Preparing Grant Applications Chandra M. Mehrotra, Ph.D. The College of St. Scholastica

NIH Review Criteria Significance: ability of the project to improve health. Approach: feasibility of your methods and appropriateness of the budget. Innovation: originality of your approach. Investigator: training and experience of investigators. Environment: suitability of facilities and adequacy of support from your institution.

Developing Your Research Plan Creating a top-quality research plan is critical to your application’s success in peer review. Your plan describes what you are proposing to do, why it is important, and how you will do it.

Developing Your Research Plan (continued) Your research plan will have four main sections: Specific Aims Background and Significance Preliminary Studies/Progress Report Research Design and Methods

Developing Your Research Plan (continued) The following page limits apply only for items a-d: R01: 25 pages RO3: 10 pages R15: 25 pages R21: 15 pages Read the PHS398 grant application kit carefully to make sure you are including all needed sections and are complying with formatting requirements.

The research plan should answer the Content The research plan should answer the following questions: What do you intend to do? Why is it worth doing? How is it innovative? What has already been done and what other researchers have done in this field? What will this new work add to the field of knowledge?

Content (continued) What have you done to establish the feasibility of preliminary studies you are proposing? How will the research be conducted?

Suggestions Make sure that all sections are internally consistent and they dovetail with each other. Show knowledge of recent literature and explain how the proposed research will further what is already known. Make sure you reference all the methods and concepts you have used in the Literature Cited section of the research plan.

Suggestions (continued) Consider getting a statistician involved early on to advise you on sample sizes and the amount of data you need to collect. Well-designed statistical methods impress reviewers favorably.

Suggestions (continued) Use consultant(s) with an established track record. Clearly indicate how the collaborators or consultants will fit into the proposed project. List consultants as key personnel and provide biosketches for each of them.

Research Plan Part A: Specific Aims PURPOSE: To describe concisely and realistically what the proposed research is intended to accomplish. CONTENT: The specific aims should cover: broad, long-term goals. the hypothesis or hypotheses to be tested.

Specific Aims (continued) SUGGESTIONS: Begin with a brief narrative describing the long-term goals of the project and the hypotheses guiding the research. This is followed by a numbered list of Aims. State each hypothesis clearly. Make sure it is understandable, testable, and adequately supported by citations in the Background and Significance section and by the data in the Preliminary Studies section.

Specific Aims (continued) Be as brief and specific as possible. Each aim should consist of only one sentence. Most applications have 2-4 specific aims. Be certain that all aims are related. Focus on aims where you have good supporting preliminary data and scientific expertise.

Research Plan Part B: Background and Significance PURPOSE: The purpose of this section is to state the problem to be investigated, the rationale for proposed research, the current state of knowledge relevant to the proposal, and the potential contribution of this research to the problem addressed.

Background and Significance (continued) CONTENT: This section should cover: the rationale for the project. the state of existing knowledge. gaps that the project is intended to fill.

Background and Significance (continued) SUGGESTIONS: Make a compelling case for your research project. Establish familiarity with recent research. Make sure citations are specifically related to the proposed research and include them in the Literature Cited section.

Background and Significance (continued) Stress any innovations in experimental methods (e.g., new strategies, research methods used, interventions proposed). Tell the reviewers how your work furthers the NIH mission to improve health through science – just moving the science forward is not enough.

Research Plan Part C: Preliminary Results/Progress Report PURPOSE: This section should include prior work by the investigator(s) relevant to the proposed project. Preliminary results are important to establish the experience and capabilities of the applicant and to provide experimental support for the hypothesis and the design.

Preliminary Results/Progress Report (continued) CONTENT: This section should include: a description of recent studies by the applicant that established the feasibility and importance of the proposed project. a brief description of older studies by the applicant that provide important background information relevant to the project.

Preliminary Results/Progress Report (continued) SUGGESTIONS: Do not dwell on results already published. Summarize the critical findings in the text and include reprints in the appendix. Include tables and figures, if necessary. Include enough information to show you know what you are talking about. Tell the reviewers how your early work has prepared you for the new project.

Research Plan Part D: Research Design & Methods PURPOSE: This section should describe experimental design and procedures – how you will perform the proposed research. When reviewers judge your application, your research design and methods section has the most weight. CONTENT: This section should include: An overview of the research design. Specific methods to be employed to achieve the proposed goals.

Research Design & Methods (continued) Content: A detailed discussion of the ways in which you will collect, analyze, and interpret data. A projected sequence or time table (work plan) Expected results and alternative approaches that will be used if the unexpected results are found.

Research Design & Methods (continued) CONTENT: A description of new methodology used and why it represents an improvement over the existing ones. Include both genders, minorities and their subgroups, and children as appropriate to the research goals. Note that reviewers will also assess your plans to recruit and retain subjects.

Research Design & Methods (continued) SUGGESTIONS: 1. Number the sections to correspond to the specific aims. 2. Give sufficient detail. Do not assume that the reviewers will know how you intend to proceed. 3. Create a graphical timetable showing how and when you will accomplish your aims, including any overlap of experiments and alternative paths.

Research Design & Methods (continued) SUGGESTIONS: 4. If relevant, explain why one approach or method will be used in preference to others. 5. If only international subjects are used, describe how the sample will be selected. 6. Cite references whenever possible.

Abstract The primary purpose of the abstract is to describe succintly every major aspect of the project except the budget. The abstract is used in the grant referral process to determine what study section is appropriate to review the application and to what institute it is most relevant.

Abstract (continued) Members of the study section who are not primary reviewers may rely heavily on the abstract to understand your proposal. The abstract is allocated only half a page and is confined to the designated space provided in the application. Write the abstract last so that is reflects the entire proposal.

Modular Budget The NIA pilot grant program will allow modular budget procedures for application and award. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach.

Modular Budget (continued) DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application.

Modular Budget Justification NARRATIVE BUDGET JUSTIFICATION Prepare a Modular Grant Budget Narrative page. (See http://grants2.nih.gov/grants/funding/phs3 98/modbudgetsample_same.doc for sample pages.) At the top of the page, enter the total direct costs requested for the award.

Modular Budget Justification (continued) Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request.

Biosketch The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team.

Biosketch (continued) A biographical sketch is required for all key personnel. No more than four pages may be used for each person. A sample biographical sketch may be viewed at: http://grants2.nih.gov/grants/funding/phs39 8/biosketchsample.doc

Some Useful Web Sites Description of NIA Research Support: http://www.nia.nih.gov/funding/research-support/respro.html Receipt Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm Forms and Instructions: http://grants1.nih.gov/grants/forms.htm

Useful Web Sites (continued) FAQ Page : http://grants1.nih.gov/grants/forms_faq.pdf General NIH Guide Notice: http://grants.nih.gov/grants/guide/index.html For Modular Grant applications see: http://grants.nih.gov/grants/funding/modular/modular.htm For other grants, such as R03 see: http://grants.nih.gov/grants/funding/r03.htm Helpful site at Northwestern for R03s: http://nuinfo.nwu.edu/orsp/mod.html

Human Subjects Clearance? NIH now requires PIs and major personnel associated with a project to complete an NIH-approved course on human subjects before the grant is awarded. It will take about an hour or so to go through the site and complete the course and you will get a certificate with a number See: http://cme.nci.nih.gov/