volume xlii, number 2 fall 2011 joural o eear...

Volume XLII, Number 2 Fall 2011

Journal of Research Administration

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Journal of Research Administration Volume XLII, Number 2, 2011

Journalof

ResearchAdministration

Published by the Society of Research Administrators International

Volume XLII, Number 2, 2011 Journal of Research Administration

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Journal Review BoardChair: Thomas J. Roberts, EdD

Members: Jose Acosta, MD, MBA, FACSJohn Baumann, PhDVaughan Caines, MScPhilip Cola, MABryan Ford, PhD, MSWMaggie Griscavage, CRAJames Hanlon, CHRPRene Hearns, PhD (cand), MPA, CRAElizabeth Holmes, PhDMartin Jamieson, MBA, ACMAJeanne Mattern, PhD, LSW, CCRPJessica MoiseJennifer Morgan Shambrook, PhDSandra Nordahl, CRATamara O’Black, JDPaul O’KeefeJames Ragain, DDS, MS, PhDJacqueline Rychnovsky, PhDFabian Sandoval, MDDavid Schindel, PhDTimothy Sparklin, MSW, CIMRenee Vaughan, MDiv, MA, CRA, RCCJoann Waite, MA, PhD (cand)Jill Williamson, JD

Manuscript Editorial BoardChair: Mary Adams, MTS

Members: Kate Bent, PhD, RN, CNSMarie Anselm Cooper, IHM, EdDKristina Duryea, MA, GCRADarlene GilsonTanisha Hammill, MA, MPH, CRAPeggy Harrel, PhDAnita Hartmann, PhD, CIP, CRAFrances Jeffries, PhDSarah Hope Lincoln, PhD (cand)Carol Mullen, PhDElsa Nadler, EdDCamille Nebeker, MSMary Perkins, DHealthCatherine Schempp, PhDPei Lin Shi, MA, CRASally Sivrais, MSJackie Solberg, CRAStephen Tela, PhDJulie Zadinsky, PhD, RN

SRA International Staff LiaisonBrian Walrath

Editor Edward F. Gabriele, DMin

Senior Associate Editor Bruce Steinert, PhD, CCRA

Associate EditorsIbrahim Adib, MD, MPH, DrPH (cand) Timothy Atkinson, EdD Annette Debisette, PhD, RN Cindy Kiel, JD

David Langley, PhDCharles MacKay, PhDPhillip E. Myers, PhD Pamela Krauser Vargas, MBA

Business Manager Sharon McCarl, MBA, CRA

Intellectual Property Counsel J. Michael Slocum, JD

2011 Journal Editorial Board

Journal of Research Administration Volume XLII, Number 2, 2011 1

The Journal of Research Administration is published by the Society of Research Administrators International, Falls Church, Virginia 22046 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.

Correspondence Manuscripts are to 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: JRA Editor.

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per year international. Make checks payable to The Journal of Research Administration. Subscriptions for SRA Members are included in an individual’s annual dues. All subscriptions include electronic access to the two yearly print-editions mailed separately via USPS. 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, 500 N. Washington Street, Suite 300, Falls Church, VA 22046 USA. Phone: +1-703-741-0140. Periodicals are postage paid at Falls Church, VA and at an additional mailing office.

Copyright © 2011 by the Society of Research Administrators International.

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-affiliated institutions 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, 500 N. Washington Street, Suite 300, Falls Church, VA 22046 USA or through email at [email protected].

The Journal of Research Administration

Volume XLII, Number 2, 2011 Journal of Research Administration2

IntroductionFrom the Editor’s Desk ............................................................................... 11 Edward Gabriele

ArticlesPaved With Good Intentions: Rethinking the Ethics of ELSI Research ...... 15Daniel Seltzer, Laurie Zoloth, Cristina Traina, Lynne Kiesling

University Research Centers: Heuristic Categories, Issues, and Administrative Strategies ............................................................................ 25Kelly Hall

Institutional Responses on Strengthened Intellectual Property Rights in Agriculture and Needs’ Assessment on Intellectual Property Management of Public Research Institutions in Asian Developing Countries .................. 42Jane Payumo, Howard Grimes

The Evolution of the Council of Academic Hospitals of Ontario Statement of Principles ................................................................................................ 59Katie Porter, Sarah Lampson

Research Administrators as Servant Leaders ............................................ 64Joann Waite

Grant Development for Large Scale Research Proposals: An Overview and Case Study .......................................................................................... 77Ira Goodman

Research Administrator Salary: Association with Education, Experience, Credentials and Gender.............................................................................. 86Jennifer Morgan-Shambrook, Thomas J. Roberts, Robert Triscari

ReviewsBook Review: Trust and Integrity in Biomedical Research – The Case of Financial Conflicts of Interest (2010)......................................................... 101Jere Boyer

Book Review: Madame Curie Complex: The Hidden History of Women in Science (2010) .......................................................................................... 107Cameron Nelson

Voice of ExperienceVoice of Experience: The America Invents Act – A First for America ....... 113J. Michael Slocum

Table of Contents


Contributing Authors

Jere Boyer, PhD is Senior Scientific Advisor for Clinical Research Management in Hinckley, Ohio. He reviews new solicitations, provides long-range planning for the firm, and provides protocol editing. Boyer provides consultation for human subjects’ protection documents and issues. He is also on the faculty of the Northeast Ohio Medical University. Dr. Boyer is certified in microbiology and in human subjects’ protection. He is widely published in microbiology and human subjects’ protection in research.

Ira Goodman is Associate Director for Administration at the Moores Cancer Center, University of California San Diego. He has been in departmental, central administration and research center positions. He holds a bachelor’s in biology and chemistry, a master’s in clinical management, and a master’s in public administration. He is a certified research administrator holding the CRA distinction. Mr. Goodman has written extensively on research administration. He received the 1997 SRA Rod Rose Award.

Howard Grimes, PhD is Vice President for Research and Graduate School Dean, Washington State University. Dr. Grimes has overseen the largest growth in grant funding in WSU history. He is well published in his research area (soybean lipoxygenases) and continues to teach and publish articles reflecting his administrative experience. Currently, he is actively involved with the Council of Graduate Schools as Chair of the Best Dissertation Award Committee and with the AAAS as Elected Fellow.

Kelly Hall, PhD is Chief Training and Compliance Officer of Pathology Faculties International, LLC, a provider of digital diagnostic services. Dr. Hall has developed and led graduate programs, research centers, and campus sites as a consultant, director, and faculty member. She teaches research methods and organizational development. Dr. Hall has co-authored several articles about service-learning outcomes and partnerships.

L. Lynne Kiesling, PhD is a Distinguished Senior Lecturer in the Department of Economics at Northwestern University. Dr. Kiesling’s research examines economic regulation, institutional design, and market design in the electricity industry, with emphasis on the effects of regulation on innovation and technological change. At Northwestern she is also a faculty affiliate of the Northwestern Institute on Complex Systems and the Center for the Study of Industrial Organization.

Sarah Lampson, BA is the Clinical Research Agreements, Contracts and Grants Specialist, Cancer Research at Hamilton Health Sciences Corporation in Ontario, Canada. She founded an email discussion group of Canadian clinical contract reviewers and chairs a national mentoring program committee through Network of Networks. She has authored or presented 10 articles or talks on research administration this year, as well as a book, Steer Your Career: A Research Administrator’s Manual for Mapping Success.

In This Edition



Cameron R. Nelson, JD, RN, LLM (cand) is an attorney in Arlington, Virginia. Prior to entering the practice of law, Ms. Nelson practiced as a Registered Nurse for ten years, specializing in Oncology and Palliative Care. She volunteered to serve as an editor and author for the Legal Handbook for Cancer Survivors, a publication of the Virginia State Bar Young Lawyers Conference.

Jane G. Payumo, PhD is a Postdoctoral Research Associate of Office of Research at Washington State University (WSU). She also acts as licensing assistant of the WSU’s Office of Intellectual Property Administration, where she helps translate WSU research into economic development opportunities. An intellectual property rights advocate, she helps spread the importance of IPR and technology transfer management to the global community through her several publications and speaking engagements at local and international events.

Katie Porter, MA, BEd is the Clinical Research Agreements and Contract Specialist at Hamilton Health Sciences Corporation in Ontario, Canada. She is also a regular lecturer at McMaster University on topics including ethics, risk, and legislation in clinical research. This year Katie published a series of articles featuring best practices on training, recruiting and retaining research administration staff. She has recently co-authored a book entitled, Steer Your Career: A Research Administrator’s Manual for Mapping Success.

Thomas J. Roberts, EdD is Associate Vice President for Research at Florida Gulf Coast University in Fort Myers, Florida. He has been a professional research administrator for nearly twenty-five years and authored the first doctoral dissertation focusing specifically on the field of research administration. He is the 2007 recipient of the Rod Rose Award for Outstanding Scholarship and earned his doctorate in Educational Leadership from the University of Central Florida.

Jennifer Shambrook, PhD is Director of the Grant & Contract Management Office at St. Jude Children’s Research Hospital in Memphis, Tennessee. Dr. Shambrook is the author of the 2007 and 2010 Research Administrator Stress Perception Surveys (RASPerS). Her area of research is workplace stress in the academic environment and its association with human behavior. Dr. Shambrook is a recognized leader in research administration and has presented workshops on research administration throughout the world.

Daniel Seltzer, JD, MA is a practicing attorney in Oak Park, Illinois, with a strong background in bioethics. He previously held a position as a Senior Researcher in the Center for Bioethics, Science and Society at Northwestern University where he was responsible for examining the social and ethical implications of nanotechnology. He is currently preparing to participate in a Northwestern University project researching ethical and societal issues pertaining to synthetic biology.

In This Edition


J. Michael Slocum, JD is a senior member of the law firm of Slocum & Boddie, P.C. He has more than thirty years of experience in grant and contract law. He is a Distinguished Faculty member of the Society of Research Administrators. He is a member of the Virginia State Bar, and is President of Slocum & Boddie, PC in Springfield, Virginia.

Cristina L. H. Traina, PhD is Professor of Religious Studies at Northwestern University in Evanston, IL, USA. She has published widely in ethics and has served on Northwestern University ELSI committees.

Robert Triscari, PhD is the Department Chair of Special Education, Early Childhood Education, Elementary Education, and Research at Florida Gulf Coast University in Fort Myers Florida. Dr. Triscari has over 25 years of experience in teaching and research in K-12 and higher education. He has published in psychometrics and statistics and has served as a consultant to the US Department of Education on policy and educational measurement issues.

Joann Waite, MOL, PhD (cand) is Director of Sponsored Research and Programs at Gonzaga University in Spokane, Washington, USA; and has held a notable record of leadership positions and speaking in research administration. She conducts workshops for faculty on proposal preparation. She implemented a full sponsored research office, including pre- and post-award processes and is the primary liaison between the university and its sponsoring agencies.

Laurie Zoloth, PhD is Director of Northwestern University’s Brady Scholars Program in Ethics and Civic Life; and Professor of Religious Studies, Bioethics and Humanities. She was president of the American Society of Bioethics and Humanities and the founding chair of the Howard Hughes Medical Research Institute Bioethics Advisory Board. She is a recipient of the NASA National Public Service Award and a Hastings Center Fellow.

In This Edition

FROM THE EDITOR’S DESK

From the Editor’s DeskDr. Edward Gabriele

Even to the most casual observer, the development of any art or science always involves some form of conflict or contest. If we could scratch beneath the story lines of a writer’s or scientist’s life, we would find there inevitable collisions of thought, commitments, and passion. Understandably, many of us --- if not all of us --- judge collisions as unfortunate occasions to be avoided. Yet there is another way to think about these contests. Like the striking of flint, the collisions that occur in art and science are what strike the sparks of ingenuity. Sometimes it is from those sparks that rooms are lit, lives are warmed, and the human imagination is caught up in the flames of things that are new.

In this calendar year of 2011, a type of collision is present. On the one hand, we celebrate this year the 100th anniversary of Marie Curie’s 2nd Nobel Prize --- the prize for chemistry for her discovery of radium and polonium. In an age of discrimination against women and an age that still often held science suspect, Madame Curie catapulted outside of human limitation and stretched our understanding of the world around us with all that is possible.

Yet in this same calendar year, and with a sobriety to match our Curie-esque celebration, we remember somberly how madmen horrifically misused science, knowledge and technical skill to shatter human lives and hopes in New York City, in Washington, DC and in a Pennsylvania field.

Madame Curie changed our lives for the good. Mad terrorists used scientific discoveries to invade our lives with fear.

Two historical realities.

Incredible opposites.

How do we respond?

There are those perhaps that most unthoughtfully might look to the horrors of 9/11 and want to shut down or obstruct the human imagination. Perhaps there are others who might not see the tragedy of 9/11 as a call to careful reflection, only reaction. Most of all, the harsh collision of these anniversaries calls us to remember that in all of the professions there is a need for social responsibility and the protection of human dignity as fundamental to all the arts and sciences. Such a call requires the service of learned and prudent women and men who can remind us of our common commitment to a Greater Good. Such a Good promotes the very best of all we can know and experience. Such a Good also reminds us of the dangers of egotism, of self-indulgence, of territoriality, of the addiction to power.

Introduction



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In the world of research, the evolving nature of research administration as a profession is to serve as one of the voices that calls our communities to that Greater Good that works to ensure that all we do is for human betterment. In the early days of our profession, we understandably were called to carry out needed and essential management activities. During the following decades of regulatory proliferation, our professional lives took on responsibility for sponsor compliance. Yet today something much deeper is at work in our midst.

Research administration, in all of its iterations and levels, is essentially a service of leadership wherein we call our individual members and our institutions-at-large to a greater consciousness of our obligation to preserve the very character of who we are and what we do. We are not merely compliance officers. Rather, whether simply or perhaps even invisibly, our activities in finance or logistics or sponsored projects administration are essentially a conduit by which we call our communities to a sense of “conscience” and consciousness about the quality of what we are all doing for the public trust. Indeed, one of our emerging roles today is that of development where we assist our communities to look to future opportunities and means by which the human condition is advanced and made better through research.

This is indeed a special year. A year when we can be energized by the exhilaration of “genius becoming innovation” --- a phrase I am fond of using to define the experience of research itself. Yet this is also a year when we can recall how fragile discovery can be in the hands of those who would seek revenge, would be dedicated to violence, or who would use the arts and sciences to enslave others. This is a year when we are all called to the collision that occurs here. How do we personally respond?

I would suggest that in this year we might want to allow these disparate and contrary images to be for us in research administration a flint. Let the images strike new fire in each of us. Perhaps in the sparks new opportunities for service might be illuminated. If we take the time to reflect critically on the flint being struck, perhaps something might be sparked within us --- giving us new energy to serve with greater insight and enthusiasm the communities who need us so they can help others.

As you page through the ingenuity found in this edition of the Journal of Research Administration, read well and read deeply. The disparate articles are indeed different and represent wide dimensions of our profession’s leadership throughout the world. Yet each time you begin a new article, listen carefully. Listen long and patiently. You just might hear something very different. A scratch. A collision of metal against stone.

But be careful. You just might get singed.

And you might be glad you did!

ARTICLES


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Paved With Good Intentions:Rethinking the Ethics of ELSI Research

Daniel Seltzer, JD, MADaniel Seltzer, Attorney at Law

943 S. Kenilworth Ave.Oak Park, Illinois

Tel: (312) 259-1244Email: [email protected]

Laurie Zoloth, PhDProfessor, Medical Humanities and Bioethics

Northwestern University’s Feinberg School of MedicineProfessor, Department of Religious Studies

Director, Brady Program in Ethics and Civic Life Weinberg College of Arts and Sciences, Northwestern University

Crowe Hall 5-1631860 Campus Drive

Evanston, Illinois Tel: (847) 644-8807

Email: [email protected]

Cristina LH Traina, PhDProfessor, Department of Religious Studies

Weinberg College of Arts and Sciences, Northwestern UniversityCrowe Hall 5-179

1860 Campus DriveEvanston, Illinois


Lynne Kiesling, PhDDistinguished Senior Lecturer, Department of Economics

Weinberg College of Arts and Sciences, Northwestern UniversitySenior Lecturer, Social Enterprise at Kellogg

Kellogg School of Management, Northwestern UniversityLeverone Hall 392

2001 Sheridan RoadEvanston, Illinois



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Authors’ NotePortions of this research were supported by the Nanoscale Science and Engineering Center (NSEC) for Integrated Nanopatterning and Detection Technologies at Northwestern University under National Science Foundation Award Number EEC-0647560. Any opinions, findings and conclusions are those of the authors and do not necessarily reflect the views of the National Science Foundation. The authors would like to acknowledge the valuable input and suggestions of the following members of the SEIN Committee of the NU-NSEC: Mark Sheldon, PhD, Michael Kennedy, PhD, and Joshua Kellar, PhD. Please send all correspondence to the first author.

AbstractEthical, Legal and Social Implications (“ELSI”) research has played an increasingly important role in scientific research. Tens of millions of dollars, many of which are public, are spent funding scientific research projects. Taxpayers are demanding that scientific advancement move forward, hand-in-hand with careful examination of the many ethical and social issues that are raised by the emerging sciences. It is not uncommon to find grants that include ELSI components. This raises a potential problem relating to the ability of ethicists to undertake serious, objective reflection and make independent, normative suggestions. If the Principal Investigator (PI) of the grant controls the funding of the ethics component and ELSI reflection suggests acts or omissions that would negatively affect the PI’s scientific project, especially given the current economic climate in which reductions in ethics and humanities funding jeopardize other employment, ethicists may be placed in a position of having to decide between seriously jeopardizing their career, or ignoring the moral problem and compromising their professional integrity. One suggestion to avoid this conflict is to separate the funding of ELSI components from the scientific portion of the grant and to erect a secure firewall between the two. Other solutions certainly exist, and the purpose of this paper is to raise the issue to stimulate debate.

Keywords: conflict of interest, ELSI, ethics, funding

IntroductionEthical, Legal and Social Implications (“ELSI”) research has been a new constant in

basic genomic projects for two decades. In the last 10 years, the inclusion of ELSI research as a required component in a wide range of sponsored basic and translational research projects – from medicine to chemistry – has reassured the public that scientists who receive public funding work closely with academic bioethicists, legal scholars and social theorists to carefully explore the implications of new science. These grants have also inspired a generation of bioethics research on genetics, genomics, stem cells, climate change, synthetic biology and nanotechnology. This article, while celebrating this attention to ethics, raises the issue of whether the structure of funding such work creates inadvertent conflicts of interest and commitment. This paper asks: if the Principal Investigator (PI) of the grant controls the


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funding of the ethics projects, can ethicists undertake serious, objective reflection and make normative suggestions independently and fearlessly, especially in an economic climate in which reductions in ethics and humanities funding jeopardize other employment?

Ethical issues in science research have concerned both scientists and the public for decades. The first formal designation of funding for study of basic research by federal agencies is most clearly linked to biological advances in the 1950s and 1960s that eventually led to the development of recombinant DNA (rDNA) technology in the early 1970s. Paul Berg of Stanford developed a method of joining fragments of monkey virus SV-40 (a tumor gene) and bacteriophage lambda. Further work, however, was halted due to concerns that this rDNA could find its way into E. coli, the most widely used bacterial species in laboratories, also commonly found in human intestine, and risk infection of lab workers. This concern was deepened by the fact that, at that time, researchers working with rDNA increasingly were biochemists not practiced in the standard safety measures used by microbiologists. Due to concern within the field itself, in 1975 a conference was organized at the Asilomar Conference Center in Pacific Grove, California to discuss the potential biohazards and regulation of rDNA. Known as the Asilomar Conference, this meeting of scientists drafted voluntary guidelines to address the concerns of rDNA technology and research (Profiles in Science).

History of ELSIThe history of the specific funding called “ELSI” began in the mid-1980s as the

NIH and Department of Energy undertook the task of mapping out the human genome, under what was to become the Human Genome Project (HGP). Harking back to the Asilomar Conference, those in charge of the HGP, as well as researchers, social scientists and lawmakers, understood that exploring uncharted areas of science was likely to raise a number of complex moral issues for individuals and society (Human Genome Project). James Watson was appointed the Director of the HGP in 1988 and determined that the project would set aside funds specifically to study the ELSI issues arising under the HGP, openly explaining that the intent was to reassure a public concerned with the increasing reach and power of science. Each year, between three and five percent of the funds earmarked for HGP was dedicated to ELSI. From the beginning, the HGP’s ELSI program has examined a variety of issues, ranging from privacy, to commercialization, to the use of Genetically Modified Organisms (GMOs) as food. While it was initially contemplated to address the potentially harmful consequences of the project, the HGP and ELSI programs shared the common goal of addressing larger moral issues from the outset; thus ELSI, rather than impeding HGP progress, was “viewed as an important adjunct that would facilitate its success” (Everson 2007, p. 124). The expansion of the ELSI program to a variety of emerging technologies provides evidence of its success. Such expansion includes the National Nanotechnology Initiative, which dedicates approximately five percent of its budget to ELSI issues. The emergence and increasing understanding of the importance of, and funding for, ELSI allowed rigorous consideration of essential ethical questions within emerging science projects.


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Issues with ELSI FundingAs with many scientific methods, however, continued practice reveals weaknesses

embedded in the ELSI programs’ strengths. While the intentions of government support of ELSI are to be lauded, unintended consequences have emerged that must be addressed for serious research in ethics to have power and credibility. While a few centers are funded directly and dedicated entirely to ELSI research (Centers of Excellence in Ethics Research, or “CEER” grants), most of the current funding schemes for ELSI projects result in serious structural conflicts of interest. Specifically, when the PI of the larger grant also controls the finances of its ELSI component, the ELSI faculty and staff are placed in the untenable position of evaluating critically the project that pays their salary.

The problem of ethics centers being funded by the labs they “oversee” was most clearly revealed in the case of human genetic intervention trials. In 1999, while participating in a Phase I clinical trial at the University of Pennsylvania, 18 year old Jesse Gelsinger died from an immune reaction to the viral vector containing a potential future gene therapy to correct X-Linked SCIDS, a defect that was, in his case, fully treatable by diet and medication. It was later revealed that the physician leading the research, Dr. James Wilson, was president and a major shareholder of Genovo, Inc., the company that not only supplied the funding for the research, but also held the patents on the gene therapy procedure being used (Hoey, 2003). Additionally, Genovo provided limited funding for Pennsylvania’s Center for Bioethics. The Center’s director, Arthur Caplan, Ph.D, held a tenured appointment in a department headed by Dr. Wilson. While not speaking to the issue of wrong-doing by Caplan, the Danforth Committee – an independent panel of experts gathered by the University of Pennsylvania to evaluate their gene therapy group after the Gelsinger incident – recognized the potential for compromise of the bioethicist’s work and identified “the need for independence between bioethicists and the researchers” (Wilson 2009, p. 236).

A similar situation occurs when the ethicist is working as part of a larger project in which funding for the ELSI researcher’s position comes from, and is administered by, the project’s PI. This hierarchical relationship between PI and ethicist is common to many NIH- and NSF-funded projects. Should a dispute arise over the subject matter of the ethical research itself (e.g., ethical concerns about a potentially commercially lucrative product; questions about publication protocol; conflicts of interest; questions about relative safety; or issues that emerge from concerns of students in the lab), this leads inexorably to a potential conflict of interest. The scarcity of research tax dollars and, at least in emerging technologies, comparatively strong governmental support of commercialization of federally funded research mean that scientists and universities increasingly find themselves in situations in which research offers an opportunity for substantial and desperately needed monetary rewards. What would occur if the ethicist recognized ethical, legal or social issues, which, when further researched and published, could interfere with the progression, commercialization or direction of the scientific research? While one would hope that the ethicist’s research and recommendations would be granted due deference, it is quite possible that the PI and/or university, calculating the potential loss of income dollars from patents or commercialization


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of the research, would choose not only to disregard the ELSI issues, but also to take action to dissuade that particular line of inquiry. The issue of conflicts is just as problematic in the reciprocal situation in which the ELSI researchers do not object to the nature, goal, or interpretation of the emerging science, but rather come to respect deeply and, in this sense, advocate for the work. This advocacy can be a form of “regulatory capture,” made worse if the continued funding for ethics is linked to the successful extension of the grants.

Undue influence to get the “right answer” about the implications of research can be exerted in a variety of ways when the research funds for ELSI issues are controlled by the PI on the larger grant. Pressure can be applied on the ethicist by reducing funding, or threatening to terminate it entirely, under the argument that, with limited overall funds, the PI can only allocate funding to successful lines of research (subjectively determining that the ethical line of research is “going nowhere”). It is not clear that a PI could actually de-fund a mandated set-aside; however, the PI can dismiss the particular ethicist and replace him or her with one who is more cooperative. This position of economic superiority can create a hostile workplace, in addition to an implicit understanding that the particular ethicist (or entire ethics group) will not be included on future grant proposals. Likewise, the PI may make vague claims that the particular ethicist’s research, because it is not as easily quantifiable as science research because it raises moral issues considered outside of the narrow science goal, is inapplicable and therefore is no longer eligible for funding, thus providing a basis to dismiss the ethicist in favor of one who will be more cooperative. Pressure can be subtle, because the culture of science creates specific norms that often operate within hierarchical systems, and it also creates a fiercely competitive atmosphere where criticism is perceived as interference with a goal all agree is noble in intent. Attention to data that are troubling, or attention to quiet voices of dissent within labs, can raise issues of “loyalty” and “teamwork,” fatal nomenclatures for graduate students who are dependent on recommendations from the very PI whose work might be worrisome. ELSI research is intended to be the voice of the “stranger” in the lab, but if the stranger is dependent on the host for his or her support, the situation can become more vexed. The dependence for funding places ethicists in the untenable position of deciding between pursuing the ethical inquiry and risking their career, or ignoring the moral problem and compromising their professional integrity.

The situation is compounded when the ethicist is in a position of power inferior to the science PI. For example, the ethicist may be a post-doctoral researcher or a non-tenured professor, or simply a faculty member from a humanities department, while the PI on a large government grant is likely not only to be tenured, but also to have some notoriety in the field and a capacity to wield a certain amount of professional respect. This disparity of power may cause the ethicist to back down from pursuing a line of research that could be confrontational, a public conflict that would pit the unknown ethicist against the well-respected scientist. Finally, the university, having its own conflicts of interest, may weigh the potential research dollars the PI has already brought in and the potential future dollars through future grants and patents, and be biased in favor of the PI in internal disputes that could arise between the PI and the ethicist.


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As the Danforth Committee has previously argued, “the need for independence between bioethicists and the researchers [is] advised.” In the above scenarios, the lack of independence is a direct result of the funding structure: the party who is subject to ethical review funds the ethicist, in whole or in part, and has the power, if not to withdraw that funding at will as relates to the particular ethicist and seek a more agreeable ethicist, at least to exclude the ethicist from any future funding opportunities lead by the PI. If the PI is well-renowned and has significant influence at the institution, such exclusion may, if not overtly, at least covertly, influence the decision of other PIs in determining whether to include a “troublesome” ethicist in their future grant proposals, or to seek an ethicist who will be more cooperative. As research funding becomes more difficult to obtain and as the rewards for success in science become more lucrative, the potential for conflict intensifies. The authors would argue that the entire premise of academic freedom depends on the ability to speak truth to power, to publish critiques freely, and to be able to explore the implication of powerful research by powerful researchers transparently and rigorously. To do so, ELSI research needs a firm financial and intellectual foundation, entirely separate from the control of the investigators who undertake the scientific research. One solution is for granting agencies who call for ELSI research — as they should on all emerging science research — to bifurcate the ethics administration and budget of the ELSI research from the research administration and budget of the science itself, by requiring each proposal to include separate ELSI PIs who are awarded and administer their own funds and whose success or failure is judged by their peers in the field via publication and paper acceptance, not by the science PIs whose work is at stake. Critical to this strategy would be the review of grants by committees that include ELSI trained scholars. However, such an approach encounters the inherent problem of ethics-as-critique. If funding is dependent on research understood as “problematic” in some way, then the ethicist is oddly incentivized to see problems everywhere. Ideally, universities should fund ELSI centers directly and independently of the research undertaken.

Possible SolutionsWhile one may properly laud the efforts and intentions of the many who have

recognized the need to fund ELSI projects, in particular funding for difficult ethical conundrums, one must recognize that putting ideas into practice can take time, effort and, most importantly, the ability to adapt. Like any good project that is devoted both to descriptive and normative goals, ELSI projects must be funded and administered separately from the research groups with which they partner. Experience has led the authors to understand the deep value of collaborative research projects that include what has been termed the “embedded ethicist” (Zoloth, 2009) who is serious about listening to and learning the science content and method in the lab. It is to a research group’s long-term advantage to cultivate a productive, candid working relationship with ELSI projects so that the scholars truly can understand the research and help researchers think about the moral pitfalls (and potentials!) of their projects along the way. By this integrative, but separately funded and administered method, a research group and the ELSI group can hope to develop and “encourage a broader societal capacity to manage [the research] for the public interest while


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such management is still possible” (Guston 2010, p. 1). The failure to give ELSI groups sufficient independence in publicly funded research undermines the purpose of investing in ELSI – to identify early the ethical, legal and social issues inherent in basic research that may become problematic. ELSI scholarship is intended to point to critical issues of public concern about science research that are outside the scientist’s area of expertise, but which are critical to the process of discovery in a democratic society.

Public funding of science depends on public support and trust: trust that scholars of ethics, social theory and law keep a steady, independent, and informed academic gaze on the research in the lab and clinics. What this paper suggests as a way forward – the separation of funding and the erection of a secure firewall between funding of ethics and science within grants – is only a beginning. For truly collaborative interdisciplinary work to proceed, full recognition and authority for each discipline in the collaboration will be critical. This paper raises this issue directly to the funding agencies for their consideration and calls for a new national standard for ELSI research.

The Research Administrator’s Role

The Research Administrator can play an important role in advancing this new national standard, from the top on down. One recommendation is that it begins with the Office of Research Integrity (or similar department responsible for ensuring ethical compliance with grant requirements) developing recommendations encouraging the inclusion of ethical elements in all major grant proposals of the institution. While an ELSI component may already be required in some grant proposals, many RFPs do not currently require an ELSI element. The inclusion of an ELSI component can strengthen any proposal and provide additional incentive for a grant to be awarded. By implementing an institution-wide policy recommending that ELSI issues be, at the very least, openly discussed in all proposed research, research administrators can work to advance research at their institution that not only is ethically conscientious but also promotes the goal of developing ethically aware scientists.

Institutions may be hesitant to promulgate even “recommended” policies on the basis that such action encroaches upon the academic freedom of faculty. Academic freedom has been considered a First Amendment right by some courts, including the Supreme Court (Sweezy v. New Hampshire, 1957). The imposition of recommended policies affecting research plans may be seen in a negative light by faculty. Much as faculty generally object to the use of student evaluation forms, which are seen as prima facie evidence of administrative intrusion into the laboratory promulgated by administrations to impose politically correct standards on faculty members (Haskell, 1997), faculty may argue that recommending ESLI components to grant proposals places administrative interests in laboratory research plans and attempts to coerce faculty researchers to conform to politically correct standards. However, while much credence is given to the notion of academic freedom, the Commission on Academic Tenure in Higher Education believes adequate cause for dismissal of tenured faculty exists where there is “demonstrated incompetence and dishonesty in teaching and


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research” or the researcher engages in “conduct which substantially impairs the individual’s fulfillment of institutional responsibilities” (Haskell, 1997). Thus, any complaint that ELSI consideration in grant proposals infringes upon academic freedom is specious given the obligation for researchers to perform competent and honest research and to fulfill institutional responsibilities to honor funding institutions’ guidelines. This is especially true for NSF and NIH grants, which have responsible and ethical conduct of research (“RCR”) requirements that obligate grant recipients to develop a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research.

Department and individual research administrators, therefore, may use the ethical discussions as primary or secondary investigator education opportunities. By following an institution-wide recommendation of discussing ELSI in grant proposal planning and drafting meetings, and coordinating the inclusion of the university’s ethics staff, the research administrator can assist the PI in developing a plan to comply with RCR requirements and promote the transformation of institution culture, by advancing ethical consideration in research. While RCR requirements are a strong step in the right direction, any plan that provides for training and oversight from a captive ethical resource is subject to the same conflict issues described above.

By these methods, research administrators can advance their roles and responsibilities in ensuring that faculties are aware of regulations, policies or procedures which may affect the conduct of their research; ensure that they and their institutions are keeping abreast of evolving standards, thereby promoting appropriate stewardship of external funds supporting research; and recognize and fulfill responsibilities to the local communities as relates to health and safety issues of research.

Perhaps most importantly, the promotion and adoption of separate ELSI funding, and research administrator involvement, will help ensure that the potential for, or appearance of, conflicts of interest which could have serious ethical and monetary consequences to the university are addressed in an appropriate and timely manner.


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ConclusionThere is a strong need for continued ELSI funding. As scientists continue research

in areas of science that raise potentially troubling outcomes, the public needs to be assured that science advances in a safe, legal and ethical manner. While there is not a problem, per se, in the funding of ELSI research, it has become clear that the current funding scheme raises the potential for serious conflicts of interest. When scientists control the administration of ELSI funding, overt and covert pressures may be placed upon ethicists to make conclusions conducive to the progression and advancement of the overall science of a project. This raises serious questions of independence that undermine the ability of the ethicist to speak truthfully, critique freely, and research rigorously the ethical, legal and social aspects of scientific research. This not only violates the academic freedom of the ethicist, but also places the research institution in danger of violating its duty of responsible research to the public. Such acts may conclude with the disintegration of public trust and public backlash against important scientific research. By separating the ELSI funding from the science funding – separating the observer from the observed, from a monetary standpoint – institutions can better ensure that ELSI research dollars advance ELSI goals. Research administrators can take a lead role in advancing ELSI roles in a number of important ways. First, research administrators can help adopt and advance rules or recommendations relating to the inclusion of ELSI components in research. By promoting dialogue early in the research planning process, research administrators can advance ethical awareness among scientists. This can help develop a culture of interdisciplinary cooperation and ensure that research administrators are advancing their obligations to the institution and the community at large.


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ReferencesEverson, T. (2007). The gene: A historical perspective. Westport, CT: Greenwood Press.

Guston, D. H. (2010). Societal dimensions research in the National Nanotechnology Initiative. Consortium for Science, Policy & Outcomes, Report #10-02. Retrieved October 1, 2010 from www.cspo.org/library/reports/?action=getfile&file=291&section=lib.

Haskell, R.E. (1997). Academic freedom, tenure, and student evaluation of faculty: Galloping polls in the 21st century. Education Policy Analysis Archives, 5(6) Retrieved April 20, 2011 from http://www.bus.lsu.edu/accounting/faculty/lcrumbley/educpoly.htm.

Hoey, J. (2003). Profits, pressure, and perception: Expensive research collides with medicine. Journal of Rheumatology, 30(8), 1661-1662.

Human Genome Project Information. (n.d.). “DOE ELSI program emphasizes education, privacy: A retrospective (1990-2000),” Department of Energy, Genomics.energy.gov. Retrieved September 29, 2010 from http://www.ornl.gov/sci/techresources/Human_Genome/resource/elsiprog.shtml.

Profiles in Science. (n.d.). The Paul Berg papers. National Library of Medicine. Retrieved October 13, 2010 from http://profiles.nlm.nih.gov/CD/Views/Exhibit/narrative/dna.html.

Sweezy v. New Hampshire, 354 U.S. 234 (1957).

Wilson, R. F. (2009). Estate of Gelsinger v. Trustees of University of Pennsylvania: Money, prestige, and conflicts of interest in human subjects research. In S. H. Johnson, J. H. Krause, R. S. Saver, & R. F. Wilson (Eds.), Health law and bioethics: Cases In Context (pp. 229-255). Frederick, MD: Aspen Publishers.

Zoloth, L. (2009). Second life: Some ethical issues in synthetic biology and the recapitulation of evolution. In M. A. Bedau and E. C. Parke (Eds.), The ethics of protocells: Moral and social implications of creating life in the laboratory (pp 143-164). Cambridge, MA: MIT Press.


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University Research Centers:Heuristic Categories, Issues, and Administrative Strategies

Kelly Hall, PhDPathology Faculties International, LLC

830 Xenia AvenueYellow Springs, OH 45387


Author’s NoteThis paper includes research that was originally published as the author’s doctoral dissertation, Profile and Distinguishing Characteristics of Educational Centers in the United States (Hall, 2005).

AbstractUniversity-based research centers can bring prestige and revenue to the institutions of higher education with which they are affiliated. Collaborating with corporations, units of government, and foundations, centers provide services to organizational leaders, policy makers, and communities. University research centers continue to increase in number and influence. Despite these increases and unique attributes of centers, center leaders are subject to cultural norms, political moves, and traditional flows of resources within their institutions. Survey and secondary data analyses of 176 educational centers confirmed and provided a ranking for characteristics associated with Ikenberry and Friedman’s standard, adaptive, and shadow heuristic introduced in 1972. Interviews with 12 center directors yielded a list of center administrative issues and strategies to address issues of planning, leadership, institutional relations, funding, and management. Center and university leaders can use findings to categorize and better understand the organizational behavior of centers to improve effectiveness.

Keywords: university research center, research center administration, research center strategy, research center planning, research center funding, research center management, research center assessment, research center evaluation

IntroductionUniversity-based research centers can bring prestige and revenue to the institutions

with which they are affiliated (Brint, 2005; Feller, 2002). Collaborating with corporations, governments, and foundations, centers provide services to organizational leaders, policy makers, and communities. Growth in the number of centers since the 1950s reflects their increased presence in the university setting. There are 17,000 research centers in the US and Canada, an increase of 1,500 since 2009, when there were 15,500 (Miskelly, 2011; Wood, 2009). Growth is estimated at a rate between 5% and 10% a year since 1965, when 3,500


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centers were first identified (Palmer & Kruzas, 1965). In the United States, unlike in other nations, most research organizations are housed at institutions of higher education and are not independent (Orlans, 1972).

For the purpose of this study, centers are defined as non-department entities, encompassing a broad range of sub-organizational structures in higher education: bureaus, clinics, institutes, laboratories, programs, and units. Here, the term center is used to connote all forms of organized units that may exist beyond and between academic departments (Ikenberry & Friedman, 1972). Beyond research and training as their primary services, centers vary across a number of dimensions: size of support and research staff; the position of faculty versus professional staff researchers; level of separation from academic departments; degree of integration with the university; funding mix; extent of inter- or multidisciplinary focus; and relative emphasis on applied research (Vest, 2005; Klein, 1996; Stahler & Tash, 1994). Universities considering creating or evaluating research centers are urged to plan carefully before launching or maintaining them. A number of inter-related issues affect center success. This article presents survey and interview data to illuminate center types, issues, and strategies used to address issues. Center stakeholders can use findings to create policy regarding center start-up and maintenance. Center type categories provide a frame in which to place different types of centers to serve different functions within a university system. Resources could be allocated based on the promise and purpose of the center as aligned with the university’s mission. University and center policies and priorities could be informed by research findings presented.

Heuristic CategoriesIkenberry and Friedman (1972) proposed a heuristic to categorize university-

based centers into three types: standard, adaptive, and shadow. Types were distinguished by four characteristics: (a) the ability to store resources; (b) the degree to which procedures are specified; (c) stability in goals and tasks; and (d) stability of resources to achieve goals and tasks. For this study, these and characteristics available from The Research Centers Directory (2002) were operationalized into survey questions to confirm and rank heuristic characteristics. Survey responses were received from 176 of 296 (60%) educational research center directors to whom the survey was sent. Cramer’s V was used to calculate nominal variable coefficients of association based on center type for each characteristic. The result was a rank of characteristics that differentiate between center types. Table 1 presents ranked characteristics. Note that nine heuristic characteristics are better at distinguishing among center types than six directory characteristics. Nine heuristic variables were strongly associated at varying levels of strength based on a moderate interpretation of the Cramer’s V. Six other variables, operationalized from The Research Centers Directory, were weak to moderately strong as coefficients measuring characteristics among center types. Note that the moderate strength of having a presence on the World Wide Web is a distinguishing characteristic among center types. The Internet is a new phenomenon since Ikenberry and Friedman’s heuristic was developed that has affected centers’ reach into the external environments they serve. After 40 years, Ikenberry and Friedman’s heuristic categories are


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still valuable as a way to categorize center types. Standard, adaptive, and shadow designations can be used to categorize different types of center. A description with examples follows.

Strength andCharacteristic

Heuristic (H) or Directory (D) Variable V Rank

Extremely Strong

Stability of financial resources H .504 1

Employment of administrative/professional personnel H .496 2

Very Strong

Employment of clerical personnel H .474 3

Employment of faculty personnel H .387 4

Policies and procedures in addition to institutional ones H .368 5

Strong

Employment of student personnel H .306 6

Moderately Strong

Permanent allocation of space H .298 7

Active advisory committee H .297 8

Publication of training materials D .297 8

Presence on the World Wide Web D .289 10

Moderate

Locus within institution D .242 11

Written mission and goals H .234 12

Federal designation D .233 13

Institutional financial support D .220 14

Weak

Federal government support D .174 15

Table 1: Center Characteristics Ranked by Association Value for Distinguishing among Center Types

Standard Type

A standard center or institute has stability in goals and resources to house, equip, and support employment of a full cadre of administrative/professional, clerical, faculty, and student personnel. Financial resources are from diverse streams including institutional and federal funding (Brint, 2005). A standard center holds status similar to other academic or administrative units within an organization of higher education, such as a computing lab or admissions office, occupying permanent allocation of space and sometimes an entire building. A standard center has its own advisory board and its own policies and procedures


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that its personnel follow in addition to university governance guidelines. Based on these characteristics, two examples of standard type centers were selected—the National Center for Rural Health Professions and Learning Systems Institute. The Learning Systems Institute was selected as a standard type based on survey data and the National Center for Rural Health Professions was selected based on the author’s personal knowledge about its characteristics, having served on its founding national advisory board.

National Center for Rural Health Professions. In 1998, the Director of the Rural Medical Education Program, Michael Glasser exclaimed to me from across a small hospital conference room in rural Illinois, “We should start a center!” Dr. Glasser was the faculty champion with the vision needed for center start-up. Today, the National Center for Rural Health Professions (NCRHP) serves as the centerpiece program for University of Illinois College of Medicine Rockford’s campus, where Glasser now serves as assistant dean. The campus is undergoing a major building transformation after a campaign that leveraged federal, state, and local dollars to raise capital using the national center as a signature program. NCRHP was granted center status by the Illinois Board of Higher Education in 2003 after three years of holding temporary designation.

Statewide, the purpose of the NCRHP is to meet the health care needs of rural Illinois residents and communities. Nationally, the center serves as a place for research and development of programs effectively training and retaining rural healthcare practitioners. NCRHP is the lynchpin of inter-disciplinary projects involving multiple health professions: dentistry, medicine, nursing, pharmacy, public health, and social work. The center employs 12 staff members and is guided by a 23-member advisory board comprised of the dean; representatives of partner disciplines; state agency and network representatives; outreach, recruitment, and retention specialists; and a hospital administrator. NCRHP houses three programs that focus on five activities: interdisciplinary education, faculty development, community outreach, research and evaluation, and policy.

Learning Systems Institute. Florida State University’s Learning Systems Institute’s History webpage describes an exemplar of a standard center.

Dating back four decades, the Learning Systems Institute (LSI) has evolved over the years to adapt to changes in technology, educational trends and client needs. The institute began as two separate organizations launched in the late 1960s on Florida State University’s campus. The Center for Educational Technology helped institutions outside the university with training needs, while the Division of Instructional Research and Service provided similar services to Florida State faculty. In the mid 1970s the two organizations combined to create a more robust LSI.

LSI founder Robert Morgan served as the organization’s director for 30 years. Under his leadership, the institute attracted some $150 million in projects and earned a reputation as an expert manager of international development projects related to education. Among the largest of these was a U.S. Agency for International


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Development project to revamp South Korea’s public school system, a highly successful multi-year, $60-million effort.

Morgan drew top talent to the LSI, including renowned educational psychologists Robert Gagne and Robert Branson. As the organization evolved, these and other faculty designed and conducted major training for the U.S. Army, developed educational technology for several foreign countries, and pioneered Florida State’s distance learning, among other efforts. In 2001, Laura Lang was named LSI director. Building on Morgan’s legacy, she has continued to move the institute forward, expanding the institute’s range in K-12 education and the study of expert performance. Between 2000 and 2009, contract and grants funding increased significantly, spurred in part by the creation of two major educational research centers (the Florida Center for Reading Research and the Florida Center for Research in Science, Technology, Engineering and Mathematics) entrusted to LSI by the Florida Legislature.

Standard centers are easily recognized and are perceived not only as part of the institutions with which they are affiliated but also as separate organization entities. Adaptive centers are less easily recognized as viable organizational units beyond the universities with which they are affiliated.

Adaptive Type

“Adaptive institutes undergo a continuous process of redefining their goals, initiating and terminating projects, securing and releasing staff: in short, adapting to a persistent instability” (Ikenberry & Friedman, 1972, p. 36). Using resources not owned by the center, faculty and other personnel can be configured to meet the needs of a specific contracted project or service provision: for example, to respond to a state or federal request for research or to provide educational psychology or curriculum development services. Given their resource dependence (Pfeffer & Salancik, 1978), adaptive centers might lay dormant from time to time, thus becoming shadow centers. With the advent of the World Wide Web, adaptive centers can appear bigger and more stable than they truly are. The Center for the Study of Education Policy and Fitz Center for Leadership in Community are two examples of adaptive centers. The Center for the Study of Education Policy was selected as an adaptive type based on survey data and the Fitz Center for Leadership in Community was selected based on the author’s personal knowledge about its characteristics.

Center for the Study of Education Policy. The Center for the Study of Education Policy at Illinois State University is an example of how a departmental unit can use an adaptive center “umbrella” to house and showcase research, professional development, service, publication, and database products and services. Established in 1960 to study public school financing, the center now houses activities related not only to finance but to current and emerging policy issues affecting the whole education continuum: pre-kindergarten through grade 16 and beyond. Attributes such as the publication of several journals, organization of regular conferences within the center, and the number of people associated with the center—


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two co-directors, several research associates, and 31 faculty or staff affiliates—create the look and feel of a standard center. The Center for the Study of Education Policy is not a separate entity with its own personnel structure. Rather, the center serves as a place to house ongoing faculty and independent center projects, expanding and contracting to meet departmental and client needs.

Fitz Center for Leadership in Community. The Fitz Center for Leadership in Community at the University of Dayton initiates and sustains partnerships for community building and leadership opportunities for students. Directed by Dick Ferguson, the center is named for Brother Ray Fitz, who serves as Ferree Professor of Social Justice after having served 23 years in the presidential post. Based in the College of Arts and Sciences, the Fitz Center offers six civic leadership development opportunities that move students along a service-learning leadership continuum. These six programs were developed over a number of years as the Fitz Center responded to community and university opportunities and needs. The Fitz Center is an example of how centers sometimes serve as a unit to coordinate multi-disciplinary student learning outcomes that require formal collaboration with external stakeholders.

Both adaptive center examples presented—the Fitz Center and Center for the Study of Education Policy—operate as extensions for academic functions coordinating research and student learning opportunities across departments. Adaptive centers function at the periphery between academic departments and external organizations. Shadow centers, presented next, are less likely to have this coordinating feature.

Shadow Type

Shadow centers have no staff, space, budget, or current observable accomplishments. Sometimes called paper centers or institutes, shadow centers might exist to provide a forum in which teams of faculty from different disciplines can work or to monitor a cross-departmental function. Shadow centers might also exist to provide less commendable functions:

. . . the provision of comfortable sinecures for faculty members and administrators the institution wishes to move out of the mainstream; the satisfaction of private and solely personal faculty ambitions; the luxury of faculty fantasy; and a means for institutional and self deception. (Ikenberry & Friedman, 1972, p. 39)

The Applied Social Research Unit and Smart Communities are examples of shadow center types. Smart Communities was categorized as a shadow center through response to the study survey and the Applied Social Research Unit, a center in which the author worked for a decade, and is categorized as a shadow center based on its current characteristics.

Applied Social Research Unit. The Applied Social Research Unit of Illinois State University is an example of how centers can move between center types over a number of years based on inter-related internal and external factors influencing center operations. Once a standard center with multiple revenue streams, permanent office space for 10, and


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employment of full-time administrative and graduate assistant personnel, the Applied Social Research Unit became an adaptive center as revenue streams dried up. Personnel changes resulted. A flooding and then demolition of the professional office building the unit occupied forced the relocation to one of the residential properties the university had purchased. These factors, combined with internal competition for resources support from other centers, led to the Applied Social Research Unit turning into a shadow center. Core staff complete a couple of ongoing projects annually. With a cadre of professional faculty and staff who could be readily engaged, the Applied Social Research Unit is poised to adapt and fulfill project consultancies and contracts for external agencies that are consistent with its mission.

Smart Communities. San Diego State University’s Smart Communities center is an example of how the Internet has changed the face of centers. An endowed faculty member, John Eger, is not only passionate about building creative and innovative communities, but is also a media communications expert. Eger uses Internet and other media to promote an idea he champions and to offer his expertise in service to communities. He has no interest in hiring permanent staff or acquiring university office space. Eger’s interest lies in the long-term engagement of communities to effect positive change. Smart Communities is an example of how a center structure can be used to “shadow” a concept and consultancy services of a faculty member.

Advantages and Disadvantages of Center Types

Each center type operates with structural and functional advantages and disadvantages. Standard centers function as institutionalized departments with loyal personnel and recognition as viable units. Compared to the bureaucratic inflexibility of standard centers, adaptive centers have the advantage of being flexible organizational units. Their survival depends on being responsive and changing to meet societal or market needs. Adaptive centers however, lack access to permanent personnel and resources. Shadow centers have no permanent resources or staff but may be better positioned than a department to marshal resources for special projects. Understanding advantages and disadvantages across the center type continuum, combined with an understanding of issues and strategies used to address issues, presented next, will help stakeholders designate and evaluate center functions and structures to meet client and affiliated institutional needs.

Administrative Issues and StrategiesInterviews with 12 directors of education-focused centers were held to gather

information about issues and strategies to address issues of center administration. Selection criteria for formal interviewees included directors’ willingness to be interviewed as indicated on their returned survey, having 5 or more years of experience as center director, and directors who were one of the first 60 respondents to the survey described above. Hence, selection criteria included principles of both purposeful and convenience sampling methods (Maykut & Morehouse, 1998). Of the 12 center directors interviewed, 2 were directors of shadow centers, 4 represented adaptive centers, and 6 were from standard centers. Those


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directors interviewed had been affiliated with their centers for an average of 13 years. Table 2 presents 5 issues and 23 related strategies coded from interviews. As with survey data, Cramer’s V was calculated for each strategy as a way to rank strategies.

Issues that emerged fell into these categories: planning, leadership, institutional, funding, and center management.

Issue Categories and Related Strategies V Rank

Planning Strategies

Concentrating on the center’s mission .85 1

Holding conferencing events .64 6

Doing applied work .61 7

Meeting requirements and standards of university approval and review .56 18

Leadership Strategies

Holding a broad spectrum vision of what could be .71 2

Making leadership transition within center .58 8

Balancing multiple roles .56 18

Being a founding director .55 21

Institutional Strategies

Working beyond traditional faculty roles .71 2

Limiting commitments to university committee activities .56 18

Garnering support from higher administration .53 23

Funding Strategies

Being involved with federal funders .69 4

Maintaining operations during times of dwindling funding .58 8

Being self-supporting .58 8

Relationship building .58 8

Writing grants .54 22

Management Strategies

Using or promoting available technology .64 5

Managing projects: accountability, deadlines, priorities .58 8

Employing a core staff .58 8

Creating a cooperative work environment .58 8

Delegating work within the center .58 8

Hiring quality people .58 8

Mentoring student workers .58 8

Table 2: Categories and Ranks of Administrative Issues and Strategies


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Planning

Planning is the most important topic of center administration. The longevity of centers is directly related to their ability to adapt, and so plans must be flexible and must allow a center to change. At the same time, centers should remain true to their vision. A dynamic mission statement helps keep centers actively focused on their identified niche.

Concentrating on mission, successful center directors are able to build capacity through niche specialization as recommended by Leslie and Fretwell (1996). Focusing on a center’s mission rather than on creating a formalized planning document coincides with the “soft” planning approach (Tornatzky, Gray, & Geisler, 1998) that is part of an embedded “smart structure” (Clark, 1998, p. 77). This serves to monitor needs and to adapt to university-based entrepreneurial units such as research centers. A director of an adaptive center observed, “We spend our time surviving and recreating ourselves.” External and internal constituents must be addressed at all points of the planning process.

By finding a niche and continually assessing client needs, the center is better able to make a place for itself within institutional guidelines. Directors report directing evaluation primarily toward their external environments and clients by conducting regular needs assessments. Defining the appropriate niche can guide marketing plans and attract faculty as well as clients. Conferences and training workshops are also a way for a center to brand itself relevant its affiliate institution of higher education.

Aligning center activities with university expectations is recommended not only by center directors interviewed but by authors who have addressed center functions (Perlman, Gueths, & Weber, 1988; Friedman et al., 1982). Holding conferencing events and doing applied work are direct services (Veres, 1988) that not only maximize institutional prestige but also support scholarly activities (Matkin, 2001; Slaughter & Leslie, 1997; Lindlof, 1995). Support of the scholarly core is recommended by center directors interviewed and by seminal authors on research centers, R. S. and R. C. Friedman (1984). Planning such conferences and seeking out cutting edge projects—applied research projects and projects that promote technology—are essential to the life of a center. Advisory boards are useful for testing project ideas. Standard centers have standing advisory boards, but boards can be informally established to help adaptive and shadow centers plan their work and work their plan.

Leadership

Centers need an entrepreneurial champion with vision and passion for their purpose (Clark, 1998; Friedman & Friedman, 1977; Kerr, 1998; Perlman, Gueths, & Weber, 1988). Center leaders balance multiple roles, carefully navigating their work within the institution by dealing with director employment issues, and by collaborating with higher administration, their affiliated departments, other departments, faculty, and institutional systems. Connected to the core of their center, these individuals are often the founders of the centers they lead. “This is my baby!” exclaimed one interviewee. Promoting the mission of


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the center requires four skill sets in communication, academic expertise, time management, and administration.

Center leaders come from a variety of backgrounds, but agree that individual vision and passion drives their entrepreneurial behavior and ability to use skills to administer their centers. Center leaders must be able to delegate, provide a strong sense of direction, and focus on the task at hand while still being willing to shift gears.

Flexibility is especially crucial in adaptive and shadow centers for which survival of the center is the focus. Role strain is common in center work (Boardman & Bozeman, 2007), but is more likely present in adaptive and shadow centers, in which directors consider themselves first as faculty members with teaching and research responsibilities, and second as center leaders. This leads to a situation in which leaders in shadow and adaptive centers have shorter tenure in their center position than directors of standard centers who are founders and keepers of their institutionalized center roles.

Institutional Support

Centers need university support in terms of mission, money, and space (Fink, 2004). The definition of support varies between center types. Standard center directors define support more in terms of mission and money, while adaptive centers define support more in terms of people power and other tangible resources such as space. The politics of garnering support from higher administration to work beyond faculty roles involves compromise, e.g., between centers’ ability to offer “additional visibility to a defined area of study important to the university” (Friedman & Friedman, 1984, p. 27) and academic traditions that support discipline-based faculty publication and funding (Clark, 1998). Interactions between centers and their affiliated departments and/or institutions can be challenging and, at times, strained (Boardman & Bozeman, 2007). Faculty ignorance about a center’s purpose and role in the larger context of an institution is detrimental to the center. It is important that departments understand centers to avoid competition. Center directors must make a concerted effort to work within the institution’s boundaries and guidelines to mitigate tensions (Friedman & Friedman, 1984; McCarthy, 1990; McCarthy, Jones, & St. John, 2000; Veres, 1988).

“Centers are do-tanks rather than think-tanks,” as described by one director interviewed. Dealing with the culture of the traditional academy and misconception of center roles, directors had recommendations about how center leaders can navigate within their institution at different levels. These levels include higher administration, faculty, their affiliated departments, other departments, and institutional administrative systems. Directors typically serve as the key point person for the center, broadening the center’s sphere of influence among institutional constituents. Incorporating institutional representatives in center activities, coordinating activities with the center’s department, promoting affiliated departments, supporting departmental faculty with professional development opportunities and other means of funding, and partnering with disciplines are among the variety of successful methods center directors employ to tackle institutional issues or tensions. To make


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room for these activities, directors of standard centers limit their involvement in university committee activities.

Other potential bridges between centers and departments include joint appointments and negotiation of space allocation (Sa, 2007). Space allocation as a means of negotiation surfaced as both a point of tension and a point for gaining leverage at an institution. In general, the health of a center in relation to the institution is evident in its space allocation. The advice of center directors in regard to working with institutional administrative support systems can be boiled down to: (a) utilization, (b) delegation, (c) structural alignment, and (d) acquisition of space.

Directors interviewed and previous authors suggest the sharing of equipment, staff, funds, and employment opportunities for faculty as ways to build relations within the institution (Friedman & Friedman, 1984; McCarthy, 1990; McCarthy, Jones, & St. John, 2000). Despite the need to clarify career paths in center work 25 years ago (Friedman et al., 1982), directors interviewed suggest that institutions have not changed in this regard. A change in established reward systems within higher education is needed for entrepreneurial endeavors such as centers’ success (Clark, 1998).

Funding

As confirmed by this research, the cyclical and temporary nature of center funding makes it difficult for administrators to plan and for affiliated personnel to remain committed to the organization (Friedman et al., 1982; Geles, Lindecker, Month, & Roche, 2000). Loss of or insufficient center funding is ranked as the number one reason for center closure. “It can make or break a center,” according to one center director. A well-endowed center can get lazy, while a center constantly struggling for funds may lose its focus and passion.

Obtaining and stabilizing funding is a crucial role for center administrators, as noted by this study and previous research (Friedman et al., 1982; Geles et al., 2000; Gray & Walters, 1998; Veres, 1988). Centers with diverse financial resources fare better during financial transitions. Building relations and writing grants, especially federal grants, were important strategies to become self-supporting and maintaining operations during times of decreased revenues. Indeed, grants are the main source of funding for centers.

Directors in this study noted that building and maintaining personal relations with personnel representing funding sources is also recommended by authors of other center research (Freidman & Friedman, 1984; Levine, Walters, & Gray, 1998; McCarthy & Hall, 1989; McCarthy, Jones, & St. John, 2000; Veres, 1988). Relationships increase the chance for grant proposal success. With the federal government as the major funder of research centers (Breneman & Finney, 2001; Hauptman, 2001; Slaughter & Leslie, 1997), standard center directors advise center leaders to take advantage of federal technical assistance and program support mechanisms as they build and sustain partnerships.


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Outreach into the community is equally important, creating a give-and-take relationship between communities and the institution contingent upon community needs (Boardman, 2010). Shadow and adaptive centers are more likely than standard centers to interact with geographically local or regional communities. Shadow centers rarely have federal funds to expend. Adaptive centers are subject to the ebb and flow of funding.

Whatever the level of revenue, financially independent centers share funds with their institution in exchange for use of institutional facilities, administrative services, and other indirect benefits such as reputation. Establishing relationships is important to most aspects of a center’s success, especially in the realm of funding. In some cases endowment funding is used for support, but endowment funding is rare and hard to obtain. The key to successful funding is to build relationships, whether on the federal level, the local level, or the institutional level. Center administrators must understand and attempt to influence local, state, national, and, according to this research, international policy (Ikenberry & Friedman, 1972; McCarthy, Jones, & St. John, 2000). Center directors from both adaptive and standard centers cited international work as important. This new funding source reflects the globalization of centers in the realm of globalization most generally.

Management

The analogy of starting and running a small business is one used by Walters and Gray (1998) to describe center management as relating to a center’s culture, environment, and staff management. A cooperative work culture is a characteristic of centers that work (Gray, 1998; Tornatzky, Lovelace, Gray, & Geisler, 1998). Differences between center and departmental work include: teamwork versus individual work, the focus of work (applied versus theoretical focus), technical resources sometimes available in centers compared to those in departments, and comparable or heavier work load of center affiliates.

Strategies for creating a pleasing work environment include office aesthetics, access to office equipment and technology, flexible work scheduling, and a collaborative and cooperative work culture. Centers thrive, particularly in comparison to departments, because they reward teamwork and leverage resources both on and off campus. Ingredients for success include: efficient meetings, use of available technology, employment of a core staff that remains steady, and appropriate delegation of work. Making these things happen, however, can be a challenge. Center directors emphasized the challenge of hiring people who are committed and trained. When successful hires are made, center members tend to fall into two major groups: entrepreneurial and collegial. Staff members—students, academic professionals, clerical staff, and faculty—must be self-managing, and directors must take on the task of training them in this direction.

Research indicates that the ability to hire a quality, self-managing core staff, including graduate and postdoctoral students, is key to center staff management (Friedman & Friedman, 1986; Friedman et al., 1982; McCarthy, Jones, & St. John, 2000). Standard centers are in a better position than adaptive centers to hire professional staff and engage


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students. Adaptive centers face problems with staff turnover. Shadow centers rarely have staff beyond a key faculty member. Students are a good personnel resource but must be mentored and managed. Standard center leaders spend more time managing rather than completing projects. Leaders in standard centers must be able to manage projects and to delegate tasks.

Standard centers have the advantage of being able to focus on a singular vision usually originated with their founder/leader, while adaptive and shadow centers struggle to find a balance of responsibilities. Shadow centers are at a particular disadvantage as they are focused more on their faculty responsibilities and less on their role as center leader. Shadow centers, therefore, are unable to move forward and experiment with delegation, funding sources and student mentorship. Center leaders do not have to be the only educators or staff trainers. Mentorship roles are important in centers. Student workers can play an important role in centers. In short, a collaborative and pleasing work environment is essential, as is a core staff, and leaders ready and able to delegate tasks.

Strategies for university-based center leaders revolve around planning, leadership, the institution, funding, and management. Planning and center management strategies are different for shadow, adaptive, and standard centers. Leadership and strategies for dealing with institutional issues also differ from center to center but less so. Each center type struggles, with shadow centers being the most vulnerable given their insecure funding and dependence on a lone champion. The applied, contractual nature of center work affects the nature of center administration. Center administrators are advised by successful center directors to use tested strategies: concentrate on the center’s mission by working beyond traditional faculty roles to fill a niche for clients within an applied field; hold a broad vision of what could be for the center’s future, and share this vision passionately to build relationships with federal and other funders; ensure that technology is part of the center’s product and process management mix. Implementing these specific strategies into the daily operations of center life will offer a better chance of center success.

ConclusionMore than a quarter century ago, Ikenberry and Friedman (1972) devised a heuristic

to distinguish center types based on functional and structural attributes. The results of this research revealed that the heuristic is still useful for categorizing centers in terms of finances, and human and physical resources. Research also provided insight into issues center directors face administering their centers. Planning, leadership, institutional support, funding, and management issues are those that distinguish among standard, adaptive, and shadow types. Universities with existing or expanding research center capacity should plan carefully, because it is the most important strategic activity for center success. Planning should not only take into account financial, structural, and functional factors such as those accounted for by the standard, adaptive, and shadow heuristic, but should also consider factors of organizational behavior. Leaders’ ability and relations with internal and external constituents, mission alignment with the university’s purpose and a market niche, work culture, and technological support for web design and global communication are all important to present-day center success.


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Institutional Responses on Strengthened Intellectual Property Rights in Agriculture and Needs’ Assessment on

Intellectual Property Management of Public Research Institutions in Asian Developing Countries

Jane Payumo, PhDPostdoctoral Research Associate

Office of Intellectual Property AdministrationWashington State University

1610 NE Eastgate Blvd., Suite 650Pullman, WA 99163-5623

Tel: +1 (509) 335-8608Email: [email protected]

Howard Grimes, PhDVice President for Research and Dean, Graduate School

Washington State University324 French Ad Grimes Way Pullman, WA 99164-1030

Tel: +1 (509) 335-6412Email: [email protected]

Authors’ NoteThis research was supported by the research grant [001-01-06R-2928-0005] of Dr. Howard Grimes, Vice President for Research and Dean, Graduate School of WSU and based on the doctoral dissertation of Jane Payumo. The authors thank Taurean Sutton for his help in sending the email reminders and in setting up the statistical software; Charisma Love Gado and Christy Fry-Pierce, for editing and proofreading this paper, respectively; Dr. Leona Ding, Dr. Dana Moore, Dr. Philip Wandschneider, Dr. Keith Jones, Dr. Raymond Jussaume, Dr. Karim Maredia and Dr. Tom Okita for their help in improving the survey questionnaire, and the staff of Washington State University’s Social and Economic Sciences Research Center (WSU-SESRC) for helping conduct the web-based survey.

AbstractIntellectual property rights (IPRs) are being introduced or strengthened in developing countries as a result of international agreements such as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO). This study conducted a web-based survey to gain perspective on the impact of IPRs to public research institutions in developing countries and how these institutions have responded to IPR developments. Specifically, this survey collected information from research directors (n=43) of public research organizations in India, Malaysia, Philippines,


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Thailand, and Vietnam. Overall, this study strongly indicates that research administrators in the five countries are positive towards IPRs and the implementation of measures to build their institutional IPR management capacities. They have also started to build their IPR structures and procedures by setting up IP policies and offices, but strengthening is needed, particularly in the area of technology commercialization. This research serves as a reference for international institutions interested in and/or evaluating capacity programs allowing them to craft projects that can better foster the importance of IP management to these and similar institutes in the developing world.

Keywords: commercialization, developing countries, IPR, IP management, technology transfer, public sector, capacity building, public agricultural research

IntroductionPublic research universities are the main source for new technologies and innovations

in developing countries. As intellectual property rights (IPRs) are expanded to include the agricultural sector, universities must adapt by taking on new roles and challenges to drive the implementation of new agricultural models in these societies. IPRs are rights over IP conferred by law, and form part of a nation’s policy to encourage invention, innovation, and dissemination of technology for economic development. IPRs is a broad term used to cover patents, trademarks, plant breeders’ rights, copyright, trade secrets and other types of rights that the law gives for the protection of investment in creative effort and knowledge creation.

A lively debate has emerged in the academic literature about possible implications of IPRs to public agricultural research. Such implications of IPRs, in general, can be divided into three themes: access of proprietary technologies, conduct of R&D, and dissemination of research results. With IP protection becoming a norm for public research institutions, it is also an open issue as to how many agricultural innovations will be available in the public domain, and how many will be patented and available for a fee (Maredia, Oehmke, & Byerlee, 2004). Sociologists of science, who use the tools of humanities and social sciences to study science and technology as a social activity, find this as a violation of scientific cultural norms because, to them, scientific progress is linked with an ideal of free and open dissemination of scientific information. Expansion of IPRs will restrict free circulation of ideas and will adversely affect and/or impede dissemination of new technologies and innovations and exchange of information among scientists, an important aspect of scientific research.

Hence, under this changing environment for IPR protection, agricultural research organizations in developing countries need to analyze efficient and effective ways of acquisition of new technologies or products. Access to new technologies and modern scientific methods covered by IPRs would require them to negotiate deals and execute formal licensing agreements (Maredia, Erbisch, Ives, & Fischer, 1999; Van Wijk & Komen, 1993). For institutions with budget constraints, these developments mean that they need to seek assistance for a freedom to operate (FTO) – the ability to practice or use an innovation or proprietary technologies royalty-free for research. Graff, Cullen, Bradford, Zilberman, &


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Bennett (2003) and Heller & Eisenberg (1998) claimed that these IPR-related mechanisms are additional transaction costs and serve as a barrier for these institutions that can stifle further scientific progress, since without agreement of waiver of IPRs, research delays could occur.

Likewise, the increased push for IPR protection for publicly funded research means that research institutions also need to investigate the possibility of their own organizations developing the means of protection and commercialization of their technologies and products (Salazar, Falconi, Komen, & Cohen, 2000). Public sector institutions in developed countries, especially US universities, have increased their patenting and commercialization of their research outputs, especially in modern agricultural biotechnology (Heisey, King, & Rubenstein, 2005). For Thursby & Thursby (2002), these shift research agenda of these institutions while Aghion, Bloom, Griffith, & Howitt (2002) claimed that IPRs can limit the process of cumulative scientific discovery. As Davis, Larsen, & Lotz (2000) claimed, the freedom to choose research subjects by public sector scientists may come under pressure whenever institutions “behave like firms.” Institutions are encouraged or even forced to produce patentable research results that are commercially viable, discouraging non-patentable research.

Public research institutions in developing countries have evolved in a world without IPRs. Hence, it is important to understand how they have responded and adapted to this new environment while maintaining continuity of service to their stakeholders. This paper discusses IPRs as they relate specifically to biotechnology and genetically modified organisms being used as tools to achieve sustainable improvement of crop productivity. This study uses the definition of biotechnology as covering the application of tissue culture, immunological techniques, molecular genetics, and recombinant DNA techniques in all facets of agricultural production and agro-industry.

Focusing in five countries in developing Asia, this study aims to provide such information and add insights to the state-of-the-art in the IP challenges confronting public research institutions. Realizing that the development of innovative capabilities and institutional policies depends on a strong and sustained commitment from the authorities, this study targeted institutional heads and research administrators of public research organizations doing agricultural biotechnology in India, Malaysia, Philippines, Thailand, and Vietnam. The respondents were asked about their perceptions of the concept of IPRs and the implications of IPRs on public agricultural research, and the current capability and priority needs in handling IP issues. This research can serve as reference for international institutions interested in developing action plans and/or capacity programs on IP management. This may also enable a subsequent step towards an analytical framework to investigate institutional capacity for IP management in the public agricultural institutions in developing countries.

MethodologyThe focus of this research was on public agricultural research institutions in five

countries in Asia: India, Malaysia, Philippines, Thailand, and Vietnam. The scope includes universities and research institutions conducting agricultural biotechnology in these five


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countries. This list of institutions was obtained from the Food and Agriculture Organization (FAO)-Biotech (FAO-BioDec) database (FAO, 2005), which contains baseline information on state-of-the-art crop biotechnology products and techniques that are either in use or in the pipeline in developing countries. Names and contact information of the respondents were obtained from their respective institutional websites and were included in the circulation list. The project was reviewed and approved by Institutional Review Board at Washington State University (WSU-IRB # 10650 Activity #002).

A web-based survey format was constructed to determine current perceptions, status, and needs assessment of the different public research institutions on IPRs. This was chosen for several reasons. Samples included personnel working in Asia’s public universities and research institutions with active and up-to-date websites. These institutions tend to have high-speed Internet access, minimizing difficulty in accessing a web-based survey. Web-based surveys also reduced time to completion, direct branching, and reduce overall survey costs if no significant programming is required (Schonlau, Fricker, & Elliott, 2002).

To ensure that these surveys were clear and concise, the questionnaire was pre-tested to improve the clarity of questions and instruction, and determine the understandability and validity of the contents. The pre-test group included members of the National Partners’ Initiative (NPI) of the Central Advisory Service on Intellectual Property (CAS-IP). NPI is a community of IP practitioners based in developing and emerging economies working together to support partnerships in relation to IP and technology transfer management between the Consultative Group on International Agricultural Research (CGIAR) centers and National Agricultural Research Systems (NARS). Comments received from this group were used to refine the survey instrument. None of the data collected in the pre-test were used in the final research analysis.

The online survey instrument and the resulting hosted web site was designed and managed by WSU-SESRC. Selected faculty and staff from WSU then tested the final web-based survey questionnaire and validated the survey process. The survey was designed in such a way that respondents could review and change their responses. Response to the survey was completely voluntary, and it was expected that some of the respondents would skip some of the questions. Undesirable access to survey pages was controlled through firewalls set up by the SESRC server. Randomly generated personal access codes assigned to respondents also controlled access to the survey. Respondents entered their unique access code at the survey homepage to gain access to the survey itself. Once a survey was completed, the used access code became invalid and further access to the survey using that code was denied. The SAS statistical package was used to analyze the survey data. Descriptive statistics such as mean, frequency, and percentage were primarily employed in the interpretation and comparison of data among groups. Decision rules were set for interpreting numeric data to draw final conclusions. For those items where one category received 40% or more with the other three categories receiving 25% or less of the responses, this occurrence was called “a clear majority.” A response pattern was “without a clear majority” when all four categories received 25% or less of the responses.


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The survey questionnaire consisted of 27 questions split into three sections. Section A, technology transfer capabilities, collected information on capabilities, including experiences of institutions with IP management and technology transfer. Section B, IP protection to agricultural biotechnology management, collected information on the attitudes of institutional heads and research managers on the features of IPRs and the implications to their scientists, institutions, and public agricultural research. Section C, background information collected demographic data. All three sections included multiple-choice questions, Likert-scaled responses, and open-ended questions.

Results and DiscussionThrough a web-based survey, information was collected on how research

administrators view the concept, importance, and implications of IPRs to public agricultural research. The survey was designed to determine the current capability, as well as capacity needs of their respective institutions in handling IP issues, especially those related to modern agricultural biotechnology. Ninety-one institutions (90% of 101) conducting agricultural biotechnology and their institutional heads or research administrators were selected for the survey. Of these 91, 36 institutional heads (39.56%) responded to the survey, with seven partially completing the form, resulting in a total response rate of 47%.

Profile of Respondents

As shown in Table 1, agricultural biotechnology R&D in the five countries is predominantly administered by male professionals (72.2%). This finding is expected, since the majority of government and agriculture personnel in India, Malaysia, Philippines, Thailand, and Vietnam are males (UNESCO, 2010). Most respondents were aged 51-60 (52.8%), and a majority (75%) held a Doctor of Philosophy degree. The high number of PhDs is also not surprising, especially in India, since many developing countries invest in training and higher education to increase a nation’s position as a knowledge economy. These research administrators led an institution size of more than 200-1000 employees (52.8%). Most of the respondents (30.6%) came from institutions in India and the Philippines.

Perception and Awareness on IPRs and their Developments

Respondents were asked to evaluate, on the 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), the different features of IPRs. Most of the respondents strongly agreed that IPRs give owners exclusive rights to control the users of the property (20 of 35, 57.14%); give owners the exclusive rights to sell, lease or transfer the property right (18 of 35, 51.43%); clearly define the geographic and time scope of the property (18 of 35, 51.43%); allow public access to the property under strict professional scientific guidelines (16 of 35, 45.71%); clearly define relative rights of individual innovator/inventor and institution, agency, organization (24 of 35, 68.57%); and provide income/incentives to innovators or inventors (24 of 35, 68.57%) (Table 2). To them, IPRs can be a


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source of additional income, and the key important feature of IPRs is providing incentives to innovators or inventors. Six survey respondents reported that IPRs as incentives can specifically help inventors remain in their own countries and develop new technologies. One institutional head explained that incentives from the government are few or nonexistent, resulting in the

Characteristics Frequency Percent N

GenderMale 26 72.2

36Female 10 27.8

Age

Less than 30 2 5.6

3631-40 4 11.1

41-50 11 30.6

51-60 19 52.8

Position in the institution

Professor 4 11.8

34

Associate Professor 4 11.8

Assistant Professor 1 2.9

Director 13 38.2

Senior Research Scientist 7 20.6

Other 5 14.7

Highest level of education

Bachelor (BA/BS) 3 8.3

36Master (MA/MS) 5 13.9

Doctor (Phd/EdD/DSc) 27 75.0

Others 1 2.8

Number of staff supervised

None 5 13.9

36

1-5 5 13.9

6-10 6 16.7

11-19 7 19.4

20 or more 13 36.1

Size of institution

Less than 200 employees 7 19.4

36200 - 999 employees 19 52.8

1,000 - 4,999 employees 9 25.0

5,000 - 9,999 employees 1 2.8

Country

India 11 30.6

36

Malaysia 2 5.6

Philippines 11 30.6

Thailand 4 11.1

Vietnam 8 22.2

Table 1: Socio-Demographic Characteristics of the Respondents


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Features of IPRs Frequency (Percent)

Strongly Disagree

Somewhat Disagree

Somewhat Agree

Strongly Agree

Do Not Know

Total

Give owners the exclusive rights to control the users of the property

4(11.4)

4(11.4)

6(17.1)

20(57.1)

1(2.9)

35(100)

Give owners the exclusive rights to sell, lease or transfer the property right

2(5.7)

6(17.1)

9(25.7)

18(51.4)

- 35(100)

Clearly defines the geographic and time scope of the property

2(5.9)

6(2.9)

9(44.1)

18(47.1)

- 35(100)

Allow public access to the property under strict professional scientific guidelines

1(2.9)

5(14.3)

16(45.7)

13(37.1)

- 35(100)

Clearly defines relative rights of individual innovator or inventor and institution, agency, organization

1(2.9)

2(5.7)

8(22.9)

24(68.6)

- 35(100)

Provide income/incentives to innovators or inventors

2(5.7)

1(2.9)

5(14.3)

26(74.3)

- 35(100)

Analysis: Most of the respondents positively responded on the different features of IPR.

Table 2: Respondents’ Perceptions on the Features of IPR

flight of best researchers to foreign lands. Higazi (2005) highlighted the importance of incentive policies to reverse “human capital flight” or the “brain-drain” phenomenon.

Most of the respondents (83.4-88.9%) are aware of the three most discussed IPR-related international treaties and conventions: World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (WTO-TRIPS); the Convention on Biological Diversity (CBD); and the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) (Table 3). They also claimed that their institutional IP policies comply with these international treaties.

Implications of IPRs to Public Research Institutions and Public Agricultural ResearchThese questions aim to reveal common perceptions of respondents regarding the

benefits and risks of IP to public research institutions and to public agricultural research in general. As cited by one of the survey participants, many universities receive governmental funds to support R&D and generate new technologies. Such technologies are then freely accessible to the public. The use of IPR’s has been criticized as privatizing knowledge and restricting public access to publicly funded research. A majority of the respondents (50-76.5%), however, did not share this same perspective as they agreed on the positive influence of IPRs on agriculture and agricultural research. As presented in Table 4, they strongly agreed that IPRs do not constrain or reduce the flow of technology transfer among national agricultural research systems (51.56%). Respondents further stated that IPR regulations do


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not delay the research process or result in research stoppage (57.5%), and do not promote competition, but rather enhance collaboration with the private sector (55.9%). Respondents also agreed that IPRs:

1. foster creativity and stimulate invention and new innovations by scientists (76.5%); 2. help increase agricultural production (50%); 3. promote and disseminate use of new knowledge and technologies (50%); 4. promote domestic and foreign investments in biological innovations(55.9%);5. serve as incentives/reward mechanism for scientists/researchers (67.6%); 6. foster public-private sector collaboration (50%); 7. provide additional budget for institution (52.9%); 8. influence institutional policy to generate more agricultural biotechnologies and

products (50%); and 9. result in more focused R&D, increased institutional productivity, and credibility

(60.0%).

Current Capacity and Capability-Building Needs of Institutions on IP Management and Technology Transfer

A majority of the respondents (70%) indicated that their institutions possess an office that manages the identification, promotion, and commercialization of intellectual property (Table 5). These offices provide a one-stop shop to advance the development of each institution’s technologies, inventions, and discoveries, facilitate patent protection, and foster strategic collaborations with industry through licensing, sponsored research, and new venture agreements. The Philippine Rice Research Institute, a rice R&D institution located in the Philippines, has an IP Management Office that evaluates technologies for protection,

International Treaties Response Frequency Percent N

1. The Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Well Informed 15 41.7

36Somewhat Informed 17 47.2

Not Sure/Not Aware 4 11.1

2. Convention on Biological Diversity




3. The International Treaty on Plant Genetic Resources for Food and Agriculture




Analysis: Most of the respondents (83.4-88.9%) are aware on these international treaties. They also claimed that their institutional IP policies comply with these international treaties.

Table 3: Awareness of Respondents on International Laws on IP and Agricultural Biotechnology


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Features of IPRs Frequency (Percent)

Strongly Disagree

Somewhat Disagree

Somewhat Agree

Strongly Agree

Do Not Know

Total

Foster creativity and stimulate invention and new innovations by scientists

1(2.9)

1(2.9)

5(14.7)

26(76.5)

1(2.9)

34(100)

Help increase agricultural production 2(5.9)

2(5.9)

11(32.4)

17(50.0)

2(5.9)

34(100)

Promote and disseminate use of new knowledge and technologies

2(2.9)

2(5.9)

12(35.3)

17(50.0)

2(5.9)

34(100)

Promote domestic and foreign investments in biological innovations

1(2.9)

12(35.3) - 19

(55.9)2

(5.9)34

(100)

Serve as incentives or reward mechanism for scientists or researchers

1(2.9)

12(35.3) - 23

(67.6)2

(5.9)34

(100)

Facilitate access of biotech IPs from other laboratories or countries

1(2.9)

5(14.7)

15(44.1)

11(32.4)

2(5.9)

34(100)

Increase costs of accessing research material or tools

1(2.9)

2(5.9)

14(41.2)

16(47.1)

1(2.9)

34(100)

Foster public-private sector collaboration 2(5.9)

1(2.9)

12(35.3)

17(50.0)

2(5.9)

34(100)

Source of additional budget for institution 1(2.9)

2(5.9)

11(32.4)

18(52.9)

2(5.9)

34(100)

Influence institutional policy to generate more agricultural biotechnologies and products

1(2.9)

1(2.9)

13(38.2)

17(50.0)

2(5.9)

34(100)

Result in more focused R&D, increased institutional productivity, and credibility

1(2.9)

2(5.7)

10(28.6)

21(60.0)

1(2.9)

35(100)

Distort and conflict with public mission of institution resulting in social disservice

9(27.3)

6(18.2)

11(33.3)

6(18.2)

1(3.0)

33(100)

Delay publication of research and has a negative effect on science

8(23.5)

6(17.6)

14(41.2)

5(14.7)

1(2.9)

34(100)

Require big investment (manpower, facilities, finances) for institutions

4(11.8)

7(20.6)

14(41.2)

8(23.5)

1(2.9)

34(100)

Promote competition rather than collaboration with the private sector

7(20.6)

12(35.3)

8(23.5)

6(17.6)

1(2.9)

34(100)

Divert resources to areas resulting only in IPRs; thus, inhibit or hamper exploration of fundamental long-term basic research questions

7(20.0)

10(28.6)

10(28.6)

6(17.1)

2(5.7)

35(100)

Delay the research process and often times result in stopping research

8(24.2)

11(33.3)

9(27.3)

3(9.1)

2(6.1)

33(100)

Constrain or reduce the flow of technology transfer among national agricultural research systems

8(22.9)

10(28.6)

5(14.3)

10(28.6)

2(5.7)

35(100)

IPR agreements are too legalistic for scientists to understand and comply

3(8.8)

7(20.6)

13(38.2)

9(26.5)

2(5.9)

34(100)

Prevent or serve as threats to future scientific investigation from IPR on previous research

7(20.6)

9(26.5)

9(26.5)

7(20.6)

2(5.9)

34(100)

Analysis: Majority of the respondents were positive on the impact of IPR to agriculture and agricultural research.

Table 4: Perception of Respondents on the Impacts of IPR to the Agriculture and Agricultural Research


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facilitates patent prosecution, and handles commercialization agreements with the private sector. Other institutions in the Philippines with IP offices have similar administrative organization and functions.

Table 5: Current Capacity on IP Management and Technology Transfer

Investments in IP management

Frequency Percent N

Office engaged in IP identification, protection, promotion and commercialization

Identification

Yes 25 69.4

36No 10 27.8


Protection

Yes 25 67.6

37No 12 32.4

Not Sure/Not Aware 0 0

Promotion

Yes 25 65.8

38No 10 26.3


Commercialization

Yes 25 65.8

38No 10 26.3


Institutional IP policies and procedures

Yes, policies existing 28 73.7

38Yes, policies in discussion 2 5.3

No policies existing or planned 7 18.4

Not aware/don't know 1 2.6

Number of staff working IP management unit

None 14 37.8

371-3 9 24.3

4-5 9 24.3

More than 5 5 13.5

Budget for IP management activities

None 17 45.9

37

Less than $20,000 13 35.1

$20,000 - 24,999 1 2.7

$25,000 - 39,999 1 2.7

$40,000 - 44,999 1 2.7

$45,000 - 59,999 1 2.7

$60,000 - 79,999 2 5.4

$80,000 and above 1 2.7

Analysis: Majority of the respondents (>70%) indicated that their institutions have offices that manage the identification, promotion and commercialization of intellectual property. It was interesting to note, however, that the respondents indicated that there is no regular staff working on their IP management units. Most of them also indicated that there is no regular budget for their IP management efforts.


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International Capacity Frequency Percent N

Institutional capacity rating

Very good 5 13.9

36

Good 14 38.9

Fair 9 25.0

Poor 6 16.7

Very poor 2 5.6

Effectiveness of institutional IP management program

IP management program was suited to address these programs

18 50

36

IP management program was not effectively organized to address these problems

6 16.7

Did not personally deal with these problems 7 19.4

Not sure/Not aware 5 13.9

Not sure/Not aware 5 13.9

Analysis: Most of the respondents (52.8%) considered their institutional capacity as “good enough” and well suited to address problems associated with access, generation, and technology transfer of agricultural biotechnology intellectual properties.

Table 6: Assessment of Institutional Capacity

Most respondents (73%) revealed that institutional IP management and technology transfer policies guide the operations of their IP offices. It was interesting to note, however, that the respondents indicated that there is no regular staff working in their IP management units. Despite limited human and financial resources (Table 6), many respondents considered their institutional capacity as ”good enough” (38.9%) and well suited to address problems associated with access, generation, and technology transfer of agricultural biotechnology intellectual properties (50%).

Figure 1. Percentage of respondents with experience on material exchange with different institutions. Institutional heads revealed that they did not have major problems in accessing

new biological materials from other institutions, private or public, local and abroad.

Yes, major problems

Yes, some problems

No

Not sure/unaware

Resp

onse

s

Respondents, %0 10 20 30 40

local/internationalprivate companies

Foreign laboratories

5.41

13.51

29.73

27.03

32.43

37.84

28.57

21.62


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IPRs are also criticized for restraining access and exchange of research tools within the global scientific community. Most of the institutional heads indicated that their institutions are not aware (50.19%) or do not have difficulties accessing proprietary materials and new genetic resources from other local and international institutions (public and private) (70.27%) (Figure 1). Should such problems arise, they cannot associate them with the strengthening of IPRs. Many respondents (47.2%) claimed that seeking protection and pursuing commercialization of their research outputs are not problematic for their researchers and the community they serve (Figure 2).

As shown in Table 7, many of the institutional heads indicated that they highly prioritize the further development of their institutional IP policies (29.4%), commercialization or licensing out their technologies (47.1%), and marketing their technologies (44.1%). Some of the research managers in Vietnam indicated that developing an IP policy should be a priority since IP awareness in their country is quite low. One research manager in India, meanwhile, stated that commercialization is important because it helps to accelerate the rate of transfer of technology or end products to the farmers. This helps the farming community benefit from the technology in a better and uniform fashion, instead of technology benefits trickling to only some pockets. Some respondents revealed that they give moderate priority on IP valuation (44.1%), freedom-to-operate and negotiation (32.4%), and prosecuting or filing for IPR protection (30.3%). Many of the respondents indicated that they give less priority to improving their capacity on setting up new or start-up companies (21.2%), developing legal instruments (29.4%), and technology acquisition of protected technologies (30.3%).

A Note on Interpretation of Statistics

The frequency and percentages reported here are based on a non-random sample of research administrators with email addresses available in the web and whose institutions

Respondents, %0 10 20 30 40 50

Not sure/unaware

No

Yes, some problems

Yes, major problems

Resp

onse

s

25.00

47.22

19.44

8.33

Figure 2. Percentage of respondents that claimed that their seeking protection or pursuing commercialization of their research outputs do not cause issues with their researchers

and the community they serve.


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are also listed in FAO-Biotech database. Results of the study are limited to the respondents of the survey and may not represent all public sector institutions working on agricultural biotechnology in the countries studied. No measurements of sampling or non-sampling errors were included in this report since the statistic generated here was not use to estimate a wider population.

ConclusionsPublic research institutions, the significant supplier of technological innovations in

agriculture in developing countries, now operate in an environment of intellectual property rights (IPRs). The advent of the international IPR regime, the concomitant protection of research tools and other technologies needed for research, the increased participation of the private sector in agriculture, and the increasing emergence of public-private partnerships are some of the developments that are transforming public agricultural research and pose challenges to how public research institutions manage their intellectual assets. There are profound implications for national research institutions that do not take care of the

FIP management areas needing assistance

Frequency (Percent)

1 Very low priority

2 Low

priority

3 Moderate priority

4 High

priority

5 Very high priority Total

Developing an IPR policy 6(17.6)

5(14.7)

8(23.5)

10(29.4)

5(14.7)

34(100)

Developing legal IP instruments 6(17.6)

10 (29.4)

9 (26.5)

7 (20.6)

2(5.9)

34(100)

Freedom-to-operate and negotiation

4(11.8)

5(14.7)

11(32.4)

12(35.3)

2(5.9)

34(100)

Prosecuting/filing for IPR protection

6(18.2)

4(12.1)

10(30.3)

7(21.2)

6(18.2)

33(100)

Technology commercialization or licensing out of technologies

3(8.8)

3(8.8)

4(11.8)

16(47.1)

8(23.5)

34(100)

Technology acquisition of protected technologies

5(15.2)

10(30.3)

8(24.2)

8(24.2)

2(6.1)

33(100)

IP valuation 5(14.7)

2(5.9)

15(44.1)

7(20.6)

5(14.7)

35(100)

Marketing of technologies 3(8.8)

2(5.9)

8(23.5)

15(44.1)

6(17.6)

34(100)

Setting up of new or start-up companies

9(27.3)

4(12.1)

7(21.2)

6(18.2)

7(21.2)

33(100)

Analysis: Most of the research administrators indicated that they give high priority to developing further their institutional IP policies (29.4%), commercializing or licensing out their technologies (47.1%), and marketing their technologies (44.1%).

Table 7: Priority of Institution on Each Policy on IP Management and Technology Transfer


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intellectual assets within their public trust – including local germplasm, technologies, software, information, publications, vaccines, databases, methodologies and know-how. It is therefore important to understand how these institutions have adjusted to the challenges associated with the expansion of IPRs in the agriculture sector.

This study conducted a web-based survey to gain perspective on the implementation status of IP management and technology transfer among public research institutions in developing countries in Asia. Specifically, this survey consulted institutional heads from 91 public research organizations in India, Malaysia, Philippines, Thailand, and Vietnam to determine their perceptions on the impact of IPRs on agriculture and agricultural research. This research also determined their capability, as well as capacity needs, for handling IP issues especially as they relate to the use and commercialization of modern agricultural biotechnology.

Forty-three out of 91 respondents (47%) participated in the survey. The summary of major findings and their implications are as follows:

Respondents are aware of the features and advantages of IPRs and are positive towards their implementation in public research institutions and their impact on public agricultural research. Most of the institutions (70%) have one-stop shop IP offices in place (in charge of evaluation, protection, dissemination, and commercialization), backed with internal IP policy on management and technology transfer. Yet these are different in US settings (with different entities doing the evaluation, protection, marketing and commercialization of technologies). This indicates their appreciation of the importance of IP management and acceptance that the implementation of IP infrastructure and processes is now important to help address their IPR-associated concerns on agricultural research (especially on agbiotech), and help in their institutional IPR decisions whether to deliver services and technologies for free or license them to other institutions for a fee.

The institutional heads (47.22%) indicated that they did not experience conflicts with their researchers and the community they serve with regards to protecting and commercializing their research outputs. This may indicate that their researchers and their clients understand and support their IPR initiatives. However, the institutions’ policy and procedures are not well supported with regular personnel and budget. Public institutions need more than just policy to enable ownership and protection of intellectual assets. These findings may indicate that the institutions surveyed deal with IPR management through an ad hoc committee. The nonprofit international agricultural research, International Rice Research Institute (IRRI), for instance, dealt initially with IPR issues using a similar committee, but subsequently built an in-house facility due to increasing IP management activity. This area needs further review and consideration.

The strengthening of IPRs in agriculture does not impair each institution’s access to proprietary technologies from other institutions that are needed for research. This implies that despite the proliferation of patent protection in some research tools, the practice


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of “sharing” among public sector institutions as part of their cultural norms continues. According to Kent (2004) and Pardey, Wright, Nottenburg, Binenbaum, & Zambrano (2003), the argument that access to biotech tools by public sector researchers in developing countries is restrained by IPRs is misunderstood, since certain key biotechnologies are rarely protected in developing countries. Such territorial limitations of IPR (e.g American patents enforceable only in US territory) provide far greater freedom to operate for public agricultural research centers in developing nations.

Most of the respondents considered their institutional capacity on IP management and technology transfer as good, but consider technology commercialization or licensing as their highest priority needing capacity assistance. Competency training, focused on understanding the process of licensing new agricultural innovations to the private sector, will be important for these institutions to bring their research outputs into the commercial marketplace.

A survey conducted by Maredia (2001) of 27 researchers and managers in 28 developing countries identified four indispensable broad areas that are vital in implementing the IPR framework in public research institutes. These areas include: human resources development focused on training and awareness creation on IPR issues, negotiation skills, research and marketing tools to value intellectual properties; institutional capacity building focused on establishment of an IP management office, development of guidelines, policies, and handbooks; and financial resources to meet the expenses of protecting and accessing IP technologies. Almost a decade after that study, the survey reported in this manuscript has proved that public institutions in developing countries are still faced with the same capacity challenges on IP management and technology transfer. However, these are understandable as IP management and technology transfer are quite novel concepts for these institutions. Embracing IPRs, an organizational innovation in government-funded institutes, is not an easy task. Institutional policies can be slow to take shape, dedicating resources and establishing offices. Deploying staff for these functions takes time and commitment.

The number of institutions surveyed may not be indicative of the entire picture of IP management and technology transfer in developing countries in Asia. However, this study shows that the surveyed institutions are supportive of IPRs and their management despite negative stories about impact of IPRs on public mission of public research institutions. This also indicates that the changing mindset towards managing and exploiting IP is taking shape in the public research institutions surveyed. In spite of this shift in perspective, the efficiency of the institutions’ IP management structure cannot be fully deduced considering the lack of regular personnel and budget to support their IP management efforts. Pefile & Krattiger (2007) recognize this lack of funding and inadequacy of human and financial resource capacity to invest in institutional IP management policies and resources in developing countries.

Coherent IP management and technology transfer strategies and institutional policies are essential to ensure that benefits from new technologies resulting from investments in agricultural research (e.g., agricultural biotechnology) are developed and flow to the public. This can be an expensive activity, very difficult to implement and justify. Institutions


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and countries with limited resources may consider other options to achieve the same goals (e.g., a common office for various institutions, or appointing an IP officer rather than establishing a full-fledged office). IP management bottlenecks can also be overcome creatively by building strategic alliances, outsourcing, building a seed fund, and asking for external resources. The positive perception and remarkable start of IP management and technology transfer by these institutions should guide them in further improving and/or strengthening their IP structures and procedures. Overall, this study presents the current status of IP management in surveyed institutions in India, Malaysia, Philippines, Thailand, and Vietnam, and can serve as a reference for international institutions aiming to build capacities of these institutes on IP management and technology commercialization.

ReferencesAghion, P., Bloom, N. B., Griffith, R., & Howitt, P. (2002). Competition and innovation:

An inverted U relationship. London, United Kingdom: Institute for Fiscal Studies.

Davis, L., Larsen, M., & Lotz, P. (2000). Scientists’ perspectives concerning the effects of university patenting on the conduct of academic research in the life sciences. Frederiksberg, Denmark: Copenhagen Business School, Department of Innovation and Organizational Economics.

FAO. (2005). Database of biotechnologies in use in developing countries (FAO-BioDec): FAO. Retrieved October 15, 2010, from FAO-BioDec Web site: http://www.fao.org/biotech/inventory_admin/dep/default.asp.

Graff G.D., Cullen, S.E., Bradford, K.J., Zilberman, D., & Bennett, A.B. (2003). The public-private structure of intellectual property ownership in agricultural biotechnology. Nature Biotechnology, 2(9), 989-995.

Heisey, P. W., King, J. L., & Rubenstein, K. D. (2005). Patterns of public-sector and private sector patenting in agricultural biotechnology. AgbioForum, 8(213), 73-82.

Heller, M., & Eisenberg, R.. (1998). Can patents deter innovation? The anticommons in biomedical research. Science, 280(5364), 698-701.

Higazi, A. (2005). Integration migration and development policies: Challenges for ACP-EU cooperation. Maastricht: ECDPM.

Kent, L. (2004). What’s the holdup? Addressing constraints to the use of plant biotechnology in developing countries. AgBioForum, 7(2), 63-69.

Maredia, K., Erbisch, F., Ives, C., & Fischer, A. (1999). Technology transfer and licensing of agricultural biotechnologies in the international arena. AgBiotechNet, 1(17), 1-7.


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Maredia, K., Oehmke, J., & Byerlee, D. (2004). Economic aspects of intellectual property rights in agricultural biotechnology. In F. Erbisch & K. Maredia (Eds.), Intellectual property rights in agricultural biotechnology second edition (pp. 107-123). Wallingford, UK: CABI Publishing.

Maredia, M. (2001). Application of intellectual property rights in developing countries: Implications for public policy and agricultural research institutes. Final Draft submitted to World Intellectual Property Organization. Geneva, Switzerland: World Intellectual Property Organization.

Pardey, P., Wright, B., Nottenburg, C., Binenbaum, E., & Zambrano, P. (2003). Intellectual property and developing countries: Freedom to operate in agricultural biotechnology. Washington, DC: International Food Policy Research Institute.

Pefile, S., & Krattiger, A. (2007). Training staff in IP management. In A. Krattiger, R. Mahoey, & L. Nelsen (Eds.), Intellectual property management in health and agricultural innovation: A handbook of best practice. (pp. 597-615). Oxford, UK; Davis, USA: MIHR; PIPRA.

Salazar, S., Falconi, C., Komen, J., & Cohen, J. (2000). The use of proprietary biotechnology research inputs at selected Latin American NAROS. The Hague: International Service for National Agricultural Research.

Schonlau, M., Fricker R., & Elliott, M. (2002). Conducting research surveys via e-mail and the web. Santa Monica, CA: RAND.

Thursby, J., & Thursby, M. (2002 ). Who is selling the ivory tower? Sources of growth in university licensing. Management Science, 48(1), 909-104.

United Nations Educational, Scientific and Cultural Organization (UNESCO) Institute for Statistics. 2010. Retrieved October 06, 2010, from UNESCO Institute for Statistics website: http://www.uis.unesco.org.

Van Wijk, J. C., & Komen, J. (1993). Intellectual property rights for agricultural biotechnology. Options and implications for developing countries. International Service for National Agricultural Research: The Hague.


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The Evolution of the Council of Academic Hospitals of Ontario Statement of Principles –

A Successful Harmonization Initiative

Katie Porter, MA, BEdClinical Research Agreements and Contract Specialist

Hamilton Health Sciences CorporationOffice of Integrated Research Services293 Wellington Street North, Ste. 103

Hamilton, ON L8L 8E7Tel: (905) 521-2100, ext. 74559

Fax: (905) 577-8378Email: [email protected]

Website: www.hhsc.ca/body.cfm?id=1069

Sarah Lampson, BA Clinical Research Agreements, Contracts and Grants Specialist, Cancer Research

Hamilton Health Sciences CorporationJuravinski Cancer Centre

699 Concession Street, 3rd Floor, FinanceHamilton, ON L8V 1C3

Tel: (905) 521-2100, ext. 63209Email: [email protected]

Authors’ NoteThe authors are members of the CAHO Steering Committee on Harmonizing Clinical Trial Agreements.

AbstractTo improve efficiency, consistency and transparency in clinical trial contract negotiations with industry sponsors, a Council of Academic Hospitals of Ontario (CAHO) committee facilitated the development of standard principles for member hospitals to follow during contract negotiation. Hospitals were encouraged to provide a link to the CAHO document on their websites, which facilitated greater transparency. The public availability has allowed institutions in other jurisdictions, as well as community hospitals in the province, to align their standards with those of Ontario academic hospitals.

Keywords: research administration, clinical trial agreement, harmonization initiative


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IntroductionTo improve efficiency, consistency and transparency in clinical trial contract

negotiations with industry sponsors, a Council of Academic Hospitals of Ontario (CAHO) committee facilitated the development of standard principles for member hospitals to follow during contract negotiation. The principles are available on-line for reference by institutions and industry (Slutsky et al., 2010). Hospitals were encouraged to provide a link to the CAHO document on their websites, which facilitated greater transparency. This living document was most recently updated in May 2010, and comments are welcome at any time. The public availability has allowed institutions in other jurisdictions, as well as community hospitals in the province, to align their standards with those of Ontario academic hospitals.

A strong competitor in the clinical research field, Ontario brings a wealth of resources to the table, including 25 CAHO member hospitals, each with a strong focus on research and innovation; a large and diverse patient population to draw from, and a mandate from the Ontario Government’s Ministry of Research and Innovation to establish Ontario as a globally recognized knowledge based economy (Queens Printer for Ontario, 2010).

To continue to build the foundation of research and innovation needed to draw industry-sponsored research to the province, the CAHO aimed to streamline the contract negotiation process to effectively address one of the most important factors driving clinical trial competitiveness today – speed (Ferris, et al., 2009). Outlining hospital contract standards allows companies to develop or modify their contracts to reduce or eliminate negotiation time, with the goal of starting trials more quickly.

Industry sponsors were consulted as the standard principles evolved. A draft document sent to four pharmaceutical companies received positive feedback. Input regarding indemnification, intellectual property and privacy provisions was considered and incorporated into the principles document. (Moldofsky, Arts, & Slutsky, 2010).

The CAHO statement is accessible to everyone via the internet and invites feedback via an email address. Sponsors are now working collaboratively to agree upon and document industry principles. When this document is complete and publicly available, sites will have greater clarity and consistency on sponsor objectives, and another tool to facilitate communications between parties.

CAHO Principles in the Context of Other Harmonization Efforts

Other harmonization initiatives such as the Model Agreement Group Initiative in the United States (MAGI, 2011), the United Kingdom’s Clinical Research Collaboration’s (UKCRC) Industry Collaborative Agreements Report for the Development of Model Agreements for Collaborative Commercial Research, and Medicines Australia’s Clinical Trials Research Agreements (Medicines Australia, 2011) also present principles, standard agreements and contract language. Unlike those efforts, CAHO does not provide sample


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language but instead outlines important terms a clinical trial agreement should contain. The intent of this document is two-fold:

1. To provide guidance to Ontario academic hospitals when reviewing industry-initiated clinical trial agreements.

2. To provide guidance to industry sponsors who wish to engage Ontario academic hospitals in clinical trials so they may better understand the common principles that underlie such clinical trial contracts.

A brief discussion of four significant principles, publication rights, intellectual property ownership, confidentiality and indemnification, will help illustrate this.

For academic hospitals with a strong research mandate, publication rights are paramount. Like the MAGI, UKCRC and Medicines Australia initiatives, CAHO believes that sites need to retain their ability to publish study results, positive or negative, within a reasonable time frame; however, the acceptable timeline varies slightly among groups. Medicines Australia’s Standard Clinical Trials Research Agreement for Commercially Sponsored Trials allows for publishing two years after study completion or the publication of the results of the multi-centre study. (Medicines Australia, 2011). The UKCRC timeline is not specified in days, but stipulates that publication will be upon completion “of the Clinical Trial, and any prior publication of multi-centre data, or when the Clinical Trial data are adequate (in Sponsor’s reasonable judgment).” (United Kingdom Clinical Research Collaboration, 2005). MAGI outlines timelines for review but does not identify any parameters for the timing of the initial publication from study completion. CAHO sites will only accept an 18-month delay from study completion. CAHO sites are happy to allow industry partners to copy and distribute these publications, provided proper acknowledgment of authorship is provided.

Intellectual Property ownership and rights are another important component in a clinical trial agreement. The CAHO document aligns with the MAGI, UKCRC and Medicines Australia beliefs that this part of the agreement is context-specific, depending on which parties developed the protocol, with a range of options including site ownership, joint ownership, or industry ownership, with the site retaining the option to use the intellectual property for internal research, academic and patient-care purposes.

Both sites and industry have a vested interest in protecting their confidential information. CAHO encourages member hospitals and industry partners to agree on a reasonable term of confidentiality (10 years maximum) and to maintain the confidential information they receive using the same degree of care as they use with their own information. Medicines Australia does not limit the term of confidentiality. The UKCRC (2005) Model Clinical Trial Agreement for England has a 10-year confidentiality term; MAGI (2011) suggests 3 to 10 years is common, but its template leaves a blank so the sponsor and site can come to their own agreement.


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Permitted disclosures of confidential information must include the ability to disclose information to potential study subjects during the recruitment process, or to study subjects who are or were enrolled in the study, particularly if the information relates to their health, safety, or diagnosis. THE UKCRC and Medicines Australia have similar terms to CAHO and MAGI. The MAGI (2011) document has similar parameters but addresses some additional reasons for disclosure the CAHO principles do not: disclosure to third-party payors if required to determine coverage, to protect public health or the health of third parties exposed to the study product, for peer-review and to other scholars wishing to verify study results.

The CAHO principles require a sponsor to provide indemnification for any claims caused by or arising out the conduct of the study according to the protocol, the sponsor’s negligence or intentional wrongdoing, and the sponsor’s use of the study results. The UKCRC’s Industry Collaborative Agreements Report acknowledges that indemnification is a “contentious area and one that will need to be carefully handled in a new model agreement” (UKCRC, 2005). MAGI addresses the same areas as the CAHO document, and also stipulates that the site be indemnified for “the handling, use or subsequent transfer of Specimens and Genetic Data shipped by Site per Sponsor’s instructions” (MAGI, 2011). The Medicines Australia’s Form of Indemnity (Medicines Australia, 2011) and the UKCRC’s Model Clinical trial Agreement for England only mention indemnification for subject injury.

ConclusionThe authors note clear evidence of an improvement in contract timelines since

using the CAHO principles as a negotiating tool at their place of work (a not-for-profit academic hospital). Some sponsors have proactively used the principles in drafting templates to propose to sites. Templates aligned with the CAHO document have required little, if any, negotiation, and the authors’ institution has been able to agree to such templates and implement them in under five business days from initial receipt. It is hoped that CAHO will eventually track negotiation timelines by asking for reports on this set of data from its member hospitals (Moldofsky et al., 2010).

There have been some challenges associated with the use of the standardized principles, mainly around interpretation of specific terms, by sites and industry sponsors alike. CAHO has considered the development of a glossary to address these issues. Another factor that has an impact on contract terms are policies and internal best practices, which differ among sites and are not transparent to sponsors. Sponsors have indicated frustration when these best practices appear more onerous. Also, some sites have reported inconsistently applying the principles, to the detriment of the message that they are the baseline standards. One sponsor interpreted the CAHO principles as guidelines and did not understand that all CAHO members had developed, agreed upon and committed to the parameters. In rare cases when sponsors have requested, and CAHO members have considered, exceptions to the principles, the institutions are encouraged to note the instances and forward them to CAHO. Future discussions will include a review of common areas of push-back from sponsors and


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the resolution. Themes will evolve which could prompt clarification or a revision of certain positions. In addition, it must be noted that the CAHO Statement of Principles does not take the place of legal advice. The member hospitals are encouraged to use the document to establish satisfactory terms for their agreements and to seek legal counsel when appropriate (Moldofsky et al., 2010).

By developing a set of common principles for its member hospitals, CAHO provides a tool to effectively reduce the contract negotiation timeline in Ontario. Member hospitals are clear on the minimum standard contractual requirements for working with industry sponsors and sponsors have access to clear, consistent information among various sites. By creating this living document and making it available to both member hospitals and industry sponsors alike, both parties are able to quickly establish a common ground on the relevant ethical, legal and academic issues in a contract.

ReferencesFerris, L., Lundie, M., Hill, D., Kiehlo, E., Heslegrave, R., Baluja, N., . . . Mulholland, E.

(2009). The Ontario Clinical Trials Working Group report. Clinical Trials in Ontario: Urgent Action Required. Toronto, ON.

MAGI. (2004-2011). Retrieved from http://www.magiworld.org/standards/MAGI_Model_CTA.doc

Medicines Australia. (2011). Retrieved from http://medicinesaustralia.com.au/issues-information/clinical-trials/clinical-trials-research-agreements/.

Moldofsky, M., Arts, K., & Slutsky, A.S. (2010). Development of clinical trial agreement principles. Drug Information Journal, 44, 111-117.

Queen’s Printer for Ontario. (2010). Retrieved from http://www.mri.gov.on.ca/english/about/default.asp.

Slutsky, A., Moldofsky, M., Arts, K., Lampson, S., Macpherson, P., Sales, V., . . . Gilbert, J. (2010). Statement of principles to be considered when negotiating a clinical trial agreement. Retrieved from http://www.caho-hospitals.com/wp-content/uploads/CAHO-Clinical-Studies-Agreement-Statement-of-Principles-Version-2.pdf.

United Kingdom Clinical Research Collaboration. (2005). Retrieved from http://www.ukcrc.org/regulationgovernance/modelagreements/.


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Research Administrators as Servant Leaders

Joann Waite, MOL, PhD (cand)Director, Sponsored Research and Programs

Gonzaga University502 East Boone, BCH 205

Spokane, WATel: (509) 313-5870Fax: (509) 313-6403


Author’s NoteThis article is part of the author’s dissertation materials.

AbstractWithin the sponsored research support offices in departments at research institutions, non-profits, and undergraduate institutions, research administrators are often perceived as servant leaders by their own membership organizations and those who work with them. This perception is influenced by survey results focusing on character. Parolini (2004) suggested that, “Servant leaders are defined by their ability to bring integrity, humility, and servanthood into caring for, empowering, and developing of others in carrying out the tasks and processes of visioning, goal setting, leading, modeling, team building, and shared decision-making” (p. 9). These research administrators serve and lead the external funding activities from the support offices in their institutions.

Keywords: sponsored research office (SRO), research administrator, servant leader

IntroductionThe increasing competition in recruiting students and faculty puts predominately

undergraduate institutions at a financial disadvantage. The external demands of graduate programs and the workforce are the primary cause. The demand is that undergraduate students have research and experience in their respective fields prior to a baccalaureate graduation. Both tuition-driven private and state-funded public predominately undergraduate institutions (PUI) suffer from tightening budgets. This restriction hinders a transformation from lecture-based teaching to a more desired global and experiential learning environment. Grant funding is a way for institutions to meet the external demands and recruit top tier faculty and students. Faculty can support the cultural transformation by generating grant funds for institutions. Proactive institutional leaders provide services that remove roadblocks and motivate faculty through professional development and student success. The implementation of a sponsored research office is a catalyst for increasing grant


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submissions, appropriate budgeting, and fiscal oversight of successful sponsored awards. Research administrators are often referred to as servant leaders by their own professional society’s staff-sponsored research offices. The faculty, students, and institutions all benefit from the fruitful results of grant awards.

Research Administrators as Servant LeadersThe perception of research administrators as servant leaders by their membership

organizations is influenced by survey results focusing on character. Parolini (2004) suggested that, “Servant leaders are defined by their ability to bring integrity, humility, and servanthood into caring for, empowering, and developing of others in carrying out the tasks and processes of visioning, goal setting, leading, modeling, team building, and shared decision-making” (p. 9). These research administrators serve and lead the external funding activities at predominately undergraduate institutions. Vargas and Hanlon (2007) described the primary goals of research administrators, “to both serve and lead our researchers (faculty), while still keeping in mind our responsibilities to our institutions, sponsors, and community” (p. 45).

Van Dierendonck and Nuijten (2010) suggested that leadership is a key factor for engaged employees and innovative organizations. They further observed that servant-leadership was introduced by Greenleaf (1977) and has recently been rediscovered by scholars.

The term “servant-leadership” is a leadership paradigm introduced in an essay by Robert Kiefner Greenleaf (1904-1990). Greenleaf worked first as a telephone lineman and eventually moved into organizational management at AT&T, serving in that role from the mid 1920s to the 1960s. He became a lecturer at prestigious schools such as the Massachusetts Institute of Technology, Dartmouth College, and the Harvard Business School. Greenleaf is credited with the first continuing education program model used in colleges and businesses today (Ferch & Spears, 2011). Greenleaf ’s 25-year longitudinal study of managerial lives is credited with pioneering much of today’s leadership practices. He described how he discovered the concept of servant-leadership through reading a book, Journey to the East (Hesse, trans. 1956). According to Spears (1998), Greenleaf believed the message of the story was that one must first serve society, then, through one’s service a person, will be recognized as a leader. Leadership is about service.

The servant leader is servant first. It begins with the natural feeling that one wants to serve. Then conscious choice brings one to aspire to lead. The difference manifests itself in the care taken by the servant; first, to make sure that other people’s highest priority needs are being served. The best test is: do those served grow as persons; do they, while being served, become healthier, wiser, freer, more autonomous, more likely themselves to become servants? And what is the effect on the least privileged in society; will they benefit, or at least not be further deprived. (Greenleaf, 1977, p. 27)


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The paradoxical expression, “servant-leadership,” is expansive of individual service to society irrespective of hierarchical position. This principle of a leadership-service blend differs from the hierarchical model of leadership. In hierarchical leadership the power of the leader was visible and obeyed by those lower in the organization (Crippen, 2005). In servant-leadership, through strategies of service and stewardship, a leader was identified by the people to be first among equals or “primus inter pares” (Greenleaf, 1977, p. 84).

Not Much Happens Without a Dream

Greenleaf (1977) suggested that, “. . . for something great to happen, there must be a great dream. Behind every great achievement is a dreamer of great dreams” (p. 30). The dreams of faculty developed into a proposal and eventually supported financially by a sponsor is one area in which a research administrator perceived as a servant leader is valuable at institutions. Van Dierendonck and Nuijten (2010) stated, “Given the central role of leaders in the social setting of most organizations, the behavior shown by leaders towards their followers plays an important role as to how supportive a work setting is perceived” (p. 13). Moreover, it is believed that leadership is an increasingly acknowledged factor for follower well-being. Van Dierendonck and Nuijten cited abundant evidence that a controlling, less supportive leadership style, with vague responsibilities and lack of feedback, is related to lower levels of well-being (Cartwright & Cooper, 1994; Van Dierendonck, Haynes, Borrill, & Stride, 2004). Van Dierendonck and Nuijten (2010) explained that, “A supportive environment provides positive effects, a sense of predictability, and recognition of self-worth. As such, it is likely that servant-leadership behavior is beneficial for follower engagement, job satisfaction, and performance” (p. 13).

Ten Characteristics

Ten qualities of a servant leader have been identified by Spears (1998), Ferch and Spears (2011), van Dierendonck and Nuijten (2010), and Crippen (2005), as follows:

Listening

This quality refers to a profound obligation to listening to others. There is a need for reflection, silence, meditation, and active listening, in fact hearing what is said and is not said. Servant leaders are skillful communicators and excellent listeners, to themselves (through their inner voice), as well as to others, specifically their followers (Spears, 1998). Ferch and Spears (2011) emphasized that, “Listening also encompasses getting in touch with one’s own inner voice and seeking to understand what one’s body, spirit, and mind are communicating” (p. 11). Greenleaf (1977) stated, “In saying what I have in mind, will I really improve on the silence?” (p. 31) He further stated that only true servant leaders automatically react to problems by listening first.


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Empathy

A good servant leader strives to empathize with others through supportive understanding. Greenleaf wrote that trust could be developed through the use of empathy:

Individuals grow taller when those who lead them empathize and when they are accepted for what they are, even though their performance may be judged critically in terms of what they are capable of doing. Leaders who empathize and who fully accept those who go with them on this basis are more likely to be trusted. (Greenleaf as cited in McGee-Cooper, 1998, p. 81)

Ferch and Spears (2011) stated, “The most successful servant leaders are those who have become skilled empathetic listeners” (p. 11).

Healing

A servant leader should first have an understanding of personal health, institutional health, or both. Greenleaf was a lifelong mediator (Crippen, 2005). Crippen viewed the action of mediation as a service because one is taking time to think about things and to reflect. Schinkel, van Dierendonck, and Anderson (2004) observed that feedback defined as a given response to an action or situation entails two functions: providing information on the particular situation and regulating a person’s behavior. It might be assumed that feedback about selection processes such as reviewer comments on a declined grant application lead rejected applicants to feel less negative about themselves and the organization than if no explanation were offered. They continued, “However, prudence in this matter is called for. In a meta analysis of feedback studies in a diversity of research fields, researchers stress the fact that feedback has highly variable instead of merely positive effects” (p. 198). A servant leader will understand that the detailed disclosure of data to rejected applicants may risk their self-esteem.

Awareness

Crippen (2005) and Ferch and Spears (2011) explained that the servant leader has a general awareness, especially self-awareness. Self-awareness strengthens the servant leader, and aids in the understanding of issues involving ethics and values. This quality is developed through self-reflection, listening, continually being open to learning, and forming a connection from what we know and believe to what we say or do. Greenleaf (2003) noted, “As awareness opens, one of the measures one takes of the contemporary society is the number of elaborate and seductive devices lurking about that serve no other purpose than to waste time” (p. 120). He further identified a popular illusion that one must reach a high-status position to achieve one’s goals. He maintained that, “Whatever your work is, make something out of it that enriches you” (p. 121). He asserted, “I know it is an old truism, but the only place to achieve one’s personal goals is where one is. Looking for a greener pasture for this purpose is almost certain to seal off the opportunity for achievement” (p. 120). He further considered that a sense of unity, a pulling together of all aspects of life including, job, family, recreation, church, and community, all unite into one total pattern.


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Persuasion

Rather than coerce compliance, a servant leader seeks to convince. Greenleaf (1996) wrote:

One is persuaded upon arriving at a feeling of rightness about a belief or action through one’s own intuitive sense, persuasion is usually too undramatic to be newsworthy. . . . Significant instances of persuasion may be known to only one or a few, and they are rarely noted in history. Simply put, consensus is a method of using persuasion in a group. (p. 136)

Ferch and Spears (2011) stated, “This particular element offers one of the clearest distinctions between the traditional authoritarian model and that of servant-leadership. The servant leader is effective at building consensus within groups” (p. 12). Greenleaf (2003) insisted that, “Either you persuade them or you coerce them” (p. 148).

Conceptualization

Servant leaders seek to nurture their own abilities to dream great dreams (Ferch & Spears, 2011). Managers who wish to be servant leaders must stretch their thinking to a broader-based conceptual thinking. Ferch and Spears noted that “Servant leaders are called to seek a delicate balance between conceptual thinking and a day-to-day focused approach” (p. 12). Greenleaf (1991) stressed that “The ability to see the whole in the perspective of history -- past and future -- to state and adjust goals, to evaluate, to analyze, to foresee contingencies a long way ahead” (p. 217). Through this idea of conceptualization, the leader is going out ahead to show the way as a persuader and relation builder.

Foresight

Greenleaf (1977) suggested that foresight is the ability to foresee or know the likely outcome of a situation, the “‘lead’ that the leader has” (p. 40). He further observed:

Foresight is seen as a wholly rational process, the product of a constantly running internal computer that deals with intersecting series and random inputs and is vastly more complicated than anything technology has yet produced. Foresight means regarding the events of the instant moment and constantly comparing them with a series of projections made in the past and at the same time projecting future events with diminishing certainty as projected time runs out into the indefinite future. (p. 39)

Ferch and Spears (2011) described foresight: “One knows it when one sees it. Foresight is a characteristic that enables the servant leader to understand the lessons from the past, the realities of the present, and the likely consequences of a decision in the future” (p. 13). They indicated that foresight is also deeply rooted within the intuitive mind and concluded that this might be a trait with which servant leaders are born.


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Stewardship

Greenleaf (2003) observed:

We believe work exists as much for the enrichment of the life of the person who so does it as for the service of the person who receives the benefit of it or the reward to the investors who put up the money to do it. (p. 168)

He continued, “This attitude leads us to make a great effort to organize all of our work so that teams of individuals can have discrete parts of it” (p. 170). He further stated, “In truth, we are able to maintain our level of ethical practice, imperfect as we admit it is, only because . . . we refuse to pay off.” Servant leaders play a significant role in holding their institution or organization in trust by caring for the well being of the institution and serving the needs of those in the organization (Ferch & Spears, 2011). Further, servant-leadership presupposes a commitment to serving the needs of others and highlights openness and persuasion. Block (1993) suggested that stewardship is accountability without control or compliance.

Commitment to the Growth of People

De Pree (1989) noted that the sign of outstanding leadership appears primarily among the followers. He asked, “Are the followers reaching their potential? Are they learning? Serving?” (p.12-13). Greenleaf (1977) suggested that when we accept the human condition, its sufferings and its joys, we will “work with its imperfections as the foundation upon which the individual will build wholeness through adventurous creative achievement” (p. 26). Greenleaf (2003) stated, “I have to say that we can operate as we do in the present climate only so long as our people do more for us than other companies people do for them” (p. 171).

Building Community

The servant leader seeks to identify some means for building a community of followers. Three concepts often referred to in the literature include giving back through service to the community, investing financially into the community, and caring about one’s community (Sergiovanni, 1994). The servant leader seeks to identify means for generating community among those who are within a given institution. Greenleaf wrote:

All that is needed to rebuild community as a viable life form for large numbers of people is for enough servant leaders to show the way, not by mass movements, but by each servant leader demonstrating his own unlimited liability for a quite specific community-related group. (as cited in Ferch and Spears, 2011, p. 14)

Ferland and Richie (2010) explained that inspiring a shared vision for the institution is part of being a leader, as is mentoring one’s employees and coaching them in their development as research administrators. Equally important are providing opportunities to grow, both personally and professionally, and celebrating success along the way. Ferland and Richie stated, “These are all what we used to call the ‘soft skills’ of management, but nothing proves to be harder” (p. 19).


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Servant-Leadership and Research Administrators

Anacharsis’ (2008) views oppose those of Streharsky (1991) and Southwick (2006). He stated that sponsored research office leaders, “do not often seek replenishment, which is an extremely important aspect of leadership” (p. 12). Further:

The difficulty comes in accomplishing these higher order tasks when we are so hurried and harried by our daily grind that we lack the mental and emotional energy to practice leadership behaviors we know are appropriate. Because we [sponsored research leaders lack this reserve of positive energy, we sometimes fail to make allowances for the stress-related behavior of our colleagues, to rise above the fray in a heated meeting, or to lead calmly and efficiently under time pressure. (p. 12)

As Anacharsis (2008) pointed out, this flaw can be detrimental to an inappropriately staffed sponsored research office. He stated that the leadership within that office often must “seek, create, and move their staff toward a larger vision or mission” (p. 12). Shields and Mills (2008) argued that the personality and overall stress of research administrators, the people in a sponsored research office “can be difficult” (p. 14).

In a study by Shambrook and Brawman-Mintzer (2006) of 624 research administrators, 41.3% perceived their levels of work-related stress as high. The authors explained, “Research administrators endorse working in a high-stress environment, often feel under-appreciated for their contributions, fail to maintain a healthy lifestyle, and often feel they have neglected other important aspects of their lives in deference to the demands of work” (p. 1). In addition:

Sixty-percent reported having inadequate resources to complete their job in a forty-hour workweek. When asked why they continue to work in research administration, the prevalent responses were the challenge, variety of tasks, working with intelligent colleagues, job security, and feeling a sense of purpose. (p. 1)

Shambrook and Brawman-Mintzer (2006) further emphasized the servant-leadership of research administrators: “It is interesting to note that according to qualitative data from this study, participants reported that improving the health and quality of life of others is the primary motivator for staying in this field” (p. 2). McClellan (2008) wrote, ”These pressures, which are amplified by the ‘unlimited liability’ of those who truly strive to serve others, likely combine with the inherent stressors of leadership to create uniquely stressful challenges for servant leaders” (p. 21).

Shields and Mills (2008) suggested, “Leaders influence the environment with which they lead. Their actions communicate their personal values and their vision for the organization. Leaders follow their ‘Voice’ as which is closely related to their own personal values” (p. 14). They further held that leaders affect behavior: “Leaders who model negative


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behaviors are setting an unhealthy example and may cultivate bad behavior in others, thus creating an environment in which difficult people thrive and congenial people become difficult” (p. 14). Shields and Mills observed the importance of sponsored research office leadership as good communicators who understand themselves as well as the various “types of situations and personalities that trigger bad behaviors” (p. 15).

Kouzes and Posner (1993) argued that servant leaders do not seek the attention of people; they give it to others. Servant leaders, they observed, “do not focus on satisfying their own aims and desires; they look for a way to respond to the needs and interest of their constituents” (p. 185).

Porter (2007) advanced the idea that research administrators support faculty to make the adjustment from academic writing to grant writing. Research administrators lead this transformation for faculty behind the scenes by acting as editors and preparing the faculty for the proposal review. Porter emphasized:

Grant reviewers are impatient readers. Busy people with limited time, they look for any excuse to stop reading. Reviewers are irritated if it takes great effort to understand the writing. Worse, if the proposal does not intrigue them by the very first page, they will not read any further (unless they must submit a written critique, in which case they immediately start looking for reasons to justify why the proposal should not be funded). (p. 164)

Research administrators are trained to develop interesting proposal submissions and assist faculty in the transition from academic writing to grant writing. Porter described the characteristics reviewers believe make up good grant writing:

Senior reviewers put qualities such as “clear” and “concise” at the top of the list. Brevity is not only the soul of wit; it is the essence of grantsmanship. Or to cite Mies van der Rohe’s famous dictum about modern architecture: “Less is more.” (pp. 164-165)

Porter clarified the notion that proposals are awarded based on the merit of the project, program, or research: “While no amount of editorial polishing can save a weak idea, a seasoned grant writer can add value to a sound concept by judicious editing” (p. 166). Editing is labor intensive and must be done with communication skills that do not offend the writer. Once a faculty member understands the simpler, livelier style of grant writing, the need for personal attention drops off rapidly (p. 166).

Growth of Faculty, Wiser and Freer

Research administrators acting as servant leaders are skilled at teaching faculty and potential principal investigators. Porter (2007) explained, “Research administrators are skillful at expressing to highly educated folk, who are justly proud of their intellectual achievements, the transition from academic to grant writing for successful proposals” (p. 166).


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Proactive and tactful research administrators lead the faculty in the transition from academic writing to good proposal writing habits. Porter listed strategies of successful sponsored research offices:

1) Home-grown workshops.2) Reading successful proposals.3) Editing by a grants specialist.4) Own institution red-team reviews.5) Writing tips.

Porter noted that, for young faculty and others new to grant writing, on-campus workshops are an effective way to teach grant proposal techniques.

Sponsored research offices can call on the use of experienced faculty, principal investigators, and research administrators to teach the workshops. Porter (2007) suggested that basic grant workshops be offered on a regular basis, with funding agency workshops scattered in the schedule. His second suggestion, reading successful proposals, provides examples to investigators of the difference in writing styles between academic and grant writing. Third, a research administrator should edit proposals with a view toward teaching the faculty grant-writing skills. Eventually the time dedicated to editing can diminish. Fourth, Porter’s red-team review brings together respected faculty to participate in the review and editing of multidisciplinary proposals. Once the red-team provides input, the review is used to unify the goals of the proposal into one voice. Finally, Porter suggested posting writing tips on the sponsored research office website. He recommended demonstrating the characteristics of a good grant proposal by contrasting a poorly written proposal with effective revisions.

Research Administrators as Servant Leaders

Within the sponsored research office are research administrators perceived as servant leaders by their own membership organizations. This perception is influenced by survey results focusing on character. Parolini (2004) suggested that, “Servant leaders are defined by their ability to bring integrity, humility, and servanthood into caring for, empowering, and developing others in carrying out the tasks and processes of visioning, goal setting, leading, modeling, team building, and shared-decision making” (p. 9). These research administrators serve and lead the external funding activities at predominately undergraduate institutions (PUIs). Vargas and Hanlon (2007) described the primary goals of research administrators “to both serve and lead our researchers (faculty), while still keeping in mind our responsibilities to our institutions, sponsors, and community” (p. 45).


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DiscussionTable 1 describes a sampling of other options for leadership theories. These other

theories might suit a particular research administrator and his or her institution. When given a choice, this author selects servant leaders to work in her research office. The multitude of tasks required today in a sponsored research office is far beyond those of even 10 years ago. The research administrator’s toolbox has expanded from one tool to an entire shop of peg-boards with tools handy for a moment’s notice. “If the future is going to be different, we have to go far beyond these little piecemeal gestures and begin to see the systems in which we’re embedded” (Senge, Scharmer, Jaworski, & Flowers, 2004, p. 24).

Introspection is important to determining your leadership style. How do you determine if you are a servant leader? Do you have what it takes to be one? Are you one

Leadership Theories Weaknesses: Weaknesses: Personal Reaction

Path-Goal Theory

Using a Path-Goal Theory approach to leadership has several positive features. Firstly, this theory attempts to incorporate the motivation principles of the expectancy theory and second its model is practical and easy to use.

Although there are several positive aspects of Path-Goal Theory, it fails to explain the different roles of leaders and managers. The time constraints to effectively deploy are very narrow.

Although in an attempt to clearly visualize the vision, I sometimes get caught up in the overall progress and save little time to consider the individual.

Situational Theory

Situational leadership provides a straightforward approach and is easily used. Another strength of this approach, is the fact that it teaches leaders flexibility.

Situational leadership has been criticized for several reasons, one the lack of evidence in its reliability. Second, it does not fully address interaction of groups verse individuals.

The situational approach has flexibility and allows leaders to place individuals into a workflow where they will accomplish the most, or be most productive.

Trans-formational Theory

Transformational leadership theory provides a broader view of leadership; it places a strong emphasis on followers’ needs, values, and morals.

Some suggest that this approach treats leadership as a personality trait rather that a behavior. It is also unclear as to whether or not this leader is a visionary.

I am able to communicate the positive and the negatives about implementing new technologies. I offer to staff the reasons why we need to change and how it will affect them.

StyleApproach

Style approach helps leaders distinguish when they need to be task orientated and when the need to be relationship orientated. What is the task and who is best fit to complete it, or what needs to be done and how to approach it.

Style approach suggests that most effective leadership styles are high-high style (i.e., high task, and high relationship).

Style approach has good qualities, and it is important to understand you type of leadership styles, I have often looked back at a situation the needed a direct and quick action to be taken. There was no time for input just action and a direct order from me.

TraitApproach

Trait approach gives us the ability to understand traits about leaders, if they obtain qualities like intelligence, self-confidence, determination, integrity, and sociability. Focuses more on the leader rather than the follower.

Although there are perks to understanding one’s traits, how does it measure up to understanding the situation or task at hand? There has been no research conducted on outcomes and trait approach employment.

I believe that traits and personality have much to do with a leaders ability to lead, and also feel that understanding oneself will help when employing other leadership theories.

Table 1: Leadership Theories


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Figure 1: Moving through the U.

already and didn’t have a name for it? Maybe another leadership theory from the chart below suits your style. To discover more about yourself, in this busy world, it is important to take some time to reflect upon how you manage your staff, the faculty, researchers, program officers, and your institution’s administration. Determine how you react to stress and what drives you. Are these reactions or proactive choices? Authentically speaking, are you the same at home as you are in the office? Otto Scharmer (2009) invited us to discover our personal authentic leadership.

Theory U is one possibility for discovering your authentic leadership style or even a use as a style. This article is not the place to delve into the theory but a brief discussion is warranted. The Theory U process is pictured in figure 1. In Theory U there are three spaces: awareness, stopping, and calmness, which connect you to present reality, the essence of sensing, and moving down the U. Senge et al. (2004) suggested that the bottom of the U is a “place of true stillness” (p. 189). To arrive at the stillness you enter the U through the first movement, the “way in.” The second movement Senge et al. referred to as the return. This movement is about returning to an individual’s normal levels of activity with new awareness and without losing the presence of the deepest point of awareness. This is much like redirecting, or re-orienting our attention to the flow of process behind whatever is immediately visible.

By exploring a new territory of personal leadership, moving through the U, Scharmer (2009) suggested that we can learn to connect to our originating self. For an individual a typical response occurs right after an action. Through discovering your leadership style, take a moment to observe, reflect, and then act. Through this process pay attention to what is driving your responses and then see if you can determine your leadership strengths. Can servant leadership be taught? Maybe through crisis but more than likely servant leadership is an intrinsic growth of relationships.


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van Dierendonck, D. & Nuijten, I. (2010). The servant leadership survey: Development and validation of a multidimensional measure. Journal of Business and Psychology. Retrieved from http://ahraindustrynews.wordpress.com/ 2011/01/27/the-servant-leadership-survey/.

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Grant Development for Large Scale Research Proposals: An Overview and Case Study

Ira S. GoodmanAssociate Director for Administration

Moores Cancer CenterUniversity of California, San Diego

3855 Health Sciences DriveLa Jolla, California 92093


Author’s NoteThe opinions and conclusions in this paper are those of the author and do not reflect the policies or position of the Moores Cancer Center or the University of California San Diego (UCSD). Appreciation is expressed to the highly skilled Moores Cancer Center administrative team participating in the grant development process.

AbstractWith some NIH pay lines running at or below the 10th percentile, and funding becoming scarce for large science grants, new approaches are necessary to secure large interdisciplinary grant awards. The UCSD Moores Cancer Center has developed a team approach, starting with the identification of a competitive opportunity and progressing to the designation of a project team of faculty and administrators through to the submission of a finely tuned product. An important aspect of this approach is that scientists and administrators are on an equal footing, bringing to the table unique skill sets and experience critical to the process. While every application will not be successful, the effort will not fail from an apparent absence of expertise, diligence, or awareness. Grant development will be a more critical area of research administration as competition for limited funds increases.

Keywords: interdisciplinary, grant development, research administration

IntroductionThe NIH, with a 2010 budget of $31 billion, receives nearly 80,000 applications

for support each year. Eighteen-thousand external scientists are recruited annually as reviewers of those applications to ensure the funds are invested in the highest quality research and training. As anyone in biomedical research can attest, applying for an NIH grant is increasingly dependent on professional grantsmanship. Awards are made to the most meritorious scientists and projects, following a rigorous review. This competition demands that substantially more and varied skills be applied to application preparation. While no organization could afford personal professional assistance on every application, a growing


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number of research institutes are investing in grant development offices to support new investigators and large scale grant efforts in the over $5 million range. This strategy is paying dividends at the Moores UCSD Cancer Center.

Large-scale projects were one immediate result of the National Cancer Act signed by President Nixon on December 23, 1971. The new law provided for unique authorities of the National Cancer Institute (NCI) director, and a $100 million increase in the 1972 NCI budget, followed by similar proposed increases in the ensuing years; the creation of National Cancer Research and Demonstration Centers, originally called national cancer centers and now referred to as NCI-designated cancer centers (with an initial ceiling of $5 million per center); large construction, training and contracted research programs to foster new approaches and resources in the war on cancer. It was not unusual to hire proposal writers and management consultants to coordinate the design and assembly of these formative grant proposals that would generate the centers of interdisciplinary cancer research and care envisioned in the legislation. Program project grant (PPG) applications, with their many scientific leaders, generally have been formulated by a senior investigator and assembled with the assistance of a central grants office, the principal investigator’s (PI’s) staff and perhaps his or her department’s administrative office.

PPGs at the NCI and the NIH have an erratic history. As far back as the 1979-80 budget year, then Department of Health, Education and Welfare (HEW) Secretary Joseph Califano expressed concern over the future of federal support for biomedical research. He called for a stabilization plan for research funding agencies of HEW. The Plan was summarized in a 1985 Institute of Medicine background report entitled Stabilizing the Funding of NIH and ADAMHA Research Project Grants, authored by Richard L. Seggel. Among Califano’s concerns was the growth of centers and large-scale projects. There was a two-fold dilemma: these grants were consuming an ever larger proportion of the budget and simultaneously driving down the success rate of other types of grant proposals. In 1993, Broder (then NCI director) and Cushing wrote about the support of research project grants (RPG) versus PPGs. This was at a time when NIH was seeking to maximize the number of awards it was making against its budget, ostensibly subordinating large-scale grants in favor of lower cost RPGs. While the number of PPGs awarded was fairly stable, the authors pointed out that PPGs have a high success rate, even if their funding didn’t result in the requested or recommended levels. In the 1990s, PPG applicants had a 57% rate of success in obtaining funding. In contrast, competing R01 applicants were successful only 31% of the time. The success rate for PPGs from 1987 to 1992 ran about 20 points higher than the R01 rate. Thus, the PPG was an attractive opportunity for senior investigators. However, with the budget difficulties of the 1990s, new program-type grants were not heavily marketed by the NIH.

Fast forward to the 21st century. The NIH appears to have a renewed interest in the solicitation and funding of program-type grants, perhaps as a result of a doubling in budget, although more recently that growth has diminished considerably. The Congressional Research Service of the Library of Medicine submitted a report to Congress in 2006 which stated that the NIH appropriation from 2003 to 2006 has shifted from marked


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growth to low or no increases. Congress doubled the budget in five years, from $13.6 billion in FY 1998 to $27.1 billion in FY 2003. Since then, growth has slowed to below the rate of inflation. The NIH issued more Requests for Applications (RFAs) and Program Announcements (PAs) in FY 2003 than in FY 1996 to highlight specific scientific areas. In FY 1996, NIH issued 99 RFAs; in FY 2003, 236 were issued. As a function of the total NIH appropriation, however, the number of RFAs peaked in FY 1999 at nearly 12 per $1 billion. In comparison to the annual increase in the NIH budget, the number of RFAs issued fell during the doubling period, reaching 62 per $1 billion of new money in FY 2003.

As an example, the NCI released RFA CA-00-001 “Interdisciplinary Research Teams for Molecular Target Assessment,” on November 10, 1999, with an application receipt date of March 15, 2000. Focusing on a fundamental topic in cancer research, the RFA stated that NCI sought teams to “discover, develop and validate the research tools that will make mechanism assessment in clinical trials and preclinical cancer models a reality.” The RFA used the U54, or Cooperative Agreement mechanism, an increasingly popular NCI tool for funding research, with NCI control somewhere between a grant and a contract that allowed the agency to more closely monitor the research without managing its performance. More recently, the NCI issued on June 30, 2009 Program Project grant (P01) policies in PAR-09-025. New guidelines covering letter of intent; requirement for NIH approval to submit an application at a financial threshold; electronic submission; multiple PIs, resource sharing plans and page limitations reinforce the need to provide more professional support to the grant application process.

The ApproachThe Moores Cancer Center Grant Development Office (GDO) was created in 2004

in recognition of the need to acquire large science-type grants around which to build new programs and attract the highest performing scientists. A doctoral level scientist was chosen as GDO manager based on her previous biomedical research experience, oncology degree and interest in grant development. Administrative support staff were provided by the principal investigator’s team and the Cancer Center’s administration.

While this paper explores one approach to specialized grant development, it also acknowledges three alternatives.

The “do-it-yourself ” approach is perhaps the most traditional. Many senior investigators have experience with large grant applications and can navigate their preparation with minimal support from their department’s administrative staff, including budgeting, biosketch collection/preparation, environment and resources sections.

A second approach is the use of a central facility accustomed to participating in large programs; the grants office is one example, biostatistics another. Biostatisticians serve the dual role of sharpening the research methodology while also helping to organize the data and format the proposal. The Grants Office may establish departmental or offsite bases.


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Mason and Learned (2006) reported that emerging trends are to create satellite offices or new positions within the existing office to offer various support services required in the development process. Functions of these offices could include providing grant writing and professional expertise to attract federal and state funding, or providing expertise in technology transfer and intellectual property, primarily for faculty and staff in transferring basic research to the marketplace.

Grant development is also available through commercial firms that specialize in grant opportunities, sponsor identification, grant writing, and grantsmanship. As the need for professional grant development staff grows, so too does the field, with grant consultants making up another source of assistance.

The option of choice depends on the size of the organization, the number of large grants being submitted, the ongoing need for familiarity with the program setting, technical language of the RFA and application narrative and grant assembly team members, and, finally, the funds available to support grant development.

The ExperienceToday, grant development cannot be the province of a single individual or even

a single office. When grants of $5 million to $50 million are at stake, a concerted effort is required. But the use of the GDO is not determined by the grant budget alone. The GDO has been the “assembly plant” for cancer-related proposals generally fitting the following characteristics: NIH grants coded U or P; greater than 3 projects and greater than 3 cores; collaborators from more than 4 academic departments or schools of UCSD. Most are first time proposals in new technologies in response to funding opportunities.

Because the GDO is small, its deployment is limited to multidisciplinary, Cancer Center-wide proposals of high interest, competitiveness, priority and impact -- program and center grants that would further the Center’s scientific mission, direction, programmatic themes, and translation of research to patient-benefit.

Over the past four years the GDO participated in approximately 20 Cancer Center grant applications, pursuing support for centers of academic/industry partnerships in new therapeutics, nanotechnology, systems and integrative biology, training in drug development, molecular and cellular imaging; chemical biology consortium; cancer center/minority institution partnerships addressing cancer disparities; K12 in oncology clinical research training; physical science oncology center, and multiple shared instrumentation grants. Each of these initiatives was considered to be of both high priority and high impact. On average, the GDO is involved in 4-6 applications each year.

The process starts with the identification of a competitive opportunity by a Cancer Center senior leader, the prospective principal investigator, the GDO or another source. The opportunity is carefully vetted through various Cancer Center sources to determine


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relevance to strategic goals, available resources and expertise, potential competition, principal investigator credentials, and institutional commitment. While not identical for every project, a general approach is taken once the decision is made to submit an application for a large scale grant.

The Project TeamFirst, an application project team is assembled. The team is led by the Principal

Investigator (PI) and the Cancer Center administrator or GDO. The GDO is instrumental in coordinating the entire effort. The team is joined by budget and editorial specialists, and administrative assistants. The PI may bring in other co-investigators or work with them outside of the project team. As Porter (2007) notes, good grant writing requires teamwork from the outset. Because their ultimate success depends upon nearly unanimous approval from a sizeable group of reviewers, grant writers place high value on feedback at every phase of proposal writing. Thus, there are two teams working in tandem on the application, a program or faculty team and a support or administrative team. The PI works with his or her scientific colleagues on constructing content, and the Application Project Team works on assembling the entire application, focusing on the agency proposal criteria, budget, environment and resources, regulatory, and other administrative requirements. Each member of the team has a functional responsibility aligned with his or her skill and knowledge:

Principal Investigator: Senior scientist and director of the program responsible for scientific content and planning, program organization and scientific leadership, budget allocation, and identification of required resources.

Senior Administrator: Experienced in grant coordination, NIH policy and RFA interpretation, administrative leadership of grant assembly, budget oversight, institutional resources and general grant conditions and requirements.

Grant Development Officer: Familiar with RFA requirements and grant assembly coordination; serves as liaison with funding agency and institutional grant and regulatory offices; primary communicator to grant participants; creates iteration numbering system to preempt incorrect or duplicative editing of same manuscript version; oversees grant compilation, collation and shipment.

Grant Editor: Reviews manuscripts for flow, sentence structure, syntax and style;

Budget Specialist: Works with PI to construct budget according to agency and institutional rules; prepares worksheets, summary tables and internal forms; constructs and prepares recharge rates for core facilities; coordinates budgets of program components and any external collaborators.

Administrative Assistant: Knows NIH and institutional forms; requests information and follows up; manages meeting schedule; records minutes and action items of meetings; requests signatures on grant forms and letters of support.


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Figure 1 below illustrates the grant process and flow from concept to completion.

Schedules

Once the decision was made to prepare a grant application, a Letter of Intent was submitted to the agency as required. The earlier the effort is launched, the more time is available to plan and prepare. A large scale effort requires a timeline of at least four months. Committees may then be created and a meeting schedule proposed. A critical component of the initial meetings is to draft a preparation timeline, including additional time to address last minute, unforeseen corrections/additions.

Meetings

A strict meeting schedule will help keep things on track. The meetings, either weekly or bi-weekly, require a quorum, an agenda and recording of action items. They also need a leader to keep the meetings on track, as there is usually more to cover than time allows. Shared leadership could be an effective alternative process as described by Easterly (2008). There may be two meetings. In one, the PI and a small group of colleagues join the administrative group; in the other, scientists and administrators meet separately, with integration of respective sections occurring outside of the meetings.

Manuscript Review

Of the many aspects of application assembly, the most problem prone is successive manuscript review. With multiple parties reading and editing the manuscripts it is important to develop a system to: 1) track changes (e.g., Microsoft Word Track Changes), and 2) avoid simultaneous review of each version by multiple parties. One individual needs to assume responsibility for controlling the flow of manuscripts. The GDO’s approach was to update the version number each time it was distributed for review. Manuscript review should be a scheduled task, with each draft conforming to submission, review, and editing deadlines. Matching reviewer expertise to specific functions is important. Among the areas to be considered are text content and accuracy (particularly figures), adherence to preparation guidelines, cross-referencing among sections, budget, and grammar. Regardless of expertise, any reviewer may raise questions regarding the text.

Figure 1. Large scale grant development process.


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Financial Aspects

While the budget may not be a determining factor in an award, a well-documented presentation of the amount, description and integration of the overall budget will raise the reviewers’ confidence that the grant will be well managed. Therefore, budget development is an integral part of the grant preparation process, and starting as early as possible will help ensure the described work can be carried out within the proposed funding. Budget cuts are an all too common part of the current review and award process. Cutting it too close during budget preparation could engender major, if not fatal, study design modifications at the time of a potential award. A reasonable and realistic budget is the best approach. The budget specialist should get institutional approval of the final budget as early as possible.

Measures of Success

Recognizing up front that not every application will be successful is prudent and realistic. However, unfunded applications may still prove useful. Thus, unfunded doesn’t necessarily translate into unsuccessful. Indeed, every effort has a measure of success in the process alone. In our experience new grant development has been extraordinarily productive in establishing new collaborations; identifying new resources; creating new grant preparation procedures and systems, and building new centers of excellence that will seek other means of support. The GDO has witnessed consistent growth in knowledge, expertise and efficiency with every application submitted. The success rate of funded applications in which the GDO played a significant role is above 50%. Another measure of success is the innovation brought to the process by the MCC GDO. Table 1 presents a comparison of the conventional approach vs. the MCC GDO approach:

Conventional GDO

Interpretation of RFA solely with PI RFA interpretation shared between PI and GDO

PI manages the entire process GDO manages the entire process

PI works according to his/her schedule GDO prepares the grant assembly schedule

PI concerned with all aspect of proposal PI concerned with scientific aspects only

PI prepares budget GDO prepares budget

PI seeks help on administrative aspects GDO prepares administrative aspects

PI calls group meetings GDO calls meetings

PI invites selected staff to meetings GDO invites all relevant parties to meetings

PI corresponds directly with collaborators GDO corresponds with collaborators

PI seeks letters of support GDO seeks letters of support

Table 1: Comparison of PI and GDO Functions


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While these procedures are applied consistently in the large scale grant arena, many have made their way into smaller grant applications as well. However, given the size of the GDO, the services are more limited and selective for smaller grants.

ConclusionThis manuscript provides an historical overview of NCI program type grants and

a contemporary approach to the preparation of large grant applications, with the following practical steps for future implementation:

1) Identify a grant development professional to coordinate application development and assembly;

2) Create a scorecard measuring your group against the competition, assuming a high probability of success before launch;

3) Compile a working group of administrative specialists with specific assignments;

4) Create a preparation schedule and adhere to it as closely as possible;

5) Build a manuscript review system that precludes simultaneously editing successive versions of the narrative;

6) Integrate the budget into the preparation process early and continuously;

7) Promote egalitarianism and openness in meetings to optimize expertise;

8) Never lose sight of the deadline date and monitor progress accordingly.


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ReferencesSeggel, R. L. (1985) Stabilizing the funding of NIH and ADAMHA research program

grants: A background paper. Board on Health Sciences Policy, Institute of Medicine.

Broder, S. & Cushing, M.(1993) Trends in program project grant funding at the National Cancer Institute. Cancer Research, 53, 477-484.

Easterly, D. (2008) Women’s ways of collaboration: A case study in proposal development. The Journal of Research Administration, 39(1), 48-57.

Interdisciplinary research teams for molecular target assessment; Released November 10, 1999; Retrieved September 12, 2009 http://grants.nih.gov/grants/guide/rfa-files/rfa-ca-00-001.html

Mason, E. & Learned, L. (2006) The role of “development” in a research administration office. The Journal of Research Administration, 37(1), 23-34.

National Cancer Institute program project (P01) applications November 12, 2008; Retrieved September 12, 2009 http://grants.nih.gov/grants/guide/pa-files/PAR-09-025.html

Porter, R. (2007) Why academics have a hard time writing good grant proposals. The Journal of Research Administration, 38(2), 37-43.

RFA: CA-00-001 Interdisciplinary research teams for molecular target assessment. Release Date: November 10, 1999

CRS Report for Congress (Received through the CRS Web) The National Institutes of Health (NIH): Organization, funding, and congressional issues. October 19, 2006.


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Research Administrator Salary: Association with Education, Experience, Credentials and Gender

Jennifer Shambrook, PhDDirector, Grant & Contract Management Office

St. Jude Children’s Research Hospital262 Danny Thomas Place, Mail Stop 733

Memphis, TN, 38105-3678, USATel: (901) 595-6017Fax: (901) 595-5814


Thomas J. Roberts, EdDAssociate Vice President for Research

Florida Gulf Coast University10501 FGCU Blvd. South

Fort Myers, FL 33965-6565, USATel: (239) 590-7021Fax: (239) 590-7024


Robert Triscari, PhDAssistant Professor of Research and Evaluation

College of EducationFlorida Gulf Coast University

10501 FGCU Blvd. SouthFort Myers, FL 33965-6565, USA

Tel: (239) 590-7202Fax: (239) 590-7801


Authors’ NoteThe 2010 Research Administrators Stress Perception Survey (RASPerS) was conducted as a part of the dissertation research of the first author. These data were included in a poster presentation at the Society for Research Administrators, International Annual Meeting Symposium in Chicago, IL, in October 2010.

AbstractThe 2010 Research Administrators Stress Perception Survey (2010 RASPerS) collected data from 1,131 research administrators on salary, years experience, educational level, Certified Research Administrator (CRA) status, and gender. Using these data, comparisons were made to show how salary levels are associated with each of these variables. Using both descriptive


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and inferential statistics, salary levels were examined by creating numeric values. These data show that graduate degrees, five or more years experience, and male gender are positively associated with higher research administrator salaries, while CRA credentials, associate and bachelor degrees, and two to five years work experience are not.

Keywords: research administrators, salary, education, experience, CRA, credentials, gender, equity

IntroductionSenior research administrators (RAs) serving as mentors to up-and-coming RAs are

often asked: “What is more important when it comes to salary: a Masters degree or Certified Research Administrator (CRA) credentials?” The senior RA could give an opinion based upon his or her own experience or personal preferences, but no sound empirical data exist in peer-reviewed literature addressing RAs as an occupational group.

This paper reports on a study conducted to provide empirical data to the research administration community on the findings of the 2010 RASPerS concerning the association of salary level with educational achievement, years of experience, CRA credential status, and gender (Shambrook, 2010). To determine these associations, the following hypotheses were tested:

H1. Higher education achievement will be positively associated with higher income levels.H2. Greater years of experience will be positively associated with higher income levels.H3. Attainment of the CRA credential will be positively associated with higher

income levels.H4. Higher income levels will not be associated with gender.

LimitationsWhile the survey instrument allowed for participants to indicate “some college,” no

distinction was made between someone with three courses and someone with three years of college. Thus, it was not possible with existing data to determine if “some college” indicated more or less instruction than a two-year associates degree. Another limitation of the study was that no question asked whether the CRA credential was a requirement for employment in the participant’s present job. Both of these factors may be of interest for future studies in this area.

MethodsThe study protocol was given full board review and approval by the Institutional

Review Board (IRB) of Walden University. The corresponding author was a doctoral candidate at Walden University at the time of the survey. The study population consisted of members of the National Council of University Research Administrators (NCURA), specifically chosen because research administrators are an occupational group comprised of individuals who are college educated, computer literate, and fully capable of reading and understanding their rights as study participants (Roberts & House, 2006). The study was


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conducted as an internet-based, cross-sectional survey. An electronic consent form preceded the electronic survey. Study participants positively selected a radio button to indicate they had read and understood the form before they could access the survey.

An email invitation to participate in the 2010 RASPerS via SurveyMonkey© was sent to the entire NCURA membership of 6,840 during a 10-day period in February, 2010. There were 191 potential participants who had previously opted out of SurveyMonkey© email solicitations. Three hundred twenty-six email addresses were no longer valid. Thus, the final study population was 6,323. This meant that responses from at least 893 participants were needed to achieve a 99% confidence level with a confidence interval of four or less. As shown in the results below, over 1,100 responses were received for each factor being tested.

Five factors from the Demographic Information section of the 2010 RASPerS were used for this study. Salary served as the dependent variable. The independent variables were level of educational achievement, years of research administration experience, CRA credential status, and gender. Survey questions and possible responses are shown below:

1. What is your annual income as a research administrator?a. <$35,000b. $35,000 - $49,999c. $50,000 - $74,999d. $75,000 - $99,999e. >$100,000

2. What is the highest level of education you have completed?a. High School Diploma or G.E.D.b. Some college creditc. Associate degreed. Bachelors degreee. Masters degreef. Doctoral degree

3. How many full years have you worked in Research Administration?a. <1b. 1<5c. 5<10d. 10<20e. >20


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4. Have you received your certification from the Research Administration Certification Council as a CRA?

a. Yesb. No

5. What is your gender?a. Maleb. Female

To calculate means, salary level was re-coded as shown in Table 1 so that averages of the salaries could be computed. The data were analyzed using both descriptive and inferential statistical methods. Descriptive methods included frequencies, percentages, standard deviations and means. Inferential methods included one-way analysis of variance (ANOVA), and were followed with post hoc tests where the independent variable contained more than two levels and the initial ANOVA was significant. The experiment-wide alpha level was 0.05.

Table 1: Participants (N = 1,131) Stratified by Income Level to Calculate of Means for Testing Statistical Significance of Association between Groups.

Income Level Stratification for Calculation of Means

Stratification Level Frequency Percent Salary Level

Valid 1.00 29 2.6 >$35K

2.00 202 17.9 $35-49.9K

3.00 454 40.1 $50-74.9K

4.00 243 21.5 $75-99.9K

5.00 203 17.9 >$100K

Total 1,131 100.0

ResultsParticipant responses were 1,131 for salary, education, experience and credentials.

Five participants did not indicate gender, thus gender data are analyzed with an N of 1,126. Table 2 shows the frequency and percentages for each factor group (education, experience, credentials or gender) in each income group. Percentages for each annual income group were: 2.56%, less than $35,000; 17.86%, at least $35,000, but less than $50,000; 40.14%, at least $50,000, but less than $75,000; 21.49%, at least $75,000, but less than $100,000; and 17.95% at least $100,000. The modal income group was $50,000 - $74,999, as shown in Table 2 and described by Shambrook & Roberts (2011). Descriptive information is given for each factor group below as each hypothesis is discussed.


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Number and percentage of each educational group in each income group

Education < $35K $35-49.9K $50-74.9K $75-99.9K > $100K Total HS or GED 0 1 4 1 1 7

% HS or GED 0.00% 14.29% 57.14% 14.29% 14.29% 0.62% Some College 4 19 48 11 7 89

% Some College 4.49% 21.35% 53.93% 12.36% 7.87% 7.87% Associates 2 13 11 3 2 31

% Associates 6.45% 41.94% 35.48% 9.68% 6.45% 2.74% BA 17 109 189 94 60 469

% BA 3.62% 23.24% 40.30% 20.04% 12.79% 41.47% MS 6 57 170 110 79 422

% MS 1.42% 13.51% 40.28% 26.07% 18.72% 37.31% Doctoral 0 3 32 24 54 113

% Doctoral 0.00% 2.65% 28.32% 21.24% 47.79% 11.76% Total N 29 202 454 243 203 1131 Total % 2.56% 17.86% 40.14% 21.49% 17.95% 100.0%

Number and percentage of each experience group in each income group

Yrs RA Experience < $35K $35-49.9K $50-74.9K $75-99.9K > $100K Total <1 1 12 9 2 2 26

%<1 3.85% 46.15% 34.62% 7.69% 7.69% 2.30% 1<5 17 107 120 26 14 284

% 1<5 5.99% 37.68% 42.25% 9.15% 4.93% 25.11% 5<10 6 54 140 60 38 298

% 5<10 2.01% 18.12% 46.98% 20.13% 12.75% 26.35% 10<20 4 28 139 99 80 350

% 10<20 1.14% 8.00% 39.71% 28.29% 22.86% 30.95% > 20 1 1 46 56 69 173

% >20 0.58% 0.58% 26.59% 32.37% 39.88% 15.30% Total N 29 202 454 243 203 1131 Total % 2.56% 17.86% 40.14% 21.49% 17.95% 100.0%

Number and percentage of each CRA credential status group in each income group

CRA Credential < $35K $35-49.9K $50-74.9K $75-99.9K > $100K Total CRA 3 23 66 37 32 161

% CRA 1.86% 14.29% 40.99% 22.98% 19.88% 14.24% non-CRA 26 179 388 206 171 970

% non-CRA 2.68% 18.45% 40.00% 21.24% 17.63% 85.76% Total N 29 202 454 243 203 1131 Total % 2.56% 17.86% 40.14% 21.49% 17.95% 100.0%

Number and percentage of each gender group in each income group

Gender < $35K $35-49.9K $50-74.9K $75-99.9K > $100K Total Male 2 27 77 51 65 222

% Male 0.90% 12.16% 34.68% 22.97% 29.28% 19.72% Female 27 174 375 192 136 904

% Female 2.99% 19.25% 41.48% 21.24% 15.04% 80.28% Total N 29 201 452 243 201 1126 Total % 2.58% 17.85% 40.14% 21.58% 17.85% 100.0%

Table 2: Frequency Distribution of Each Group Sorted by Income Level.


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Education

H1. Higher education achievement will be positively associated with higher income levels.

Educational achievement for participants (N = 1,131) was reported as 7 (less than 1%) with a high school diploma or G.E.D.; 89 (7.87%) with some college; 31 (2.74%) with an associates degree; 469 (41.47%) with a bachelors degree; 422 (37.31%) with a masters degree; and 133 (11.76%) with a doctoral degree. The means were calculated for each educational achievement level. Table 3 shows the income level means for each educational achievement level group. Since the overall ANOVA were significant, post hoc tests were computed. Table 4 shows the level of significance indicated by the post hoc tests when comparing each group with other groups.

The high school or G.E.D. group appears to be an anomaly, as it did not show a difference to any group. This could be due to the small N (7) for this group, or to a higher level of experience. Upon further examination of the raw data, it was found that five of the seven respondents had over 20 years of experience; one had over 10. The respondent who had less than 10 years of experience earns less than $50,000 per year.

Tables 3 and 4 show that the means do not support a significant difference in income levels between participants with associates, some college or bachelors degrees. Participants with bachelors degrees have mean income levels slightly higher than those with some college or associates degrees, but the difference is not statistically significant. Income levels are significantly higher when comparing the masters degree groups and the lower level of achievement groups, with the exception of the high school and G.E.D. group. Those with doctoral degrees have significantly higher levels of income than those with masters degrees.

The results show that those with a masters or doctoral degree will have higher levels of income than those with lower levels of educational achievement. The exception to this is for those with lower levels of educational achievement and over 20 years of research administration experience. The results support H1 -- higher educational achievement is associated with higher salaries with respect to masters and doctoral degrees, but does not support H1 with respect to associates or bachelors degrees.

Table 3: Level of Education Frequency, Mean Stratified Income Level, and Standard Deviation for Each Group

Level of Education

Frequency(N=1,131)

Mean Income Level

Standard Deviation

HS/GED 7 3.286 0.9512

Some College 89 2.978 0.9167

Associates 31 2.677 0.9794

Bachelors 469 3.151 1.0338

Masters 422 3.472 0.9906

Doctoral 113 4.142 0.9245


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Figure 1. Education.

Table 4: Post Hoc Comparisons for Educational Achievement Groups.

Tukey-Kramer Multiple Comparisons Test

Comparisons of levels of education Difference p Value Significance

HS/GED vs Some College 0.3082 p>0.05 None

HS/GED vs Associates 0.6083 p>0.05 None

HS/GED vs Bachelors 0.1343 p>0.05 None

HS/GED vs Masters -0.1859 p>0.05 None

HS/GED vs Doctoral -0.8559 p>0.05 None

Some College vs Associates 0.3001 p>0.05 None

Some College vs Bachelors -0.1739 p>0.05 None

Some College vs Masters 0.4941 p<0.001 Significant

Some College vs Doctoral -1.1640 p<0.001 Significant

Associates vs Bachelors -0.4740 p>0.05 None

Associates vs Masters -0.7942 p<0.001 Significant

Associates vs Doctoral -1.4640 p<0.001 Significant

Bachelors vs Masters 0.3202 p<0.001 Significant

Bachelors vs Doctoral 0.9902 p<0.001 Significant

Masters vs Doctoral 0.6700 p<0.001 Significant

Figure 1. Education.


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Experience

H2. Greater years of experience will be positively associated with higher income levels.

Years of experience for participants (N = 1,131) was reported as 26 (2.30%) with less than one year; 284 (25.11%) with at least one year but less than five years; 298 (26.35%) with at least five years but less than 10 years; 350 (30.95%) with at least 10 years but less than 20 years; and 173 (15.30%) with over 20 years of experience. The means calculated for each years-of-experience group are shown in Table 5. Since the overall ANOVA were significant, post hoc tests were computed. Table 6 shows the level of significance indicated by the post hoc tests when comparing each group with other groups.

Table 5 shows that the mean income level increases with increased years of experience. The ANOVA conducted in Table 6 shows no significance when comparing those with less than one year of experience with those with more than one, but less than five years of experience. The income level mean is greater for the group with more experience, but not significantly. There is a significant difference between the income levels of those with less than one year of experience and those with more than five years of experience. When comparing those with less than one year of experience with those with over 10 years of experience, the level is highly significant. For all other comparisons between groups, the difference in income level is highly significant, and there is a strong association between level of experience and level of salary.

Figure 2 shows the percentage of each years of experience group that is in each income group. Lower income category percentages decrease as years of experience increase and higher income category percentages increase as years of experience increase.

The results show that those with a higher level of experience have a higher level of salary. Thus, the data support H2, in that greater years of experience will be positively associated with higher levels of income.

Table 5: Years of Experience Frequency, Mean Stratified Income Level, and Standard Deviation for Each Group.

Years of experience

Frequency(N=1,126)

Mean Income Level

Standard Deviation

<1 26 2.6923 0.97033

1<5 281 2.6940 0.90570

5<10 298 3.2349 0.95972

10<20 350 3.6371 0.95892

<20 171 4.0936 1.04634


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Figure 2. Experience.

Table 6: Post Hoc Comparisons for Years-of-Experience Groups.

Tukey-Kramer Multiple Comparisons Test

Comparison of years of experience Difference p Value Significance

<1 vs 1<5 -0.00170 >0.05 None

<1 vs 5<10 -0.54260 >0.05 Significant

<1 vs 10<20 -0.94480 <0.001 Significant

<1 vs >20 -1.40100 <0.001 Significant

1<5 vs 5<10 -0.54090 <0.001 Significant

1<5 vs 10<20 -0.94310 <0.001 Significant

1<5 vs >20 -1.40000 <0.001 Significant

5<10 vs 10<20 -0.40220 <0.001 Significant

5<10 vs >20 -0.85870 <0.001 Significant

10<20 vs >20 -0.45650 <0.001 Significant

Figure 2. Experience.


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Certified Research Administrator (CRA) Credential

H3. Attainment of the CRA credential will be positively associated with higher income levels.

CRA credential status was reported by participants (N = 1,131), with 970 (85.76%) reporting they did not have the CRA credential and 161 (14.24%) reported they did have the CRA credential. The income level means were calculated for each group and are shown in Table 7. The mean for those without the CRA is 3.33, and 3.45 for those with the CRA. While the mean for those with the CRA credential is slightly higher, the tests for between-subject effects, shown in Table 8, indicate there is no statistically significant difference in the income levels for those with and those without the CRA credential.

Table 7: CRA Credentials Frequency, Mean Stratified Income Level, and Standard Deviation.

Descriptive Statistics: Credentials

Dependent Variable: Income Level

Have you received your certification from the Research Administration Certification Council as a CRA?

Mean Standard Deviation

N

Response No 3.3268 1.05053 970

Yes 3.4472 1.02409 161

Total 3.3439 1.04721 1131

Figure 3. Credentials.

Figure 3. Credentials.

Tests of Between-Subjects Effects: Credentials


Source Type III Sum of Squares df Mean Square F Sig.

Corrected Model 2.002a 1 2.002 1.827 .177

Intercept 6336.166 1 6336.166 5782.013 .000

Have you received your CRA? 2.002 1 2.002 1.827 .177

Error 1237.204 1129 1.096

Total 13886.000 1131

Corrected Total 1239.206 1130

a. R Squared = .002 (Adjusted R Squared = .001)

Table 8: Analysis of Variance for Between-Subject Effects for Credentials.


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Figure 3 shows the percentage of each CRA credential status group that is in each income group. As shown in Figure 3, the two groups are very similar, with no remarkable difference between those with or without CRA credentials.

The results show that there is no statistically significant difference between the income levels of those with or without CRA credentials. Thus, the data do not support H3, that CRA credentials will be associated with higher income levels.

Gender

H4. Higher income levels will not be associated with gender.

Gender was reported by participants (N = 1,126), with 904 (80.28%) indicating female and 222 (19.72%) reporting male. The income level means were calculated for each gender group as shown in Table 9. The mean for females is 3.26 and the mean for males is 3.68. The income level mean for males is significantly higher than the income level for females.

Figure 4 shows the percentage of each gender group that is in each income group. As shown in Figure 4, males have higher percentages in the higher income level groups, while females have higher percentages in the lower income level groups. There is a statistical significance between the income levels and gender difference.

As the data indicate an association between salary level and educational level, it was important to ascertain if males were paid at higher levels because of a higher level of education than females. Data were cross-tabulated to show the median salary for males and females for each educational level. Males with the same level of educational achievement were paid at significantly higher levels of salary for associates, bachelors, masters, and doctoral levels. Females were paid higher than males in only the “some college” educational category. There were no males in the high school/G.E.D. category.

Thus, the data do not support H4, that there would be no difference between genders with respect to income levels. Male participants have significantly higher salaries than their female counterparts.

Table 9: Gender Frequency, Mean Stratified Income Level, and Standard Deviation.

Descriptive Statistics: Gender


What is your gender? Mean Standard Deviation

N

Response Female 3.2611 1.02914 904

Male 3.6757 1.05214 222

Total 3.3428 1.04634 1126


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Tests of Between-Subjects Effects: Gender


Source Type III Sum of Squares df Mean Square F Sig.

Corrected Model 30.639a 1 30.639 28.673 .000

Intercept 8576.173 1 8576.173 8026.073 .000

What is your gender? 30.639 1 30.639 28.673 .000

Error 1201.038 1124 1.069

Total 13814.000 1126

Corrected Total 1231.677 1125

a. R Squared = .025 (Adjusted R Squared = .024)

Table 10: Analysis of Variance for Between-Subject Effects for Credentials.

Table 11: Comparison of Salary Means between Genders for Education and Experience Levels.

Male Female

Education N=224 N=907

Some college 2.43 3.02

Bachelors 3.47 3.08

Masters 3.63 3.41

Doctoral 4.46 4.01

Experience N=225 N=908

Less than one year 3.50 2.45

One to five years 2.79 2.67

Five to ten years 3.52 3.16

Ten to twenty years 4.04 3.54

Twenty or more years 4.44 4.00

Figure 4. Gender.

Figure 4. Gender.


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ConclusionThese data show that a masters or doctoral level graduate degree, more than five

years of experience in research administration, and male gender are associated with higher salaries in research administration. While the CRA credential may increase credibility and confidence for those who attain it, these data do not indicate that it will result in a significant increase in salary. The data also do not support an increase in salary for those with a bachelors degree when compared to those with an associates degree or only some college credit without a degree. The survey data do not show whether the CRA or a bachelors degree was a requirement for employment. This may be a consideration for a new research administrator planning their career path.

Further study is recommended to determine current employment requirements in research administration. Further study of gender disparity with respect to income levels is also recommended. With a profession that is comprised of 80% women, is the level of inequity more or less than would be expected when compared with national norms? Further study may also be done in a broader population to determine if educational attainment has similar impact on research administrators at research institutes, funding agencies, hospitals or in other non-academic occupational environs. Do degree granting institutions place a higher reward on education than non-degree granting research institutions?

These data indicate that, within their profession, research administrators are rewarded with increased levels of income for career longevity and advanced academic achievement.

ReferencesRoberts, T. J., & House, J. (2006). Profile of a research administrator. Research Management

Review, 15(1), 41-47.

Shambrook, J. (2010) Health behavior, occupational stress, and stress resiliency in research administrators working in the academic environment (Doctoral dissertation, Walden University) Dissertation Abstracts International, AAT 3412291.

Shambrook, J., & Roberts, T. J. (2011). 2010 profile of a research administrator. Research Management Review, 18(1), 19-30.

REVIEWS

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Book Review

Trust and Integrity in Biomedical Research – The Case of Financial Conflicts of Interest (2010)

Thomas H. Murray & Josephine Johnston, EditorsThe Johns Hopkins University Press, 267 pp.

Jere M. Boyer, PhDSenior Scientific Advisor

Clinical Research Management1265 Ridge Road

Hinckley, OH 44233Tel: (800) 431-9640


Author’s NoteThis treatise is edited by Thomas Murray and Josephine Johnston from The Hastings Center in Garrison, New York. Although currently out of print, it is easily obtained on-line and through other sources. The authors of each of the 10 chapters are experts in their area and will be introduced during the discussion of their specific chapter.

IntroductionIn the preface, the editors make the case that biomedical research funding has

changed over the past several decades. This is certainly true. Industry sponsorship of research has increased, from about 30 percent in 1980 to nearly 60 percent by early in the last decade. Academic institutions play a significant role in industry-sponsored research, where as high as one-half of biomedical companies’ research budgets are used to sponsor research. Such availability of research monies (in many forms, grants, and contracts) has raised concerns in public and research circles.

The editors present several examples of either actual or perceived conflicts of interest that were observed or suspected, including at the National Institutes of Health (NIH). The editors reported that several senior NIH scientists had developed relationships with industry that included hundreds of thousands of dollars in various kinds of compensations. Such charges by newspapers and other venues led to investigations and eventually to the NIH banning its employees from accepting consulting payments from pharmaceutical companies. Concerns related to the integrity of biomedical research have drawn the attention of the Hastings Center, where a project was developed to address the ethical issues involved in the management of financial conflict of interest. This book represents contributions of members of the Center’s project working group.

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Part I “Meaning and Context”

Chapters 1 to 4In Chapter 1, Financial Conflicts of Interest in Biomedical Research, one of the editors,

Josephine Johnston, a Research Scholar at The Hastings Center, asks what COI is, how it arises, who is involved with it, and how it should be managed. Medical research is grounded on the concepts of trust and the unbiased pursuit of research. Any financial interest in the research, especially by the investigators, can cast doubt on results. In a well-known case (pp. 9-10), Johnston notes that more than half the investigators involved in the Rezulin studies for type II diabetes received some form of remuneration from the sponsor. The drug was fast-tracked, but eventually removed from the market because of liver failure in some subjects. Such issues are played-up in the media and result in significant harm to research in general.

Johnston notes that management of COI is a form of risk management. There will always be conflicts of interest whenever a sponsor, an institution, the government and an investigator are involved in clinical research on an article that portends profit and provides a means of research (and personal) support. Policies are required that assist in defining the risk, what level of risk can be tolerated, and how risk might be reduced. As indicated by Johnston, some risks can never be tolerated, some that do not reach a threshold may be tolerated, and some may be ameliorated. This latter may include limited involvement in the study of the person with the COI, divestiture of the financial COI, or some other oversight of the conflicted investigator. It must be understood that research is expected to generate financial income for shareholders (p. 12). Profit from research is not “evil” but does need to be managed. As Johnston points out (p.19), “financial stake increases commitment and the chance of success.” The chapter concludes with the observation that any policy or rule must be accepted by the particular “community” in order to be effective.

Chapter 2 is coauthored by Neetika P. Cox, an independent policy consultant; Christopher Heaney, from the Center for Genome, Ethics, Law and Policy at Duke University; and Robert Cook-Deegan, M.D., Director of the Center for Genome, Ethics, Law and Policy at Duke. This chapter, Conflicts between Commercial and Scientific Roles in Academic Health Research, discusses the issue of research funding. The premise presented by the authors is that there are features of funding that can drive or intensify conflicts between the concept of Mertonian open science and the private nature (and privacy) of commercial research. As an example, federal grants and patents tend to drive openness in science as supported by Merton, while privately funded contracts tend to support privacy rather than the dissemination of data. These concepts are presented in an interesting scenario, in which John Sulston, who was involved in the human genome project, gave a lecture commemorating the 50th anniversary of the discovery of the double helix. Sulston extolled the virtues of making reference sequences available to all at no charge, to benefit both science and the human cause (an example of Mertonian open-science) (pp. 33-34). Soon after, James Davis of Human Genome Science, Inc., gave a lecture in which he described a gene sequence tied to the development of three products for cardiovascular disease, for which his company was seeking a patent. Patents, and the rights associated with them, are a strong inducement

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for commercial entities to invest in research. These two concepts seem diametrically opposed. The authors indicate that both Sulston and Davis are right and wrong and why (p.34)! In reviewing data from World War II and thereafter, they conclude that medical and health research is now “big science” and big business. They further indicate that managing the science and the business of medical/health research will be a prominent task for academic research institutions for the foreseeable future (pp. 36-37). More and better data are needed to guide future policies regarding COI of researchers and institutions. The authors suggest that transparency is only one part of the answer. In actuality we do not know what the norms and practice should be for research to achieve its intended social benefits (pp. 59-61). Several features presented by the authors in their summary (pp. 62-63) are useful in contributing to an understanding of the social value of academic research.

Chapter 3, From Conflict to Confluence of Interest, is written by Henry Etzkowitz, a Visiting Professor at Edinburgh University and a Faculty Research Fellow at Stanford University. The author initially describes the academic institution as the “perfect” place for generation and transfer of technology (p. 71). He traces the history of academic research and funding in the U.S., and discusses the various aspects that have an impact on the continuing commercialization of academic research. An entire section of this chapter presents the impact of Bayh-Dole legislation (pp. 87-89 and 92–93) on academics and their research – both pro and con. Most tech transfer offices view Bayh-Dole as the “Magna Carta” of academic transfer of technology (p. 87). Not only is this not necessarily true, but it may be detrimental (pp 92-93). The author presents a very well written discussion of the role of intellectual property protections (not only patenting) in commercialization of academic research. In a bit of a conceptual shift (but one well presented) the author indicates that various commercial interactions with industry and academia, including patents, are of significant value to the research establishment and society and outweigh conflict of interest concerns. Etzkowitz presents the concept of the university as the research co-equal of government and industry (p. 100).

In Chapter 4, Eric Campbell (Massachusetts General Hospital), Darren Zinner (Brandeis University), Greg Koski (Massachusetts General Hospital), and David Blumenthal (DHHS) present Ties That Bind. This chapter describes the nature, extent, and consequences of the “triple helix” formed by the relationships among academia, government, and industry in life and health-related research (p. 105). Excellent data are presented and discussed by the authors regarding the various relationships of each sector of the triple helix. After presenting information about what is currently known about these relationships, the authors discuss the advantages and risks associated with triple helix relationships. Also discussed are current policies in place to oversee and supervise the relationships. Finally the authors present a set of guiding policies, suggestions and principles for the disclosure and management of these interactions (pp. 123-125). The authors conclude with a caution that neither the risks nor the benefits of the relationships of academia, the government and industry should be overstated. We do not yet know or understand all of the risks associated with these relationships. As the authors state, “you manage what you measure.” We have not measured all the risks.

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Part II “Learning from Other Fields”

Chapters 5 to 8Chapter 5 is entitled Conflict of Interest in Financial Services. The author, John

Boatright (Loyola University, Chicago), describes how COI is managed in the financial services industry. He observes that COI arises mainly because financial service providers serve as agents in executing investors’ financial transactions (p. 131). COI is inherent in the structure of financial institutions because of the services they provide. The author describes in detail the management of COI in the financial industry through contracts rather than policies. Boatright presents six discussion points from the financial industry that may be applied as “lessons learned” for biomedical research (pp. 146-148).

Chapter 6 was authored by Robert Lawry (Case Western University) and is entitled, The Law and Ethics of Lawyers’ Conflict of Interest. The author beings the chapter by describing some of the historical aspects of the development of codes for handling COI, including a discussion of the American Bar Association’s (ABA) “Rules of Professional Conduct.” The chapter discusses various aspects of the ABA Rules that may be relevant to biomedical research. Lawry describes and makes a case for a move from “risk rules” that are associated with avoiding situations where a lawyer’s judgment is at risk to “harm rules” that remedy COI situations. Such a change permits more COI, provided procedures are followed, including disclosure of the conflict, obtaining informed consent, and providing screens or walls between lawyers within the firm. Lowry describes the two major conflicts lawyers confront as current and previous clients. He concludes that COI rules governing lawyers are a complex set of detailed prohibitions, often with significant exceptions (p. 169). Over time these rules have changed to allow attorneys more flexibility to represent clients even though COI may exist. The shift in self-managing COI in the legal profession mirrors that of biomedical research.

Chapter 7, Sustaining Credibility in a Context of Conflicts: The Challenge for Journalism, was written by Deni Eliott (University of South Florida). Eliott initiates the discussion of journalistic COI with the story of Mirthala Salinas reporting that Los Angles Mayor Antonio Villaraigosa and his wife of 20 years were separating. Ms. Salinas did not mention that the reason that they were separating was because the mayor was having an affair with Ms. Salinas (p. 171)! The author indicates that journalism may have some of the broadest definitions of COI and some of the strictest rules. Unfortunately these norms are not easily enforced because of the fluidity of the profession, including mergers with other public communications venues and the internet. Eliott discusses several individual and organizational COIs as they relate to professional and social concerns. She ends with an important observation about her profession that is useful to those of us in biomedical research. News organizations have the direct ability to communicate with the people they serve, but they rarely use this venue. Disclosure of competing interests ought to come early and often, along with management’s explanation of how the conflict is being handled (p. 187). Disclosure – early and often -- is most applicable to biomedical research.

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Chapter 8, Some Principles Require Principals, was written by William Sage (University of Texas). Sage begins his discussion by indicating that “money seems to have supplanted state power as the principal concern of biomedical research ethics” (p. 188). He compares the meaning of COI in law with the use of the term in biomedical research. Financial relationships have been widely criticized in biomedical research. Yet the author finds the descriptions of COI vague, particularly considering the dual roles of the physician/researcher, who must balance duty to patient with duty to research. Human relationships are fraught with conflicts. Sage contends that a COI framework is inappropriate for protecting the “purity” of biomedical research, and that the framework should focus on managing financial incentives. In closing, Sage says that COI analysis cannot create appropriate incentives to serve “principles” when those goals are not embodied in discrete, identifiable “principals” (p. 210).

Part III “Management Today and the Future”

Chapters 9 and 10David Perlman (University of Pennsylvania)) presents Chapter 9, Current

Regulations, Comparison of Guidelines, and Considerations for Policy Development. Perlman discusses current regulatory and ethical policies and how they may be helpful to organizations and institutions in developing or revising policies for the management of financial COI (pp. 220-230). Perlman presents an excellent series of charts and tables comparing current regulations and guidance documents. These summaries are intended to assist institutions and organizations to develop new policies. Perlman describes some recent events that have drawn attention to COI and how such scrutiny affects compliance efforts and public trust in the research enterprise. In conclusion, he quotes directly from the DHHS guidance, “Financial relationships in human research should not compromise any of . . . (the) principles of the Belmont Report” (p. 238).

In the final Chapter (10) Douglas Peddicord (Association of Clinical Research Organizations) presents Financial Conflicts of Interest in Research with Human Subjects. Peddicord makes his presentation from the standpoint of the Clinical Research Organization (CRO). The author indicates that financial and regulatory pressures on CROs provide strong incentives for avoiding organizational COIs. COIs for investigators and institutions are no less likely, given the budgetary constraints in the funding apparatus today, than they are for other for-profit entities, including pharmaceutical companies or a CRO. Peddicord concludes that federal regulations and oversight do, and must continue to provide oversight not only for IRBs, investigators and institutions but also for sponsors, CROs and other providers of contract services, in an even-handed manner. Regardless of the entities involved in research, especially clinical research, all participants must develop a fuller awareness of the impact of financial interests and relationships on the rights and welfare of the human subject.

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ConclusionI found the book, Trust and Integrity in Biomedical Research – The Case of Financial

Conflicts of Interest, to be an in-depth analysis of financial conflicts of interest. I enjoyed the balanced treatment of the subject and the various well-thought out concepts presented by an expert panel of authors. Many of the changes proposed regarding COI policies should be considered nationally and for researchers and institutions. I would recommend the book to all research administrators. It is well worth the time. I also appreciated the efforts of the editors to make the chapters flow – a real task with a book of this nature. The literature cited is extensive and much appreciated.

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Book Review

The Madame Curie Complex: The Hidden History of Women in Science (2010)

Julie Des JardinsThe Feminist Press at the City University of New York, 312 pp.

Cameron R. Nelson, JD, RN, LLM (cand)Arlington, VA, United States

Master of Laws ProgramLoyola University ChicagoEmail: [email protected]

Tel: (757) 375-0532

IntroductionThe tales of science learned as school-aged children are often focused on outcomes,

rather than the lives of the scientists whose work produced these results. Understandably, these results are used to teach theories and laws of science; however, our scientific education is short sighted when it lauds the end result without regard to the sacrifices made by the pioneers of science. In particular, women’s scientific accomplishments and sacrifices made to achieve success are often misunderstood and less prominent than those of their male contemporaries. In The Madame Curie Complex: The Hidden History of Women in Science, Julie Des Jardins documents holistic stories of women scientists, exploring not only their particular scientific achievements, but also their personal and professional challenges. As it provides an important perspective on the professional and academic challenges of the culture of research itself, this text has particular value for research leaders, executives, administrators, and managers.

SummaryThe Madame Curie Complex: The Hidden History of Women in Science appeals to

both the research scientist and the historian alike. Des Jardins deftly describes each woman’s scientific contributions in a manner that honors the research conducted, while remaining accessible to those more interested in the historical aspect of each woman’s story. To tell the stories of women seemingly connected only by a shared gender and interest in disparate scientific fields, Des Jardins organizes this book into three historical periods, roughly spanning the twentieth century: 1) Assistants, Housekeepers, and Interchangeable Parts: Women Scientists and Professionalization, 1880-1940; 2) The Cult of Masculinity in the Age of Heroic Science, 1941-1962; and 3) American Women and Science in Transition, 1962-.

In the first section of the book, Des Jardins describes precisely the titular difficulty that has plagued women in science for decades. In her work, Marie Curie deliberately focused

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on “pure science,” rather than humanistic or ideological applications for radium. As Des Jardins describes, Curie believed that her work with radium should not be a possession of an agenda or cause beyond science itself. Yet, as Curie embarked on an American tour to raise funds for her work, there was concern that the public would not embrace a woman working for science itself. A public relations strategy took hold that recast Curie’s motivation from science to charitable benevolence, forcing Curie to be seen through the lens of the cultural norm of the time. This carefully crafted combination of extraordinary scientific skill coupled with a maternal image elevated Curie in the public eye to a near mythical figure, one who unwittingly left a palpable sense of inferiority among American women scientists after Curie’s first American tour ended. The image foisted upon Curie resulted in tremendous fund-raising success; however, in many instances, it also had a chilling effect on women’s participation in science.

A prevailing belief during Curie’s career was that women scientists rarely achieved independent research or scientific success. Rather, women were seen as assistants or “helpmeets” to their male colleagues or, in some cases, their husbands. Despite Curie’s success, she was no exception to this erroneous belief. Des Jardins points out that when Marie Curie and her husband, Pierre, won the Nobel Prize in 1903, several members of the French Académie lobbied against her inclusion in the esteemed award, believing that she was not a partner in the scientific work. This same misconception plagued Lillian Gilbreth, a contemporary of Curie, for much of her career. Lillian and Frank Gilbreth worked together, as partners, to discover the “One Best Way” in a variety of applications, searching for the least taxing method involving the fewest movements as quickly as possible. Their work in motion study culminated in scores of professional papers, articles, and books, yet many of these were published under Frank Gilbreth’s name alone, for fear that properly including Lillian Gilbreth’s name would undermine their work in a male-dominated field. At least three books, Concrete System, Bricklaying System, and Motion Study, were published without reference to Lillian Gilbreth’s co-authorship. In some cases, she drafted entire books during his absence, but was often not credited. Once Gilbreth earned her doctorate, it became easier to include her as an author; however, despite an impressive body of work, she still struggled to gain full membership into some professional societies because she was a woman.

During this time period, any acceptance women scientists enjoyed usually came as a result of choosing scientific disciplines deemed appropriate for women, such as those that were applicable to homemaking. Des Jardins completes the first section of this book with stories of women astronomers, a career choice that, when made by women, seemed perplexing given the field’s male domination. In fact, it may surprise some to learn women were routinely denied access to telescopes in observatories until the 1960’s. Without telescopic access, the development of stellar photometry allowed women to study photographic plates and record measurements for formally trained astronomers, usually male, to interpret. At the Harvard Observatory, women who took these positions and worked under the direction of Edward Pickering were called “computers.” Despite their contribution to the research conducted at the Observatory, these “computers” were seen as “scientific housekeepers” rather than contributors to the research team. While these positions offered an entrance into the field of astronomy, women found it difficult to advance beyond these positions.

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Des Jardins focuses the second section of The Madame Curie Complex: The Hidden History of Women in Science on the period during and after World War II, beginning with a fascinating examination of women’s scientific roles in the Manhattan Project. Although many may know that wives accompanied their husbands to Los Alamos, the extent to which women scientists contributed to the project is less obvious.

Documents maintained by the Los Alamos Historical Society that identify project employees refer to scientists as male, disregarding the contributions of women scientists such as Joan Hinton. Hinton, the youngest scientist working on the bomb, was recruited to test assemblies of enriched uranium and plutonium. Her work was deemed so dangerous that she worked down a cliff in a separate building. At least twenty women worked directly on engineering the bomb and over three hundred women did scientific work at various project sites.

Lack of recognition for scientific work did not end with the Manhattan Project. Des Jardins describes the particularly discomfiting situation in which Lise Meitner, a theoretical physicist, was not credited for her conception of fission. Her long-standing partner, Otto Hahn, continued Meitner’s uranium experiments after she was forced to flee Berlin in 1938 because she was Jewish. After a thirty-year partnership with Hahn, she continued as the intellectual head of the partnership from afar. When Hahn could not explain the results of a recent uranium experiment, it was Meitner who conceived what we now know as fission, and yet Hahn won the Nobel Prize for the discovery in 1944. In the end, it was not the loss of the Nobel that most upset Meitner but rather, like Curie, being given the label of an assistant or subordinate, instead of a partner. Des Jardins believes that a pattern exists among women who won the Nobel Prize before 1970. Proximity to elite male scientists seems to be a factor in the recognition these women experienced, providing connections that, at least partially, overcame the sexism of the time. This is, of course, not to say that the work of these women was not significant in its own right, but this was a time when many women felt compelled to choose between a meaningful career in science and the traditional domestic role of wife and mother. However, those women who chose to both marry and be scientists could interact with their married male colleagues with a freedom not granted to single women scientists.

In the third and final section of the book, Des Jardins describes the work of women scientists in the last third of the twentieth century, a period of significant shift in cultural expectations of scientists. Rather than idealizing the eccentric scientist, alone in the laboratory with little social interaction, this cultural shift encompassed a move towards more collaborative efforts and scientists engaged in their communities, with a need to be consciously thoughtful of the effects of their work. Despite the social and political upheaval, sexism in science persisted. For some women scientists, a belief existed that they must work harder or be smarter than their male counterparts. Certainly, no one could doubt Rosalyn Yalow’s dedication to a career in science. Earning her doctorate in nuclear physics in 1945, she took a consulting position at the Bronx Veterans Administration Hospital and built radiation detection instruments from scratch. Yalow understood the cultural expectation to choose either science or a family, but desired to be an exception to this norm, balancing both a career and family. When Yalow was awarded the Nobel Prize in 1977 for discovery

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of radioimmunoassay (RIA), she spoke to the audience about sexism in science. To Yalow, sexism in her chosen field was something to be overcome, rather than reformed. Yalow turned down a Woman of the Year Award because excellence should not be related to sex. She vocally criticized affirmative action policies, women’s awards, and women’s scientific organizations. It is easy to imagine her disdain when journalists covering her Nobel ceremony dedicated significant portions of their event coverage to what Yalow chose to wear. Yalow was chosen to give the address to university students, and further adding to insult, the usher attempted to escort Yalow’s husband to the podium, assuming he was the honoree.

The final stories of women scientists in Des Jardins’ book involve the so-called “Lady Trimates:” Jane Goodall, Dian Fossey, and Biruté Galdikas. Perhaps the rise of documentaries and increased media coverage provided more awareness of the dedication these women displayed in their fields and their respective contributions, but as Des Jardins points out, even the National Geographic Society’s portrayal of these women scientists was subject to manipulation. Images of these women focused on an intense connection with nature resulting from a maternal mystique. Their portrayal in movies, such as Gorillas in the Mist and Project X was highly romanticized; and yet, their work rejected the detached approach to their disciplines seen in other fields and encouraged by many of their male colleagues. These were scientists who focused not only on “pure science,” as Curie strove to do, but also on the social purpose and ethics of their work. Science is not necessarily feminist solely because its researchers aim to be more humane.

The women scientists featured in The Madame Curie Complex: The Hidden History of Women in Science are skillfully profiled, with details of their personal and professional lives combined in a lively and authoritative text. While it could be tempting to do so, Des Jardins refrains from portraying these women as victims. The historical detail she brings to their stories provides the context for their successes and sacrifices.

ConclusionThis is an important book not only for those interested in scientific history and

women’s accomplishments, but also for research leaders, executives, administrators, and managers as they support the work of scientists. Several of the stories serve to remind research administrators of the exploitive danger of manipulating a scientist’s image to suit a societal ideal or norm. Des Jardins’ book also demonstrates that each scientist, regardless of whether he or she fits a stereotypical profile of success in a given field, may be poised for significant contributions in research. A research administrator should consider whether his or her own bias prevents due consideration of a scientist’s approach or proposed study. A central tension for many of the women scientists Des Jardins features is that between science and family. As many modern families split domestic responsibilities differently than in decades past, research administrators should expect that both women and men scientists alike now experience this tension. Considering creative solutions to manage both work and personal responsibilities may assist in furthering scientists’ achievements and increase our collective body of knowledge. Research administrators who choose to read this book will discover a new viewpoint on the way cultural expectations of gender have shaped science.

VOICE OF EXPERIENCE

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Voice of Experience

The America Invents Act – A First for America

J. Michael Slocum, JDPresident

Slocum & Boddie, P.C.6225 Brandon Avenue, Suite 310

Springfield, VA 22150Tel: (703) -451-9001Fax: (703) 451-8557


Voice of Experience 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. VOE is a celebrated feature column in each edition of the Journal. In this issue, J. Michael Slocum, Journal Intellectual Property Counsel, presents a robust discussion of The America Invents Act. J. Michael Slocum is Counsel to the Society of Research Administrators International and President of Slocum & Boddie, P.C., a private law firm in Springfield, Virginia.

The new America Invents Act (AIA) is the most wide-ranging revision of the U.S. Patent Laws in more than 50 years. Many of the provisions of the law relate to the arcana of practice before the United States Patent and Trademark Office (USPTO). Many of the other changes to the patent law will be of interest to any organization or individual dealing with patents – as patentee, licensee, or possible infringer. The law’s most important effect is to change the U.S. Patent system from “first-to-invent” to “first-to-file.”

The Smith-Leahy America Invents Act (H.R. 1249) was signed into law as Public Law 112-29 by President Obama on September 19, 2011. The new Law represents the single most important revision to U.S. patent law since the Patent Act of 1952.

Most importantly, the AIA moves the United States to the first-to-file system. The AIA does preserve a “grace period,” ensuring that during the year prior to filing, an invention will not be rendered unpatentable based upon any of the inventor’s own disclosures, or any disclosure made by any party after the inventor has disclosed his or her invention to the public.

The United States was the last holdout in using a first-to-invent system. Every other country in the world had moved to a first-to-file system decades ago. Patenting will now move from the familiar two steps (conception of the invention and reduction to practice) to one, in which the right to a patent for an invention is determined by the first person to file for a patent to protect that invention, even where another person can prove that he or she conceived of the invention and reduced it to practice before the patent holder filed.

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Many experts in patent practice expect greater use of provisional patent applications. (Abramson, Sullivan, Egbert, & Chiarini, 2011). These experts also expect to see organizations specializing in early development phase research needing to dedicate more resources to patent protection and dedicate those resources earlier in the process.

The AIA also recodifies the so-called CREATE Act. That Act made changes in U.S. patent laws to promote cooperative research and development among universities, government, and the private sector by allowing the sharing of confidential information among research partners of differing entities without creating a bar to the patentability of their joint invention.

The AIA contains an interesting exception to the first-to-file rule. The Act allows an inventor to make a voluntary disclosure of an invention up to one year prior to the filing date of the patent application without losing the right to patent. This appears to allow an informal public disclosure to protect the possibility of later filing a patent application for an invention that has not, as of the time of the disclosure, been fully worked out. Of course, this public disclosure prior to filing is a bar to patentability under most other countries’ laws, so it is not clear just how it would work.

The AIA also expands a defense to an infringement claim, but then denies the use of the defense in situations important to most federally-funded research organizations. For some time, alleged infringers of business method patents have been able to claim “prior use” as a defense against infringement in certain circumstances. For patents issued on or after the date of enactment of the AIA, the prior use defense can be applied essentially to most patent infringement claims. However, this defense is denied to alleged infringers for patent rights in inventions made with Federal assistance, or by a university or a technology transfer organization affiliated with a university that did not receive private business funding in support of the patent’s development (35 U.S. Code §273).

A large part of the text of the AIA is related to new ways to challenge a filing at the Patent and Trademark Office. These challenges can be: (1) “preissuance submissions” by third parties (35 U.S. Code §122); (2) “inter partes review” (35 U.S. Code §311. Et seq.); and (3) “post-grant review” (35 U.S. Code §311. Et seq.).

Of most interest perhaps to academic researchers will be the use of preissuance submissions to challenge an application during prosecution by submitting prior art patents or printed publications. Under the Act, anyone can provide information to show that the “new” invention is covered by “prior art.” (If an invention has been described in prior art, a patent on that invention is not valid.) These submissions do not require identification of the petitioner, so anyone can anonymously challenge any application. This procedure provides a researcher (or an organization) an opportunity to monitor the patent publications and take reasonably inexpensive steps to restrict the scope of patents that might limit his or her research.

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One new provision in the AIA that will be welcomed is the new “micro entity” fee structure. Micro entities will receive a 75% discount in patent fees as compared with the large entity fee.

The “micro entity” is defined as a patent applicant (inventor) who:

1. Qualifies as a small entity, as defined in the patent regulations;

2. Has not been named as an inventor on more than 4 previously filed patent applications (with some exceptions);

3. Did not, in the year preceding the year in which the fee is paid, have an income exceeding 3 times the median income for that preceding year; and

4. Has not transferred the rights to an entity that had an income exceeding 3 times the median household income.

The AIA grants the 75% fee reduction to institutions of higher education, as defined in section 101 of the Higher Education Act of 1965 (20 U.S. Code §1001), that are public institutions. Apparently, private universities do not benefit.

As most people in US research are aware, the Bayh-Dole Act granted universities, other nonprofit organizations, and small businesses the right to title to inventions developed using Federal funds. In 1984, Congress amended the law to ensure that universities and small businesses operating Government facilities (GOCOs) got the same right to elect title to an invention. However, the 1984 amendment permitted GOCOs to retain the balance of any royalties or income earned from licensing inventions, up to 5% of the annual budget of the facility, for further research, development, and related activities. If the balance exceeds 5% of the facility’s annual budget 75% of the excess was recouped by the Government, with the remaining 25% of the excess also retained by the GOCO for further research, development, and related activities.

The AIA maintains the essence of the amendment requiring GOCOs to reimburse the taxpayer if they are sufficiently successful in commercializing a product invented with taxpayer dollars, but instead of reimbursing 75% of the excess to the Government, the GOCO will retain 85% for further research, development, and related activities and reimburse the Government 15% (35 U.S. Code §202).

Of course, the primary question in everyone’s mind concerning this new law is the effect of the shift in the rules from a “first-to-invent” system to a “first-to-file” system. There is an ongoing argument between those who claim that first-to-file disadvantages small inventors and leads to lower quality patents, and those who emphasize administrative simplicity and the cost savings of first-to-file as a way to aid those same small inventors. Incredibly, two authors have just published a paper using the Canadian experience with the same change the US is considering as a natural experiment to shed the first empirical light on the question.

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David S. Abrams and R. Polk Wagner, two law professors at the University of Pennsylvania, watching the increased interest in patent and intellectual property occasioned by the passage of the AIA and other “blockbuster deals involving patents” (Abrams & Wagner, 2011), noted “how little actual empirical analysis exists that might allow us to predict the changes that the America Invents Act will put into effect.” They decided to analyze the situation by comparing the change in share of patenting by individual inventors in Canada before and after that country’s change in the patent law, and using the same metric in the US as a control, isolating and measuring the impact of the Canadian change to First-to-File (FTF) on individual inventors. Their analysis found strong evidence that the change to FTF reduces patenting behavior by individual inventors.

The data used in the study also allowed the authors to test the proposition that the change to FTF would lead to lower quality patent disclosures. They conducted that analysis, finding no significant change in patent quality due to the 1989 Canadian law change using several different quantitative measures. They also conducted several additional analyses, including investigations into the other changes that occurred in the same reform of the Canadian patent laws. Their results survive, giving a level of confidence that FTF results in a reduction of patenting by individual inventors relative to firms.

The level of science demonstrated by the research design is commendable. The research design used a modern econometric technique known as a difference-in-difference analysis. That allowed the authors to control for effects other than the priority rule change. By comparing the observed differences in individual patenting behavior in Canada across the 1989 change in the law to the differences in individual patenting behavior in the US during that same time period, they were able to isolate the effect of the law change on individual patenting behavior (in Canada).

The level of readability is also commendable. While no one would mistake the text for a rousing beach novel, the language is clear, not full of jargon or obscure legal references left unexplained, and thankfully linear in presentation. The obvious (and not so obvious) questions that arise in thinking about differences in Canada and the US are addressed as they occur, and some surprising facts are included. (For instance the authors note that (using 1990 populations) there were 6.32 Canadian patents granted per 1,000 people and only 3.59 patents per 1,000 Americans.)

The authors admit their study cannot answer the question of why individual inventors patent less under an FTF regime as under a first-to-invent priority system. However, they identify several possibilities. The first is that larger firms may have more resources to allocate to the patenting effort. They do not find any strong evidence of such a cause, and they cite some evidence that would indicate that no basis exists for assigning this as the cause of the difference. However, that evidence is itself not dispositive.

Another possible cause identified is that there might be an actual decrease in proportion of inventions by individual inventors, perhaps because there are minimal

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incremental costs to additional patent filings in an FTF regime. They speculate that individual inventors may use other means to protect their interest in such an environment. For instance, they mention the possible increase in the use of protection by means of trade secrets.

The authors also speculate that individual inventors, after the change to an FTF system, become demoralized or disillusioned with the patent system, and accordingly seek fewer patents. However, the only evidence given for such a rationale is the surge in filings in Canada shortly before the change in the law in that country. No indication is given that there has been any equivalent increase in the US.

Finally, the authors opine that there less patenting by individual inventors because they join firms after FTF rule. They note that it may be possible to test this theory empirically, by matching inventors’ names before and after the 1989 change in Canada. They identify this question as an avenue for future research.

ReferencesAbrams, D.S., & Wagner, R.P. . Priority rules: An empirical exploration of First-to-Invent

versus First-to-File, Public Law and legal theory, University of Pennsylvania Law School Research Paper No. 11-37, Social Science Research Network Electronic Paper Collection at: http://ssrn.com/abstract=1921488. Retrieved September 6, 2011.

Abramson, R., Chiarini, L., Egbert III, W. , Sullivan, P. NEW US PATENT LAW: The America Invents Act of 2011, pdf available at http://www.hugheshubbard.com/NEW-US-PATENT-LAW-The-America-Invents-Act-of-2011-09-26-2011/


Notes

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