Ola HAWAII Team-Science Pilot Projects Program 2017 Full Proposal NIH/NIMHD 2U54MD

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1 Ola HAWAII Team-Science Pilot Projects Program 2017 Full Proposal NIH/NIMHD 2U54MD PURPOSE: Ola means health and to heal in Hawaiian. Achieving health and wellness for communities in Hawaii, which suffer disproportionately from genetic, environmental and socio-economic disparities in health and healthcare access, is the rationale for the newly funded Research Centers in Minority Institutions (RCMI) Specialized Center. The strategic goal of the Center, named Ola HAWAII (Health And Wellness Achieved by Impacting Inequalities), is to grow and support a community of health disparities scholars (the workforce ) to harness the power of diverse thought (the thinkforce ) to determine the causes of and interventions for health disparities in the Pacific. To achieve this goal, Ola HAWAII will provide modest funding, on a competitive basis, for collaborative research projects conducted by faculty of the University of Hawaii System. New and early-stage investigators, and under-represented minorities and individuals with disabilities, are particularly encouraged to apply. The purpose of this announcement is to provide guidelines and criteria for proposal submissions from applicants who were notified that their Letters of Intent were favorably reviewed. RESEARCH SCOPE: Proposals that focus on the science of health disparities among Native Hawaiians, Pacific islanders, Filipino, and/or other populations in Hawaii will be considered highly responsive to this Funding Opportunity Announcement. In addition, proposals, which entail a translational research emphasis and leverage linkages between basic science and clinical medicine and/or community engagement, leading to adoption of best practices, are highly encouraged. Ola HAWAII is also open to the full spectrum of life science research. That is, proposals involving fundamental research seeking new knowledge about basic molecular mechanisms, using newly developed tools or repurposing existing tools, will also be given full consideration. Research proposals involving foreign sites, however, will not be considered. AVAILABLE SUPPORT: Applicants may request an annual budget with direct costs between $25,000 to $50,000, with no indirect costs. It is anticipated that the size of the Ola HAWAII Team-Science pilot project awards will vary based upon the scope of the proposed research. Applicants must utilize infrastructure support from the Ola HAWAII Cores, e.g., biostatistics, bioinformatics, RN/study coordination, histopathology, community-engagement, behavioral and/or other support. APPLICATION REQUIREMENTS Eligibility: Any faculty member of the University of Hawaii System, holding a doctoral degree (e.g., M.D., Ph.D., Pharm.D., Dr.P.H., D.S.W., Ed.D., Sc.D., etc.) and possessing the skills, knowledge and resources necessary to carry out the proposed research, is invited to submit a letter of intent. A faculty member may submit only one letter of intent, as principal investigator. New and early-stage investigators, and individuals from under-represented racial and ethnic groups, as well as individuals with disabilities, are encouraged to apply. Multiple principal investigator arrangements are also encouraged. Current and past awardees of RCMI BRIDGES and RMATRIX may apply for continued support of their original projects or for new projects. On the other hand, individuals who are principal investigators of active NIH R01, R35, R37, R56, P01, P20, P30, P50, P60, U01, U19, U54, DP1, DP2 (or similar) and/or K99R00 grants are ineligible to apply as principal investigator or multiple principal investigator. Similarly, those with R01-equivalent awards from the National Science Foundation, Department of Defense and national societies and foundations, such as the American Heart Association, are ineligible, as are graduate students. These individuals, however, may serve as collaborators or co-investigators. Collaborator(s): All applicants must designate at least one co-investigator or other principal investigator(s) as a collaborator. Collaborators may be non-uh System faculty. The proposed research must involve a transdisciplinary team of investigators, comprising clinician scientists (e.g., physician, psychologist, social worker, nurse, etc.), basic scientists from disparate disciplines, and/or community partners. Additional collaborators may be from the lay community.

2 Mentor(s): All applicants are required to designate one or more mid-level or senior-level mentor(s). Mentors may be non-uh System faculty. IMPORTANT DATES Invitation to submit full proposal Thursday, October 5, 2017 Deadline for full proposal Proposal review completed and selections made IRB and IACUC approvals; other support due date Wednesday, October 25, 2017 (5:00pm) Tuesday, November 7, 2017 November 8, 2017 Proposals submitted to NIH/NIMHD for review and approval Mid November or as soon as all documentation reviewed and compiled. Earliest anticipated award date January 2018 Progress Report due dates Mid-Year Report Due Date: May 1, 2018 Final Progress Report Due Date: July 31, 2018 Project deliverables 1. Presentation at Regional/National Meeting or JABSOM Biomedical Symposium. 2. Completion of Ola HAWAII data collection metrics. 3. Continuous participation in the Independent Development Plan. 4. Within six months of pilot project completion, submission of at least one manuscript to a referenced journal acknowledging Ola HAWAII support with a PMCID #. 5. Within one year of pilot project completion, submission of at least one grant using the data gathered from the pilot project. FULL PROPOSAL SUBMISSION INSTRUCTIONS Use the application forms provided and upload your documents as follows: a. Cover Page b. Project Summary c. Detailed Budget d. Budget Justification e. Biographical Sketches f. Letters of Support g. Research Plan h. Human Subjects (including Targeted/Planned Enrollment Table), if applicable i. Vertebrate Animals, if applicable Applications will not be required to go through mygrant. Paper applications will not be accepted. Incomplete applications, handwritten applications or applications not adhering to the following specifications will not be reviewed and will be returned. Also, applications submitted after the deadline will not be reviewed. Font Use an Arial typeface, black font color, and font size of 11 points or larger, for text. A symbol font may be used to insert Greek letters or special characters; the font size requirement still applies. Type density, including characters and spaces, must be no more than 15 characters per inch.

3 Type may be no more than six lines per inch. Use black ink that can be clearly copied. Print must be clear and legible. Paper Size and Page Margins Use a standard page size (8½" x 11"). Use at least one-half inch margins (top, bottom, left, and right) for all pages, including continuation pages. Page Formatting Use only a standard, single-column format for the text. Avoid using a two-column format since it can cause difficulties when reviewing the document electronically. The application must be single-sided and single-spaced. Consecutively number all pages throughout the application. Do not use suffixes for page numbers (e.g., 5a, 5b). Do not include unnumbered pages. The name of the Principal Investigator should appear in the upper right-hand corner of each page. The page order of the application should be as follows, adhering strictly to page limits: a. Cover Page (Page 1) Complete the cover page. b. Project Summary (1 page) The project summary should describe succinctly every major aspect of the proposed project. It should contain a statement of objectives and methods to be employed. The Project Summary should include: brief background of the project; objective(s), specific aims, and central hypotheses; significance of the proposed research and relevance to public health; unique features and innovation of the project; methodology (action steps) to be used; expected results; and scientific impact of the results. c. Budget (1 page) Complete the detailed budget form and enter the totals under each budget category. d. Budget Justification (1 page) Provide a justification for each budget item requested. Applicants may request an annual budget with direct costs of $25,000 to $50,000, no indirect costs. Principal Investigators of the project must include a minimum of 2% effort paid from the grant. Other Co-Investigators and project staff salary support may be considered if appropriately justified. Cost sharing and honorariums will not be allowed. Incentives for research participants are allowed. Travel support is allowed to present accepted abstracts at professional meetings, but must be limited to domestic travel only, not to exceed $2,500. Supplies directly related to the project should be included. Request for equipment (including computers) requires proper justification and plans for future use of the equipment upon completion of the project. Any supplies and equipment purchased by Ola HAWAII funds are property of Ola HAWAII. In addition to funds, applicants must incorporate into their proposal how they will use at least one Ola HAWAII core. Request for personnel and infrastructure support available through the Ola HAWAII program includes: biostatistics; informatics; RN/study coordination; histopathology. There is no cost for use of existing Ola HAWAII core infrastructure. Selected proposals will be awarded a combination of funds plus infrastructure support; thus, it is anticipated the size of the Ola HAWAII Team-Science pilot project awards will vary based upon the scope of the proposed research.

4 e. Biographical Sketches (Not to exceed 5 pages for each key personnel) Using standard NIH format ( please submit a biographical sketch for the Principal Investigator and any additional key personnel, including mentors. Include current research support (source of funds, title of research, period of time covered, specific aims and role of the investigator) for all currently funded projects and those pending future funding. Please state any areas of potential overlap the proposed project may have with current and pending projects. f. Letters of Support Include letters of support from co-investigator(s), collaborator(s), mentor(s), community/hospital partners confirming and describing their roles in the project. g. Research Plan (Please adhere to page limits; use Continuation Page) Please keep these questions in mind as the following items are organized (g.1-g.4) What do you intend to do? Why is the work important (relation to health disparities, population science, etc.)? What has already been done? How are you going to do the work? The application is limited to 5 pages (1 page for Specific Aims; 1 page for Significance and Innovation; and 3 pages for Experimental Plan). All tables, graphs, figures, diagrams, charts and other displays must be included within the page limits. Please include a brief mentoring plan. g.1. Specific Aims (1 page) Briefly describe the background/research to date, which has led to the present application. Critically evaluate existing knowledge and specifically identify gaps in knowledge that the project will fill. State the long-term goal and the principal objective of the proposed research. State the hypotheses to be tested and relevance to health disparities. State the specific aims and summarize the experimental plan for each aim. g.2. Significance and Innovation (1 page) For the Significance section, state the magnitude and importance of the health disparity; who or what group is most impacted; what has been tried and why a solution is currently unavailable; why a solution is needed now, relating each aim to the problem; and why your team is particularly well qualified to solve the problem. For the Innovation section, state what recent advances make the proposed solution likely to succeed; the novel technologies the proposed research uses; the innovative approaches proposed; how the repurposing of existing technologies benefit the research; and access to unique resources or patient populations. g.3. Experimental Approach/Research Design/Mentoring Plan/Project Timetable (3 pages) Describe the research design and experimental approach to the research question and state the procedures and methods to be used in achieving the specific aims. Include how the data will be collected, analyzed, and interpreted. State the expected results, and point out potential problems or obstacles and alternative approaches. For junior investigators, a brief mentoring plan must be included. A project timetable is required and must indicate targeted completion of each specific aim. The timetable should also include plans for abstract and/or manuscript submission, as well as preparation of future grant applications. g.4. Literature Cited (1 page) List all references in numbered, sequence within the text. Each reference must include the names of all authors, title, book or journal name, volume number, page numbers, and year of publication. Please limit the references to relevant and current literature pertinent to the proposed research. h. Human Subjects (no page limits) Please follow the guidelines for documentation of certification for protection of human subjects in accordance with NIH guidelines ( For Non-Exempt Human Subjects Research, please be sure to include all required sections beginning on Page II-7 of the NIH document. If you are conducting human subjects research, you must also complete the Targeted/Planned Enrollment Table.

5 Applications with an incomplete human subjects section may be considered ineligible for review. IRB approval letter or copy of the first page of the IRB application is required for the full application submission. Every application will require either an IRB or IACUC approval letter. If multiple IRB entities are involved, the IRB approval letters, or copy of first page of each IRB application, must be uploaded. IRB approval letter(s) can be uploaded with your human subjects plans or if you need to obtain IRB approval, please submit the approval letter to Ms. Susan Ordinado by Wednesday, November 8, 2017 to be considered for funding. i. Vertebrate Animals (no page limits) Certification for protection for the care and treatment of laboratory animals should be obtained for all applicable projects, in accordance with NIH guidelines. IACUC approval letter(s) can be uploaded with your vertebrate animal plans or if you need to obtain IACUC approval, please submit the approval letter to Ms. Susan Ordinado by Wednesday, November 8, 2017 to be considered for funding. SCIENTIFIC REVIEW PROCESS Full proposals will be reviewed by faculty with subject-matter expertise and NIH study section experience. In all cases, individuals with conflicts of interest, either real or perceived, will not be assigned as reviewers. A 9-point scoring scale and NIH-type review criteria will be used. Specifically, proposals will be critiqued for significance, innovation and impact; applicant qualifications; research design and potential of success; and use of Ola HAWAII cores. Written critiques from reviewers will be summarized in aggregate form and provided to applicants. FUNDING DECISIONS Applications will be ranked according to impact scores. Funding decisions will be made by the Ola HAWAII leadership, based on the following considerations: strong focus on the science of health disparities; complementary skills and expertise of applicant(s) and collaborator(s)/mentor(s); high-impact and highly innovative research; high use of RCMI and other cores; strong publication record of applicant(s) and collaborator(s)/mentor(s); clear timetable for NIH grant applications; high potential for grants success. All projects will need to be in compliance with UH and NIH/DHHS Federal policies, rules and guidelines for research involving human subjects and vertebrate animals. Certificates of training on human subject protections will be required for all personnel in projects involving human subjects. RCMI funds will be distributed only after receiving NIMHD approval. POST AWARD INFORMATION AND REQUIREMENTS 1. Investigators must submit IRB or IACUC approval letters to Ms. Susan Ordinado susano@hawaii.edu) by Wednesday, November 8, 2017 to be considered for funding if the approval letter was not initially submitted with the full application. 2. A mid-year (May 1, 2018; 5:00 pm Hawaii Time) and final progress report (July 31, 2018; 5:00 pm Hawaii Time), based on the RPPR format susano@hawaii.edu). Failure to submit the mid-year progress report will result in suspension of funds until the report is submitted. Failure to submit the final progress report, including planned abstract submission, will result in exclusion of any of the project personnel from submitting future research applications to Ola HAWAII for consideration. 3. Investigators will be required to have abstracts submitted to either a regional/national meeting or the JABSOM Biomedical Symposium. Copies of submitted abstracts should be sent to Ola HAWAII ( susano@hawaii.edu) at the same time that the abstracts are submitted to the meeting. 4. Investigators are required to submit their manuscripts, abstracts and presentations resulting from grantrelated support to the Ola HAWAII Administrative committee prior to acknowledging the Ola HAWAII award. 5. Investigators must continue to work on their Independent Development Plans. INQUIRIES We welcome the opportunity to answer your questions about the Ola HAWAII Team-Science Pilot Projects Program. Applicants may contact: Marla J. Berry, Ph.D. Director, Investigator Development Core Ola HAWAII

6 John A. Burns School of Medicine