CDU-UCLA U54 Cancer Center Partnership to Eliminate Cancer Health Disparities Request for Applications (RFA) for Pilot and Full Projects focused on

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1 CDU-UCLA U54 Cancer Center Partnership to Eliminate Cancer Health Disparities Request for Applications (RFA) for Pilot and Full Projects focused on Cancer Health Disparities

2 U54 Cancer Center Partnership Pilot Funding Overview and Instructions Purpose The CDU-UCLA U54 Cancer Center Partnership is now inviting research grant applications from investigators interested in cancer health disparities research. The partnership is particularly focused on translational research in cancer health disparities. The purpose of this U54 Cancer Center Partnership Full Project and Pilot Funding is multifold: The applications themselves will assist the CDU/UCLA U54 Cancer Center Partnership with ongoing development and enhancement of national research priorities for cancer health disparities research. Applicants will be expected to establish the significance of the proposed research and build a case for why it should be considered an important contribution to cancer health disparities. The U54 Cancer Center Partnership aims to develop a strong focus on translational cancer research and will particularly support projects and programs that address cancer health disparity questions including but not limited to breast, prostate, colorectal, and gynecological cancers. The CDU/UCLA U54 Cancer Center Partnership full project and pilot proposals will be utilized as part of a competitive proposal in response to the funding opportunity announcement (FOA) from the NIH/NCI titled: (U54) Comprehensive Partnerships to Advance Cancer Health Equity (CPACHE). The Project and Pilot Funding are designed to support studies that will investigate innovative mechanistic studies into the biological/genetic/behavioral aspects of cancer health disparities. Partnership among CDU and UCLA investigators is required. The Project and Pilot Funding are designed to facilitate and nurture the growth of a nationwide cohort of scientists with a high level of translational research expertise in cancer health disparities research. Most notably, this funding is to provide additional support for the development and advancement of the careers of junior faculty and provide incentive for competitive researchers to dedicate careers to investigating cancer health disparity issues. The Current Priority Areas for the CDU-UCLA U54 Cancer Center Partnership are the following: Priority 1: Increase the number and quality of cancer research projects at CDU by supporting full and pilot projects and increase the number of cancer researchers at CDU (category: cancer research and outreach). Priority 2: Enhance research capability of CDU's Integrated Clinical and Tissue Biomarker Data Base Program (ICTBP) (category: cancer research, training and outreach). Priority 3: Create institutional capacity at CDU for performing cancer-related clinical trials by leveraging the community and existing clinical research facilities and resources (category: cancer research, training, and outreach). Priority 4: Expose undergraduate and medical students, graduate students, fellows, and faculty to cancer research training and encourage them to pursue or advance their careers in this area, and implement a formalized mentorship program whereby junior research investigators are counseled and mentored during their career development process (category: cancer research, training, and outreach). Priority 5: Bring culturally and linguistically appropriate cancer research information to the community and increase community capacity to develop and implement culturally appropriate health prevention strategies through community-partnered participatory research (category: cancer outreach). U54 Cancer Center Partnership Funding Overview and Instructions Eligibility Eligible applicants must be Faculty with appointments at Charles Drew University of Medicine and Science and/or University of California, at Los Angeles. Applicants MUST have a co-investigator at the partnering institution and

3 demonstrate substantive and mutually beneficial collaboration. Applications MUST have a cancer health disparities focus. Total Awards CDU/UCLA U54 Cancer Center Partnership intends to submit 2 Full Project awards and 2 Pilot Project awards as part of the U54 CPACHE Grant Application. The Full Projects and Pilots are anticipated to be supported for 2 years (9/1/2018-8/31/2020), contingent on NCI/CPACHE funding. How to Apply Step One: Submit a Letter of Intent to milenapavlova@cdrewu.edu. o LOI must be no more than 1 page (Arial 11 Font) and must indicate: o Proposal title o Full Project or Pilot Project o Specific Aims o Relevance to U54 Priority Areas o Co-Investigator at the corresponding institution. Current NIH Biosketches are needed for the PI and Co-Investigator. The Letter of Intent and Biosketches are due April 27, Step Two (Invited Investigators Only): Full Project Award Information: Funding may be requested for a Total DIRECT Cost of up to $157,000/year for 2 years. Invited Investigators must submit a Full Project Application by completing the following: a. The Application PI Information Form b. Specific Aims (1 page). c. Research Strategy (12 pages) Must include: Significance, Innovation, Preliminary Studies, Approach, Impact, and References Cited. The maximum limit is 12 pages; this does not include references or mentoring plans. The Font should be Arial Black, Size 11. d. NIH Format Biosketch (PHS 398) e. NIH Format Other Support Page (PHS 398) f. NIH Format Budget and Budget Justification (PHS 398) g. Resources Form (PHS 398) h. Planned Enrollment Report (PHS 398) If applicable. i. All Personnel Form (PHS 398) j. Mentoring Plan for each Junior Investigator or Trainee i. Not to exceed 6 pages; this is separate from research strategy ii. Candidate Background, Career Goals and Objectives Scientific Biography, Career Development/Training Activities during the Award Period, Training in the Responsible Conduct of Research. iii. Must include at least one senior level mentor (Associate to Full Professor) k. Please attach all Institutional Research Approvals such as IACUC and IRB approvals if relevant to research performed. l. Invited Applicants will be required to submit Full Project Applications by June 1, Pilot Project Award Information: Funding may be requested for a Total DIRECT Cost of up to $ 80,000/year for 2 years. Invited Investigators must submit a Pilot Application by completing the following: a. The Application PI Information Form b. Specific Aims (1 page). c. Research Strategy (6 pages) Must include: Significance, Innovation, Preliminary Studies, Approach, Impact, and References Cited. The maximum limit is 6 pages; this does not include references or mentoring plans. The Font should be Arial Black, Size 11.

4 d. NIH Format Biosketch (PHS 398): e. NIH Format Other Support Page (PHS 398) f. NIH Format Budget and Budget Justification (PHS 398) g. Resources (Environment) Form (PHS 398) h. Planned Enrollment Report (PHS 398) If applicable. i. All Personnel Form (PHS 398) j. Mentoring Plan for each Junior Investigator or Trainee i. Not to exceed 6 pages; this is separate to research strategy ii. Candidate Background, Career Goals and Objectives Scientific Biography, Career Development/Training Activities during the Award Period, Training in the Responsible Conduct of Research. iii. Must include at least one senior level mentor (Associate to Full Professor) k. Please attach all Institutional Research Approvals such as IACUC and IRB approvals if relevant to research performed. l. Invited Applicants will be required to submit Pilot Applications by June 1, All PHS templates available at: A sample template is provided at the end of this RFP. Applications can be ed to Milena Pavlova (Executive Assistant/Coordinator - Division of Cancer Research, Center to Eliminate Cancer Health Disparities) at milenapavlova@cdrewu.edu. Please copy communications to the U54 Principal Investigators- Dr. Jay Vadgama at jayvadgama@cdrewu.edu and Dr. Robin Farias- Eisner at RFEisner@mednet.ucla.edu Important Deadlines 1. LOI Submission deadline is: April 27, Invited Application Submission deadline is: June 1, Proposal Guidelines MANDATORY INCLUSION OF U54 SPECIFIC FACTORS: a) Relevance of the Proposal to Cancer Health Disparities b) Relevance of the Proposal in addressing U54 Priority Areas (and focus on Translational Research) Refer to Cancer U54 Priority Areas. c) Must identify co-partner at CDU and/or UCLA. Drs. Vadgama and Farias-Eisner will assist you in seeking suitable partner if you need assistance. d) The application must articulate how the goals and objectives will enhance career development of junior faculty at CDU and/or UCLA. e) How the long-term partnership will enhance the infrastructure for cancer research, education, training, and care at CDU. REVIEW PROCESS: A peer-review process will be utilized in order to review and score the applications, similar to NIH (R) grant reviews. The U54 Internal Advisory Committee and Program Steering Committee will be engaged in the review process. It is imperative that applications include the U54 Specific Factors integrated throughout their application since these factors will be utilized in addition to scientific merit in determining the final applicants for funding. The criteria and sections that will be used to evaluate the proposals will include: (1) Significance, (2) Investigators, (3) Innovation, (4) Approach, and (5) Environment. In addition, the overall Impact will be assessed for the likelihood of the proposal to exert sustained, powerful influence on cancer health disparities research and in the CDU/UCLA U54 Cancer Center Partnership. The applications as part of the CPACHE application will undergo an additional external peer-review.

5 PROJECT SUMMARY/ABSTRACT: Project Summary: The purpose of the Project Summary/Abstract is to describe succinctly every major aspect of the proposed project. The Project Summary must be no longer than 30 lines of text, and will not be counted in the research strategy page limit of the proposal. The abstract should include: Brief background of the project (esp. relevance to Cancer Health Disparities/Translational Research/ U54 Priority Areas) Specific aims, objectives, or hypotheses; Significance of the proposed research; Unique features and innovation of the project; Methodology (action steps) to be used; Expected results; description of how your results will affect other research areas. RESEARCH PLAN SPECIFIC AIMS: Specific Aims Purpose: The purpose of the specific aims is to describe concisely and realistically the goals of the proposed research and summarize the expected outcome(s), including the impact of the proposed research will exert on the research fields involved. The Specific Aims must be no longer than one page, and will not be counted in the page limit of the proposal. The specific aims should cover: Broad, long-term goals (esp. pertaining to U54 priority areas, and U54 specific factors); Specific objectives and hypotheses to be tested; Summarize expected outcomes; describe impact on the research field. SIGNIFICANCE: Significance Purpose: The Significance section should explain the importance of the problem or describe the critical barrier to progress in the field that is being addressed. Explain how the proposed research project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields. Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved. A focus on the effect of the research on addressing health disparities is required. Any potential effects of the proposal on knowledge and practices among members of the participating community should be included. The Significance section should cover: State of existing knowledge, including literature citations and highlights of relevant data; Rationale of the proposed research; Explain gaps that the project is intended to fill especially in Cancer Health Disparities How proposal addresses U54 Priority Areas Potential contribution of this research to the scientific field(s) INVESTIGATORS: Investigator Purpose: The purpose of this section is to describe the collaborative (CDU/UCLA) team composition. Applicants should describe how the investigator team will contribute to the proposal and the U54 priority areas. It is important to also describe the strength of the collaborative team of investigators (especially complementary and integrated expertise). If principal investigator is a junior investigator, they should have an appropriate mentor/senior collaborator and describe the training component within the proposal (a separate mentoring/career plan will be needed). Expertise and record of the investigators will also be evaluated for experience in cancer health disparities research and (if applicable) culturally appropriate interventions and training activities. Note: It is key that investigators demonstrate that the aims and objectives developed for the proposal were developed in partnership by the PI and Co-Investigator at both institutions and have engagement of each partner throughout the research (including adequate representation on the budget).

6 INNOVATION: Innovation Purpose: Explain how the application challenges and seeks to shift current research (bench or biobehavioral) or shifts current clinical practice paradigms. Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantage over existing methodologies, instrumentation, or interventions. Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions. Explain if the study design being proposed is already in existence but being applied to new underserved populations and if the proposed design will be culturally tailored for the community of interest. The innovation section should include the following: Explain why concepts and methods are novel to the research field. Explain how concepts are uniquely applied for addressing cancer health disparities research. Explain how proposal presents an innovative partnership: among CDU or UCLA investigators; builds infrastructure at the institutions; and/or presents a new training opportunity for junior faculty and trainees. Focus on innovation in study design and outcomes. Summarize novel findings APPROACH Approach Purpose: The purpose of the approach section is to describe how the research will be carried out. This section is crucial to how favorably an application is reviewed. The research design and methods section should include the following: PI s preliminary studies, data, and experience relevant to the application and the experimental design; the overview of the experimental design; Description of methods and analyses to be used to accomplish the specific aims of the project; a discussion of potential difficulties and limitations and how these will be overcome or mitigated; Expected results, and alternative approaches that will be used if unexpected results are found; Projected sequence or timetable (work plan); If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work; Detailed discussion of the way in which the results will be collected, analyzed, and interpreted; Description of any new methodology used and why it represents an improvement over the existing ones. RESOURCES/ENVIORNMENT: Resources/Environment Purpose: The purpose of this section is to describe the scientific environment. Applicants should describe how the environment (both the CDU and UCLA side) will contribute to the feasibility and success of the proposal. In this section, it is expected investigators will highlight institutional support, equipment and other physical resources available. Most notably, this is an important area to describe how the project will benefit from unique features of the CDU/UCLA scientific environment, subject populations, or collaborative arrangements. Applicants should indicate the degree and the extent to which both academic and community partners have collaborated in the past and identify mechanisms (if applicable) in which community partners will be included. If applicable, the applicant should describe how the environment is conducive for research training of students, new and early stage investigators. Details from this section should be included in the Resource Form. BUDGET AND JUSTIFICATION Purpose: The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives. HUMAN SUBJECTS Purpose: The purpose of this section is to ensure the protection of the rights and welfare of people who

7 participate in research projects. If Human Subjects will be engaged in the project, please provide copies of the IRB Approvals or Materials. These items may be attached separately at the end of the application. VERTEBRATE ANIMALS Purpose: The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research. If vertebrate animals will be used in the project, please provide copies of the IACUC Approvals or Materials. These items may be attached separately at the end of the application. Please note, the application is in PHS 398 Format in order to facilitate integration of the proposals into the CPACHE Renewal Application. For detailed instructions in completing the forms please visit: Or contact Milena Pavlova by phone: or

West Virginia Clinical and Translational Science Institute Open Competition RFA

West Virginia Clinical and Translational Science Institute Open Competition RFA Part 1. Overview Information The goal of this Request for Applications (RFA) is to support clinical and translational pilot