UNIVERSITY OF PENNSYLVANIA
CHILDREN’S HOSPITAL OF PHILADELPHIA
CLINICAL & TRANSLATIONAL SCIENCE AWARD CLINICAL TRANSLATIONAL RESEARCH CENTER (CTRC)

JUNIOR INVESTIGATOR PILOT GRANT PROGRAM (JIPGP)
GUIDELINES & SUBMISSION INSTRUCTIONS

The primary goal of the Clinical Translational Research Center (CTRC) Junior Investigator Pilot Grant Program (JIPGP) is to encourage junior investigators to develop clinical research projects that will ultimately lead to extramural NIH funding. The CTRC’s at the University of Pennsylvania Medical Center and The Children’s Hospital of Philadelphia (CHOP) replaced the General Clinical Research Centers (GCRCs) in September 2006 under the new NIH program, The Clinical & Translational Science Award (CTSA) funded by the NIH National Center for Research Resources. The JIPGP awards are designed to allow junior faculty members, clinical fellows and both M.D. and Ph.D. post-doctoral trainees with appropriate mentors to obtain funds for pilot projects that are investigator-initiated, human-based, CTRC studies that will enable an applicant to obtain preliminary data for a K23 or R03 grant submission. It is anticipated that the award will lead to a competitive extramural grant application and to a career in Clinical Translational Research Center-focused clinical investigation. At least two grants in the amount of $10,000 to $20,000 will be available at each institution effective July 1, 2008.

The JIPG awards are in partnership with the following centers: -Clinical and Translational Science Award/Institute for Translational Medicine and Advanced Therapeutics (up to 4 awards)

-Institute for Diabetes, Obesity and Metabolism (IDOM, 1 award): Funds from IDOM will support a project in research areas relevant to diabetes, obesity and metabolism.

Applicants are required to:

1. Be a full time faculty member or postgraduate fellow (for fellow applicants, preference will be given to those with an offer for a faculty position involving clinical research) at the University of Pennsylvania Medical Center or the Children’s Hospital of Philadelphia. (If applicant is a fellow, the mentor must serve as the study’s principal investigator).
2. Hold a doctoral degree from an accredited institution.
3. Have a rank equal to or less than Assistant Professor, including Post Doctoral Fellows, unless the project is a clear change in emphasis or direction of research. (especially from bench to translational research)
4. Be within five (5) years of completion of their clinical training, or be in an approved fellowship-training program.
5. Have an interest in patient-oriented research.
6. Have no past or active K- or R-award NIH funding (e.g. , K08, K12, K23, RO3, R21) or higher level NIH funding prior to the start date of the JIPGP. An applicant may have current foundation/industry support, but should not propose a JIPGP application that is similar to the existing foundation/industry protocol. (Applicants should provide Other Support pages listing all current and pending research funding).
7. Have permanent resident status or US citizenship.

1. Proposals should be prepared according to the current version of the PHS 398 using the following forms: Budget (Form Page 4), Continuation Page (for project description/narrative), Personnel Report, Biographical Sketch page of applicant and mentor, Resource page, Targeted/Planned Enrollment Table and Other Support page of applicant. The description of the project should be a 2 to 3 page narrative which should include a brief background, hypothesis, subjects, methods, analysis sections and a paragraph on how you plan to use the resources of the CTRC. Forms and instructions are available online at: http://grants.nih.gov/grants/funding/phs398/phs398.html#updatess/forms.htm
2. A letter from a senior faculty member who agrees to serve as a research mentor for the project. This letter should include:
   • An outline of the resources available to the applicant.
   • Protected time for research.
   • A clear plan for candidate’s career development.
   • Candidate’s current academic appointment.
   • Candidate’s future academic plans.
   • Discussion of institutional commitment.
   If the candidate is a fellow, a clear plan for participation in clinical research post-fellowship should be given.
3. Studies must involve living human subjects and must propose to utilize the CTRC major core areas of service for subject interventions or assessments, such as inpatient or outpatient units. (Consult with CTRC Administrators for clarification if needed).
4. Studies should be designed to collect pilot data with clear presentation of how results would be used for extramural funding applications.
5. If selected for funding, the local IRB and CTRC Council must approve the project before funds can be awarded.
6. One proposal or one award per investigator.
7. Applicants must prepare a final report upon completion of the project.

This support is in addition to already existing CTRC resources, including space, nursing, bionutrition and core laboratory support for the proposed studies, and may include biostatistical consultation, database consultation, design, and data storage. (A summary of HUP and CHOP CTRC services can be found at http://www.itmat.upenn.edu/ctrc_web/index.shtml or contact the appropriate institutional administrative manager for specific CTRC resource information - contact information below). Thus, the total resources available for the chosen projects will exceed the maximum $20,000 monetary award of this grant.

Examples of JIPGP fund budget items include purchase of research supplies, assays, subject recruitment expenses, travel expenses to one scientific meeting to present study results, and salary support for awardee and/or study staff.

EVALUATION:

Applications will be reviewed by the CTRC Council and scored on the basis of:

• Originality and scientific merit
• Potential for publishable data and for future funding
• Qualifications of applicant and mentor.
• Use of CTRC resources
• Addressing CTSA themes: Multidisciplinary Research, Translational Research and research across age groups.

Each application will be assigned a primary and secondary reviewer from the CTRC Council. Each reviewer will prepare a written critique.

All protocols are reviewed and discussed using an NIH review format. Protocols will be reviewed to ensure scientific validity and maximal patient safety.

OTHER REQUIREMENTS:
Any resulting publications in peer-reviewed journals must acknowledge the support of the CTSA grant: “The project described was supported by Grant Number UL1RR024134 from the National Center For Research Resources. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health”. Copies of publications should be sent to the appropriate institutional representative as listed below.

JIPGP awardees are required to provide a progress report at the end of the funding year. Reports are due at the CTRC two months (60 days) following the end of the funding period (or at the time of annual JIPG proposal deadline if a second year of funding is requested). The Progress Report should be a brief presentation of the accomplishments or the research project during the reporting period. The report should not exceed two pages and should follow the outline shown below:

• Specific Aims
• Studies and Results
• Significance Plans

In addition, an accounting on the disbursement of the funds will be required.

Applications must be received by March 7, 2008.

One hard copy and one electronic copy of the proposal and relevant attachments should be sent to the appropriate institutional representative:

University of Pennsylvania Medical Center: Send one hard copy and one electronic copy via email to Linda McCrae at the HUP GCRC/CTRC, 3400 Spruce Street, 160 Dulles, HUP/4283, McCrae@gcrc.upenn.edu; You may contact Ms. McCrae by telephone at 215-662-7174.

CHOP: Send one hard copy of the proposal and one electronic copy via email to Phyliss Quail in Stokes Research Administration, Abramson Research Center, Room #126; email quail@email.chop.edu

CHOP candidates should direct questions to the CTRC Administrative Manager, Veronica Mazzaccaro at Mazzaccaro@email.chop.edu. You may contact Ms. Mazzaccaro by telephone at (215) 590-2215.

FINANCIAL MANAGEMENT:
The project detailed budget provided with the proposal (PHS 398 Form Page 4) should clearly delineate the proposed use of the CTRC. Funds of $20,000 may be requested for initial year of funding. Funds may be renewable for a second year of funding; continued funding will be based on a progress report and at the discretion of the review committee. JIPGP award arrangements will be made on a case-by-case basis with the CTRC Administrative Manager to finance the approved budgetary elements directly from the CTRC grant cost center. Any unused funds at the end of the project period revert to the CTRC grant.

AWARD DATES:

	Date
Application Receipt Deadline:	3-07-08
Notification of Award:	4-14-08
Funding Period:	7-1-08 to 6-30-09

For Questions, contact your local CTRC Administrative Manager