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2009 FREA Application Guidelines

Eligibility

•Tenured or tenure-earning FIU faculty

• Faculty with federal and/or private foundation funds totaling $50,000 or more are NOT eligible to apply for a Faculty Research Enhancement Award..

Award Limitations                                                                                             1. Each faculty member is limited to one application submission per           year.                                                                                                                           2. Each award will be up to a maximum of $10,000 (direct costs)                       3. Funds may be requested for any scientifically justifiable budget category (e.g., chemical and biological supplies, OPS, sequencing charges, purchase and maintenance of animals, etc) with the following exceptions:

• Faculty salary

• Tuition fees

• Travel

• Equipment/Instrument (costing $1000 or more)

• Service contracts

• Consultants

• Books/Journal subscriptions

4. Project must be completed and funds must be spent within the 12 month of the award and a report submitted to the ABR Office.

Instructions

Read and follow the instructions carefully. Prepare the application using PHS 398 Forms (as listed below) and follow NIH guidelines with respect to font type, size, spacing and page margins. Downloadable Instructions and Form Files for PHS 398 (Revised 11/2007) can be obtained at http://grants.nih.gov/grants/funding/phs398/phs398.html

Do not exceed the page limitations set for FREA applications (see below) which differ from those set for a regular PHS 398 application. The FREA application must be complete and include the following:

Form Page 1: Face Page

Form Page 2: Summary

Form Page 3: Research Grant Table of Contents

Form Page 4: Detailed Budget for Initial Budget Period

Form Page 5: Budget for Entire Proposed Project Period

Biographical Sketch Format Page

Resources Format Page

Checklist Form Page

Personal Data Form Page

Research Plan: Continuation Format Page (Do not exceed 15 pages for the four sections)

• Specific Aim(s) [1 page]

• Background and Significance [2 – 3 pages]

• Preliminary Studies (if available) [2 – 3 pages]

• Research Design and Methods

Human Subjects, Use of Animals, Biohazards

Bibliography

Targeted/Planned Enrollment Table Format Page (if applicable)

Inclusion Enrollment Report Format Page (if applicable)

Other Support Format Page:

Senior/key Personnel Report Format Page

Appendix: A copy of the Approval statement from IACUC and/or IRB for projects involving vertebrate animals and/or human subjects, respectively.

FREA applications must be submitted to the ABR office electronically (abr@fiu.edu or smiths@fiu.edu ) as a single file WORD attachment containing all the necessary forms and sections as outlined above.

Abstract/Summary: Choose a specifically descriptive title. Limit abstract to the space designated. The abstract should contain a statement of objectives (specific aims), methods to be employed and the biomedical significance of the proposed research. State briefly the hypothesis to be tested and what the proposed research intends to accomplish for the duration of the award. Provide a summary of the research plan and the methods to be employed.

Budget:

• Limited to $10,000 (direct costs).

• Indicate your effort on the proposed project

• Justify all budget requests in the various categories, e.g., personnel (what their role will be on the project), equipment, animals etc. Only equipment/instruments costing less than $1,000 can be included in the budget. If requesting support for an OPS position, employment cannot extend beyond the 12 month period of the award.

• The award can be used to purchase supplies such as animal food, reagents, biologicals, chemicals, glassware, etc. It can also be used for sequencing charges, and to cover incidentals such as duplicating costs related to the project.

• The award may NOT be used for travel, tuition fees or faculty salary.

Research Plan.

A full discussion on developing the research plan can be found at http://grants.nih.gov/grants/writing_application.htm#developPlan. Excerpts from that document are provided for your convenience. For a FREA application you may not exceed 15 pages for the four sections of the pilot project application—Specific Aims (1 page), Background/Significance (2 to 3 pages), Preliminary studies (2 to 3 pages), Research Design and Methods; however, there is no requirement that all pages allotted be used. The research plan component of the application should include the following four sections:

Specific Aims: What you plan to do, i.e., what you intend to accomplish?

NIH normally does not fund "fishing expeditions", however, as the FREA program is intended to generate preliminary data or facilitate a new exploratory approach, a certain degree of "fishing" can be proposed. However, it is to your advantage to show feasibility. State the hypothesis to be tested or the specific question(s) that will be addressed. Avoid descriptive aims.

The purpose of the Specific Aims section is to clearly and concisely describe what the proposed research is intended to accomplish. List your aims and then all the experiments you’ll do to support each aim. Keep in mind that your experiments support your aims, and your aims are the test of your hypothesis. A strong grant application is driven by a strong, solid hypothesis with clear research objectives. You may also want to make a brief statement concerning the innovation of your proposed research. Specific aims should:

• Include specific research objectives

• Be hypothesis-based

• Be obtainable within the proposed timeframe

• Fit together in an overall framework

• Be well-focused rather than broad and diffuse

• Limited to one page.

Background and Significance: What has already been done in the field. Why is the work important? Include a critical evaluation and review of existing knowledge in the field. Identify the gaps the proposed research intends to fill. This section should describe the literature, support your views and hypothesis while also noting any scientific controversies in the field. Make sure that key references are identified..

Critically evaluate existing knowledge that leads to your pilot project, and specifically identify the gaps that the project is intended to fill. Explain why the literature about your research leads you to think this topic needs study. Provide information that directly pertains to the scientific need for your project and explicitly state the significance of the research and if the aims of the project are achieved what the payoff to biomedical or behavioral sciences and (if applicable) to public health might be? In this section:

• Show that you have critically evaluated existing knowledge, including background literature and relevant data.

• Include references that reflect up-to-date knowledge of the field

• Specify existing gaps that the project is intended to fill

• Identify controversies that the project is designed to resolve

• Conveys the importance and relevance of the research aims

• Highlight potential impacts

• Address how research results can be applied

Preliminary Studies: What you have already done on the proposed project.

Although the goal of a pilot project or feasibility study is to collect data to support a "full" research grant application, pilot project PIs should not omit this section. Use this section to support your hypothesis and the future direction of your research, and to show your expertise and knowledge of the experimental approach, methods, data collection and analyses to be employed in your project. "Preliminary" data relevant to the pilot project may consist of your own publications in the field, publications of other researchers, unpublished data from your own laboratory or others, or a combination of these. This section of the application is intended to establish the PI’s experience and competence to pursue the study and the likelihood of success. If you do not have the required expertise for a scientific methodology, enlist a mentor or consultant and include a letter of support or agreement in the Appendix of the application. Thus

• Discuss how previous work leads to the current proposal

• Emphasize how the previous work demonstrates feasibility of proposed methods

Research Design and Methods: How you will fulfill Aim(s), how you will do the work.

Methods must relate to Specific Aim(s). For clarity, number the research design to correspond to the numbers of Specific Aims. Be clear about the methods and experimental design you will use. Be clear in describing the experimental details of your proposal. Avoid proposing experiments based on general observations. This section is critical for demonstrating that the applicant has developed a clear, organized and thoughtful study design that tests the central hypothesis and is not a list of recipes for methods, experiments and data collection. Describe any novel concepts, approaches, tools, or technologies for the proposed pilot project. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. Provide a tentative sequence or timetable for the project (keep in mind that the award is only for 12 months. The methods section should—

• Provide an overview of the proposed design and conceptual framework

• Include details related to specific methodology; explain why the proposed methods are the best to accomplish the study goals

• Describe any novel concepts, approaches, tools or techniques

• Include details of how data will be collected and the results analyzed

• Consider required statistical techniques

• Include proposed work plan and timeline

• Consider and discuss potential limitations and alternative approaches to achieve study aims

Bibliography: 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.

Appendix Materials: Do not include in the Appendix essential information that should be within the body of the grant application. The appendices should contain supportive or supplemental information such as letters of support or commitment from collaborators, and if applicable, IRB approvals, sample consent forms, IACUC approvals as appropriate, etc. Letters of commitment should clearly spell out the roles of the collaborators.

Human Subjects: If the research will include human subjects, describe the criteria for participant inclusion in the research and the protections put in place to protect the participants from research risks as well as the recruitment and data collection schedule.

Use of Animals: Describe how the animals are housed. Also indicate when the animal protocol was reviewed and approved as well as the reviewer of the protocol. Confirm that your institution has an Animal Welfare Assurance on file with the Office of Laboratory Animal Welfare and provide the assurance number and effective dates of the assurance.

All projects that involve animals or human subjects must be reviewed by the Institutional Animal Care and Use Committee and Institutional Review Board respectively; and a copy of the approval, on the institution’s letterhead, must be submitted with the application.

Biohazards: Identify any select agents to be used in the proposed research and describe institutional procedures for the safe handling and disposal of such agents. Also describe the training that is provided for individuals that handle select agents. (Select agents are hazardous biological agents and toxins that Health and Human Services or the US Department of Agriculture has identified as having the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products.) CDC maintains a list of HHS and USDA Select Agents and toxins. (http://www.cdc.gov/od/sap/docs/salist.pdf)

 
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