Pilot & Collaborative Studies (PCS) Funding Program FAQs What is PCS? The Center for Clinical and Translational Science and Training (CCTST) is supported by a NIH Clinical and Translational Sciences Award (CTSA). Integral to the mission of the CCTST is stimulating the development of pre-clinical and human clinical trials that seek to improve medical care. For its major pilot award program, the CCTST has adopted and expanded the pilot award program previously administered at CCHMC as part of the Translational Research Initiative (TRI), now offered through the Pilot & Collaborative Translational & Clinical Studies (PCS) Core. What is Translational Research? Clinical translational research is the confirmation in human clinical testing or observation that the products, procedures and health service processes created to improve health deliver the expected benefits without unacceptable side effects. While this category includes Phase I through IV clinical trials, with assessments of safety and clinical effectiveness, T1 research is typically limited to Phase I or II studies. Pre-clinical translational research is laboratory research that leads to a plan or design for new or improved elements of health care, whether intended for internal use or use by others outside of the AHC. It includes the conceptual formulation, design, pre-clinical, and post-clinical testing of a range of diagnostic and therapeutic products and procedures. In some cases the term pre-clinical is preferred to non-clinical because nonclinical also encompasses laboratory testing done after the introduction and testing of an agent, device, or procedure in humans. What are T1, T2, T3, and T4? T1 research seeks to apply clinical or basic research knowledge in an identifiable pathway towards the development of trials and studies in humans. T2 research is validation of T1 research in phase II and III trials. T3 and T4 research are aimed at enhancing the adoption of best practices in the community and in health policy, respectively. PCS T1 Funding programs support T1 research, and are especially designed to support novel findings developed at the University of Cincinnati and its affiliates with a principal focus on the Academic Health Center (AHC) encompassing Cincinnati Children s Hospital Medical Center (CCHMC); the University of Cincinnati Colleges of Medicine, Pharmacy, Allied Health and Nursing; UC Health University Hospital; and the Cincinnati Veterans Affairs Medical Center (VAMC). Inter-institutional and interdisciplinary projects are especially encouraged. T1 translational research seeks to develop the translation of observations made in the AHC research laboratories into clinical studies involving humans, or the use of clinical observations to define basic research hypotheses or studies. Innovative use of clinical material in basic laboratories is considered translational research. A research study is responsive to the RFA as T1 translational if it: uses new approaches or discoveries to address clinical problems; develops new experimental or diagnostic reagents and procedures for diagnosis or treatment; and/or develops new models of human diseases (including tissue culture and animal models) and verifies the relevance of these to the clinical issues in human subjects. Why is collaboration between institutions encouraged with all protocols? Is collaboration required? The CCTST encourages interdisciplinary research and interactions between basic scientists and clinicians within and between the University of Cincinnati and Academic Health Center institutions to foster the
development of pre-clinical and clinical investigations for patients with serious diseases. Thus, studies that include the participation of individuals in divergent departments and institutions and between clinicians and basic scientists are preferred. Among similarly scored projects, those involving interdisciplinary collaborations will be given priority during the administrative review. How do I find PCS or other CCTST funding opportunities? The CCTST website lists various funding opportunities at http://cctst.uc.edu/research-central/fundingopportunities. PCS funding programs are located at http://cctst.uc.edu/programs/pilot-studies. What funding opportunities do you have? New T1 research proposals These grants are for one year of support. The next request for letters of intent (LOIs) will be announced in late summer 2012. The maximum allowable budget (direct costs) is $100,000. The number of awardees will be determined by the quality of the proposals, the total amounts of the requested budgets of sufficiently meritorious proposals, and available funds. Funding for this program includes $800,000 from CCHMC and $400,000 from UC. To be eligible for CCHMC funds, either the principal investigator or a co-investigator must hold a faculty appointment at CCHMC with 80% or greater FTE. Competing T1 renewal applications For those projects previously supported by the CCTST, a second year of support may be sought. Those applying for a second year are not required to submit a LOI, only an email per the RFA. Renewal applications will be reviewed in the same manner as new applications. They must include a Progress to Date section, and must convincingly justify the need for more support. Innovative Cores To help build adequate local infrastructure to support clinical and translational research, funds are available for the establishment of new cores. Core proposals of up to $50,000 per year for one or two years will be considered. Cores supported by this program may include laboratory and clinical facilities, equipment, and services that will be shared by multiple investigators. The CCTST is primarily interested in supporting new, innovative cores that promote the mission of building a local or networked infrastructure for conducting non-clinical or translational/clinical research. Established cores seeking bridge or supplemental funding, or cores that primarily support basic (discovery) research, are not likely to be successful through this mechanism. Junior Investigators The T1 Junior program allows entry level faculty an opportunity to have proposals reviewed in a pool of their peers. Limited to new research proposals for one year of support, the maximum allowable budget (direct costs) is $25,000. The program is intended to lead to other funding such as the full T1 Pilot Awards or extramural awards. Thus, no renewals for a second year of support will be considered. It is not permissible to be a PI or Co-PI on a T1 application and a PI on a T1 Junior application during the same funding cycle. Investigators eligible to apply for a T1 Jr. award: Currently hold a faculty appointment at UC, CCHMC or VAMC at the level of Instructor, Assistant Professor, or Research Assistant Professor, or expect to at the time of the award (note: if not yet faculty, a letter from your program director must verify expected start date); Have less than 8 years from their first faculty appointment to the start of the award period; Have never been PI or co-pi on an R-series NIH award or a Project Leader on a P01 (prior coinvestigator on R-series is allowed, as is prior or current PI on K-series awards and Core Director on a P01) Have not previously been a PI or co-pi on a T1 Pilot Award (prior co-investigator is allowed);
Retreats What does this fund cover? Support is available for multidisciplinary retreats/workshops/symposia (on or off campus) that will further the mission of the CCTST. Ideally, these events will provide a rich forum for basic, translational, and clinical scientists to interact and develop new initiatives. How much is available? Up to $3,000 per event is available from the CCTST. Funds are contingent upon matching funds derived from other resources (typically clinical or research division resources or grants). Awards are made on a continuing basis, so application early in the fiscal year is encouraged. Who can apply? Applications will be accepted from all 80% or greater FTE faculty members based at UC, CCHMC, or Cincinnati VAMC, including nursing, health outcomes and other health care faculty with advanced degrees (M.D., Ph.D., or equivalent). Clusters of investigators spanning disciplines and programs made up of basic and clinical faculty are strongly encouraged to apply. Just-In-Time Core Funds Grant Program What is the purpose of this grant? This small grants program is designed to support clinical and translational science investigators who are seeking preliminary data in the next 3-6 months for K23, R01 or similar grant submissions and need the services of one or more of the institutional cores. How much is available? Investigators may apply for up to $7,500 annually in support for services that would help them obtain preliminary data needed for a new or revised application for extramural funding. Which cores are participating? The latest list is available at http://cctst.uc.edu/programs/pilot-studies NOTE: If the core you wish to use is not on this list, or if you are a core director and would like your core to be added, please send a formal request to catherine.scharf@cchmc.org. Include rationale regarding how your core is utilized for clinical or translational studies. The CCTST leadership will consider the request. Human Subjects Why do your forms ask about Human Subjects? Recording data involving Human Subjects is legally required. Please do not respond to category and leave 4b blank if your protocol does not contain Human Subjects. If you do have Human Subjects within your protocol, please provide the IRB s FWA number on item 4b. Human subject research data metrics use identifiers that mean exempt. If there are no identifiers, then the research data are not exempt. What does it mean to have Human Subjects Protection Certification? Answering yes means that the PI has been certified by completing the CITI training every 3 years (every 2 years at the VAMC).
What is a Letter of Intent (LOI)? The LOI is used for the research applications (T1 new research proposals, junior T1 proposals, cores), but not the retreats or JIT awards. It is also not required for competing renewal applications. The LOI consists of the application face page and 1 page describing the hypothesis and specific aims. No supplemental material will be accepted for the LOI. The aims should include a brief description of the research design and methods. For core proposals, the LOI consists of the application face page and a one page description of the proposal. No signatures are required for the Letter of Intent. All individuals need to go through sponsored programs as they would for any other grant (most divisions have a grant administrator to help faculty do this), but for the LOI stage we won't require the details of the face page such as division chief signatures or these numbers or budget numbers -- mainly we're interested in their contact info at this stage. Which signatures are required? For the invited applications, the signatures of all investigators and their respective division director or departmental chairperson(s) are required. No signatures are required for the Letter of Intent. How much budget detail is needed? Articulated detail is needed for the budget and justification because it is necessary for the performance of the award. All projects including consortium/contractual expense items need to submit a separate detailed budget on Form Page 4 and a budget justification. Each item listed on Form Page 4 must be clearly justified on Form Page 5. The awards will be funded by an institutional funding source and will not be eligible for revision without approval during the project year. How much supplemental information is allowed on any application? The animal and human subject protections, references, letters of collaboration and contracts are not included in the 5 pages. No other supplemental materials are allowed. Additional supplemental materials exceeding the 5 pages of the application will not be forwarded to reviewers for consideration of the application. For example, do not include clinical trial protocols, reprints, figures, etc. How do I actually submit a PCS application? All applications are received as one collective attachment, preferably in a.pdf. This protects your data and enables data management. Please refer to the RFA for specific details. Can I be a PI or Co-PI on more than one application for the same program at the same time? Yes, but there is maximum of only one award per funding program per cycle. Only one application will be invited for review from the same PI, so if a PI submits multiple LOIs and more than one ranks high enough during the LOI phase to be invited, the applicant will be asked to select only one for final submission. Who decides awards? The review of applications is performed in 3 phases: (1) Letters of Intent (LOI), (2) Scientific Review, and (3) Administrative Review. During the first phase, the 1 page Letters of Intent will be scored and ranked by at least 5 members of the review committee, and the worst score for each applicant will be discarded. The top applicants will be invited to submit formal 5 page applications. No critiques will be provided to applicants at the LOI phase. During the second phase, the 5 page applications will be reviewed by 2-3 scientific reviewers, a biostatistician, and a member of the intellectual property office. The committee will meet and discuss applications similar to an NIH study section, and members present for the discussion will score each application. During the third and final phase, the applicant rankings will be reviewed by the CCTST leadership, and the cut-off for awards will be determined. Some budget cuts may be made during this phase if necessary
to accommodate top-ranked applications. Interdisciplinary applications, particularly those from divergent arenas of the AHC, may be given priority during this administrative review. The success rate of invited applications is expected to be ~40%. Critiques from the second phase of the review will be provided to the applicants after awards are announced. Can a deadline be extended? All deadlines for submissions are firm, with no exceptions other than 1) death in the PI's immediate family or 2) acute severe illness of the PI. Who can I contact if I have more questions? Please email catherine.scharf@cchmc.org for additional information.