and receives Some equipment that is available cannot be National Institutes of Health (NIH) funding installed because of the cost of laboratory through subcontracts from universities in the renovation and the training of staff to United States. However, any international operate the instruments. Another hardship collaborative program only operates is that dependable electric power is always successfully if there is adequate funding for subject to fluctuations, which can strain both the U.S. institution and its Nigerian components of state-of-the-art instruments. collaborator. Often funds are available Supplying back-up generator power to an for the U.S. partner, but unless there is entire university is not an effective solution some mechanism for channeling money to due to the unaffordable cost of diesel. enable the African partner to participate, the These power interruptions and fluctuations collaboration has little value. The African result in loss of computer services, with universities must learn research management the result that many experiments must be to meet federal flow-through requirements. repeated. Fortunately, some sponsors are realizing the reality of the situation, and finding ways to Despite these hardships, there are some re- resolve the issue. emerging pockets of world-class research. Research efforts are supported by limited At present, the Nigerian universities have university funds and monies provided by only small pockets of research. To increase the MacArthur Foundation and the Carnegie the breadth of their research programs,

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 113 they need access to the latest laboratory accomplished by encouraging research and instrumentation and extensive training in development in computer science, advanced state-of-the-art techniques. This can be materials, and other fields of science where accomplished through collaborations in the former Soviet researchers are internationally United States and elsewhere. The Nigerian competitive, and by building research universities also are conscious of the competence in agricultural, biomedical, need to develop and implement a research and natural resource sciences, which can management infrastructure. improve local public health, food production and resource management. It is hoped that SRA International, with support from both such activities are able to raise standards of the MacArthur Foundation and Carnegie living and promote economic development. Corporation, is working with seven Nigerian institutions to build their research Through the efforts of the United States management capacity. The MacArthur government and several private foundations, Foundation, in May 2007, sponsored a non-profit organization, the U.S. Civilian representatives from SRA International to Research and Development Foundation conduct site visits of MacArthur-sponsored (CRDF) was established. CRDF is funded Nigerian universities. The goal of the site by the National Science Foundation, visits was to review their research programs the State Department and other federal and research management infrastructure, agencies. The mission of CRDF is to discuss research management with them, foster and to maintain the research efforts and identify two universities that would of leading scientists in the countries of the gain the most by sending a delegation to the former Soviet Union by providing them United States to visit American universities with limited research funding, modern to build research collaborations and learn laboratory equipment and training to how American Universities conduct research support their research programs. CRDF management. In addition, the delegations has partnered with SRA International to are to attend the 2007 SRA International provide training for scientists and research Annual meeting and visit U.S. federal managers, both in their home countries and government funding agencies. in the United States. SRA International members from the University of California The Former Soviet Union Davis, the University of Kentucky, At the time of the fall of the former Soviet San Diego State University, Utah State Union, universities and research institutes University, the Medical University of South in Russia, Georgia, Kazakhstan, Moldova, Carolina, the University of Liverpool, the Ukraine and other newly independent Research Administration and Management countries were left without public support. Strategy Group, Inc., the Technology Research programs that once were directed Commercialization Group, LLC and by officials in Moscow were left to flounder. elsewhere have helped train research and In the early 1990s, a major threat to world technology managers from 16 Russian stability was the possibility of unintentional universities and research center directors transfer of Soviet weapons technology. from university institutes and independent The solution has been to encourage the research organizations from countries of the conversion of the former Soviet research former Soviet Union. enterprise from a defense and weapons In these ways, SRA International serves basis to a more peaceful basis. This is being the global research management profession

114 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration by providing basic skills, disseminating best the equipment provided by CRDF and practices, and encouraging and enabling the training that their research scientists productive collaborative research that will received in the United States and elsewhere. increase the pace of scientific discovery by mobilizing brain power across the Through generous donors, Nigeria has some world, and promote the economic and of the latest instrumentation and technology social development of all parts of the world for conducting HIV research. The training through the advance of knowledge-driven of scientists in the United States and in economies by skilled people. Europe is invaluable to these scientists as they have built collaborations. This has Blending Research, Economic allowed the University of Ibadan to receive Development and U.S. National Security support from the NIH through subcontracts Over the past 20 years there has been from academic institutions in the United increasing recognition globally that the way States. The training of these investigators, university research is managed, as distinct their collaborations with scientists in from the research itself, can play a critical the United States and the state-of-the-art role in the success of universities and their equipment they have available for their impact on society (Kirkland, 2005). This research is having a major impact on their is especially evident in the experiences we universities and on the next generation have witnessed in Africa and states of the of graduates, and potentially will impact former Soviet Union. economic development within the country.

In a meeting sponsored by CRDF in The examples above only highlight the November, 2006 in Almaty, Kazakhstan, types of research that are being conducted leaders from over 20 research centers from at foreign universities in some countries. states of the former Soviet Union were However, what we discussed here is only able to show how they have utilized the a small portion of what is happening research equipment provided by CRDF around the world. Research programs to build their research program; two even sponsored by the NIH are global — either reported that they were able to develop through research subcontracts from U.S and license technologies based on their academic institutions or through the Fogarty research. For example, a research institute International Center, which provides training in Kazakhstan has been able to develop opportunities in the United States for foreign solar panels with a much higher efficiency nationals. The NIH also is seeking to build than what is normally achieved. This may the research management infrastructure in result in a new company to produce and countries such as India so that its research commercialize the panels. Another research programs can be effectively and efficiently center discussed how it has utilized research managed. The National Science Foundation equipment for not only research purposes, (NSF) also supports international research but also to market its expertise and make its efforts, and has sent delegations to China equipment available to industry. This center and elsewhere to discuss issues of research has generated over $1 million in income and management. The research supported is reinvesting the money to support research by these two federal sponsors adds new projects, expand laboratories, purchase knowledge to the areas of research that new equipment and hire additional staff. are within the missions of the federal The positive economic impact in these two agencies. In addition, it is hoped that cases could not have been possible without support of these research activities may lead

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 115 to new products and processes, such as the Higher Education, “to the relief of college development of new pharmaceutical agents researchers, the U.S. Commerce Department for the treatment of malaria. The ability of has abandoned a plan that would have countries to collaborate with scientists from restricted foreign students’ and scholars’ other areas of the world is necessary for access to sensitive technology based on their the development of their people and for the countries of birth rather than their countries impact education and research can have on of citizenship or permanent residency. This their economy. is and will make a very large impact on future scientists from these countries, but Looming over these very exciting and from other countries as well.” (Field, K. productive collaborations and initiatives, 2006). however, are questions central to the Export Control Regulations. Could the equipment Conclusion and laboratories be used for nefarious We live in a world where international purposes? Could the training received by research collaborations are expanding nearly the international researchers be applied to every day. Fundamental research provides purposes other than those allowed? The new knowledge about the world in which answer to both of these questions is – Yes, we live. This knowledge may eventually but! — and this is a large “but.” Generally, find application and be translated into new it has been observed that knowledge products and processes. Research may lead and expertise that are used to gain new to new ways to improve crop production knowledge and applied to the health and to feed people, to a new understanding economic welfare of people in the nations about disease processes and new therapies, involved must be considered. and new products and processes that can improve a country’s economy. There is an undeniable need to maintain national security, both in the United In this article we discussed a few examples States and other countries. However, of the positive impact from collaborations it is important to balance technological between institutions in the United States innovations and knowledge expansion and elsewhere. The success of these with societal needs and applications of that programs not only aids the United States, knowledge and technology. Universities and but also has an impact on the collaborating research institutions must have workable country. Basic research collaborations export policies and the knowledge to and training of future scientists from less enforce them. Faculty must be aware of developed countries must be encouraged and their purposes and follow the policies, and supported. research administrators must lead efforts to provide appropriate training and ensure While there is a need to maintain national compliance. security in the United States, an appropriate balance must be met. The dialogue must Universities have always held to the continue among agencies within the “fundamental research exemption,” but federal government that sponsor research post 9-11 the National Science Foundation and those that are responsible for export reported that the number of foreign control regulations. Any discussion graduate students admitted for study to the also must include leaders in academic United States had declined. This has since administration, faculty, and representation reversed. As reported in the Chronicle of from organizations such as the American

116 Volume XXXVIII, Number 2, 2007 The Journal of Research Administration Association for the Advancement of http://www.access.gpo.gov/nara/cfr/ Science, Council on Government Relations waisidx_02/31cfr500_02.html. and the National Association of State and Iverson, E. (2002). ITAR Briefing Paper. Land Grant Colleges. The appropriate Retrieved August 26, 2007, from balance will not only raise the economies of http://www.asee.org/conferences/erc/ less developed countries, but will also aid presentations/upload/ITAR-Briefing- the United States. Paper.doc. Kirkland, J. (2005). The demand for References research management support in African 22CFR120 - 130 Retrieved August 26, 2007, universities. Retrieved August 26, from http://www.access.gpo.gov/nara/ 2007, from www.acu.ac.uk/resman/pdf/ cfr/waisidx_05/22cfrv1_05.html. App3BackgroundPaper.pdf. Ehringhaus, S., Owens, M., Smith, T., & National Policy on the Transfer of Scientific, Turman, R. (2003). AAU Memorandum: Technical, and Engineering Information. Homeland Security Workshop- Retrieved August 26, 2007, from http:// Summary and Action Steps. Retrieved www.fas.org/irp/offdocs/nsdd/nsdd-189. August 26, 2007, from www.ncsu.edu/ htm. sparcs/export/aau_workshop.doc Truman, H. S. (1948). Address to the Export Administration Regulations Centennial Anniversary AAAS Annual Database. Retrieved August 26, 2007, Meeting. Retrieved August 26, 2007, from http://www.access.gpo.gov/bis/ear/ from http://www.aaas.org/spp/yearbook/ ear_data.html. chap2.htm. Field, K. (2006). Commerce drops plan Stackhouse, J., Sultan, J., & Kirkland, to limit researchers. The Chronicle of J. (2001). Research management in Higher Education. Retrieved August African universities. Retrieved August 26, 2007, from. http://chronicle.com/ 26, 2007, from http://www.acu.ac.uk/ weekly/v52/i21/21a02501.htm. resman/pdf/ResearchManagementinAfri Foreign Assets Control Regulations. canUniverities.pdf Retrieved August 26, 2007, from

The Journal of Research Administration Volume XXXVIII, Number 2, 2007 117 Research Administrators Certification Council

The Research Administrators Certification Council was formed in 1993. It is an independent non-profit organization. The Council is composed of active certified research administrators. The designation of Certified Research Administrator (CRA) means that an individual has met the Council's eligibility requirements and has demonstrated a level of knowledge necessary for a person to be a professional research or sponsored programs administrator. The benefits of certification are many: CRA Review sessions are currently Professional recognition scheduled at various U.S. locations. Personal satisfaction An indicator of expertise Check www.cra-cert.org to find a session near you. Increased opportunities for employment If you are interested in holding a CRA Review session Advancement opportunities at your institution, contact us at [email protected]. Increased credibility with clients Serve as a role model to others www.cra-cert.org Phone: 212-356-0693 [email protected]

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