COMPONENTS OF A GOOD GRANT PROPOSAL Philip T. LoVerde

RESEARCH PLAN GOOD IDEAS OVERALL GOAL SPECIFIC AIMS PRELIMINARY DATA HYPOTHESIS-DRIVEN GRANT –ASK QUESTIONS IN TERMS OF A TESTABLE HYPOTHESIS

RESEARCH PLAN START WITH AN OUTLINE INCLUDE SUFFICIENT INFORMATION NEEDED FOR EVALUATION GRANT SHOULD STAND ALONE BE SPECIFIC AND INFORMATIVE TELL THE REVIEWER WHAT YOU ARE GOING TO DO AND HOW YOU ARE GOING TO DO IT

RESEARCH PLAN WHAT DO YOU INTEND TO DO? WHY IS THE WORK IMPORTANT (SIGNIFICANCE)? WHAT HAS ALREADY BEEN DONE? HOW ARE YOU GOING TO DO THE WORK?

GRANT PROPOSAL SPECIFIC AIMS BACKGROUND AND SIGNIFICANCE PRELIMINARY DATA RESEARCH DESIGN AND METHODS LITERATURE CITED

SPECIFIC AIMS LIST LONG TERM OBJECTIVES WHAT IS THE SPECIFIC RESEARCH THIS APPLICATION IS INTENDED TO ACCOMPLISH STATE HYPOTHESES TO BE TESTED OR QUESTIONS TO BE ANSWERED State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved.

HOST GENETIC CORRELATES IN SCHISTOSOMIASIS A. SPECIFIC AIMS: The overall goal of this grant is to define the contribution of host genetics to the initiation and outcome of infection with Schistosoma mansoni. To accomplish our goals we will identify relevant immunological phenotypes by their responses to defined schistosome antigens and use these phenotypes to identify loci (genes) involved in determining resistance/susceptibility to re-infection and the host contribution to different clinical forms of schistosomiasis. These studies are best performed on subjects from endemic areas, who are exposed to the parasite under natural conditions of transmission. Although experimental infections provide important information, they are not able to reproduce the complex interactions between genetic, immunological and environmental factors that determine patterns of disease epidemiology in human populations. The overall focus of this grant is to develop immunological phenotypes (variables) involved both in resistance/susceptibility to re-infection and development of different clinical forms of schistosomiasis and then to identify the genetic determinants (loci) of these immunological phenotypes. We will study large well-characterized extended families from endemic areas to address the following specific aims:

BACKGROUND & SIGNIFICANCE OUTLINE THE BACKGROUND (RATIONALE) LEADING TO THE PRESENT APPLICATION CRITICALLY EVALUATE EXISTING KNOWLEDGE IDENTIFY GAPS THAT THE PROJECT IS INTENDED TO FILL STATE IMPORTANCE OF RESEARCH DESCRIBED IN THE APPLICATION RELATE SIGNIFICANCE TO SPECIFIC AIMS

PRELIMINARY DATA SUPPORT THE AIMS OR HYPOTHESES DEMONSTRATE EXPERIENCE OR COMPETENCE OF PI DEMONSTRATE ABILITY TO PERFORM PROPOSED METHODS PROVIDE PUBLISHED AND UNPUBLISHED RESULTS

RESEARCH DESIGN AND METHODS SPECIFIC AIM PROVIDE HYPOTHESIS OR RATIONALE OVERVIEW OF DESIGN TECHNIQUES (METHODS) USED TO TEST HYPOTHESIS HOW WILL DATA BE COLLECTED, ANALYZED, AND INTERPRETED

RESEARCH DESIGN AND METHODS DISCUSS EXPECTED OUTCOMES DISCUSS PROBLEMS, PITFALLS, LIMITATIONS OF THE PROPOSED PROCEDURES ALTERNATIVE APPROACHES TENATIVE TIMETABLE FOR PROJECT

OUTLINE OVERALL GOAL AIM 1: AIM 2: AIM 3: AIM 1: HYPOTHESIS BACKGROUND AND SIGNIFICANCE PRELIMINARY DATA IF NONE, DO I NEED TO GENERATE SOME RESEARCH DESIGN AND METHODS

OUTLINE CONTINUED AIM 1: HYPOTHESIS BACKGROUND AND SIGNIFICANCE PRELIMINARY DATA IF NONE, DO I NEED TO GENERATE SOME RESEARCH DESIGN AND METHODS METHODS CONTROLS ANALYSIS (STATISTICS, POWER CALCULATIONS) EXPECTED OUTCOMES ALTERNATIVE APPROACHES

OUTLINE CONTINUED RESEARCH DESIGN AND METHODS METHODS CONTROLS ANALYSIS (STATISTICS, POWER CALCULATION) EXPECTED OUTCOMES IF I PERFORM EXPERIMENT, WHAT WILL HAPPEN IS THIS THE BEST APPROACH, LIMITATIONS ALTERNATIVE APPROACHES AIM 2 AIM 3

INSTRUCTIONS COVER PAGE BIOGRAPHIC SKETCH –RECENT AND RELEVANT PUBLICATIONS BUDGET –REALISTIC –JUSTIFICATION REFERENCES –RELEVANT ONES LETTERS –COLLABORATORS –REAGENT PROVIDERS

FOLLOW INSTRUCTIONS FONT SIZE MARGINS SPELL CHECKER AND GRAMMAR –HELP FROM COLLEAGUE PAGE LIMITATIONS (EVERY GRANT IS DIFFERENT)

OTHER ISSUES HUMAN SUBJECTS –INSTITUTIONAL REVIEW BOARD (IRB) –INCLUSION OF WOMEN, CHILDREN, MINORITIES ANIMAL WELFARE –INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) –BIOHAZARDS APPENDIX –SPECIAL FIGURES –MANUSCRIPTS: IN PRESS

HAVE KNOWLEDGABLE COLLEAGUES READ PROPOSAL FOR SCIENCE AND FOR PROPER ENGLISH

Research Strategy-NIH (a) 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. (b) Innovation 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 intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation or intervention(s). Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions.

RESEARCH STRATEGY (c) 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 as well as any resource sharing plans as appropriate. Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. 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. Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised.

Research Project Evaluation Criteria Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed). Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Approach: Are the overall strategy, methodology, and analyses well- reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?.

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