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Center for Translational Medicine Translational Pilot Program Application Requirements 2017-2018 Grant Cycle Jeffrey Kahn, M.D., Ph.D. Professor and chief of pediatric infectious disease Director, CTM Translational pilot program Agenda


  1. Center for Translational Medicine Translational Pilot Program Application Requirements 2017-2018 Grant Cycle Jeffrey Kahn, M.D., Ph.D. Professor and chief of pediatric infectious disease Director, CTM Translational pilot program

  2. Agenda • Overview • Award Information • Pre-requisite Requirements • Application and Submission Information • Office Hours/Staff Contact • Questions and Answers

  3. Overview Program Goals • Promote and support the development and testing of new research ideas ; • Stimulate novel translational ideas of young investigators; • Encourage interdisciplinary collaboration ; and • Assess the feasibility of new approaches to translational research through inter-disciplinary collaboration that lead to extramural funding .

  4. Overview Project must address at least one of the following: • Translational Research: Includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies is also an important part of translational science. • Clinical Research: Includes clinical trials with human subjects to test intervention safety and effectiveness, behavioral and observational studies, outcomes and health services research, and the testing and refinement of new technologies. The goal of many clinical trials is to obtain regulatory approval for an intervention. • Community-Based Research: Is a collaborative effort between academic researchers and non-academic based community members that aims to generate social action and positive social change through the use of multiple knowledge sources and research methods. Ideally, the research questions originate from off-campus communities and the process involves meaningful participation by all partners in every stage of the research. • Health Services Research: Examines how people get access to health care, how much care costs, and what happens to patients as a result of this care. The main goals of health services research are to identify the most effective ways to organize, manage, finance, and deliver high quality care; reduce medical errors; and improve patient safety. • Team Science: Is used to refer to a collaborative approach that draws concepts and technologies from multiple fields to develop a new perspective on answering research questions or solving complex problems. While traditional single-investigator driven approaches are ideal for many scientific endeavors, coordinated teams of investigators with diverse skills and knowledge may be especially helpful for studies of complex social problems with multiple causes.

  5. Overview Review Criteria The main criteria for funding will be the scientific quality , innovation , sustainability (i.e., the likelihood of obtaining future extramural funding), and environment . Therefore, it is particularly important for mentored applicants to provide details of the sustainability of the research environment to ensure a high likelihood of success. Applicants will also be judged based on their career trajectory and the quality and suitability of the research-training environment.

  6. Overview Additional Review Criteria • Protection for Human Subjects, Inclusion of Women, Minorities, and Children , as applicable to 45 CFR Part 46 and according to NIH guidelines for the review of human subjects found in: http://grants.nih.gov/grants/how-to-apply- application-guide/forms-d/supplemental-instructions-forms-d.pdf • Vertebrate Animals according to NIH guidelines found in: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html • Overall Impact : Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on research field(s) involved.

  7. Award Information Funding SOURCE National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) ANTICIPATED Approximately six (6) awards NUMBER OF AWARDS AWARD BUDGET Not to exceed $50,000 AWARD PROJECT May 1, 2017 to April 30, 2018 PERIOD

  8. Approved uses of Funds PERSONNEL May be used for any of the following salary support: non-PI research personnel such as research nurse, technician, data entry personnel, consultants, etc. Personnel costs must include the appropriate amount of fringes. SERVICE Funds may be used to offset costs for laboratory analyses, data collection, database design/support, research coordinator services, or other services provided by core facilities on the UT Southwestern campus. A list of UTSW Service Providers PROVIDERS is provided on the Application Forms spreadsheet. Applicants should seek consultation with proposed service providers to ensure sufficient funds are requested and that all related services are included. A price quote must be attached to the application if core service funding is requested in the budget. Price quotes are price estimates based on discussions with the core(s) of your choice. Price quotes must be generated by and come from the core facility. EQUIPMENT Equipment is an article of tangible nonexpendable personal property that has a useful life of more than 1 year and an acquisition cost per unit that equals or exceeds $5,000. Equipment may be purchased only if such equipment is essential and allocable and not otherwise available for use by the applicant through a core facility on the UT Southwestern Campus. All equipment purchases must comply with the NIH Grants Policy Statement and UT Southwestern purchasing requirements. SUPPLIES Funds may be used to offset materials and supplies necessary to carry out the proposed research. INPATIENT AND Funds may be used to offset costs for inpatient or outpatient research visits, including hospital fees, nursing, metabolic services and meals, facility usage fees, investigational drug services, lab processing, etc. OUTPATIENT CARE COSTS OTHER EXPENSES Funds may be used to offset costs for study subject payments, publication-related expenses, and expenses not included in the other budget categories.

  9. Non-approved uses of Funds PI SALARY AND FRINGE Not allowed. Not allowed. TRAVEL INDIRECT COSTS (F&A) Including subcontracts with CTSA partnering institutions. NOTE: Applicants from partnering institutions should obtain a waiver for F&A from their institution as a condition of award ( contact the CTM for assistance in obtaining this letter ).

  10. Requirements Required Pre-requisites • Must have eRA Commons Account. • To obtain go to * : Registration http://www.utsouthwestern.net/intranet/administ ration/sponsored-programs/. C lick on NIH eRA Commons User Account Request form, complete and submit. * If not from UTSW, contact institution. • IRB or IACUC approval must be in place prior to IRB/IACUC submission of an application for funding. • Strongly recommended that study approval be submitted to the Approval review office to allow sufficient time for board to review/approve by the submission deadline of December 15, 2016. NOTE: If having difficulty getting timely approval, please contact CTM when IRB is submitted and we will work with contacts to expedite.

  11. Application and Submission Information Form • Face Page • Current Committed Effort • Budget • Budget Justification

  12. Face Page: Budget Request Total Budget Request Do not enter in amount. This amount will automatically populate from the budget page.

  13. Face Page: Principal Investigator/Application Information ______________________________________________________ Name Last name and first name of applicant. eRA Commons ID Indicate eRA Commons ID. Degree Indicate highest degree obtained. Academic Rank Official rank as designated by applicant’s primary institution. NOTE: A mentor is required for applicants who are post-doctoral fellows, residents, and fellows. Proposed Effort % Indicate amount of effort devoted to the project. Effort must be sufficient to achieve the proposed aims during the project. Must be reported in the current committed effort tab. Department/Division Full official name of institutional department where applicant holds primary appointment. Institution Institution where applicant holds primary appointment. Applicant’s office phone. Phone E-mail Applicant’s institutional e-mail address. Administrative Administrative official who will serve as contact for administrative matters in the event that CTM has questions/concerns during the application/review process. Contact/Phone Financial official who will work with the CTM (if funded) on subledger set-up and who is Department Financial involved with processing HCM forms and budgetary information in the Department. Contact/Phone

  14. Face Page: Project Information Title of Project State the title of project exactly as it appears in the IRB or IACUC approval letter. Type of Project Using the definitions from the FOA, select which type(s) of research most appropriately describes your proposed project. Human Subjects Research Provide IRB number, if applicable. NOTE: Must have IRB approval at the time the application is submitted. Vertebrate Animal Research Provide the status/number of IACUC approval, if applicable. Project/Performance Site Physical address and name of lab (if applicable) that will serve as the primary performance site for the work being performed under the proposed request. Primary Location

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