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REQUEST FOR APPLICATIONS CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE (CTSI) PILOT PROJECT GRANTS Letter of Intent Receipt Date: February 23, 2009 Application Receipt Date: March 23, 2009 A. Background. The purpose of the recently created Penn State CTSI is to foster innovative, inter-disciplinary clinical and translational research and training at Penn State. The goal of this RFA is to catalyze the development of interdisciplinary research teams (also called “Translational Research Clusters”) that address relevant health problems, and to assist them in the generation of preliminary data that support future applications for extramural funding. Vibrant and successful teams will serve as a training ground for the next generation of scientists who are able to combine disciplinary depth with transdisciplinary literacy. Funding is being provided by the College of Medicine, the Huck Institutes for the Life Sciences, the Social Science Research Institute, and the Institute for CyberScience. Applications in response to this RFA should propose research projects that will expand Penn State’s portfolio of translational research, capitalize on existing strengths by creating new interdisciplinary research teams and synergies, and fill gaps in the translational path from basic science to the bedside and the community, and back. B. Eligibility Criteria. Research Team members must have faculty appointments at Penn State. Proposed projects must have the characteristics of interdisciplinary translational research as described above. In particular, proposals should describe collaborations among investigators with primary professional expertise in different fields. Projects should have the potential to grow into vital, self-sustaining programs that have healthrelated impact directly or by enabling others. Relevant disciplines include but are not limited to basic biomedical, social, behavioral and environmental sciences, medicine, community-engaged and participatory research, information technology, health economics and policy, engineering, or health evaluation sciences. Inter-campus collaborations are strongly encouraged. Applicants for this award remain eligible to apply for support under other institutional programs, provided there is no scientific overlap among pending applications. C. Program Guidelines. Applicants may request up to $50,000 in direct costs for a period of up to 12 months. The project budget and duration must be commensurate with project goals and investigator readiness. Applicants are strongly encouraged to propose projects that provide high return on investment as defined by the review criteria defined in this RFA and by prospects for future extramural funding. Even if high risk, projects with the potential for high impact will be viewed favorably. Although no departmental matching funds are required, departments are encouraged to provide resources that would help ensure the success of the project, including support of investigator effort. The award cannot be used for salary support of tenure-track faculty or staff physicians. In addition to supporting efforts to obtain preliminary data in a novel collaborative research project, the funds may also be used in part for other activities necessary for the development of the collaboration, including travel, workshops, or retreats. However, these expenses should only make up a small portion of the budget and must be kept within the context of a research effort. D. Application Process. A letter of intent identifying the project, names of the team members, and a short (25-line maximum) description of the project is due by February 23, 2009. An application using the form that accompanies this RFA is due by March 23, 2009. Both should be sent by email to Andrea Lazarus, Ph.D., CTSI Administrator, alazarus@psu.edu. E. Review Process. Applications will undergo an initial review for scientific and technical merit by faculty reviewers from both Hershey and University Park campuses. Reviewers will consider the following elements in their reviews:  Scientific merit. Is the proposed work meritorious from the perspectives of the fields represented?  Research Team. Is a new collaboration, or a new direction for an existing team, proposed? Are the investigators well-qualified to undertake the project? Does the research plan appear to have been prepared by the entire team (e.g., is there substantive contribution from each field represented)?  Translational nature. Does the project build pathways for translation by joining previously disconnected areas of expertise or research programs, filling gaps between programs, or moving work closer to application in the clinic or community, or does the project seek to derive important scientific questions from observations in the community or clinic?  Strategic fit. Will the proposed work help Penn State build critical mass in a relevant health-related field? Does it build upon existing strengths in important ways, or complement ongoing research at Penn State?  Innovation, transformation, and potential impact. Does the proposed project innovate or transform the way health-relevant research is conducted at Penn State? Does it suggest novel approaches to clinical and translational research, application of distinctive capabilities, or access to unique populations that would allow Penn State to excel in ways that others could not? Does it translate methodologies from one field to another, thereby cultivating new synergies? Does the project have the potential for high impact?  Potential for extramural funding. What are the project’s prospects for follow-on extramural funding? F. Awards. Approximately eight awards are anticipated, the number being dependent upon the number and size of meritorious applications. Applicants will be notified in May 2009 regarding the outcome of the reviews of their applications, with funds becoming available after approval by the Pennsylvania Department of Health (DOH). Applicants should note that DOH rules require IRB approval of clinical studies prior to submission to the DOH for approval. 2 CLINICAL AND TRANSLATIONAL SCIENCE INSITUTE (CTSI) PILOT PROJECT GRANTS PROPOSAL DUE DATE: MARCH 23, 2009 Formatting requirements:1 Except where otherwise noted, responses must be single-spaced, in Times New Roman font size no smaller than 12-point type, and left-aligned. Please submit this form electronically to Andrea Lazarus, PhD, Administrator for the CTSI, at alazarus@psu.edu by MARCH 23, 2009. You must also provide a copy of this application, along with any proposal clearance form(s) that may be required by your academic or research unit. PROJECT TITLE Corresponding Investigator – Please provide contact information for the faculty member who will be the point of contact for correspondence concerning this application. CORRESPONDING INVESTIGATOR NAME (First Name MI Last Name) POSITION/TITLE EMAIL ADDRESS DEGREE(S) COLLEGE/DEPARTMENT MAILING ADDRESS (Street, City, State, Zip Code) Research Team Members – Beginning with the Corresponding Investigator, provide the requested information for the faculty members who will be collaborating in the proposed project. For “Role on Project”, please give a short description of that person’s contribution. If available, please attach a biosketch for each collaborator, in NIH or NSF format, to this application. RESEARCH TEAM MEMBERS NAME OF PERSON AND DEGREES COLLEGE/DEPARTMENT ROLE ON PROJECT 1 These formatting requirements and the content of certain sections are designed to speed the process for releasing PA Tobacco Settlement formula funding to awardees by allowing the CTSI Administrator to transfer text to the state application form. 3 Project Overview – On this page, provide a succinct (no more than 25 lines) overview of the proposed project. Do not assume the reader to have technical knowledge of any specific field of study. Include (a) the project’s broad objectives and specific aims; (b) the research design and methods for achieving the objectives and aims; and (c) the expected outcomes, including relevance to human health. 4 Research Plan – The research plan should be organized into the sections highlighted below. In addition to the guidance provided with each heading below, be sure to attend to the review criteria outlined in the RFA. Do not exceed 7 pages excluding references. (1) Project Objectives. Outline the long-term objectives of your project as well as the specific aims of this proposed pilot work. Reviewers will focus on the long-term objectives in judging potential impact of the program. The specific aims should be focused on answering key questions or collecting key data during the proposed project period. (2) Background and translational significance. Explain the larger context of the project, including a description of any unsolved problems, unmet needs or observations that provide motivation or reveal an opportunity. Be sure to highlight any unique aspects of the team such as the combination of disciplines or the transfer of a methodology or theoretical framework from one field to another. (3) Research design, methods, and team. Describe the specific work to be done in this pilot study in order to fulfill the specific aims. All material in this section should be suitable for review by a multidisciplinary group of reviewers. The contributions of expertise by all investigators involved in the project should be made apparent. (4) References. 5 Supplementary Data Research Subjects and Materials - Will the project use any of the following subjects or materials? (A) Human subjects? Yes No (B) Human embryonic stem cells? Yes No (C) Recombinant DNA? Yes No (D) Vertebrate Laboratory Animals? Yes No Other Funding Sources - (A) Indicate other funding sources that are being sought by the applicant for the proposed research project. (B) Indicate sources of other funds that currently support the project. (A) Are other funds being sought for this project? If yes, specify other sources of funding being sought: Yes No (B) Do other funds currently support a project having scientific overlap with this one? Yes No If yes, briefly describe each project, source of current funding, and overlap with this proposed project. Will the proposed project utilize the GCRC? Yes No 6 Protection of Human Subjects - If the research involves the use of human subjects, please attach a detailed description of the procedures that will be followed to assure protection of human research volunteers. Include detailed information on informed consent, data confidentiality and risks and benefits. If the research involves a clinical trial, describe procedures related to the Data Safety and Monitoring Board. IRB approval is not required before submission of this application, but will be required prior to submitting the application to PA Department of Health for approval. 7 Budget: Use PHS 398 Detailed Budget http://grants.nih.gov/grants/funding/phs398/fp4.pdf and include a budget justification relating funds to the Research Plan. If activities are planned at both the Hershey and University Park campuses, you will need to prepare separate budgets for each location. 8