Information - Department of Pathology
Information and Instructions for Application BioNIUM Awards Program FY15 (2014-2015) The goal of this document is to provide the information you need to successfully complete your application to the BioNIUM Awards. TABLEOFCONTENTS Introduction ........................................................................................................................................................................................... 2 Anticipated Number of Awards & Funds Available ............................................................................................................................... 2 Award Period ......................................................................................................................................................................................... 2 Requisite ................................................................................................................................................................................................ 2 Eligibility ................................................................................................................................................................................................ 2 Evaluation Criteria ................................................................................................................................................................................. 3 Review and Selection Process ............................................................................................................................................................... 3 Progress Reporting ................................................................................................................................................................................ 4 Deadlines and Award Timeline .............................................................................................................................................................. 4 APPLICATION INSTRUCTIONS ................................................................................................................................................................ 4 General Information .............................................................................................................................................................................. 4 General Instructions .............................................................................................................................................................................. 4 Detailed Instructions ............................................................................................................................................................................. 5 SECTION 1. PRINCIPAL INVESTIGATOR CONTACT INFORMATION ........................................................................................... 5 SECTION 2. PROJECT INFORMATION ........................................................................................................................................ 5 SECTION 3. RESEARCH PLAN .................................................................................................................................................... 6 3A‐ SPECIFIC AIMS ............................................................................................................................................................................. 6 3B‐ RESEARCH STRATEGY .................................................................................................................................................................. 6 3C‐ LONG‐TERM GOALS .................................................................................................................................................................... 7 3D‐ BIBLIOGRAPHY AND REFERENCES CITED (IN THE RESEARCH STRATEGY SECTION) .................................................................... 7 3E‐ RESOURCES: Facilities and Equipment ........................................................................................................................................ 7 3F BUDGET AND BUDGET JUSTIFICATION ......................................................................................................................................... 7 3H‐ CURRENT BIOSKETCHES FOR THE PRINCIPAL INVESTIGATOR AND EACH CO‐INVESTIGATOR ................................................... 8 SUBSECTION LETTERS OF SUPPORT (e.g., Co‐Investigators, Consultants) ........................................................................................ 8 Submitting your application: ................................................................................................................................................................. 9 Useful Tips & Links ................................................................................................................................................................................. 9 BioNIUM Awards Program 2014-2015 Page 1 BioNIUM Awards Program Funding Opportunity 2014-2015 Information & Instructions for Application Introduction BioNIUM Mission and Vision-Outlines Mission: • Early detection and diagnosis • Targeted delivery and treatment monitoring • Restoration of tissue and organ function Vision: • Multidisciplinary collaboration and technology development • Integrate nanotechnology and medicine to: – Develop and deploy devices and systems – Interact with living tissue – Provide size and physical property advantages • Educating the next generation of physicians, scientists and engineers. Anticipated Number of Awards & Funds Available The BIONIUM Awards Program will provide three $20-30K for direct research costs. These funds are intended to be flexible and can be used to fit a variety of scientific needs. Examples of allowable research costs include salaries for technical personnel, laboratory supplies, animals used to conduct the proposed research. Capital equipment (>41.5K) and travel expenses are not allowed. Faculty salary is not an allowable expense within the budget. The BIONIUM Program expects budgets to be realistic estimates. Award Period The award period is for one year, from August 1, 2014 to July 31, 2015. No-cost extension of support may be available upon request, and contingent on progress. Requisite Applicants are required to team up with an appropriate clinical collaborator (or in exceptional circumstances, a biomedical scientist) to develop a proposal that aims to “Seek a Problem; Solve a Problem”. The teams must put forward a clinically critical problem that can be solved by a better device / better diagnostic sensing / imaging approach or better therapeutic delivery, each through use of nanotechnology. The applicant/s must propose the use of micro/nanofabrication facility to solve the problem by developing tangible devices. The goal of these Awards is to push investigators to think in a strictly clinically (and biomedically) translational manner, while also promoting development of intellectual property at UM, followed by development of larger proposals to a mechanism like NCI Nano Platform Technologies U01 or IMAT R21/R33, or DoD IDEA Awards. A significant part of the budget must be devoted to cover the BioNIUM nanofabrication facility user fees. Eligibility Academic Status: All full-time faculty from UM, Jackson and the Miami VA are eligible. BioNIUM Awards Program 2014-2015 Page 2 Adjunct faculty, residents, clinical and post-doctoral fellows are not eligible. Eligibility criteria must be met as of the date of submission. Applications with pending appointments will not be accepted. Citizenship status: There are no restriction based on citizenship status. Resubmissions: Only new applications to the Miami BIONIUM Awards Program are allowed. On our future cycles, only new submission and one resubmission will be allowed. Evaluation Criteria The scientific and technical merit of the proposals will be evaluated using the NIH peer review criteria (1) Significance, (2) Innovation, and (3) Approach. Applicants should familiarize themselves with the review criteria by which their application will be evaluated. Significance – Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Important: For the Miami BIONIUM, the significance criteria also include the following: Will this line of research yield information that can ultimately lead to improvements in the health of our community and/or reduce health disparities? Innovation – Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Approach – Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Integration: Evidence of the involvement of different scientific disciplines or sub-disciplines in the center's activities. Clarity of the thematic integration and potential or evidence of synergy among participating cores and research projects. To aid in this determination, reviewers may look at the quality of provisions for the sharing of resources, procedures for formal and informal planning, and plans for developmental or pilot work. Data analysis: Quality and extent of data analytic capacities, data base facilities, coordination, and data resources. As needed, the quality of provisions for shared laboratory resources, the quality of laboratory space, and the quality of clinical facilities. Adequacy of provisions for sharing of findings, data base development and analytic capacities, evidence of innovative, state-of-the-art analytic capability. Review and Selection Process The review process of the BIONIUM Awards Program is a two-tier process: (1) All applications will undergo scientific and technical merit review by ad-hoc reviewers selected by the Directors of the BIONIUM Program. Reviewers may be selected from a pool of investigators outside UM. (2) Applications within the funding range will undergo a programmatic review by the BIONIUM Awards Program Committee. All applicants will receive feedback on their proposal. BioNIUM Awards Program 2014-2015 Page 3 Progress Reporting To allow tracking of the progress and success of each project, the funded investigators will be required to submit (1) an interim progress report at 6 months into the funding period (February 2015), and (2) a final report at the end of the 12-month funding period, no later than 60 days after the end of the award period (30 September 2015). (1) For the Interim Progress Report, awardees must submit: A detailed summary of research performed during the period of the award A report on accruals to the study and/or an accounting of number of samples analyzed A report on efforts and strategies to ensure successful accruals and/or sample analyses including remedial plans when initial efforts have been suboptimal A report on the results of any interim analyses conducted, publications or presentations related in any way to the subject of the award activities (2) At the completion of the award term, awardees must submit a final report containing: A detailed summary of research performed during the period of the award A list of grants, both submitted and funding supported by the award A bibliography of all publications, both submitted and accepted, and presentations (posters and talks). Additional information may be required by the BioNIUM Awards Program Directors. Deadlines and Award Timeline Full Application: June 16, 2014- 5:00 PM. Funding decisions will be announced by August 2014 APPLICATION INSTRUCTIONS General Information The BioNIUM Award Program encourages the applicants to consult or seek support from with existing experts’ services and cores of the Clinical and Translational Science Institute (CTSI), such as biostatistics, ethics, regulatory, etc. Detailed information about these services is available on the CTSI website at http://www.miamictsi.org/researchers/ctsi-research-services. Information on various additional services provided at UM can be found at http://uresearch.miami.edu/?p=371&s=35. General Instructions The application for the BIONIUM Awards will be submitted electronically. The application form was modeled on the NIH R21 application form, and was developed by the Miami CTSI using REDCap software (University of Vanderbilt). Please request access to the electronic application form (also called “surveys”), by clicking on the link on the BIONIUM website http://pathology.med.miami.edu/bionium/bionium-2014-award. This will give you access to your unique URL for the application form. IMPORTANT: DO NOT SHARE OR DISTRIBUTE THE URL YOU RECEIVE. You can save the information entered at any time, and return to it at a later time. Make sure to save the code provided to you by the software as you leave the application for the first time. After you complete and submit your application, the system will acknowledge your electronic submission and generate an automated response (not an email) to notify you that the submission was received. Important! If you do not receive an automated confirmation, your application may not have gone through. Please contact the Program Administrator before the deadline to resolve the issue. BioNIUM Awards Program 2014-2015 Page 4 Some of the fields must be completed electronically, others will require uploading documents (e.g., abstract, specific aims, etc.). Please ensure that all uploaded documents include your name in their name. All fields marked as “must provide value” are required fields. Your application cannot be processed if any required field is not completed. An automated message will prompt you to complete the missing fields. Use the templates provided. For the NIH templates (e.g., Biosketches, Resources), you may copy and paste information prepared for previous submissions. Adhere to the page limitations. Appendices are not allowed, except for High-resolution colored figures and data, and Manuscripts accepted for publication. Note: Submission of additional materials is not required. Adding materials to reviewer workload may be counterproductive, so carefully consider the need to send additional materials. Format requirements for all uploaded Word documents: Font: Arial, 11 pt. Margins: 0.5 inch (36 pt.) for top & bottom, right & left. Single-spaced. Detailed Instructions The main sections of the application form are described in details below: 1. Principal Investigator Information 2. Project Information 3. Research Plan SECTION 1. PRINCIPAL INVESTIGATOR CONTACT INFORMATION Most of the fields in this section are required fields. SECTION 2. PROJECT INFORMATION 2A- Project Title 2B- Public Health Relevance Statement (Up to 5 sentences): The purpose of this statement is to clearly articulate the projects’ potential to improve public health. The public health relevance statement should be written in plain language that can be understood by a general, lay audience, as well as your reviewers and colleagues. 2C- Scientific Abstract: (Up to 300 words) - TO BE UPLOADED in the space provided in the electronic application form. 2D- Type of Application (New application, or First Re-Submission) 2E-Total budget requested- The budget details will be listed in Section 3F of the application. 2F- Co-Investigators: Please list the names of your Co-Investigators in this project, their role, their institution, and their department/division. This will help the BIONIUM Awards review committee for the selection of reviewers. 2G- Categories of Research (Diagnostic, Imaging, Therapeutic, Functional Restoration, Other) 2H- Request to exclude reviewer(s) (Optional): Consider that all UM faculty are potential reviewers. You may name two potential reviewers who you believe could not provide an impartial review and you may request these persons not review your application. The Review Committee will consider this request but is not required to accommodate it. You may include a onesentence justification for your selection (optional). BioNIUM Awards Program 2014-2015 Page 5 SECTION 3. RESEARCH PLAN The RESEARCH PLAN includes the following subsections: SUPPORTING DOCUMENTATION: Use the templates provided in the document “BioNIUM Pilot Awards-FY15Templates” accessible on the BIONIUM website http://pathology.med.miami.edu/bionium/bionium-2014-award. 3A- Specific Aims 3B- Research Strategy 3B1- Significance 3B2- Innovation 3B3- Approach 3C- Long-Term Goals 3D- Bibliography and References Cited 3E- Resources (Use template provided) 3F- Budget and Budget Justification (Use modified NIH template provided) 3G- Current Biosketches for the PI and each Co-Investigator (Use NIH template provided) LETTERS of SUPPORT: Scan and upload all letters of support as one PDF in the space provided into the electronic application form. SUBSECTION RESEARCH PLAN Sections 3A to 3D will be uploaded as one Word document or one PDF in the space provided in the electronic application form. 3A- SPECIFIC AIMS Limited to 1 page (Arial font, 11 point, single-spacing, 0.5” top, bottom, left & right margins). State concisely the goals of the proposed research and summarize the expected outcomes, including the impact that the results of the proposed research will exert on the field involved. List succinctly the specific aims of the research proposed (e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology). 3B- RESEARCH STRATEGY Limited to a TOTAL OF 6 PAGES for subsections 1 to 3 (Significance, Innovation and Approach) (Arial font, 11 point, single-spacing, 0.5” top, bottom, left & right margins). Organize the Research Strategy in the order specified below. Start each section with the appropriate section heading – 1. Significance, 2. Innovation, 3. Approach. Cite published experimental details in the Research Strategy section and provide the full reference in the Bibliography and References Cited section (Section 3D). 1. SIGNIFICANCE Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. Explain how the proposed 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. 2. INNOVATION BioNIUM Awards Program 2014-2015 Page 6 Explain how the application challenges and seeks to shift current research or 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. 3. APPROACH Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted, and any resource sharing plans as appropriate. Discuss anticipated results (including benchmark for assessing success to achieve the proposed aims), and potential problems Provide a timeline for project completion within one year (Table) If the project is in the early stages of development, describe any strategy to establish feasibility. 3C- LONG-TERM GOALS LIMITED to 25 LINES (Arial font, 11 point, single-spacing, 0.5” top, bottom, left & right margins) Describe the future direction of your research, your long-term goals, and the project timeline for submitting extramural grant application(s). Specify which type of grant you expect to submit. Describe how the goals of the submitted proposal and future extramural grant(s) may promote the overarching goal of the BIONIUM, which is to incorporate ideas and approaches from multiple disciplines and/or propose innovative translational research initiatives, as appropriate to the scientific question. 3D- BIBLIOGRAPHY AND REFERENCES CITED (IN THE RESEARCH STRATEGY SECTION) Include at least the first three authors, full title of the article, journal, volume and page numbers. SUBSECTION SUPPORTING DOCUMENTATION Sections 3E to 3G will be uploaded as one Word document or one PDF in the space provided into the electronic application form. 3E- RESOURCES: Facilities and Equipment This information is used to assess the capability of the organizational resources available to perform the effort proposed. Identify the facilities to be used (Laboratory, Animal, Computer, Office, Clinical and Other). If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project. Describe only those resources that are directly applicable to the proposed work. (http://grants.nih.gov/grants/writing_application.htm). Use the NIH templates provided in Forms and Templates. You may copy and paste this section from earlier grant applications. If you are using the Nanofabrication facilities, please provide a brief description of how they are used. 3F BUDGET AND BUDGET JUSTIFICATION Budget: Use the template 3F1 provided in Forms and Templates. This is a modified NIH template: it includes direct costs only, and outlines which items are “not allowable”. BioNIUM Awards Program 2014-2015 Page 7 Each award is up to $30,000, to be used for direct costs only, for a one-year project period (01 August 2014 to 31 July 2015). Only allowable direct costs may be charged. Specimen acquisition expenses are allowable. The Miami BIONIUM expects budgets to be realistic estimates. The BioNIUM Awards funds are intended to be flexible and can be used to fit a variety of scientific needs, including salaries for technical personnel, supplies and other miscellaneous items required to conduct the proposed research. Faculty salary is not an allowable expense within the budget. Equipment and Travel: Capital equipment (>$1.5K) and travel expenses are not allowed. Patient care is not an allowable expense within the budget. Justification for each item listed in the budget. Use template 3F2 provided in Forms and Templates. Senior/Key Personnel & Other Personnel: o Names and positions of all personnel must be individually listed and the percentage of time to be devoted to the project by each person should be noted even when no salary is being requested. If the individual has not yet been selected, please list as "TBD.” o Justify the need for each person listed. o Information on UM-Approved Composite Fringe Benefit Rates for FY2015 is available at http://www.miami.edu/finance/index.php/ora_homepage/um_rates_information/fringe_composite_frin ge_benefit_rates/ Reagents, Supplies, Animals, Expenses related to Study Participants 3H- CURRENT BIOSKETCHES FOR THE PRINCIPAL INVESTIGATOR AND EACH CO-INVESTIGATOR Please use the template provided in Forms and Templates, or the NIH template available at http://grants.nih.gov/grants/funding/phs398/biosketch.pdf for the Principal Investigator and for each one of the Co-Investigators. You may also copy and paste previously completed current biosketches. Also include in this section: A- Positions and Honors. B- Selected Peer-Reviewed Publications. Provide a bibliography of any references cited in the Research Plan. Each reference must include the names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. Make sure that only bibliographic citations are included. C- Research Support: Use tables provided for (i) ongoing research support and (ii) completed research support. Include both institutional and extramural support and indicate any potential scientific overlap. Add additional tables as needed for each grant. SUBSECTION LETTERS OF SUPPORT (e.g., Co-Investigators, Consultants) Scan and upload letters of support as one PDF in the space provided into the electronic application form. Letters of commitment in your application should clearly spell out the roles of your collaborators. The award application should contain a signed and dated letter from each collaborator that lists the contribution he or she BioNIUM Awards Program 2014-2015 Page 8 intends to make and his or her commitment to the work. These letters are often the primary assurance to the reviewers that this work can/ will in fact be done. For consultants, letters should include rate/charge for consulting services. For New Investigators, a letter from the Department Chair is highly recommended. The letter should state whether the applicant has independent laboratory space and has established an independent research project/program, or if she/he is on the path of becoming independent. If it is the latter, the letter should state how the BIONIUM Award will help achieve the independent status for the applicant, and which arrangements (provide specifics) can be made to ensure the applicant’s path of independence if the grant is funded. Submitting your application: After you complete and submit your application, the system will acknowledge receipt of your submission and will generate an automated response (not an email) to confirm that the submission was complete and received. IMPORTANT! If you do not receive an automated confirmation, your application may not have gone through. Please contact the Program Administrator (Teresa Brown at 305-243-6121 or at t.richardsonbrow@med.miami.edu before the deadline to resolve the issue. Useful Tips & Links How to merge multiple files into one PDF: https://www.adobe.com/content/dam/Adobe/en/feature-details/acrobatpro/pdfs/combine-multiple-documents-intoone-pdf-file.pdf Fringe & Composite Fringe Benefit Rates: http://www.miami.edu/finance/index.php/ora_homepage/um_rates_information/fringe_composite_fringe_benefit_r ates/ Miami BIONIUM website: http://www.miamiBioNIUM.org/ BioNIUM Awards Program 2014-2015 Page 9
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