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					               The University of Texas Southwestern Medical Center at Dallas
                              Department of Clinical Sciences

                          REQUEST FOR APPLICATIONS (RFA)
                            2010 Clinical Research Scholars Program

                        Sponsored in part by National Institutes of Health (KL2 RR024983)
           Administratively Linked to the UT Southwestern Medical Center CTSA Grant (UL1 RR024982)

The Department of Clinical Sciences at the University of Texas Southwestern Medical Center is seek-
ing applications for participation in the Clinical Research Scholars program, which supports the career
development of individuals who are dedicated to a career in clinical investigation, and who aspire to
develop into future leaders in clinical research. Sponsored in part by the National Institutes of Health
(CTSA KL2 mechanism), program support is provided for the clinical research training and career de-
velopment of persons in relevant disciplines and professions (including but not limited to internal medi-
cine, surgery, pediatrics, obstetric/gynecology, dentistry, nursing, pharmacy, statistics, epidemiology,
behavioral sciences psychology, and engineering) as well as their various specialties and sub-
specialties.

Beginning July 1, 2010, individuals selected as Clinical Research Scholars will enter an intensive, indi-
vidualized and comprehensive educational and training program that will typically last three 3 years,
(pending successful progress in the program), which will fully prepare them for a career as an indepen-
dent clinical investigator.

Interested individuals may submit applications following the distribution of this RFA. The deadline for
submission is February 1, 2010. All applications will be reviewed and selected applicants will be inter-
viewed. The department anticipates that awards will be announced by April, 2010.

Goals of Program

The goals of the Clinical Research Scholar Program are to:

   1.      provide a comprehensive, individual, multidisciplinary education in the principles and
           methods of clinical research and in the skills and strategies required for the development of
           successful research careers through a didactic curriculum focused on patient-oriented
           research;

   2.      provide an in-depth, practical, multidisciplinary, collaborative training experience in the plan-
           ning, execution, and analysis of clinical research, initially through an apprenticeship in an
           ongoing research project and subsequently by the conduct of an independent research
           project;

   3.      promote the career development of the Clinical Research Scholar by ensuring a smooth
           transition to a tenure-track or clinical scholar track faculty appointment that will allow them to
           sustain their research in a multidisciplinary environment that will provide meaningful recogni-
           tion for achievements in clinical research.
Eligibility

       To be eligible, applicants must:

              a. have a clinical doctorate, a Ph.D. degree, or equivalent, including but not limited to
                 M.D., D.O., D.D.S., D.M.D., D.V.M, O.D., D.C., Pharm.D., Sc.D., as well as epidemiolo-
                 gists, behavioral scientists and nurses with doctoral degrees.

              b. have completed the post-graduate training required for their doctoral degree (e.g., in-
                 ternship and residency for those with an M.D. degree) by the date of the start of the pro-
                 gram (July 1, 2010);

              c. have shown exceptional talent and aptitude towards scholarship and critical thinking, as
                 evidenced by prior work, interviews with the members of the Clinical Research Scholar
                 Selection Committee, and letters of recommendation from knowledgeable mentors;

              d. be able to participate in the program for at least 3 years and devote 75% of their time to
                 its completion (50% for surgical subspecialties);

              e. be committed to a career as a clinical scientist;

              f.   neither be nor have been a principal investigator on an R01, R29, or subproject of a
                   Program Project (P01), Center (P50, P60, U54) or mentored career development
                   (K-series) grants or other equivalent research grant awards, except for R03 and R21;

              g. have strong support from their department chair, as evidenced by a commitment to pro-
                 vide:

                       i. at least 75% protected time for the duration of the Scholar’s participation in the
                          program, and no less than 50% for scholars from surgical programs, for a mini-
                          mum of 3 years; funding for the candidate’s salary and fringes during this time (to
                          the extent not supported by the NIH). The 75% effort is based on the entire
                          amount of time worked in a typical week, and should include proportionate
                          amounts of normal weekday time;

                      ii. a tenure-track or clinical scholar track faculty appointment for at least 2 years fol-
                          lowing satisfactory completion of the program;

              h. hold U.S. Citizenship, or be a non-citizen national, or have been lawfully admitted for
                 permanent residence and possess an Alien Registration Receipt Card (I-151 or I-155),
                 or some other verification of legal admission as a permanent residence. Individuals on
                 temporary or student visas are not eligible for NIH funding.

        UT Southwestern strongly encourages applications from women, minorities, and people with dis-
                                             abilities.

       The Clinical Research Scholar Selection Committee, Chaired by Dr. Ethan Halm will review all
       applications, interview those with particular promise, and make the final selections. Applicants
       are subject to NIH approval, as appropriate.




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Components of the Clinical Research Scholars Program

The program will identify and recruit individuals of exceptional scholarship and aptitude towards critical
thinking from a wide range of academic backgrounds who show unusual promise and are willing to
commit themselves to an intense and sustained program of training and career development. The pro-
gram will ensure that each yearly class includes scholars whose backgrounds span multiple disciplines
or fields of medicine.

During their first year, the Clinical Research Scholars will take didactic courses in a comprehensive cur-
riculum which has been designed to fulfill the needs of the clinical investigator. The curriculum will offer
not only the components of a conventional training program that focuses on public health disciplines
(e.g., biostatistics, epidemiology and health services research), but it will also provide courses impor-
tant to (1) patient-oriented research (e.g., critical thinking, experimental design, clinical pharmacology,
ethics); (2) translational research (e.g., molecular and genetic principles and methods); and (3) leader-
ship, management and career development (e.g., presentation skills, grant writing, negotiation skills,
leadership training). During the first year, most scholars will begin and often complete a mentored
project. In this project, the Clinical Research Scholar will function as a co-investigator in an ongoing
research project in the laboratories of the clinical investigator mentor. By the end of the first year, the
Clinical Research Scholar will write an original and critical review of the literature that synthesizes cur-
rent knowledge and provides unique insights in a specific area of focus.

During the second year, the Clinical Research Scholar will formulate a plan for an Independent Re-
search Project to be carried out during the second, third and potentially subsequent years. This project
will be presented in the form of a formal research grant application, which will include a research plan,
proposed timelines for execution, a description of resources available and needed, and a description of
the multidisciplinary team that will execute the project. The grant application will be formally reviewed
using rigorous criteria similar to those utilized by the NIH, defended and revised, and if ultimately
approved, will be submitted to the IRB for review and approval.

During the second, third and potentially subsequent years, the Clinical Research Scholar will carry out
an Independent Research Project as the principal investigator overseeing a multidisciplinary research
team, which may include a biostatistician, data manager, research coordinator, collaborators and con-
sultants. Initial support for the Independent Research Project will be provided by the resources availa-
ble to all Clinical Research Scholars (through the Department of Clinical Sciences) and specific finan-
cial resources allocated to each scholar by his or her department. Using these resources, the Clinical
Research Scholar will carry out the research plan, file interim progress reports and budget requests,
and finally write a manuscript summarizing the results of his or her work at the end of his or her partici-
pation in the program.

The progress of each Clinical Research Scholar will be closely monitored by several independent eva-
luators. Furthermore, during each year of the practicum phase, the progress and work of each Clinical
Research Scholar will be evaluated by the Career Development Committee. This review committee will
evaluate the quality of the scholar’s achievements, as reflected by his or her written work and as sum-
marized by the Clinical Research Scholar in a formal presentation to the Committee, during which the
Clinical Research Scholar will defend his or her research plan, progress and data.




                                                     3
Curriculum for the Clinical Research Scholars Program

Formal, rigorous and comprehensive training in clinical research methodologies is essential for pur-
suing a career as an independently funded investigator. This requirement will normally be met by Scho-
lars enrolling in the Masters of Science in Clinical Science (with Distinction) program in the Southwes-
tern Graduate School of Biomedical Sciences. The curriculum for the Masters program will consist of
required and elective courses, participation in seminars, workshops, lectures, mock panels, visiting pro-
fessorships, and practicum projects. All scholars selected for participation will be required to apply
separately to the Master’s of Science in Clinical Science (with Distinction) program.

Under some circumstances, such as when a candidate already has two years of advanced training in
clinical research through a prior MPH or Masters of Science program, the Scholar will take a reduced
set of courses to fill in training gaps and/or update previous training. Such individuals will still be re-
quired to fully participate in all of the Clinical Scholars career development, practicum research expe-
riences, and works-in-progress activities.

Required Courses
During the first year, the Clinical Research Scholars will generally be required to take all modules of the
didactic curriculum for the Masters of Science in Clinical Science (with Distinction). Scholars from sur-
gical subspecialties (with only 50% protected time) will likely require more than one year to complete
the required course work. Scholars with prior formal training in specific areas in a comparable training
program may apply for exceptions for specific courses or modules.

The Program Coordinator will supply a copy of the curriculum plan detailing the required and
elective courses and required research practica. Course descriptions are located here.

Practicum Research Experience

The primary goal of the practicum research experience is to expose each Clinical Research Scholar to
the experiences typical of an independent clinical investigator, but in a mentored and supportive envi-
ronment.

The First Year of the Program

The practicum phase will begin during the first year when the Clinical Research Scholars meet with
their mentors to identify a specific area of focus. Based on the knowledge and skills obtained in the di-
dactic curriculum, the Clinical Research Scholar will complete a mentored research project. The Clini-
cal Research Scholar will conduct a thorough review of the literature, analyze and weigh the available
evidence, bring a critical level of thinking to the process and identify specific questions that need to be
prospectively addressed in future research which will form the basis for the Independent Research
Project. In doing so, the Clinical Research Scholar may work with the faculty of the didactic curriculum,
who will act as consultants or collaborators. The findings of the literature review will be reviewed with
the mentors and presented at a research conference of the Clinical Research Scholar’s peers. Based
on the feedback received, each Clinical Research Scholar will write an original and critical review of the
literature that synthesizes current knowledge and provides unique insights into unresolved issues. The
review will provide a thorough review of all relevant literature and/or a resynthesis of available data and
result in a written manuscript that provides novel (and preferably iconoclastic) insights. The manuscript
will be completed by the end of the first year and will be submitted for publication in a peer-review jour-
nal.

In addition, by the end of the first year, the Clinical Research Scholar will have completed the mentored
project and will submit a proposal for his or her second (apprenticeship) year. This proposal will de-
scribe the Clinical Research Scholar’s proposed involvement in specific research projects, which will be
ongoing in the laboratory of the clinical investigator mentor or preceptor (see below). The Career De-
velopment Committee will review the proposal to ensure that (1) the Clinical Research Scholar will be

                                                      4
functioning as a co-investigator in the proposed research and not simply fulfilling a “worker-bee” role (2)
the research project(s) is(are) prospective studies that are clinically relevant and hypothesis-driven and
are likely to lead to interpretable data; (3) the Clinical Research Scholar will participate actively in the
analysis of data; in the preparation of presentations, and in the writing of manuscripts; (4) the Clinical
Research Scholar participation will be recognized by co-authorship on abstracts and manuscripts; and
(5) the experience will prepare the Scholar for his or her independent research years.

During the first year, the Clinical Research Scholar will begin a hands-on apprenticeship in ongoing re-
search project(s). During the Mentored Research Project, the Scholar will function as a co-investigator
in the proposed research. The Clinical Research Scholar will participate actively in the development of
protocols, the submission of IRB documents, the accrual of patients, the analysis of data, the prepara-
tion of presentations, and the writing of manuscripts. This participation will be recognized by co-
authorship (as appropriate) on abstracts, presentations and manuscripts. During this phase, the day-to-
day efforts of the Clinical Research Scholar will be assisted by a preceptor – an early or mid-career
clinical investigator (with specific experience in the research methods of interest to the Clinical Re-
search Scholar) – who will act as a junior mentor and will be formally added to the mentoring team. The
addition of the preceptor will not only add to the training of the Clinical Research Scholar, but will pro-
vide mentoring experience for the preceptor in the expectation that the experience will help the precep-
tor evolve into an established mentor. This apprenticeship phase may involve the ongoing research
projects of the clinical investigator mentor or preceptor, and the scholar will rely primarily on the re-
sources already available for the ongoing research.

The Second Year of the Program

Based on the experience provide by the apprenticeship and with the guidance of his or her mentors, the
Clinical Research Scholar will formulate a plan for an independent research project to be carried out
during the second, third and subsequent years. The plan for this research project will be presented as a
formal research grant application, which will be due 3 months before the end of the second year. [The
Clinical Research Scholar’s literature review may form the background and significance of the proposal
and work carried out by the Clinical Research Scholar during his or her apprenticeship may comprise
the preliminary results section of the grant application.] The proposal will be developed with the close
advice and guidance of the Clinical Research Scholar’s mentor, but the Scholar will also assemble the
elements of a research team, which will execute the project and be involved fully in its conceptualiza-
tion and planning. This team may initially consist primarily of a consulting clinical investigator, a consult-
ing biostatistician, epidemiologist and/or clinical pharmacologist, although it will be subsequently sup-
plemented by other personnel (study coordinator, data manager or research pharmacist). The members
of this team may consist of individuals who served as faculty for didactic courses or seminars, work-
shops or mock panels.

The grant application will also include a detailed plan for the implementation of the research project.
This will consist of: (1) a timeline for execution of the project; (2) a description of the resources availa-
ble to the investigator (from the mentor’s or preceptor’s laboratory or from other arrangements made by
the Scholars); (3) a description of resources needed (space, equipment, research nurse/study coordi-
nator, laboratory support); (4) a description of the members of the investigator’s multidisciplinary team
(co-investigators, collaborators, biostatistician, clinical pharmacologist) and assurances about their
ability and willingness to participate; and (5) a budget with appropriate justification. In essence, the plan
proposed by the Clinical Research Scholar will have all of the elements of a formal research grant ap-
plication and will use standard NIH forms (PHS Form 398).

The Clinical Research Scholar will submit the grant application to the Grant Review Committee and
meet with its members to present, discuss, and defend the research proposal. The Committee will criti-
cally evaluate the plan’s merit based on the criteria similar in rigor to that used for the NIH peer-review
process.




                                                      5
During its review, the Grant Review Committee will provide criticisms and suggestions for revision and
modification of all of its elements (including the research plan, compliance with federal policies, rules
and guidelines for clinical research, timelines, and budget request). Based on this feedback, the Clinical
Research Scholar will revise the proposed plan to address all of the issues raised by the committee – a
process which will be guided by his or her mentors and his or her consulting team. The process of re-
view and revision will continue until the Committee determines that the criteria specified above have
been fulfilled. The Clinical Research Scholar will then submit the proposal to the Institutional Review
Board for review and approval prior to its initiation.

The Third and Subsequent Years of the Program

During the third and subsequent years, the Clinical Research Scholar will carry out an independent re-
search project. In doing so, the Clinical Research Scholar will function as the principal investigator and
oversee a multidisciplinary research team and will be guided by his or her mentors. The Scholar will
meet regularly with his or her mentors to review progress, identify obstacles that need to be overcome,
make revisions in the research plan, and review interim data, if any. The Clinical Research Scholar will
also make presentations to his or her group on the successes achieved, difficulties encountered, and
lessons learned.

At the end of the third and fourth years, the Clinical Research Scholar will file (with the assistance of his
or her mentors) a progress report on his or her project, which will be similar in content and presentation
to that of a non-competing grant application. This request for continuation of the project will include a
brief progress report on the research plan, a budget request for the following year, a list of core facilities
required, and a list of co-investigators, collaborators, and consultants. The application will be reviewed
by the Program Director in the context of the feedback that the Clinical Research Scholar has received
during his or her annual review by the Career Development Committee. Following completion of the
project, the Clinical Research Scholar will file a final progress report and will write a manuscript or ma-
nuscripts summarizing the results of his or her work. Both will be reviewed by the Scholar’s mentors.
The manuscript(s) will be submitted for publication in a peer-review journal.

Although the Clinical Research Scholars will generally carry out their practicum as individuals (rather
than as a group) and will focus on a specific area of research, they will be expected to present and de-
fend their ideas, research plans, interim and final results, and conclusions to the entire peer group on a
periodic basis throughout their participation in the program. In addition, the progress of each Clinical
Research Scholar will be closely monitored through a comprehensive series of evaluations. Further-
more, during each year of the practicum phase of the program, the progress and work of each Clinical
Research Scholar will be evaluated by the Career Development Committee. This review will consider
the Clinical Research Scholar’s written work (e.g., formal grant application and manuscripts) and the
quality of a formal presentation by the Clinical Research Scholar to the Committee.

Post-program Career Development and Institutional Recognition

Toward the end of each Clinical Research Scholar’s participation in the program, the Program Director
will meet with each Clinical Research Scholar to develop a plan for his or her career development. This
will include defining (1) the strategy of an independent research career (including the plans for tenure-
track faculty appointment) and (2) the mechanisms for salary and research support (including the plans
for application for peer-review grants). The goal is to act as an advocate for the Clinical Research
Scholar while identifying a realistic path of transition from the protected environment of the Clinical Re-
search Scholar Program to the real-life environment of academic medicine. Scholars are expected to
present their plan to their Department Chairs.

In general, the sponsoring department or institution will be expected to provide Clinical Research Scho-
lar’s who satisfactorily complete the program with tenure-track appointment and at least 50% protected
time to pursue their research for a minimum of 2 years, or until they can obtain peer-review support.


                                                      6
Goals of Achievement in Program

A Clinical Research Scholar will be deemed to have completed the program when he or she has:

   1.      satisfactorily completed all required courses (24 credit hours of didactic courses and 12 cre-
           dit hours of the practicum experience) for a total of 36 credit hours; For Scholars who enter
           the program with a prior two year MPH or MS in clinical research, an individualized course
           requirement plan will be developed in conjunction with the Program Director, Scholar, and
           their mentor.

   2.      participated actively in the program’s workshops and maintained active and regular atten-
           dance at seminars, lectures, grand rounds, and visiting professorships;

   3.      satisfactorily completed an apprenticeship year as co-investigator on on-going projects,
           generally resulting in co-authorship;

   4.      successfully carried out an independent research project and produced preliminary or final
           data of sufficient quality and quantity to make it highly likely that the Clinical Research Scho-
           lar will be able to compete successfully for peer-review funding as an independent investiga-
           tor, as assessed by both the Clinical Research Scholar’s mentors and by the Career Devel-
           opment Committee.

   In general, individuals who complete the required program components will have this achievement
   formally recognized by the granting of a Master’s of Science in Clinical Sciences (M.S.C.S.) with
   Distinction degree.

Application Instructions and Submission Process

Application forms will be available starting the week of December 7, 2009, and will be posted online,
here. The Department of Clinical Sciences office is located on South Campus in E5.506 and we may be
reached at (214) 648-9400. Please contact Dena Wheaton in the Department of Clinical Sciences at
(214) 648-2410 with specific application or selection process questions.

The application consists of 3 parts: (1) the first part is completed by the applicant and includes a state-
ment of personal interest and motivation; (2) the second part consists of letters of recommendation
from knowledgeable individuals, who know the applicant well and/or will act as mentors or collabora-
tors; and (3) the third part consists of a letter of recommendation and commitment from the applicant’s
department chair. All applicants must discuss their interest with their department chairs prior to submit-
ting an application. Applications that do not have these three components will be considered incomplete
and will not be considered by the Selection Committee.

The Clinical Research Scholar Selection Committee will invite selected potential candidates for inter-
views in February/March, 2010. We will seek NIH approval, when appropriate. There will be an an-
nouncement of those selected for participation in the program by April, 2010. Candidates are subject to
NIH approval.

Letter of Intent:
Please submit a brief letter of intent by January 4, 2010.

Application Deadline:
The deadline for submission of applications, and application materials, is February 1, 2010.




                                                     7
Program Commitment

Following acceptance into the Program, each Clinical Research Scholar will review with the Program
Director (every 6 months), his/her progress including didactic course requirements and electives, So-
cratic Curriculum participation, the status of the 4 practicum elements (Mentored Research Project,
Critical Literature Review, Independent Research Project, Grant Application) and general career devel-
opment.

NIH Support

The Clinical Scholars Program is supported, in part, by a KL2 award from the NIH, which is part of UT
Southwestern’s Clinical and Translational Science Award (CTSA). Unfortunately, the level of funding
provided by the NIH for the KL2 programs is highly variable and unpredictable. As a result, the De-
partments nominating candidates cannot rely on salary support for Clinical Scholars who are accepted
into the program, and Department Chairs should be prepared to provide full support if no NIH funding
emerges. Details about the level of NIH funding are not likely to be available to us until after the final
selection process for the Clinical Research Scholars has been completed.




                                                     8
                       SCHEDULE FOR APPLICATION AND SELECTION PROCESS



Call for Applications Issued                                 December 7, 2009

Letter of Intent Due                                         January 4, 2010

Clinical Research Scholar Program Application Due            February 1, 2010

Interviews/Scholar Selection Process                         February/March, 2010

Announcement of Candidates Selected                          April, 2010

Program Start Date                                           July 1, 2010




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