Proposal for the Establishment of the Clinical and Translational Science Institute
I. Purpose and Background
In 2002, the National Institutes of Health Director, Elias A. Zerhouni, M.D., convened a series of
meetings to chart a new path for medical research in the 21st century. The purpose was to identify
major opportunities and gaps in biomedical research. The outcome, referred to as the NIH Roadmap
(see Appendices A and B), describes an all-encompassing vision for a more efficient and productive
system of medical research. This groundbreaking initiative not only outlined new funding priorities in
the near-term but also provided a strategic, long-range plan for public financing of research in the
21st century. In 2005, consistent with the Roadmap strategy, the NIH launched a new program
called the CTSA (Clinical and Translational Science Awards) designed to transform clinical and
translational research, so that new interventions, whether preventative or therapeutic, can be
developed more effectively and delivered more efficiently to the community. In this sense,
translational science is defined as the process of applying discoveries generated through research in
the laboratory and in preclinical studies, to the development of trials and studies in humans. The
CTSA encourages the development of novel methods and approaches to clinical and translational
research, enhances informatics and technology resources, and improves training and mentoring to
ensure that new investigators can navigate the increasingly complex research system. These efforts
encompass two areas: Bench to Bedside (moving findings from the laboratory to clinical care) and
Bedside to Community (translating evidence into community practice). The reasons for this new
approach are complex and are explained briefly in the next section and in Appendix C.
It is important to realize, however, that in order to become eligible for the competitive and substantial
funding available through the CTSA program, the NIH requires that each applicant university
establish a new Center, Department, or Institute in clinical and translational science. In accordance
with this directive, the University of Louisville seeks to create the Clinical and Translational
Science Institute (CTSI) to promote the development of clinical and translational research as
a distinct discipline and to provide an institutional “home” for this endeavor. A planning grant
to support the development of the CTSI was funded in October 2006, and within two years, we
expect to apply for full CTSA funding. The full grant could total as much as six million dollars a year
and will include a variety of clinical research centers, educational programs, pilot projects, career
development plans, and joint ventures with the allied health community.
The following aims will support the CTSI mission.
1) Expand and develop the clinical and translational educational opportunities and degrees
offered through the CTSI and the Graduate School. The CTSI will provide support for predoctoral (T32) and postgraduate/terminal-degreed (K12) educational programs to promote clinical
and translational science education at U of L. (For additional information on these two programs,
see Appendix D). Bench to Bedside and Bedside to Community represent two distinct challenges in
moving biomedical discoveries into community practice. Currently, the School of Public Health and
Information Sciences offers a Certificate and the Master’s of Science degrees in Clinical
Investigation Sciences. These will continue to operate with input from the CTSI and have been used
for the “Bench to Bedside” focus. The MSc degree will be offered to physicians in subspecialty
training, dentists and nurses, as well as faculty members pursuing a career in translational research.
The MSc degree will be redesigned for terminal-degreed clinicians in subspecialty training programs
and others in medicine, dentistry, nursing, public health, etc. for whom protected time away from
patient care and teaching duties can be required and arranged. The current curriculum is shown in
Appendix E.
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University of Louisville currently offers the interdisciplinary MS and Ph.D degrees. During the last six
months, the CTSI leadership, with the help of Dr. DeMarco, have utilized the interdisciplinary MS
degree to develop postgraduate (post MD and/or Ph.D.) a Mentored Clinical Scientist Development
Program Award, termed a K12 award by NIH. The K12 program provides an award to educational
institutions to support career development experiences for clinical investigators leading to research
independence, and it is a mandatory component of the CTSA. For the CTSI, these degrees will be
aimed at a diverse cast of professionals from different programs (postdoctoral students, clinical
fellows, and junior faculty) who are preparing for a career in academia with an emphasis on clinical
and translational sciences. These programs will be truly interdisciplinary, involving the College of
Arts and Sciences, Speed School of Engineering and Kent School of Social Work, as well as the
HSC schools (Medicine, Dentistry, Nursing, Public Health and Information Sciences) and others.
The CTSI has worked closely with the Graduate School and will continue to work with the Provost’s
transition team to develop new programs and enhance existing curricula to meet the CTSA
challenge.
Both the MSc and Intedisciplinary degrees are being offered with a translational research emphasis
to complement existing graduate degrees and postgraduate education. These degrees will not
substitute for specific School/College degrees required for careers in specific disciplines, ie. PhD in
Nursing.
Additionally, the CTSI will coordinate a comprehensive mentoring program in clinical and
translational sciences in several concentration areas including cardiology and cardiovascular
surgery, oncology; community and geriatric medicine; neurological sciences; pediatrics;
ophthalmology; clinical and environmental toxicology, transplantation; and clinical outcomes/public
health. Appendix F details development components for future faculty and mentoring groups.
2) Develop novel clinical and translational methodologies and resources. The CTSI will
continue to build upon key areas of strength including pharmocogenetics, proteomics, metabolomics,
drug development and design, and bioethics. These resources are critical for new drug/device
development and new biomarker discovery.
3) Integrate university-wide activities in bioinformatics, clinical informatics, statistical and
regulatory support into a central cohesive unit to promote the clinical and translational
science enterprise at UofL. The NIH Roadmap identifies these areas as major barriers to the
conduct of effective biomedical research. The CTSI will build research capacity in the areas of
computational biology, bioinformatics and biostatistical expertise in accordance with the paradigm
shift in research and funding opportunities in the life sciences and in accordance with the NIH
Roadmap.
4) Expand and integrate a clinical and translational research resources network. Over the
past ten years, UofL and its healthcare partners have begun developing the critical resources
needed to perform clinical and translational research. Existing and expanded networks throughout
the city and state will be used to translate research into best practices. Moreover, we will continue
to seek new partnerships, particularly in areas/populations that are medically underserved.
Background
Between 1999 and 2003, the NIH doubled its budget for research. During that same period, UofL
not only matched the increase – but actually quadrupled – our amount of NIH funding. Indeed, UofL
was the national leader in percentage of increased funding as described by Brainard in “What the
NIH Bought with Double the Money” Chronicle of Higher Education (50(22): p. A17-A20, 2004). This
was accomplished via a fortuitous convergence of resource development, strategic planning, support
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from our healthcare partners, and direction from the state to become a nationally recognized
metropolitan research university. UofL continues its trajectory (NIH funding of $49 in 2004 and $77
million in 2005) despite the fact that the NIH budget has been stagnant since 2003.
The doubling of the NIH budget resulted in many important discoveries that now need to be applied
to clinical practice (the bench to bedside concept) as quickly as possible. As Dr. Zerhouni noted, “It
is the responsibility of those of us involved in today’s biomedical research enterprise to translate the
remarkable scientific innovations we are witnessing into health gains for the nation” (Zerhouni EA.
Translational and clinical science – time for a new vision. N Engl J Med. 2005 Oct 13;353(15):16213). The CTSAs are meant to serve as an institutional “home” to provide integrated physical and
academic resources unique to an individual institution in order to facilitate the conduct of clinical and
translational research.
The purpose of the CTSA funding announcement is to assist institutions in forging a
“uniquely transformative, novel, and integrative academic home for Clinical
and Translational Sciences that has the consolidated resources to: 1) captivate,
advance, and nurture a cadre of well-trained multi- and
inter-disciplinary investigators and research teams; 2) create an incubator for
innovative research tools and information technologies; and 3) synergize
multi-disciplinary and inter-disciplinary clinical and translational research and
researchers to catalyze the application of new knowledge and techniques to
clinical practice at the front lines of patient care” (NIH Roadmap for Medical
Research: Engineering the Clinical Research Enterprise, 2005).
Accordingly, the NIH specifies that each institution must create a program specific to its unique
needs and structure, and must offer educational opportunities, mentoring, and degrees to further the
mission. All such programs must “accrue significant institutional support, be granted status as a
major administrative entity within the applicant institution, and the program director must have
authority, perhaps shared with other high-level institutional officials, over requisite space, resources,
faculty appointments, protected time, and promotion.” (NIH RFA-RM-07-007: Institutional Clinical and
Translational Science Award U54, 2006)
Since there are 126 medical schools, this NIH initiative will effectively divide medical schools into tier
one and tier two categories. It is vital that we capitalize on this opportunity to promote our research
agenda; failure to do so will significantly inhibit our ability to maintain or grow our research
capabilities. Creation of the CTSI is absolutely necessary to ensure that UofL maintains our
nationally recognized centers of excellence and strengthens our prominence in the national
healthcare arena.
As evidence of institutional support, the CTSI must be formally approved by the University before
submission of the proposal to NIH by the October 24, 2007 deadline.
II. Impact on University Goals
The CTSI has a direct tie-in to the University’s mission to become a preeminent metropolitan
research university. Indeed, without the CTSI, it will be difficult, if not impossible, to achieve our
biomedical research goals. The CTSI will have a major impact on all five institutional goals as
established in the Challenge for Excellence.
Goal One: Student Success. The training and career programs, which are required and
recommended components of a CTSA, will provide training and mentored career development for
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predoctoral and postdoctoral students, fellows, and faculty. The CTSI will provide research
education, training, and career development opportunities (including certificates, interdisciplinary MS
and Ph.D degrees, fellowships and new faculty awards) for physicians, nurses, dentists, research
coordinators, and research scientists. The CTSI will take the lead in training the next generation of
clinical and translational researchers.
Goal Two: Research, Creative, and Scholarly Activities. Obviously, biomedical research is
directly related to Goal Two. Continuing to build on existing strengths within the University, and
fostering innovations through the CTSI, will strengthen UofL’s national reputation as a leader in
biomedical research. A goal of the CTSI, which is harmonious with the NIH Roadmap, is breaking
down barriers and fostering collaborative research within UofL as well as with the national and
international scientific community. A major goal of CTSAs is to encourage cross-departmental,
cross-school, and cross-campus interactions. The CTSI will foster these collaborations and
further the goal of Research, Creative and Scholarly Activities.
Goal Three: Accessibility, Diversity, Equity and Communication. The CTSI will maintain a
focused commitment to identifying, attracting, training and retaining minorities as well as individuals
from other groups who have traditionally been underrepresented in science-related fields.
Moreover, a goal of the CTSI is to partner with historically medically underserved populations
and geographic groups to translate medical research results into standard of care.
Goal Four: Partnerships and Collaborations. Over the past 10 years, UofL and its healthcare
partners have begun developing critical resources needed to perform clinical and translational
research and to care for citizens of the region and state. We now have networks throughout the city
and state which can be used to translate research into best practices. In addition to University
Hospital, the CTSI will partner with the James Graham Brown Cancer Center, the V.A. Medical
Center, Jewish Hospital and St. Mary’s HealthCare, and Norton Healthcare (which includes Kosair
Children’s Hospital), and the Louisville Metro Public Health Department to develop satellite
opportunities for patient recruitment and translational research in the central and western half of
Kentucky, southern Indiana, as well as several additional sites in eastern Kentucky. Adewale
Troutman, MD, MPH, Associate Professor, School of Public Health and Information Sciences and
Director of the Louisville Metro Public Health and Wellness will chair the taskforce to coordinate all
the community partners and community sites. Thus the CTSI will have an extensive presence in
rural areas, small cities, and inner city neighborhoods. These enhanced partnerships will not only
improve our science, but also the health and well being of the citizens in our region.
Goal Five: Institutional Effectiveness of Programs and Services. The CTSI will improve the
effectiveness of programs and services in fulfilling the mission and vision of the university. Indeed, it
can be argued that failure to follow the path outlined by the NIH Roadmap for research would
negatively affect institutional investments and outcomes.
Appendix G lists the specific Scorecard goals toward which the CTSI can make a positive
contribution. In addition to advancing University goals, it is readily apparent, based upon a review of
mission statements from the involved Colleges and Schools, (Appendix H) that the mission and the
goals of the CTSI are in harmony with those of our partner academic units.
Section III. Governance
NIH requires that the Director of the clinical and translational science institute (CTSI) report to a high
level position within the University. Accordingly, Dr. Craig McClain, Director of the CTSI, and
Associate Vice President for Translational Research, will report to Dr. Manuel Martinez-
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Maldonado, the Executive Vice President for Research. The proposed organizational chart is shown
in Appendix I.
Dr. McClain, will have overall responsibility for administration of the CTSI. As Project PI and
Director, Dr. McClain will devote at least 20% of his time to the CTSI program. Dr. McClain is a
widely recognized expert in liver disease, nutrition, oxidative stress and cytokine research. In
addition, he has extensive administrative and mentoring experience and is a knowledgeable grants
and program administrator. His research has been continuously federally funded since 1977 and he
currently receives research support from the VA, NIH, and industry. He is also a member of the NIH
Peer Review Advisory Group (PRAC) and is past president of the American College of Nutrition. Dr.
McClain’s UBM, and administrative assistant, as well as the U of L Clinical Research Center
administrator and nurse, are included in the CTSI budget (Forms 1 and 2) and will assist Dr. McClain
in the day to day operation of the Institute. The Office of Sponsored Programs and Health Sciences
Center Research Office have and will continue to work with Dr. McClain in the formation of the CTSI
and the CTSA grant proposal as a part of grant preparation and support responsibilities and the
Department of Medicine Grants Facilitator will also provide assistance.
Dr. Carlton Hornung, Ph.D., M.P.H. has extensive experience in clinical research education and
training and, as Program Director for Education, will devote 30% of his effort. Dr. Hornung, as
Education Director, will report to Dr. McClain. Dr. Hornung created the Clinical Research,
Epidemiology and Statistics Training (CREST) program at UofL in 1999 and obtained Clinical
Research Curriculum Development (NIH K30) funding from NIH in 2000.
Dr. Tom Knudsen, Professor of Dentistry, is a well-known expert in bioinformatics. Since the NIH
defines bioinformatics as a key area, Dr. Knudsen is currently Program Director for Informatics and
devote 10-15% of his time to developing this important resource at UofL. Dr. Knudsen currently
serves as the PI on three NIH research grants.
Pediatrics is defined by NIH as a key area for all CTSA awards. Thus, Dr. Jan Sullivan will
serve as Program Director for Pediatrics and will devote 10% effort to this. Dr. Sullivan
directs the Kosair Pediatric Pharmacology Research Unit, which is funded by NIH.
The Executive Committee for the CTSI will consists of Drs. McClain, Hornung, Knudsen, Sullivan,
and the chairs of the working group committees. This committee will meet at least quarterly.
An Internal Advisory Committee has been formed and will play a vital role in this multidisciplinary and
interdisciplinary effort. In addition to Drs. McClain , Hornung, Knudsen and Sullivan, members
include Drs. Ron Atlas, Dean of the Graduate School; Rick Clover, Dean of the School of Public
Health and Information Sciences; Don Miller, Director of the Brown Cancer Center; Denis Kinane,
Associate Dean for Research and Enterprise of the School of Dentistry, Rob Keynton, Department
Chair of Bioengineering; Barbara Speck, Associate Dean for Research in the School of Nursing;
Riaan Van Zyl, Associate Dean for Research of the Kent School, Ken Ramos, Department Chair of
Biochemistry; Eleanor Lederer, Acting Vice Dean for Research, School of Medicine; David Hein,
Department Chair of Pharmacology & Toxicology; Manuel Martinez, EVPR; George Pack, Associate
VPR; a representative from Jewish Hospital and St Mary’s HealthCare; and a representative from
Norton Healthcare. Beverly Daly, Sponsored Programs Development; and Rita Wedig, HSC
Research Office will serve ex officio. The Internal Advisory Committee will meet at least twice a
year, and more often as needed.
To avoid potential conflicts of interests, the NIH has requested that applicants delay the formation of
external advisory committees until after several rounds of full CTSA grants have been awarded.
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After the CTSA has been awarded, we will be free to invite nationally known experts on clinical and
translational science to serve on the CTSI External Advisory Committee.
Several additional working committees have been formed and have been meeting regularly over the
course of the planning period. These include members specializing in Education, Bioinformatics and
Biostatistics, Community Engagement, Facilities/Cores/Centers, Hospitals, Regulatory Affairs and
Ethics, Partnerships in Innovation, and Pilot Projects. The Chairs of those committees constitute the
Executive Committee which will meet frequently with the Director and the Internal Advisory
Committee to determine policy and procedures. Committee members are listed in Appendix J.
Section IV. Resources
Initially, 2-3,000 square feet of space will be needed as operational space for the CTSI. Currently
space has allocated in K building (wing) 2nd floor and Carmichael building. Increased space will be
provided by the University commensurate with the Institute’s growth and ability to generate revenue.
For example, Vanderbilt University, which just applied for a CTSA award in January, is
building a 350,000 square foot building to house their CTSA effort. Additional resource detail,
including necessary staff support, is provided in the budget section.
Section V. Evaluation Plan
The CTSI will conduct a formative evaluation that will provide on-going feedback to CTSI Program
Directors, the Internal Advisory Committee and the Executive Committee. Implementation and
achievement of educational and research goals will be assessed. Key constituency groups – senior
and junior faculty linked to the Institute, students in CTSI programs, and representatives from
medical and community health networks outside UofL – will provide input about CTSI initiatives and
suggestions for expanding or improving the Institute’s activities will be solicited.
The evaluation will draw heavily on existing UofL data systems to track student enrollment and
graduation from certificate and degree programs, professional presentations and publications, as
well as grant submissions and awards. CTSI program records (committee minutes, faculty
appointments, etc.) will provide information on faculty involvement with CTSI planning and
implementation of educational, mentoring and research initiatives. Each year the evaluation staff will
pull together this information in order to monitor CTSI progress on key indicators related to
enrollment and graduation rates, research funding and scholarly outcomes.
The CTSI will form an interdisciplinary research review group to review unfunded research proposals
for clinical and translational research. The purpose of the review will be to provide suggestions to
strengthen proposals. These could include: other research faculty to be added to the research
proposal; additional novel clinical or translational methodologies or resources to be utilized; and
computational, mathematical, or statistical modeling expertise available through CTSI that could be
used to enhance research proposals. This information will help the CTSI Program Directors, the
Internal Advisory Committee, and the Executive Committee understand what needs to be done to
build a greater research capacity at UofL.
In addition, each year the evaluation staff will conduct electronic surveys of students involved in
CTSI related certificate and degree programs, junior faculty and clinical fellows mentored by senior
research faculty, non UofL medical and community health representatives with a commitment to
research, and senior research faculty connected with the CTSI program. Each survey will focus on
respondents’ degree of involvement with CTSI activities, reviews of their involvement and
suggestions about how CTSI can expand or improve its initiatives to more effectively achieve its
goals.
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APPENDIX A:
http://nihroadmap.nih.gov/overview.asp
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APPENDIX B:
8
APPENDIX C:
CTSA Info
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Appendix D
Descriptions of the K12 and T32 Career Development Components of the CTSI
K12 Mentored Clinical Scientist Development Program Award (required by the CTSA)
The purpose of the National Center for Research Resources (NCRR) Mentored Clinical Research
Scholar (CRS) Program Award (K12) is to support an institutional career development program for
physicians and other doctoral level investigators interested in clinical and translational research, to
develop the skills to become independent patient-oriented clinical investigators. The institutional
programs are to include activities that will provide candidates a comprehensive understanding of
clinical research approaches that are fundamental and not necessarily disease-specific. Under this
award, recently trained physicians and others will be selected to participate in an integrated didactic
and mentored research program. Funds provided by this award may be used to support full or
partial completion of an advanced degree in health-related research (e.g. M.S., M.P.H., Ph.D.). K12
Awards are granted to educational institutions, not individuals.
In concert with a proposed mentor, an applicant for the CRS program proposes a comprehensive,
individualized career development program that will prepare the trainee for an independent career in
clinical research including patient-oriented research. The didactic and research phases of this
program must include acquiring expertise across a broad spectrum of research methodologies,
technologies, concepts, use and management of large datasets, bioinformatics and other research
tools as well as communication skills required for a participating physician or dentist to be well
trained in their selected research discipline. The program should be designed to accommodate
candidates with varying levels of research experience. If appropriate, candidates should be exposed
to both research that is typically undertaken with a few investigators and to research approaches that
require a multidisciplinary team to address complex research questions. The team research
approach fosters cross-disciplinary collaborations.
The K12 award will provide for a minimum of two years and a maximum of five years of consecutive
funding for each Clinical Research Scholar, consisting of consecutive 12-month appointments. In
general, 75 percent of the Clinical Research Scholars' full-time professional effort must be devoted to
the K12 Program. However, certain clinical specialties can have less than 75 percent, but no less
than 50 percent, protected time for this program if sufficiently justified (for example, surgical
specialties requiring 50 percent direct patient care time to keep up surgical skills).
(K12 description adapted from NIH FRA-RM-04-006, Multidisciplinary Clinical Research Career
Development Programs, http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-04-006.html)
T32 Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research
Training Grants
The NIH will award NRSA T32 grants to eligible institutions as the primary means of supporting
predoctoral research training to help ensure that a diverse and highly trained workforce is available
to assume leadership roles related to the Nation’s biomedical, behavioral and clinical research
agenda. The primary objective is to prepare qualified individuals for careers that have a significant
impact on the health-related research needs of the Nation. For the CTSA grant, predoctoral funding
is available only for disciplines in translational science.
This program supports predoctoral training programs at domestic institutions of higher education.
Only domestic, non-profit, private or public institutions that have strong and high-quality research
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programs in the area(s) proposed for research training and have requisite staff and facilities may
apply for grants to support a T32.
Awards for T32 institutional NRSA research training grants may be for project periods up to five
years in duration and are renewable. Trainees are required to pursue full-time research training.
(T32 description adapted from NIH PA-06-048.
http://grants1.nih.gov/grants/guide/pa-files/PA-06-468.html)
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Appendix E:
Existing Educational Components of The Clinical and Translational Science Institutes.
Graduate Certificate: The Graduate Certificate program will become a vehicle for students who
want to enter a graduate/professional discipline to obtain training in clinical and translational
sciences. They can either use the certificate to site for their clinical research coordinator certification,
apply the credits toward their graduate degree, or complement their existing degree with an
appreciation for translational sciences. We will utilize existing courses and develop new ones to
teach students basic skills including biostatistics, epidemiology, responsible conduct of human and
animal research, regulatory issues and health services and outcomes research.
M.Sc. Deqree Curriculum: The present curriculum for the M.Sc. degree is listed below;
however, to meet the needs of the “Bench to Bedside” mission of this degree, the curriculum will be
examined by an interdisciplinary team. This endeavor will also address comments from K30
reviewers and the current guidelines of the CTSA.
Year 1
Summer Semester
PHCI 501 – From Bench to Bedside: Introduction to Clinical Research (credit hours, 1)
Fall Semester
PHCI 611 - Introduction to Clinical Epidemiology (2)
PHST 600 – Introduction to Biostatistics (3)
PHCI 631 – Social and Behavioral Science in Health Care (2)
PHCI 610 – New Drug and Device Development (2)
PHCI 699 – Mentored Research (1-6)
Spring Semester
PHEP 602 – Epidemiological Methods (3)
PHCI 624 – Clinical Trials I (2)
PHCI 632 – Ethical Conduct of Health Care Research (2)
PHCI 699 – Mentored Research (1-6)
Year 2
Summer Semester
PHCI 601 - Evaluating the Health Care Literature (1)
PHCI 699 - Mentored Research (1-6)
Fall Semester
PHCI 625 – Clinical Trials II (2)
PHCI 650 – Medical Decision Analysis (2)
PHCI 602 – Health Services and Outcomes Research (2)
PHCI 699 – Mentored Research (1-6)
Spring Semester
PHCI 699 – Mentored Research (1-6)
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Appendix F:
Future Postdoctoral, Fellow and Faculty Development Components of the Clinical and
Translational Science Institutes
From Fellow to Faculty: Recruiting New Faculty: We will implement a two year program and
create a pool of funds to support the transition “From Fellow to Faculty” for one fellow in Pediatrics
and one fellow in medicine who are interested in a career in academic medicine. Dr. Larry Cook
(EVPHA) and Dr. Gerard Rabalais (Pediatrics) are supporting this career development program for
physician scientists. It will be modeled after the NIH K12 Career Development Award. If Uof L
obtains a CTSA grant, this program will be expanded to support the recruitment of new faculty for the
SON, SOD, SPHIS and the basic sciences on the Belknap campus. These awards will be
competitive. A goal is to have the CTSI provide salaries for 75% protected time for these ‘clinical
research scholars’ for two years while they complete the Interdisciplinary MS or the MSc degree.
Scholars funded under this initiative will be required to submit a K08 Mentored Clinical Scientist
Research Career Development Award, K23 Mentored Patient-Oriented Research Career
Development Award or similar proposal to satisfy degree requirements. The clinical research
scholar will be given a three-year, term faculty appointment at the rank of Lecturer or Assistant
Professor (depending upon the Department’s board certification requirements for academic rank),
and the Department Chair must guarantee 75% protected research time for three years.
Faculty Development: The CTSI, along with our Office of Sponsored Programs and the Health
Sciences Center Research Office, will assist faculty in identifying funding sources and in the
preparation of multi-disciplinary, multi-school and multi-institutional grant proposals. The Institute will
establish a library of successful grant proposals to share with potential applicants. Junior faculty will
have a senior established investigator assigned to them as a mentor and an epidemiological and/or
biostatistician supported by the Center will guide them in the preparation of their grant proposals.
We will also help them obtain internal or external funding for necessary pilot studies. We will provide
guidance in the preparation of budgets and other required documents. We will conduct mock study
sections to review proposals and provide applicants with written comments prior to submission.
Helping faculty become better teachers and mentors for students is an important task of the
CTSI. To accomplish this, we will encourage all faculty, and especially junior faculty, to attend our
monthly seminar series for health educators conducted by the SOM.
The CTSI will include an Education Committee with faculty drawn from across the University and
nominated by their respective Deans. This committee will be charged with identifying duplication of
clinical and translational science courses in the health professional schools and the graduate school,
identifying gaps and/or inconsistencies in course offerings, and suggesting innovative ways in which
we can meet the education and training needs of the next generation of clinical and translational
scientists. The committee will consult with experts from around the country on strategies for creating
inter-disciplinary and inter-school curricula and learning environments. Having a shared learning
environment may be the single most important factor in stimulating interdisciplinary, inter-school and
inter-institutional research. The committee will coordinate training grant efforts across the university
to ensure the best utilization of resources and best utilization of our senior mentors.
Mentoring: At U of L, we have a strong pool of senior mentors who are enthusiastic about guiding
new students/faculty/fellows. We have listed three investigators from each of our initial focus areas
of mentoring. An asterisk denotes mentors holding endowed chairs, or university scholar awards,
thus demonstrating the impact of the Challenge for Excellence. All faculty members listed below
have extensive mentoring experience. Dr. McClain, the Director, is an excellent example. He has
mentored over 23 residents and fellows, and more than 25 students have obtained Ph.D.’s in his
laboratory working in the areas of nutrition or toxicology, or have served as postdoctoral fellows in
those areas. Perhaps most importantly, he has mentored 19 junior faculty who obtained 21 career
awards similar to the NIH K awards; all but two are still in academic medicine. Currently, he serves
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as mentor for four K-awardees, and another has just finished working with his group. Two already
have RO1 funding. It can be clearly demonstrated that strength in mentoring is a highlight of our
program.
Cardiology and Cardiovascular Surgery:
*Sumanth Prabhu, MD, Professor of Cardiology, SOM
*Laman Gray, MD, Professor of Surgery, SOM
*Rob Keynton, Ph.D, , Chair and Professor of Bioengineering, Speed School of
Engineering
Oncology:
*Donald Miller, MD, Ph.D, Director, Brown Cancer Center & Professor, SOM
Glenn McGregor, MD, Assoc. Professor of Pharmacology, SOM
*John Eaton, Ph.D, Deputy Dir., Brown Cancer Center & Professor, SOM
Community and Geriatric Medicine:
*Toni Miles, MD, Ph.D, Professor of Community & Geriatric Medicine, SOM
Adewale Troutman, MD, MPH, Director, Louisville Metro Public Health and Wellness
& Assoc. Professor, SPHIS
Kay Roberts, EdD, FAAN, ARNP, Professor, SON
Neurological Sciences:
*Christopher Shields, MD, Chair and Professor of Neurosurgery, SOM
*Manuel Casanova, MD, Professor of Psychiatry, SOM
*Scott Whittemore, Ph.D, Professor of Anatomical. Sciences, SOM
Ophthalmology:
*Henry Kaplan, MD, Chair and Professor of Ophthalmology, SOM
*Gary Foulks, MD, Professor of Ophthalmology, SOM
Tongalp H. Tezel, MD, Assistant Professor of Ophthalmology, SOM
Pediatrics:
*David Gozal, MD, Professor & Dir. Pediatric Research Institute, SOM
Jan Sullivan, MD, Professor & Dir. of Kosairs Charities Hosp. CRU,
Pediatrics, SOM
*Dennis Molfese, Ph.D, Professor, Birth Defects Research Center, SOD
Clinical and Environmental Toxicology:
*Craig McClain, MD, (Principal Investigator) Professor of Gastroenterology, SOM
*Aruni Bhatnagar, Ph.D., Professor of Cardiology, SOM
*David Hein, Ph.D, Chair & Professor of Pharmacology, SOM
Transplantation:
*Suzanne Ildstad, MD, Prof., Dept. of Surgery & Dir. Institute of Cellular
Therapeutics, SOM
Haval Shirwan, Ph.D, Professor of Microbiology & Institute of Cellular Therapeutics,
SOM
Robert Dowling, MD, Professor of Surgery, SOM
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Clinical Outcomes/Public Health:
*Denis Kinane, BDS, PhD, Associate Dean of Research, SOD
William P. McKinney, MD, Associate Dean of Research & Professor, SPHIS
*David Tollerud, MD, MPH, Chair and Professor of Environmental. & Occupational
Health Sciences, SPHIS
*Endowed chairs and University Scholars
16
Appendix G:
Scorecard Goals
Specifically, formation of an innovative, robust CTSI would make a positive contribution toward
achievement of the following Scorecard goals:
1.6
1.11
2.3
2.4
2.5
2.6
2.7
2.8
2.9
2.10
2.11
2.12
2.14
2.16
2.17
2.18
3.3
3.17
3.18
3.19
4.1
4.2
4.3
4.8
4.9
4.11
4.12
4.13
4.14
Number of undergraduate students involved in research or creative activity in
collaboration with faculty
Number of disciplines graduating doctoral students
Nationally recognized programs
Total number of grants and contracts awarded
Total grants and contracts -- dollar amount received by PI’s unit
Total grants and contracts -- dollar amount by collaborating investigators.
Total number of research grants and contracts proposals submitted
Total number of research grants and contracts awarded
Total research grants and contracts -- dollar amount received
Total federal research grants and contracts – dollar amount received
Extramural research and development expenditures (NSF)
Federal research and development expenditures (NSF)
Invention disclosures received
Number of faculty on sponsored research
Number of students on funded research
Total publications in refereed journals
Number of African American professional students
Number of African American students receiving doctoral degrees
Number of women receiving doctoral degrees
Number of African American students receiving master’s degrees
Number of faculty teaching across academic disciplines
Number of interdisciplinary grant applications
Number of interdisciplinary research projects
Number of joint grants with industries (e.g. SBIR)
Number of partnerships that support local metropolitan area government agencies
Number of partnerships that support community-based organizations
Number of partnerships that support health-care organizations
Number of partnerships with state and regional agencies
Number of collaborative programs with K-12 educational institutions
17
Appendix H:
Mission Statements
School of Medicine
To be a vital component in the University of Louisville’s quest to become a premier,
nationally recognized metropolitan research university,
To excel in the education of physicians and scientists for careers in teaching, research, patient care
and community service, and
To bring the fundamental discoveries of our basic and clinical scientists to the bedside.
School of Nursing
The University of Louisville School of Nursing is an essential partner of a research intensive
academic health science center in a nationally recognized University serving a metropolitan
community.
The School of Nursing is a community in which faculty, staff and students collaborate to promote
excellence in the profession of nursing. This is accomplished through research and scholarship that
inform undergraduate and graduate education, support evidence-based practice and foster advances
in nursing science. Students are prepared to demonstrate excellence in nursing science, practice
and leadership in a variety of settings for the benefit of clients across the lifespan and to meet the
evolving health care needs of society. As a citizen of the larger community, the emphasis of the
School of Nursing is to address the complex health needs of diverse and dynamic populations
through nursing education, research, scholarship and service.
School of Public Health and Information Sciences
The School of Public Health and Information Sciences will be a national center of excellence for
research and education in population-focused health sciences, including community health,
population health, and health information sciences.
School of Dentistry
The University of Louisville School of Dentistry, through excellence in teaching and research, will
educate competent dental professionals. The school will provide quality dental care and will serve
the community to fulfill our urban and statewide missions.
Speed Engineering School
The mission of the J. B. Speed School of Engineering is to serve the university, the Commonwealth
of Kentucky, and the engineering profession by providing high quality educational programs to all
students; engaging in research and scholarship that will extend knowledge; and assisting the
economic development of the regional, state and national economies through technology transfer.
Kent School of Social Work
The Kent School of Social Work seeks to prepare competently trained social workers who practice
from a strong professional value base to serve the metropolitan mission of the university. These
social workers are educated to practice with individuals, families, and communities and to promote
social justice.
In the context of a research institution, the Kent School is committed to knowledge development that
informs the practice of social work, recognizing the importance of collaboration among differing
disciplines to solve complex social problems.
18
Arts and Sciences
The mission of the College of Arts and Sciences is to improve life in the Commonwealth and
particularly in the greater Louisville urban area, creating knowledge through its research, sharing
knowledge through its teaching, and guiding all its students to realize their potential.
19
Appendix I:
University of Louisville’s
CTSI
President’s Office
President
Provost
Executive VP for Research
Executive VP for Health Affairs
Internal Advisory Committee
-Deans
-Hospitals
-Others
Director, CTSI
External Advisory Committee
Program
Director, Education
Program
Director, Pediatrics
Program
Director, Informatics
CTSI Executive Committee
Pediatrics
Novel Clinical &
Translational
Methodologies
Clinical
Research
Resources
Regulatory
Affairs
Community
Bioinformatics
Outreach
AHEC
TroverClinic
Health Depts.
20
Translational
Technology &
Resources
Pilots
Education
Studies
Interdisciplinary
MS/PhD
Training grants
Curriculum Dev.
Biostatistics
Methodologies
& Ethics
Appendix J:
CTSI Workgroups
Education:
Program Director: Carl Hornung, Professor, School of Public Health &
Information Sciences
Ron Atlas
Dean, Graduate School
Erin Mulford-Brown Jewish Hospital and St. Mary's HealthCare
Beverly Daly
Staff, Sponsored Programs Development
Carl Hornung
Professor, School of Public Health and Information Sciences
Anna Faul
Associate Dean, Kent School of Social Work
Cynthia McCurren
Acting Dean, School of Nursing
Russell Prough
Special Assistant to the Dean; Professor of Biochemistry, School
of Medicine
Peter Rowell
Professor of Pharmacology, School of Medicine
Richard Stremel
Professor of Physiology, School of Medicine
Edward Halperin
Dean, School of Medicine
Rod Barber
Professor, Kent School of Social Work
Paul DeMarco
Assoc. Dean, Graduate School
Gerald Dryden
Assistant Professor, of GI, School of Medicine
David Hein
Chair and Professor of Pharmacology, School of
Medicine
Steven Koenig
Associate Professor, School of Medicine and Speed Sch. Engineering
Susan Muldoon
Assistant Professor, School of Public Health and Information
Sciences
David Scott
Associate Professor, School of Dentistry
Bioinformatics:
Patricia Cerrito
Richard Clover
Nigel Cooper
Bruce Edwards
Adel Elmaghraby
Robert Esterhay
Aly Farag
Tom Knudsen
Troy May
Greg Pugh
Kenneth Ramos
Walter Sobczyk
Thomas Whittman
Ben Yandell, Jr.
Peter Walton
Andrew Lane
Charles Moyer
Program Director: Tom Knudsen, Professor, School of Dentistry
Professor of Mathematics, College of Arts and Sciences
Dean, School of Public Health and Information Sciences
Professor of Anatomical Sciences, School of Medicine
Privacy Officer, University of Louisville
Professor, Speed School of Engineering
Chair of Health Management and Systems Science, School
of Public Health and Information Sciences
Professor, Speed School of Engineering
Professor, School of Dentistry
Chief Information Officer, University of Louisville Hospital
Jewish Hospital and St. Mary's HealthCare
Chair of Biochemistry, School of Medicine
Associate Professor of Pediatrics, School of Medicine
Jewish Hospital and St. Mary's HealthCare
Norton HealthCare
Professor, School of Public Health and Information Sciences
Professor Medicine, JGBCancer Center
Dean, School of Business
Biostatistics, Methodology and Ethics:
William Dougherty
Bioclinical Statistician, University of Louisville Hospital
Rudoph Parrish
Chair of Bioinformatics and Biostatistics, School of Public Health
and Information Sciences
21
Ramona Stone
Paul McKinney
Susan Muldoon
Mark Rothstein
Larry Palmer
David Doukas
Jane Goldsmith
Osborn Wiggins
Kathy Baumgartner
Richard Baumgartner
Assistant. Professor, Kent School of Social Work
Assoc. Dean, School of Public Health and Information Sciences
Assoc. Professor, Biostatistics, Director of the CREST Program
Director, Institute for Bioethics, Health and Law
Professor, Institute for Bioethics, Health and Law
Professor, Family and Geriatric Medicine
Assoc. Prof, Biostatistics
Chair, Department of Philosophy
Department of Epidemiology
Department of Epidemiology
Community Engagement
Marti Arvin
Privacy Officer, University of Louisville
Theresa Baker
Trauma Coordinator, University of Louisville Hospital
Ann Banks
Office of External Affairs, U of L
Gerard Barber
Professor, Kent School of Social Work
Ellen de Graffenreid Director of Marketing, U of L Health Science Center.
Bonnie Ciarroccki
Jefferson County Public Schools
Sharon Elsesser
Norton HealthCare
Mary C. Lyle
Co-Director, UAW-Ford Community Healthcare Initiative
Lee Mayer
Assistant Professor, School of Dentistry
Suzanne Meeks
Professor of Psychology, College of Arts & Sciences
Toni Miles
Professor of Family and Geriatric Medicine, School of Medicine
Debbie Molnar
Jewish Hospital and St. Mary's HealthCare
Mark Pfieffer
Professor of Medicine
Irma Ramos
Assistant Professor, School of Public Health and Information
Sciences
Kay Roberts
Professor, School of Nursing
Faye Jones
Assoc. Dean Medicine and Director Area Health Education Centers,
University of Louisville
Adewale Troutman Director of Louisville Metro Public Health and Wellness and Associate
Professor, School of Public Health and Information Sciences
Rita Wedig
Director, HSC Research Office
Translational Technology and Resources:
Teresa Fan
Assoc. Prof. of Chemistry, College of Arts and Sciences
Aly Farag
Professor, Speed School of Engineering
Jon Klein
Professor, School of Medicine; Director, Proteomics Core
Steven Koenig
Associate Professor, School of Medicine and Speed Sch. Engineering
William Pierce
Professor of Pharmacology, School of Medicine
Greg Rempala
Assoc. Prof., Mathematics and Center for Genetic & Molecular Medicine
Robert Topp
Professor, School of Nursing
Michael Voor
Associate Professor of Orthopedic Surgery, School of Medicine
Ronald Gregg
Assoc. Prof. Biochemistry, JGB Cancer Center
Eugenia Wang
Professor, Biochemistry and Director Gheens Ctr. For Aging
Alfred Jensen
Professor, JGB Cancer Center
Johnathan Chaires Professor, Medicine, JGB Cancer Center
Michael Nantz
Professor, Department of Chemistry
Russ Prough
Professor, Biochemistry, Special Assist. to Dean of Medicine
22
Clinical Research Resources:
Lale Akca
Outcomes Research Institute
Bob Barbier
CFO, University of Louisville Hospital
Furqan Siddiqui
Director of Clinical Research, University of Louisville Hospital
Mary Jane Kennedy Assistant Professor of Pediatrics, School of Medicine, Co-Director,
KCPCRU
Eleanor Lederer
Professor and Acting Vice Dean for Research, School of Medicine
Steve Mahanes
Manager Clinical Research Center
Ed Miller
Jewish Hospital and St. Mary's HealthCare
Lynn Simon
Medical Director, Jewish Hospital and St. Mary’s HealthCare
Steven T Hester
Vice President, Medical Affairs Norton Healthcare
Tracy Williams
Vice President, Norton HealthCare
Linda Keithley
Veterans Administration.
Steve Winters
Professor, Medicine, Director Clinical Research Center
David Tollerud
Professor, Medicine, Director, P30 Clinical Trials Center
Jan Sullivan
Professor, Pediatrics, Director, KCPCRU
Ann Swank
Professor of Exercise Physiology and Health Sciences, College of
Education and Human Development
Jason Chesney
Department of Medicine, BCC Clinical Trials
Craig McClain
Professor, Department of Medicine; Assoc. VP Research
Larry Cook
Executive VP, Health Affairs
Regulatory Affairs
Mary Jane Adams
Marti Arvin
Karen Beatty
John Burke
Gary Foulks
Nancy Gentry
Rhonda Hoffman
David King
Angela Lewis-Klein
Beth McCracken
Holly Neibergs
Cathy Whalen
Cheri Hildreth
University of Louisville Hospital
Privacy Officer, University of Louisville
Clinical Research Center, Liver Disease, School of Medicine
Director of Human Subjects Protection Program, University of Louisville
Professor of Ophthalmology, School of Medicine
Jewish Hospital and St. Mary's HealthCare
Jewish Hospital and St. Mary's HealthCare
Director of Industry Contracts, University of Louisville
Pediatric Pharmacology Research Unit, Pediatrics, School of
Medicine
Director of Research, Norton Hospital
Director of Clinical Trials, Norton Hospital
Pharmacy Manager, University of Louisville Hospital
Director, Environmental Health and Safety, University of Louisville
Novel Clinical and Translational Methodologies:
Joanne Berryman
Jewish Hospital and St. Mary's HealthCare
Mark Carter
Jewish Hospital and St. Mary's HealthCare
John Eaton
Professor, School of Medicine
Teresa Fan
Associate Professor of Chemistry, College of Arts and Sciences
Steven Gailar
President and CEO, Metacyte Business Labs
Robert Keynton
Chair and Professor Bioengineering, Speed School of Engineering
David King
Director, Office of Industrial Contracts
Sean Kuntz
Manager, Metacyte Business Labs
David Phelps
Venture Capitalist, CreoSalus
Roland Valdez
Professor of Pathology, School of Medicine
James Zanewicz
Director of Technology Transfer, University of Louisville
Irene Litvan
Professor, Neurology
23
.
Pilot Projects
Sven-Ulrik Gorr
Robert Keynton
Carolyn Mervis
Paul McKinney
Barbara Speck
Christopher States
Stephen Winters
Manuel Martinez
Professor, School of Dentistry
Chair and Professor, Speed School of Engineering
Professor of Psychology, Arts and Sciences
Associate Dean and Professor, School of Public Health and
Information Sciences
Associate Dean and Professor, School of Nursing
Professor of Pharmacology, School of Medicine
Professor of Endocrinology, School of Medicine
Executive Vice-President for Research
Pediatrics: Program Director: Jan Sullivan, Professor of Pediatrics, School of Medicine
Cook, Larry
EVPHA
Gozal, David
Professor, Pediatrics
Rabalais, Gerard
Professor and Chair, Pediatrics
Sullivan, Jan
Professor, Pediatrics
Paul Epstein
Professor, Pediatrics
David Adamkin
Professor, Pediatrics
Mary Jane Kennedy Asst.Prof., Pediatrics, Associate Director, KCPCRU
Gary Marshall
Pediatric Clinical Trials Unit
24
NARRATIVE FOR FORM 2: Amount and Sources of Revenue*
1. Regular state appropriation and tuition and fees
a. New money
Drs. Martinez and Halperin have promised 2.5 new FTE for bioinformatics and biostatistics (I,1 a, b,
c, d on the budget page). Each are funded at approximately 50%, thus U of L Departments/Schools
are providing the remainder of the funds to support a full FTE. The first 2 positions will be
cosponsored by Schools of Dentistry, Nursing and Department of Pediatrics. Letters from Drs.
Martinez and Halperin are attached documenting these commitments.
A K12 postgraduate scholars program (fellow to faculty, page 1 and 10) is required for the CTSA
grant, and Dr. Cook has committed to providing $75,000/year (2 year program, total $150,000) for
the “fellow to faculty” program. The stipend will cover 75% release time, tuition, books, etc. Most
of the fellows must pay out-of-state tuition, thus that has been included in the $75,000.
b. 1. Internal reallocation for Personnel to cover Services needed in the CTSI:
The K12 as mentioned above will require a core of clinical and translational courses. The same
courses (approximately 22 hours) are now provided in the CREST Program (MSc Degree) in School
of Public Health and Information Sciences (pages 9 and 10). A portion of the money Dr. Cook
allocates for the CREST program will cover the cost of the K12 core courses (see Dr. Cook’s letter).
These courses will be billed at a flat fee, including $7,000/2 credit hour or $4000/1 credit hour to the
CTSI.
Dr. Cook and Dr. Halperin currently fund the CRC, thus salary support for the CRC administrator and
nd
for the CRC nurse will come from those funds. In addition, nursing support is increased for the 2
rd
and 3 year to cover the increased use of the CRC. University Hospital is now looking for PRN
support to assist the CRC nurse with the increased workload.
Because of the need for investigators, clinical and translational, to be competent in compliance and
regulatory issues, it will become mandatory by the hospitals that training in those specific areas are
covered. The partner hospital personnel (year 1 University Hospital), Executive Vice President for
Research and CTSI administration have the expertise to teach those courses. Letters from University
Hospital and Dr. Martinez include those personnel costs.
b.2. Internal reallocation for CTSI Administration:
Drs. McClain’s, Hornung’s, and Knudsen’s first year salary allocation to CTSI is covered by the
Planning grant. The succeeding years will be covered by Dr. Martinez (letter provided). Because the
CTSA RFA strongly recommends that a Pediatric component be included in the grant, Dr. Jan
Sullivan will devote 0.1 FTE to the CTSI. Her salary will be contributed by the Department of
Pediatrics as Dr. Gerard Rabalais letter indicates. Also included in the CTSI administration income is
the Administrative Assistant, and the Unit Business Manager. Their salaries will be covered in
LICTS by the EVPR (included in Dr. Martinez’s letter).
All operating and capital costs, will be covered for the CTSI by Dr. Martinez except for the first
year’s travel which is predominately covered by the planning grant.
25
2. Institutional allocation from restricted endowment: None
3. Institutional allocation from unrestricted endowment: None
4. Gifts: None; however, plans will be developed for a $10,000,000 fund raiser.
5. Extraordinary state appropriation: None
6. Grants or contracts
a.
Private sector
b.
Local government
c.
State
d.
Federal We have been awarded a CTSA planning grant, which would cover $150,000 for
year 1, 10/06-9/07in support of Drs. McClain, Hornung, Sullivan, and Knudsen.. A full CTSA grant,
approximately $ 4 million, will be submitted in the next year. Thus there is a possibility that it could
nd
be funded in years 3 to 4. We do not expect a fundable score until at least the 2 submission.
e.
Other
7. Capitation: None
8. Capital: None
9. Other (please specify): None
26
Budget Rational for Clinical and Translational Sciences Institute
I, and II. A 3% increase in salaries and supplies/year has been included for all 3 years except for new
FTE.
I, 1. a Three bioinformatics people and two biostatisticians will ultimately be part of CTSI; however,
the positions for the Institute are all funded at approximately 50% and are in the budgets of Dr.
Martinez and Dr. Halperin. The positions are being matched and allocated as follows for the first
year, FY 07-08,: a junior faculty (biostatistician) FTE, CTSI portion of the salary $54,574 (fringe
$11,733), and matching funding from the Schools of Dentistry and Nursing for one full FTE; a
second position (biostatistician) at the senior faculty level, CTSI portion of the salary $94,650 (fringe
$20,350) will be matched by the Department of Pediatrics. Thus the total amount allocated for CTSI
for year 1 is $181,307 has been matched. Thus 2 positions will be offered.
For subsequent years, FY2 (two junior faculty positions at 50% funding, $132,615) and 3 (one senior
level faculty at 50% funding, $115,000), the same method will be used to financially supplement
those positions. The three positions for FY2 and 3 are bioinformatics positions. Drs. Martinez,
McClain, and Knudsen are drafting long term bioinformatic needs based on the UofL Research
Strategic Plan. When the Strategic Plan is completed, the focus and faculty requirements can be
developed that complement the CTSI. This will impact the source that will be approached for the
matching funds to provide a full FTE.
I, e. The existing FTEF includes .2FTE for Dr. McClain, .3FTE for Dr. Hornung, .1FTE for Dr.
Sullivan and .15FTE for Dr. Knudsen.
In addition, the funding for faculty who will teach in the K12 postgraduate core education program
are listed in this section. The School of Public Health and Information Sciences (SPHIS) and CTSI
have listed core courses for this component of the CTSA grant and SPHIS will charge the CTSI a flat
fee which includes approximately $7,000 for 2 credit hours, or $4000 for 1 credit hour. The SPHIS
have calculated that the first year’s charge will be $96,250. That amount was increased 3% for years
2 and 3 as indicated above.
I, 1.e & II. The Clinical Research Centers (CRC, University Hospital and Kosair Children’s Hospital)
as a part of the CTSA must offer training in regulatory issues (human subjects and HIPAA), clinical
trails, budgeting, etc. This component of the CRC will be covered by part-time faculty. The parttime FTE faculty are individuals employed at our partnering hospitals whose jobs include the skills
needed to teach segments of the program. In addition, components of the program (regulatory) will
be covered by Dr. Martinez’s staff. The budgets for the 2nd year will increase with the offerings of
budgetary issues, compliance, audits, hospital credentialing, etc. These courses will be available to
all faculty and students interested in translational research and a portion of them required for clinical
research at partnering hospitals.
I, 3. The Clinical Research Center (CRC) Administrator (Steve Mahanes) and Nurse (Karen Beatty)
are included in the budget and are currently covered in Dr. Cook’s budget and will be reallocated to
the CTSI. The CRC is a mandatory part of CTSI as it is required for all Clinical and Translational
Scientific Awards (CTSA). We anticipate the need for a second nurse starting in year 2.
27
Included in the CTSI administrative budget are a secretary (administrative assistant) and a unit
business manager. The Secretary is a current employee who will spend 50% of her time in year 1 on
CTSI and increase to ¾ time in year 2; the UBM is likewise an existing UBM who will spend 25% of
her time in year 1 and increase over to 50% in year 2.
II, 1. The CRC supplies are not included in this budget as they are dependent on the clinical studies
being conducted in the CRC.
The general supplies for the CTSI are covered in Dr. Martinez’s budget. The supply category does
include office supplies for CTSI and supplies/advertising needed for recruitment of the faculty
indicated above.
II, 2 The travel category includes bringing in experts for consultation and evaluation (external review
committee) and the costs for recruitment of faculty listed above.
II, 3. No additional Library support is needed. A letter from Neal Nixon, the Director of Kornhauser
Library is attached.
II, 4. Support is for post-doctoral research and clinical fellows (must have completed MD degree and
residency). The figure ($75,000/fellow) assumes out-of-state tuition and fees and at least a 75%
stipend as required for an NIH K12 program. This is a fellow to faculty program that requires the
scholar in the 2nd year to apply to NIH for K23 grant support. Dr. Cook has agreed to support one new
K-12 Scholars each year. Thus there will be one new and one existing K12 scholar for the 2nd and 3rd
years. A K12 program is required for a CTSA.
II, 5. The equipment category for the CTSI includes computers and software for the new faculty in
biostatistics and bioinformatics, in addition, a copy center will need to be available in the CTSI
facilities for education (available also to CTSI) and instructional media.
III. Renovation costs include present facilities and additional facilities available in the future in the
K building. Both require some remodeling and furnishings to accommodate CTSI personnel. A
portion of those costs will be included.
28