CTSA Inter Institutional Pilot Project Award: UNM HSC, KUMC & Utah REQUEST FOR APPLICATIONS Issue Date: January 28, 2014 Introduction The Clinical and Translational Science Awards (CTSA) of the University of New Mexico Health Sciences Center (UNM HSC), University of Kansas Medical Center (KUMC) and the University of Utah are soliciting applications from all faculty members senior as well as junior investigators for pilot projects that will exemplify the CTSA mission of developing clinical and translational research, to promote and support the bench to bedside to community and practice and back goal of the National Institutes of Health. The purpose of this RFA is to promote inter institutional collaboration across the CTSA consortium by funding innovative, translational research projects that involve two or more CTSA institutions. Clinical research is defined in accordance with the NIH definition as research conducted with human subjects or on material collected from humans for which an investigator directly interacts with a human subject to broaden knowledge about mechanisms of disease, therapeutic interventions, or clinical trials, or to develop new technology. Epidemiological population based, behavioral studies and community interventions, as well as outcomes and health services research, are considered clinical research. Translational research is defined to include four emphases 1. Phase 1 translational research (T1) includes the process of applying basic research discoveries to develop trials and other studies in humans (i.e., case series, phase I and II clinical trials). 2. Phase 2 translational research (T2) is directed at better patient outcomes and the development of evidence based guidelines. 3. Phase 3 translational research (T3) implements evidence based guidelines into health practice through community practice (delivery, dissemination, and diffusion research). 4. Phase 4 translational research (T4) evaluates the health outcomes of applications of translational research in the community. Basic or clinical research performed on human samples linked to outcomes and/or identifiers counts as translational research. Purely non human animal research does not qualify. The research activities at each participating research site will be funded by that institution s CTSA. Because each institution participating in this program decides how much funding will be devoted to the program, the amount of funding available will vary depending on the institutions of the investigators involved in a proposal. It is anticipated that funds up to $25,000 direct costs per project per participating institution may be available for these collaborative projects. The total funding available for a particular collaborative project will depend on the number of participating institutions and the level of funding that each of these institutions had decided to devote to the program. Investigators should contact their own institutions CTSA leaders to determine the level of support being provided for the collaborative pilot grants. Please note: All funds not spent by the end date of the Pilot Project Award will be returned to the participating institution and NIH. No extensions will be granted. For proposals that require IRB approval and/or IACUC approval, IRB and/or IACUC approval is required before the application due date (March 1, 2014) for proposals to be considered for review. Application Deadline and Funding Cycle Application Deadlines: Each investigator will submit one application to their parent institution by close of business March 1, 2014. 1
Funding Cycle: If awarded, the pilot funding will be made available from the participating institutions to be used in research at that participating institution by the funding date established by the institution. Eligibility and Project Requirements Principal Investigators for these awards must be members of the institution s faculty (junior or senior investigators). Successful projects will exemplify the CTSA s mission of developing clinical and translational research. All investigators selected to receive funding will be expected to submit a Final Progress Report at the end of the funded project and an additional report one year later, detailing progress to date, expenditures, and all submitted publications and grant applications (pending or funded) relating to the pilot project. Projects must be approved at each participating CTSA and by each CTSA s PI. Evaluation Criteria Each application will be reviewed at each separate institution. The review committee will consist of each institution s normal pilot project review committee. Each application will be reviewed by that institution s evaluation criteria which may include but is not limited to: 1. Scientific merit/quality of research plan (30 points) 2. Probability of extramural funding, if successful (30 points) 3. Utilization of CTSA Resources (20 Points) 4. Value added by a multi institutional approach (20 Points) Presentations and Publications Awardees are expected to submit collaborative extramural grants. Awardees are expected to publish their findings in scholarly peer reviewed journals and present their research at professional meetings. All publications, grants, and presentations resulting from research funded by Frontiers or using Frontiers resources should cite Frontiers as a contributing source of support and indicate Frontiers NIH CTSA grant title and number. Investigators are responsible for submitting any peer reviewed journal articles resulting from research funded by this award to PubMed Central, the NIH digital archive of biomedical and life sciences journal literature. See http://grants.nih.gov/grants/guide/notice files/not OD 08 033.html. Budget Guidelines Separate budgets will be submitted to each participating institution, according to that institution s guidelines. Funds may be used for any research purpose other than faculty salary support. Typical expenses include laboratory supplies, small equipment, patient costs, consultants, or support for pre/postdoctoral students (note: if working in the lab, not as trainees), technicians, or research assistants. Awards are not transferable to any other institution. The award period at each of the participating CTSA institutions will depend on the respective budget/project period dates reflected on the official Notice of Award from each parent CTSA. Because CTSA funds are not generally allowed to be carried over from one fiscal year to the next, a variety of approaches may be considered to permit a sufficiently long award period at each institution participating in a collaborative project, such as 2
funding the first and second portions of the award period with NCATS funds from consecutive fiscal years. Consult with your institution s Sponsored Projects/Grants office for any other approaches. How to Apply Emphasis on concise communication of the relevant information will help to demonstrate effective proposal writing and communication skills, and the likelihood of success in developing the full, competitive proposals to follow these pilots. Investigators will write one application with separate budgets split out for each participating institution. This full application should be submitted to each participating institution. Applications should include, in the following order: 1. Cover Letter signed by each participating investigator 2. Research Plan ( 5 pages, in the following order): a. Specific Aims b. Research Strategy i. Significance ii. Innovation iii. Approach (Please note: this does not include references. References can be placed at the end of the Research Plan and will not be counted as a part of the 5 page limit.) 3. NIH Biographical Sketches for each investigator c. The NIH biographical sketch form can be found at: http://grants.nih.gov/grants/funding/phs398/biosketch.doc d. A sample NIH biographical sketch form can be found at: http://grants.nih.gov/grants/funding/phs398/biosketchsample.doc 4. Detailed Budget and Budget Justification (to include an itemized table of the budget followed by a budget justification summary). 5. Specific plan to obtain extramural funding including a timeline of grant submission ( 2 pages). 6. Proof of IRB and/or IACUC Approval, if applicable. Please provide IRB and/or IACUC Approval #s in Cover Letter. 7. No appendices are allowed. Details of services offered by each Institutional CTSA can be found at the individual web sites of the parent CTSAs. At KUMC, these resources include the following: Regulatory Knowledge and Support Program This program assists investigators with resources to navigate and meet all regulatory and administrative requirements for clinical and translational research. Pilot and Collaborative Studies Funding Program Investigators affiliated with Frontiers institutions may apply for funding for clinical or translational pilot and feasibility studies with the expectation that such pilot funding from Frontiers will lead to larger successful peer reviewed grant applications for extramural funding. Requests for Proposals (RFPs) occur in the fall. 3
Community Partnerships for Health (CPH) The Community Partnership for Health program connects investigators with Kansas and Kansas Citymetropolitan area communities for research projects that will be conducted in and with communities to improve the health of the community. Services for investigators include training and partnershipbuilding for respectful access to and working with diverse communities. Biostatistics A solid statistical foundation is integral to any research project. Biostatisticians skilled in a full range of statistical and methodological approaches are available to consult with investigators and provide support for research method design, statistical support, and statistical analysis. Biomedical Informatics The Frontiers Biomedical informatics program provides informatics resources to support investigator research, including online survey tools and access to state and other data resources for health research. Biomedical informatics staff can help investigators select the most appropriate database for their projects. Clinical and Translational Science Unit (CTSU) The CTSU includes a wide range of resources, from a fully equipped Exercise Physiology Lab to a stateof the art Metabolic Kitchen. With examination, infusion, and observation rooms, experienced research nurses and medical staff in the CTSU can monitor patients on clinical trials in a safe and controlled environment. Translational Technologies Resource Center (TTRC) The TTRC provides investigators with access to advanced in vivo, and cell and tissue imaging resources, a genomics and proteomics lab, and tissue repositories. The TTRC also manages the Pharmacokinetic and Pharmacodynamic Program within Frontiers to support pre clinical, clinical and post marketing phases of the drug development process. Institute for Advancing Medical Innovations (IAMI) The IAMI assists investigators with advancing new drugs, drug products and drug delivery platform technologies through the approval process. The IAMI also provides proof of concept awards and an Office of Project and Portfolio Management to identify projects, create project teams and set timelines. Personalized Medicine and Outcomes Center (PMOC) The PMOC focuses primarily on supporting investigators with research that focuses on translating scientific discoveries into practical applications for patients. This includes assisting with analysis of large databases; quality assessment and quality improvement analysis; health and healthcare economics, health status and decision analysis; and survey design and qualitative research support. Ethics Program The Ethics Program consults with investigators regarding the ethical implications of their research at every stage from design to reporting of results. The program also provides training, facilitates community collaboration and aims to stimulate the field of research ethics. 4
Rationale for not using Frontiers Core services needs to be specifically justified. The following costs are not covered by these awards: faculty salaries postdoctoral salaries graduate student stipends administrative or office costs (e.g., office supplies, telephone, etc.) meals or hospitality (i.e., no food, beverages, or alcohol) travel other items typically supported by indirect costs Applications must adhere to the following formatting specifications: 11 point Arial font Single spaced ¾ margins on all sides 8 ½ x 11 (i.e., standard size) paper Number all pages KUMC (Frontiers) Specific Information for this RFA Please note the following information specific to applications to Frontiers: Questions to Frontiers PIs: Please contact either Richard Barohn, MD (rbarohn@kumc.edu) or Lauren Aaronson, RN, Ph.D. (laaronso@kumc.edu) Questions about administrative issues regarding the Frontiers Pilots Program: Peter Smith, Ph.D. (psmith@kumc.edu) or Kelly Robertson (krobertson@kumc.edu) Please submit completed applications via e mail in one PDF file to Kelly Robertson (krobertson@kumc.edu) no later than COB March 1, 2014 and clearly mark in the subject line that this is an inter institutional CTSA pilot grant. Applications that are late or do not adhere to the above instructions may not be reviewed. 5