Patient Services Collaborative Grant (PSCG) Application Instructions For grant year July 1, 2013-June 31, 2014 DEADLINES Continuous Application Dates Funds available: January 1, 2014 For questions regarding these instructions, please contact: Rita Pickler, PhD, at Rita.Pickler@cchmc.org, 513-803-5064, or Stephany Clevenger at Stephany.Clevenger@cchmc.org, 513-803-0430 1. Deadlines: Applications will be accepted on a continuing basis with award decisions within 60 days of submission of the completed application. Funds awarded will be available for use within 30 days of the award decision. A letter of intent (LOI) should be submitted to Dr. Pickler 30 days prior to the planned submission of the grant application in order to facilitate the review process and verify eligibility of the proposal under this mechanism. 2. Purpose: The purpose of the PSCG program is to stimulate collaborative, interdisciplinary, patient-focused research that will lead to improved outcomes for children and their families. Applications should be led by a principal investigator who is a faculty member with a primary affiliation in a research division in the Department of Patient Services at CCHMC and at least one collaborator from other Patient Services Divisions, Departments or Institutes at CCHMC, or other research institutions. The PSCG mechanism is designed to promote collaborations across disciplines and research methods to foster the development of clinical investigations of children and their families, consistent with the mission of the Department and CCHMC. All collaborative research projects will be considered for funding so long as the applicants and organizations meet the eligibility requirements. Because CCHMC and its collaborating partners are aware of current trends in health care reform nationally and within the state of Ohio the PSCG mechanism encourages proposals for research related to the following areas: Care coordination within and outside of the children’s hospital setting, particularly in relation to Chronic Care Outcomes (CCOs) and the Accountable Care Act (Ohio ACO) initiative, which has resulted in the formation of the Children’s Health Network (CCHN). Strategies that positively affect patient flow, length of stay, readmission within 30 days of discharge, and unnecessary utilization of hospital services prior to admission and/or after discharge. Research aimed at improving these metrics and/or defining better hospital performance measures that also capture the quality of pediatric care are encouraged. Strategies aimed at reducing hospitalization of patients with asthma or other chronic conditions. Quantitative improvements in the quality and or safety of pediatric care within the medical center. Other projects based on collaboration between a PI from the Dept. of Patient Services 1 of 12 and investigators from other departments and organizations that are not necessarily related to health care reform but that have direct impact on pediatric patient care. 3. Funding Pools: Funding for this program is provided by the Department of Patient Services, Cincinnati Children’s Hospital Medical Center (CCHMC) and collaborating Departments and Institutes at CCHMC as well as external research institutions. The Department of Patient Services will contribute up to $50,000 of support per year for direct costs per project. Collaborating CCHMC Departments and Institutes and external participating research institutions must contribute matching funds for each dollar from CCHMC, with a minimum of $10,000 from each research partner. The maximum allowable budget (direct costs) can be up to $100,000, dependent on the number and support of collaborating entities. The number of awards will be determined by the quality of the proposals, the total funds requested by meritorious proposals, and available funding. 4. Eligible Research: Collaborative research supported by this mechanism can include the entire spectrum of translational research ranging from T1 to T4. T1 research seeks to move a basic discovery into a candidate health application. T2 research assesses the value of a T1 application for health practice leading to the development of evidence-based guidelines. T3 research attempts to move evidence-based guidelines into health practice, through delivery, dissemination, and diffusion research. T4 research seeks to evaluate the "real world" health outcomes of a T1 application in practice. Basic and pre-clinical research studies can be considered for funding through this mechanism if the application clearly articulates the short-term potential for translation to human studies in pediatrics. 5. Collaborations: The PSCG program is specifically targeted at encouraging collaborations between Patient Services researchers and researchers in other Divisions, Department, and Institutes at CCHMC as well as other research institutions. Projects involving interdisciplinary collaborations that have a high potential for improving patient outcomes within patient services divisions will be given funding priority. Proposals meeting these criteria and targeted at the specific research questions outlined above in Section 2 will be given highest priority. Review criteria will also include potential for future funding of continued collaborative research arising from a PSCG award. 6. Types of Grants Available: a. New research proposals: These grants are for one year of support with the possibility for a one-year extension, if approved by all funding partners. Funds will be available within approximately 30 days of the completed review and funding decision. A second year of funding is dependent on progress in achieving the specific aims and expenditure of first year grant as well as support from all collaborating funding organizations. b. Budgetary notes: The Division of Research in Patient Services at CCHMC will provide matching funds up to $50,000 per project, for each dollar provided from the collaborating research entities. Funds provided by the Department of Patient Services may be used for salary support for the PI, who must have a faculty appointment at the time of the application and a primary affiliation with a division of the Department of Patient Services. Funds can also be used to support data collectors, data entry personnel, lab personnel, etc. CCHMC funds may not be used to provide salary support for faculty in other Departments or Institutes at CCHMC or any other institution. c. Competing renewal applications: A second year of support may be sought through a competing renewal process. Applications for competing renewal should include a progress report summarizing work during the first year toward achieving the specific aims of the proposal, as well as budget for the second year of the study with justification 2 of 12 for both carry-over and new funds. 7. Eligibility: The Principal Investigator (PI) must hold a primary affiliation with a division of the Department of Patient Services at CCHMC and a faculty appointment at University of Cincinnati. Collaborators can be faculty members in other Divisions of Patient Services or other Departments and Institutes at CCHMC or at other research institutions. To be eligible and responsive to this RFP, faculty must develop collaborative research proposals from 2 or more of the participating entities. Questions about eligibility should be referred to Prof. Pickler at the above address. 8. Letter of Support: Applications must include a letter of support from the PI’s Division Research or Scientific Director. Additional letters of support must be received from all collaborating entities and should address both the funding commitment and the commitment to release the faculty to complete work related to the project. Also included in the letters of support should be a statement regarding the priority of the research proposal to the supporting research organization. 9. Application Process: Applicants must submit a single integrated, electronic application to the Patient Services Collaborative Grant Program at the email address listed above using the templates provided in the instructions. The scientific plan section of the application will be limited to 5 pages plus 1 page of literature citations. The plan, following the outline of an NIH application, must describe the translational nature of the proposed project and the details of the multi-institutional collaboration proposed. A budget, Facilities & Resources section and NIH biosketches, should also be included. Human subjects and/or animal research approvals must also be included. If IRB approval is pending, applicants will need to address human subjects issues using NIH guidelines. 10. Proposal format: Proposals must be submitted in single spaced text, one-half inch margins, and no smaller than an 11-point font. Arial or Helvetica typefaces are preferred. Composition of the proposal must conform to the format described in section 11 immediately below and follow the page limits explicitly. The primary applicant’s name must appear in the upper right hand corner of each page, and each page must be numbered in the order of the required elements. 11. Composition of research proposal: New research proposals require the following elements in the order specified. a. Face page (check all appropriate IBC, IACUC, IRB, or Radiation Safety approvals or indicate pending if submitted or planned if not yet initiated) b. Abstract [scientific (summary) and lay (narrative)] c. Detailed Budget (1 year; use PHS 398 form provided) d. Budget justification e. Facilities & Resources from each participating institution should be described f. Biosketch(es) (include PI and co-investigators; use PHS 398 form 4 page format with personal statement, 15 most relevant publications, and other support) g. Specific Aims (1 page) h. Research Strategy (5 pages) (significance, Innovation, Approach, Preliminary Studies) For 2nd year competing renewals include Progress Report here. i. Statements regarding human subjects and/or animal protections j. Literature cited 3 of 12 k. Consortium/contractual arrangements l. Letters of support Division Director, collaborating CCHMC Departments or institutes, collaborating institutions, or consultants 12. Supplemental items: Supplemental items are not permitted and will not be reviewed. Human subject protections, references, letters of support, and contracts fall outside the 5 page limit for the Research Strategy but these sections will not be considered in the scoring process and should not be used to circumvent page limits. 13. Overview of Review Process: The review of applications is performed in two phases: (1) Scientific Review, and (2) Administrative Review. The applications will be reviewed by 2-3 scientific reviewers with relevant background and experience in pediatric research. The reviewers will be selected by the Leadership Council of Research in Patient Services (RPS) and will include ad hoc reviewers from each of the participating institutions. The 23 reviewers will provide written critiques using criteria and format similar to an NIH review process and scoring system. Review criteria will include an assessment of potential of the project to stimulate long-term collaborations and to compete for extramural grant support following the completion of the 1-year funding by the PSCG mechanism. Administrative review will be conducted by RPS Leadership Council, which will review the impact scores assigned by the review committee, confirm funding commitment by collaborative partner organizations, and make final funding decisions based upon available resources at the institutions, alignment of the proposal with the specific areas encouraged in this RFA (Sec. 2) and merit of the application reflected in the priority scores. Critiques from the review process will be provided to the applicants after award decisions are made. 14. Progress Reports: The investigators of funded projects will be required to submit a progress report to the PSCG leadership six months after funding begins and again after completion of the one-year of funding. These reports should be limited to two pages, including a list of any publications or abstracts arising from the work as well as information on whether and how the funding has increased collaborative translational research among the participating institutions. The RPS leadership council will review progress reports and make decisions about 2nd year renewal applications. If a second year of funding is requested, the format listed below in Section15 should be followed for the request. 15. Composition for competitive renewal: a. Face page b. Budget requested, including anticipated unobligated funds from year one and requests for additional fund c. Budget justification d. Other support e. Progress report (use the 2-page format outlined in Section 14 to report progress toward aims, problems in achieving aims, plans for achieving aims in the second funding year, and accomplishments) 4 of 12 Patient Services Collaborative Grant Program (PSCG) Grant Application 1. TITLE OF PROJECT (Do not exceed 56 characters, including spaces and punctuation.) 1a. Type of application: Research proposal TR Faculty Development Award No Retreat proposal 2. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR New Investigator 2a. NAME (Last, first, middle) 2b. DEGREE(S) 2c. POSITION TITLE 2d. MAILING ADDRESS (Street, city, state, zip code) Core proposal Yes 2e. DIVISION 2f. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT 2g. TELEPHONE AND FAX (Area code, number and extension) TEL: E-MAIL ADDRESS: FAX: 3. CO-INVESTIGATOR New Investigator No Yes 3a. NAME (Last, first, middle) 3b. DEGREE(S) 3c. POSITION TITLE 3d. MAILING ADDRESS (Street, city, state, zip code) 3e. DIVISION 3f. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT 3g. TELEPHONE AND FAX (Area code, number and extension) TEL: 4. No E-MAIL ADDRESS: FAX: Human Subjects Research 4a. Research Exempt Yes No Yes If “Yes,” Exemption No. 4b. Human Subjects Assurance No. 4c. No 6. No 6a. Date 6b. No. Vertebrate Animals Yes If “Yes,” IACUC Approval 7. 7a. IBC Protocol Yes If “Yes,” Approval Date: 7b. Approval Number: No 5. Human Subjects Protection Certification: No Yes 5a. Certification Date: NIH-Defined Phase I Clinical Trial Yes 8. No 8a. Date Radiation Yes If “Yes,” Approval Animal Welfare Assurance 9. DATES OF PROPOSED PERIOD OF SUPPORT (month, day, year—MM/DD/YY) From Through 07/01/2012 06/30/2013 10. COSTS REQUESTED Direct Costs ($) 12. The undersigned reviewed this application for a CCTST research award and are familiar with the policies, terms, and conditions of CCHMC concerning research support and accept the obligation to comply with all such policies, terms, and conditions. Primary Applicant: Division Chair of Primary Applicant: Signature of Primary Applicant Affiliate applicant: Date: Signature of Affiliate Applicant Date: Date Application Received by CCTST: Signature of Division Chair of Primary Applicant Date: Division Chair of Affiliate Applicant: Division Chair of Affiliate Applicant: Received By: 5 of 12 Date: 6 of 12 Principal Investigator/Program Director (Last, First, Middle): Scientific Abstract: Using technical language, briefly describe the proposed project in 200 words or less. Lay Abstract: Using non-technical language, briefly describe the proposed project in 100 words or less. 7 of 12 Principal Investigator/Program Director (Last, First, Middle): DETAILED BUDGET FOR BUDGET PERIOD DIRECT COSTS ONLY PERSONNEL (Applicant organization only) ROLE ON PROJECT NAME TYPE APPT. (months) % EFFORT ON PROJ. FROM THROUGH 00/00/13 00/00/14 DOLLAR AMOUNT REQUESTED (omit cents) INST. BASE SALARY SALARY REQUESTED FRINGE BENEFITS TOTAL Principal Investigator SUBTOTALS CONSULTANT COSTS EQUIPMENT (Itemize) SUPPLIES (Itemize by category) TRAVEL PATIENT CARE COSTS INPATIENT OUTPATIENT ALTERATIONS AND RENOVATIONS (Itemize by category) OTHER EXPENSES (Itemize by category) SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD CONSORTIUM/CONTRACTUAL COSTS $ DIRECT COSTS FACILITIES AND ADMINISTRATIVE COSTS TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (Item 10, Face Page) Principal Investigator/Program Director (Last, First, Middle): 8 of 12 $ BUDGET JUSTIFICATION 9 of 12 Principal Investigator/Program Director (Last, first, middle): BIOGRAPHICAL SKETCH Provide the following information for the key personnel in the order listed for Form Page 2. Follow the sample format for each person. DO NOT EXCEED FOUR PAGES. NAME POSITION TITLE EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.) INSTITUTION AND LOCATION DEGREE (if applicable) YEAR(s) FIELD OF STUDY NOTE: The Biographical Sketch may not exceed four pages. A. Personal Statement Briefly describe why your experience and qualifications make you particularly well suited for your role (e.g., PD/PI, mentor, participating faculty) in the project that is the subject of the application. B. Positions and Honors List in chronological order previous positions, concluding with the present position. List any honors. Include present membership on any Federal Government public advisory committee. C. Selected Peer-reviewed Publications Please limit the list of selected peer-reviewed publications or manuscripts in press to no more than 15. Do not include manuscripts submitted or in preparation. The individual may choose to include selected publications based on recency, importance to the field, and/or relevance to the proposed research. Provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each article. D. Research Support List both selected ongoing and completed research projects for the past three years (Federal or non-Federallysupported). Begin with the projects that are most relevant to the research proposed in the application. Briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical Sketch. Do not include number of person months or direct costs. 10 of 12 Principal Investigator/Program Director (Last, First, Middle): RESOURCES FACILITIES: Specify the facilities to be used for the conduct of the proposed research. Indicate the performance sites and describe capacities, pertinent capabilities, relative proximity, and extent of availability to the project. Under “Other,” identify support services such as machine shop, electronics shop, and specify the extent to which they will be available to the project. Use continuation pages if necessary. Laboratory: Clinical: Animal: Computer: Office: Other: MAJOR EQUIPMENT: List the most important equipment items already available for this project, noting the location and pertinent capabilities of each. 11 of 12 To insert additional documents, select Tools from the MS Word menu, then Unprotect Document. You will be able to add text and pages as needed. To continue using the pages before this page, you must protect the document; to protect this document, select Tools from the MS Word menu, then Protect Document, then Forms. You will then be able to enter information into the fields. 12 of 12