Writing Specific Aims and Narrative

Specific Aims & Narrative Sections: Grab NIH Reviewers Attention, Get Your Grant Funded There is no grantsmanship that will turn a bad idea into a good one… …but there are many ways to disguise a good idea! 1  Not filling a critical knowledge gap or unmet need—that is, no clear public health relevance or significance  No clear impact on the field  Idea not relevant to mission of NIH/Institute “One reason for peer reviewers’ lack of enthusiasm on a grant is often that it does not address the primary scientific mission or interest of the funding agency.” Dr. Jane Scott, Program Officer NHLBI 2  Before you begin outlining your grant, knowing what NIH does and does not fund is critical  You can find this information  This should start 6‐8 months before you start  Research with no significance or impact towards understanding, diagnosing, treating diseases  Basic research ideas with no clear path to clinical translation  Extensively pursued, well‐worn ideas or incremental research that add little to what’s known 3  Grants aligning with NIH research priorities—either unsolicited aligned with NIH’s stated priorities or solicited through specific PA/RFA  Grants with high significance and large impact—those that clearly can move the field forward to address a specific unmet medical need  In the specific aims page, in significance, in innovation, and approach, begin with language that looks like this: This proposed research addresses two specific objectives of the NIH National Cancer Institute, namely: 1. Understanding specific properties of cells that inhabit a pre‐ malignant lung cancer, and 2. Understanding how mitochondrial heterogeneity within lung cancers influence progression or tumorigenesis 4  What does the NIH reviewer expect on a grant Specific Aims Page?  What is significance and impact?  What is the grant Narrative and how does that relate to your Aims and Research Strategy?       Significance: relevance to human health and disease (significance to NIH) Innovation: originality of approach Approach: feasibility of your methods (will it answer aims?) Investigator: PI training and experience Environment: suitability of facilities and adequacy of support from your institution Overall Impact: Synthesis/integration of 5 criteria scored from 1-9. Overall, the likelihood for project to exert a sustained, powerful influence on the research field(s) involved, in consideration of these criteria (and others if applicable) 5 Review Criteria Where in Application? 1. Significance Abstract Narrative Aims Research strategy: Significance 2. Investigators Biosketch: Personal Statement + Contrib. Science Research Strategy: Approach 3. Innovation Aims Research strategy: Innovation 4. Approach Aims Research strategy: Approach 5. Environment Resources: Environment Is my research important (significant) to health/disease? Plus Can I do it…and qualified to do it? Plus Will it have impact on the field? And ultimately, Relevance to public health? 6 “Most reviewers will form a general conclusion and make up their minds after reading this page… …they then read the rest of the proposal looking for support of their opinion…” -Allan Reiss, MD Stanford 7  All successful grant writers know a basic secret to writing a winning grant  Yet many applicants do not know this  It’s the FIRST PAGE of your grant: The Specific Aims  Most reviewers can assign an 85%-90% accuracy score just by reading this page  The most important but most difficult to write  MUST quickly engender robust enthusiasm for your project  The flow of logic must be compelling  The template for your entire grant  Write first and then revise as you write the rest of your grant 8  The aims contain 4 key things about your proposal:     why you want to do the work--why significant? what you want to do? how you will do it? what impact it will have?  If these can’t be pinned down within the one-page specific aims, they certainly can’t be pinned down in a larger proposal.  In fact, trying to write a proposal without clearly understanding those four things is a waste of time. Assess your Specific Aims by asking yourself: 1. Would reviewers see my proposal as tackling an important problem in a significant field? 2. Would they view my Specific Aims as capable of opening up new discoveries in my field? 3. Would reviewers regard my work as new and unique? 4. Would they view my Specific Aims as likely to exert a significant influence on the research field(s) involved? 5. Are my Specific Aims written clearly and are they easy to understand? 9 1. 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. 2. List succinctly the specific objectives of the research proposed, e.g. • • • • • • 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 1. Identify the problem/need (knowledge gap) 2. Your solution to fill the need/gap 3. Spell out your objectives/approach you will take 4. What do you expect to find and how will it impact medical research and fill the gap? 10 1 Define problem/critical need and gap(s) in knowledge: short background (current knowledge) leading to the important problem and the knowledge gap (the “need”) you will solve 2 Objective of your research to solve stated problem and fill gap by proposing central hypothesis(es) and Rationale that will fit into your long-term research goal for this work 3 Specific Aims –Objectives that test your hypotheses addressing the critical need 4 Payoff for NIH: Expected Outcomes leading to impact on the field Addressing an NIH need? If grant is unsolicited Impact — probability your study will be successful and will exert a powerful sustained influence on the field   If it won’t work, it has no impact, even with strong significance Address the grant goal AND your long-term goal(s) Important Knowns Unknowns Gap in knowledge=Unmet Medical Need The BASIS for your project 11 CRITICAL! Convince your reviewers (by educating them) that there is a significant medical gap in knowledge The knowledge gap/problem becomes the basis for a critical need that is relevant to the NIH Paragraph must get reviewer to be your advocate to your proposal MUST address: 1. Hook: Research topic and why it is critical that you conduct the research 2. Known information 3. Gap in knowledge (what we don’t yet know) 4. The critical need Do not state knowledge that is obvious to any reviewer 12  The opening sentence must be an interest-grabbing sentence that immediately establishes the relevance of the proposal to human health.  Convey that, by supporting your proposal, the reviewers will be helping NIH accomplish its goals.  A statement of current knowledge will help the less expert members of the panel get up to speed with what’s known about the topic of the application.  Identify the gap in knowledge that is holding back the field and is what you will address in the application. NO—This is not the problem or gap -Cigarette smoking is a well-recognized causal factor of lung cancer, which costs the healthcare system $3B… -Lung cancer is the leading cause of deaths among men and women in the USA and responsible for 109,302 deaths in 2015… YES—Identifies the problem/gap -Although overall rates of cigarette smoking in the U.S. have decreased in the past 20 years, smoking rates have actually increased among low-income women of child bearing age in the past 10 years -Failure to identify regional lymph node metastases in the 40,000 US patients/year with surgically resected lung cancer is associated with a 3-fold increase in cancer recurrence and decreased overall patient survival 13 HOOK your reviewer in the first sentence!  Background of what is currently known, what’s unknown, leading to GAP in knowledge.  The problem is NOT the disease itself but the gaps in our knowledge for diagnosing or treating the disease. This is NOT your problem: “Type II Diabetes currently affects more than 12% of the U.S. population, and is responsible for over 100,000 deaths and $1,000,000 in direct healthcare costs each year. This is: “Screening and control of risks typically associated with Diabetes (hyperglycaemia, raised blood pressure (BP), and dyslipidaemia) have been incorporated into evidence-based guidelines BUT achieving these risk factors to target levels to date remains elusive in clinical practice.”     Important knowns lead to conclusion that there is important unknowns Without unknowns -- gap in knowledge -- there is NO BASIS for your project The gap in knowledge must make the case for a real problem and the argument that there is a critical need—the driving force for your application Why the lack of a solution to this problem is an issue to the funding agency rather an issue for your own research 14 Known Unknown Gap, Unmet Need Re-establishing the skin’s protective barrier through wound healing is significantly compromised in certain common chronic diseases such as Type II Diabetes. Open wounds lead to serious infections if not effectively treated (1). Steroids and antimicrobial hydrogels are currently the standard of care in open wounds after surgical debridement (1-3). However, these treatments result in adequate wound closure in only 32% of serious infectious wounds (3), leading to systemic complications and death in 80,000 patients yearly (4), which is not yet fully understood. The reasons for poor wound healing involve wound microenvironmental changes in pH (6); Ca++ and Mg++ (7); and alterations in microvasculature (8-10), which have not yet been studied in wound healing. This critical gap in our understanding of wound healing has been recently identified as one of the central goals of the NIDDK and the subject of NIDDK RFA 12-124. Addressing this unmet medical need will have help us better understand how wounds heal in order for researchers to identify therapeutic targets and strategies. You have the solution to the stated problem/gap in knowledge, a “fix” for the critical need identified in Paragraph 1 15  Solution to this problem in filling the gap lead to aims must be hypothesis-based  What is your overall objective with this specific application addressing the critical need? (e.g., Develop a map of wound microenvironment leading to biomarkers of healing status)  Should also include longer-term goal you identify (e.g., develop effective biomarkers of wound healing and identify treatments that target each) Must be compatible with all known facts and evidence  It must be specific  It must be testable (i.e., there’s at least 2 outcomes)  Your aims will test your hypothesis We hypothesize that …  Your hypothesis should be formulated through the existing literature and your preliminary findings 16       Takes reviewer from the broad to the narrow focus Long-term goal—continuum of your research over multiple periods of grant support—the big picture that encompasses the gap identified Objective of this application—to fill the knowledge gap or meet the need you identified Central hypothesis links to your aims/objectives Rationale—what will become possible after the research is completed that is not possible now? After reading this paragraph, reviewers should know the continuum of your research, what the next step in that continuum is, why you want to take the next step, and what’s your best bet in how to take that step Here, you provide the reviewer a step-by-step development of the key objectives (Specific Aims) that will address the problem and address the “critical need” 17  Aims must test your hypothesis  Aims address the problem and fill the gap  Aims are SPECIFIC, measurable, and do-able in time frame of the grant  Be related, but not dependent on each other  For each aim, summarize experimental approach in 2-4 sentences: SHORT  Each aim should show a part of how you answer your original hypothesis  R03, R21: 1-2 Aims; R01: 3-4 Aims 18