Clinical & Translational Science Center CTSC Community Interventions Leading to Better Health Outcomes Award REQUEST FOR APPLICATIONS {revised} Re-Issue Date: August 2, 2011 Introduction The Clinical and Translational Science Center (CTSC) of the University of New Mexico Health Sciences Center (UNM HSC) is soliciting applications from all UNM HSC faculty members for pilot projects, exemplifying one of the CTSC missions: to support intervention studies in New Mexico communities. The purpose of this request for applications (RFA) is to support the pilot projects that will produce preliminary data for competitive NIH grant applications in clinical and/or translational (T1, T2, T3, or T4) research using UNM’s CTSC infrastructure. The goal of this program is to provide seed funding to help investigators be successful in applying for new extramural awards. Projects should be short, and concentrate on obtaining key preliminary data needed to significantly strengthen a well-developed plan for an NIH application. Proposals are expected to be completed within one year and an extramural grant submitted at that time. These interventional studies may use a variety of approaches to interact in communities, including but not limited to a community based participatory research approach. 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. As part of our clinical and translational science award (CTSA), the NIH has identified the need to speed the movement of clinical research findings into the everyday practice of health care delivery. As part of this effort, we are funding all types of clinical or translational science that may address health priorities and/or health disparities in New Mexico communities. To support this initiative, we will award several grants ranging from $5,000-$25,000 to be spent between 01 October 2011 and 30 September 2012. Please note: All funds not spent by the end date of the Community Interventions Leading to Better Health Outcomes Award (30 September 2012) will be returned to the CTSC and the NIH. No extensions will be granted. For proposals that require IRBapproval, IRB submission is required by the date of application for your proposal to be considered for review. 1 Application Deadline, Notice of Awards and Funding Cycle Application Deadline: 01 September 2011 Notice of Awards: 26 September 2011 Funding Cycle: 01 October 2011 to 30 September 2012 Eligibility and Project Requirements Principal Investigators for these pilot awards must be members of the UNM HSC faculty. Projects are required to be a clinical or community interventional study. Projects will cover a wide range of translational or clinical science. Projects must be performed in New Mexico. 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. Evaluation Criteria Applications should be well written, precise, and succinct. Applications will be subject to both scientific and programmatic review and will receive scientific review by the CTSC Review Committee. The following criteria will be used in evaluating these proposals: 1. Scientific merit/quality of research plan The focus must be on promoting a measurable improvement in health or health care in a community in New Mexico. 2. Relevance to health priorities and/or health disparities of New Mexico communities (For a listing of health priorities in NM, refer to the New Mexico Health Data Report 2011 at http://hsc.unm.edu/research/ctsc/community_brief.shtml.) Investigators must articulate in their proposals why their topic is a statewide priority. Additional diseases or topics that are not included in the Health Priorities document will be considered for funding with justification. 3. Probability of extramural funding, if successful For comprehensive proposals that will require more than six months to complete, requests for funding should be only for the preliminary period of work, with a detailed plan for competitive re-application to obtain funds to complete the project. There is no guarantee of subsequent funding, and projects that lead to publication(s) and/or extramural funding submission(s) within shorter time periods are preferred. Presentations and Publications 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 the CTSC or using CTSC resources should cite the CTSC as a contributing source of support and indicate the CTSC’s NIH CTSA grant title and number: “University of New Mexico Clinical and Translational Science Center, DHHS/NIH/NCRR #1UL1RR031977-01." 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 2 Researchers conducting health disparities research agree by their acceptance of this funding to present their research findings to the NM CARES Health Disparities Center. Budget Guidelines Awards may support research costs, as well as these CTSC core services (please note – utilization of CTSC staff is strongly encouraged): community liaison services from CTSC nursing and trial coordinator services biostatistical services, including o study design assistance o power analysis o data analysis clinical bioinformatics warehouse services RIOSNet biochemical laboratory services and sample processing survey development and implementation development of customized, web-based data collection tools full-service bionutrition services, including o metabolic rate assessment o body composition o study meal preparation o DXA bone densitometry Costs not covered under these awards: faculty 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 non-HSC staff salaries CTSC staff hours for community-engaged research services should be projected instead of costs; awards for this will be calculated in hours, not dollars Participant incentives, if included, should be minimized (i.e., not to exceed $20 per participant) and need to be carefully justified. The CTSC currently has unused gift certificates for participants and will provide these a priori. How to Apply Applications should include in this order: 1. A completed Cover Sheet Form (“CTSC Pilot and Collaborative Research Projects Program Grants Application” form). This form can be found at: http://hsc.unm.edu/research/ctsc/docs/CTSC_pilot_project_application_9Dec2010.pdf 2. Your Research Plan ( 5 pages, in the following order): a. significance (1/2 page) b. background and justification of your research’s health priority in New Mexico (1 page) 3 c. approach, including a description of your collaboration with the community partner d. specific plan to obtain extramural funding including: 1) an outline of planned specific aims of the future NIH application that this CTSC award would support, 2) brief explanation of why the data generated by this CTSC award will significantly strengthen such a future NIH application, and 3) a timeline of planned NIH grant submission ( 2 pages). Projects are expected to submit for extramural funding by the end of the pilot funding phase 3. NIH Biographical Sketches for the significant participants (maximum of 3 sketches, 4 pages each). The NIH biographical sketch form can be found at: http://grants.nih.gov/grants/funding/phs398/biosketch.doc A sample NIH biographical sketch form can be found at: http://grants.nih.gov/grants/funding/phs398/biosketchsample.doc 4. Detailed budget, budget justification, and justification that funds can be spent by 30 September 2012 ( 2 pages; budget in table format, followed by a concise budget justification in narrative form) See the Budget Guidelines section for details. 5. No appendices are allowed. 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 Send your completed application via e-mail in one PDF file to Bambi Wolf (BWolf@salud.unm.edu) by 5:00 pm 01 September 2011. Applications that are late or do not adhere to the above instructions may not be reviewed. Please call Bambi Wolf (2-6556) with any questions about this RFA or the application process. 4