There is no grantsmanship that will turn a bad idea into a good one… but there are many ways to disguise a good one! -William Raub, Past Deputy Director, NIH Introduction The NEW Research Strategy 2010 Organization, aesthetics, writing DO NOT write the application for yourself unless you are going to fund it yourself Write the application to satisfy the research priorities of the funding Institute Significance: relevance to human health and disease Innovation: originality of approach Approach: feasibility of your methods and appropriateness of the budget Investigator: PI training and experience Environment: suitability of facilities and adequacy of support from your institution EACH receive a score from 1 (exceptional) to 9 (poor) Core Review Criteria New Application Significance Research strategy a. Significance Investigators Biosketch Personal Statement Innovation Research strategy b. Innovation Approach Research strategy c. Approach Environment Resources Environment Each criteria addressed and considered in assigning overall score, weighting them as appropriate for each application The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score For example, PI may propose important work that is not innovative but is essential to move the field forward 1. Align structure/content of application with review criteria 2. Shorten to facilitate peer review Personal Statement: Tell us why your experience and qualifications make you particularly well- suited for your role in the project Publications: Keep to 15 5 most recent 5 best 5 most relevant to application Page limit remains at 4 http://enhancing-peer-review.nih.gov Briefly state your role in this grant Experience—educational background and training addressing why you are suited for this research (job interview) How do you fit into the team? The current application builds logically on my prior work, and I have chosen co-investigators (Drs. A and B) who provide additional expertise in X, Y, Z. This is place you get scored for Principal Investigator, including Background Grants and publications you produced relevant to proposal Your track record Overall training and experience Each grant has a different personal statement See example at end of this presentation Project Summary/Abstract Project Summary – succinct and accurate description of the proposed work Informative to other persons working in the same/related field and for scientifically/technically literate reader No longer than 30 lines of text Project Narrative This is the second component of the ―abstract‖ that defines the ―relevance‖ Using no more than 2-3 sentences, describe the relevance of this research to public health Use plain language understood by the general public Current Research Plan Restructured Research Plan 1. Introduction to Application 1. Introduction to Application 2. Specific Aims 2. Specific Aims 3. Background and Significance 3. Research Strategy a. Significance 4. Preliminary Studies/Progress Report b. Innovation 5. Research Design and Methods c. Approach (incl. Preliminary Studies) 6-12 4-10 (renumbered) 13. Select Agent Research 11. Select Agent Research (Modified) 14-17 12-15 (renumbered) http://enhancing-peer-review.nih.gov/docs/application_changes.pdf Page limit for new Research Strategy will be 6 or 12 pages (+1 page for Specific Aims) Follow FOA page limit instructions (some may differ) Current Page Limit New Page Limit <25 pages (e.g., R03, R21) 6 pages 25 pages (e.g., R01) 12 pages ≥25 pages Follow FOA Instructions Content reduced by ~50% 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. o test a stated hypothesis o create a novel design o solve a specific problem o challenge an existing paradigm or clinical practice o address a critical barrier to progress in the field, or o develop new technology The Problem Gaps in Knowledge Proposed Hypothesis/Solution Specific Aims Impact: How research fills gap FIRST paragraph– Define the problem/critical need and gap(s) in knowledge—short background leading up to the stated problem and knowledge gap Proposed solution to problem and gap by proposing hypothesis(es) Specific Aims –Objectives that test the hypotheses addressing the critical need e.g., to develop, determine, identify… Avoid vague aims, e.g., ―to explore‖ Expected Outcomes leading to impact on the field Impact – probability your study will be successful and will exert a powerful sustained influence on the field (derived from significance and innovation) If it won‘t work, it has no impact, even with high significance Address the immediate problem AND your long-term goals State your hypothesis clearly Understandable Testable Specific Are your aims obtainable within the stated timeframe? Focus your research Focus aims in areas for which you have strong supporting data Aims should be related and cohesive The Problem Colon cancer is a fatal disease if not detected early. Current medical practice in the US is screening colonoscopies for all over age 50, but colonoscopies are expensive and invasive. Screening for occult blood in stool is inexpensive but ineffective, and many cancers are missed. A blood test that could accurately detect colon cancer very early would save lives. Gaps in Knowledge Current approaches for measuring proteins in blood are relatively insensitive, and unlikely to detect cancers early enough. Human variability and low signal means many independent patient samples must be measured. The Solution New proteomic technologies developed by my group offer both the sensitivity and throughput needed to identify and validate blood biomarkers for early detection of colon cancer. Hypothesis We hypothesize that colon cancers can be more effectively detected using sensitive blood biomarkers. Action Plan Specific Aim 1: Identification of plasma proteins associated with early stages of colon cancer using novel mass spectrometric approaches that provide absolute protein abundance measurements down to pg/ml levels. These measurements will be applied to a unique cohort of colon cancer patients available from clinical collaborators Specific Aim 2: Bioinformatic analysis of over-represented proteins for enrichment of specific functions using a variety of software tools including KEGG, BIND, and MetaCor Specific Aim 3: Selection and Validation of candidate biomarkers Candidate biomarkers selected on the basis of functions known to be associated with carcinogenesis will be verified by orthogonal approaches. The top ten ten verified candidates will be assessed in 1000 prospectively collected plasma samples from early stage colon cancer patients, using a novel high throughput proteomics approach Expected Outcomes and Impact The end product of this research will be an affordable accurate blood test for early detection of colon cancer without colonoscopy. Our approach will use many previously successful methods (preliminary studies) to increase the probably of success in this proposal. Successful demonstration of this approach in colon cancer will enable application to other cancers in need of early detection biomarkers. Future directions of this research also include the application of a systems biology approach to the large datasets generated in the discovery phase that will provide new insights about the earliest stages of colon cancer. Lack of original or innovative ideas Unrealistic or unfocused Are the aims specific and focused? If there are risks, justify why it‘s important to pursue and how knowledge would move the field if the aim was not met Poorly justified Relationship of aims to what‘s known and what‘s unknown should be obvious Purely descriptive, not hypothesis-driven ―This proposal looks more like a collection of experiments in which the applicants are simply listing experiments according to their expertise in specific techniques instead of testing an underlying hypothesis‖ ―Our enthusiasm was dampened by lack of a hypothesis driven by a specific mechanism.‖ Lack of cohesiveness Must be thematically related and form a cohesive unit Think of a central hypothesis unifying aims Excessive interdependence of aims for success Aim 2 to study novel monoclonal antibodies in animal disease model should not depend on Aim 1 to generate those antibodies Describing techniques Do not provide details of methods in Aims Overly ambitious 2-4 Aims (R01), 1-2 Aims (R03,R21) Gives impression proposal is unfocused or you have not thought the proposal through No significant impact (even if aims achieved) on the field Most reviewers make up their minds after reading this page Then they read the rest of the proposal looking for support of their opinion Current Research Plan Restructured Research Plan 1. Introduction to Application 1. Introduction to Application 2. Specific Aims 2. Specific Aims 3. Background and Significance 3. Research Strategy a. Significance 4. Preliminary Studies/Progress Report b. Innovation 5. Research Design and Methods c. Approach (incl. Preliminary Studies) 6-12 4-10 (renumbered) 13. Select Agent Research 11. Select Agent Research (Modified) 14-17 12-15 (renumbered) ① Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. ② Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields. ① Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved. Make a compelling case—why is this research important for the field (broadly and more specifically)? Review of published/unpublished work (incl. your own) Point out how your research will fill knowledge gaps Show that you are aware of the opportunities, gaps, roadblocks, and research being done If possible, tie significance to the mission of the NIH institute — what are their research priorities? Check institute website for research priorities Check institute PAs/RFAs objectives Too diffuse and long Showcasing comprehensive and exhaustive background This should be ~0.5-1 page focused on addressing the NIH requirements for significance Significance not related to stated problem and aims If you follow your Specific Aims, you will keep the reviewer (and yourself) focused Equating significance with illness Don‘t argue that a particular disease is significant Significance is what you will do to treat the disease Low impact research ‗Incremental changes‘ ‗Confirmatory research—duplicative‘ ① Explain how the application challenges and seeks to shift current research or clinical practice paradigms. ② 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). ③ Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions. Understand what innovation means for an NIH grant application and what the reviewers are looking for Research does not necessarily have to create a new paradigm To be innovative it can Shift a current paradigm Offer new combination of known methods leading to new perspective Refine existing model, technology It‘s less risky to use an innovative approach to solve an existing problem than to take on a problem that‘s highly innovative It can be harder to gain acceptance if your ideas are clearly outside the mainstream, especially if you are less experienced If your proposal is highly innovative, you'll need to make a strong case for why you are challenging the existing paradigm and have data to support your innovative approach But because innovation is a review criterion, you want to show how you will break new ground Not separate sections as before Each woven into Approach by Aim For NEW applications for each Specific Aim, describe not only your research approach but what preliminary studies you have to support that aim For COMPETING renewals, describe: Progress you have made toward each aim and the approach you will use Significant changes to the aims and new directions ① Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. ② How will data be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate? ③ Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. ④ 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. Preliminary Studies/Progress Report Study design/study strategy Experimental approach Experiments to address each SA Emphasize Unique methods but abbreviate standard methods, especially if used in ―Preliminary Studies‖ Methods not previously used — collaborators Use tables and figures to illustrate complex experiments with multiple arms or repetitions under different conditions Interpretation of results Even if your experiment is well designed, its interpretation is vital to the reviewer Link the interpretation to your proposed SA and hypothesis Potential Pitfalls and Alternative Approach Roadblocks to your experimental approach and how you would adjust the approach to move forward Failure to see weak points gives reviewers impression your approach is careless and less likely to succeed For early-stage PI, strategy to establish feasibility with methods A new investigator is given leeway with some aspects of the grant, such as preliminary data, but NOT with approach, anticipated results, and lack of plans for possible problems Future Directions Discuss what‘s likely not feasible for this grant period, and what future studies will focus on Milestones and Timeline By each aim, provide quantitative benchmarks for assessing your progress over the grant years Excessive detail on approaches or inconsistency in detail Level of detail proportional to the novelty of the method Standard techniques should not have detail — reference or show in preliminary studies Feasibility of each aim not shown Listing your experiments without tying them to the SAs will kill your grant Lack of ―pitfalls and alternative approaches‖ Being able to propose alternative approaches to your aims if your plan fails, or provide new directions if your hypotheses need revision, score big with reviewers Overly ambitious in scope This is a blueprint for your work, not a wish list for experiments that you think impressive If the studies are not achievable in the timeframe of the grant, this may become future work Lack of a section ―Interpretation of Results‖ Meaning of the results is not always clear to reviewers Demonstrates your capacity to predict the results consider alternative results refine your hypothesis adjust the plan assess the impact of the data Lack of clear logistical organization and plan for the grant period Provide a timeline for completing the aims Your experimental approach is not hypothesis-driven ―Fishing expedition‖ without clear goals Focus and prioritize experiments around your aims/hypothesis Excessive dependence of experimental plans Aims that depend on one other for success are susceptible to criticism Interdependence of thematically related aims is necessary, but the experiments and aims should be diverse enough to assure some level of success Quantitative benchmarks for comprehensively assessing the annual progress of the projects-- not be simply a restatement of the specific aims. Timeline and a ―pathway‖ for the development of the proposed technology. Examples: -Detect one cancer cell in 106 normal blood cells. -Increase the therapeutic index of an agent >3-fold by nanoparticle-based therapeutic solution relative to the non-nanoparticle bound agent. -Achieve >95% selectivity in targeting mixed cell populations in vitro. Summarize how these studies and this design will answer each of your aims Include milestones and timeline Outline the application Focus on strategy rather than experimental details Use graphics to convey complex info in a small space Do not decrease fonts, margins, white space More time to write shorter—thoughtful revising necessary Reduce redundancies—outline Use active voice and write short, direct sentences Read long sections aloud Give to an editor You cannot edit a 25/12-page document to 12/6 Why is my research important (significant) to health/disease? Plus Can I do it…and qualified to do it? And Will it have significant impact on the field? ―…psychological mechanisms came into play…once I lost patience with an applicant for writing a disorganized section, I was much more likely to notice other faults in the proposal. Also, when a proposal was sloppy, it was difficult not to extrapolate that the applicant‘s labwork was sloppy as well.‖ ―At the other extreme, the easier the applicant made it for me to get the information necessary to assess the application, the more likely I was—if the science was sound—to have a positive feeling about the proposal.‖ ―In >20 years of reviewing, during which time I have seen >1000 R01s, the most common shortcoming I have seen has been poor writing…‖ Bernard L. Trumpower, PhD Dartmouth Biochemist Consider the grant as a unit to establish a logical progression from Specific Aims through Approach Eliminates disorganized, illogical thought and poor transitions Eliminates redundancies and omissions Provides fixed points of reference that reduces complex revisions and eliminates redundancies Forces brevity, clarity, and a cohesive application Organization is key! Start with an outline Number headings— help reviewers navigate with ease 5.0, 5.1, 5.1.1, 5.2 Summary statements at end of each section Tables of timelines, figures of program organization Assure you have included all requirements in each section of the grant. Double check the PHS398 (and PA or RFP) instructions Don‘t jump into writing — Write your Aims page and give it to an experienced PI for evaluation. Propose something significant — Are you dealing with key controversies and problems in the field or rehashing a previous project or idea? Good ideas don‘t always sell themselves — Tell me why it‘s important up front in the significance section…tell me what‘s known and what isn‘t known and how you‘ll move the field forward or answer important questions. Don‘t cram your application like a suitcase — Pay attention to fonts, margins, and spacing. Aim each aim — Spend time on the Expected Outcomes, Data Interpretation, Pitfalls, and Contingencies section for accomplishing each aim. Pull it together — At the end of your approach section, write a succinct, one-paragraph summary of what you intend to do, how you intend to do it, and what it is going to tell you — write it like a manuscript abstract. Have a good editor/writer proofread your application — Many unnecessary errors may kill your application. IMPACT S DESCRIPTOR STRENGHTS/WEAKNESSES C O R E High 1 Exceptional 2 Outstanding Strengths 3 Excellent Moderate 4 Very Good 5 Good 6 Satisfactory Weaknesses Low 7 Fair 8 Marginal 9 Poor Non-numeric scores: NR=Not recommended for further consideration DF=Deferred AB=Abstention CF=Conflict NP=Not present ND=Not discussed Discussed applications receive impact/priority scores from all eligible reviewers in whole numbers only (no decimal ratings). Assigned reviewers also provide ratings for each review criterion [e.g. Significance, Investigator, Innovation, Approach, Environment] using the same 9-point scale. These criterion ratings are provided in the summary statement for applications, both discussed and not discussed. Criterion ratings should be considered in determining the overall impact/priority score, but reviewers should determine the relative importance of each criterion for the science or work being proposed. Which PA, RFP, Institute? Read the PHS398 and PA/RFA instructions! Formulate a solid hypothesis and write your Specific Aims (SAs) first Run your SA page past several colleagues Center research plan around SAs Follow a timeline Program Announcement (PA) Broad funding announcements for areas of priority and emphasis using particular funding mechanisms Ongoing, open for 3 years Multiple receipt dates PA-10-025 Development, Application, and Evaluation of Prediction Models for Cancer Risk and Prognosis (R01) Request for Application (RFA) More narrow than PA, by institute One-time solicitations for grant applications addressing a defined research topic Single receipt date Competition depends on # applications and $$ set aside CA09-026 The Biology of Estrogen Receptor-Negative Breast Cancer in Various Racial and Ethnic Groups (U01) Does your research involve human subjects or are you just analyzing human data? Protection of Human Subjects Identify the risks Describe protection against those risks Consent (IRB) Justify inclusion of Women, Minorities, Children Inclusion Enrollment Table (ethnic & racial categories) Research on transplantation of human fetal tissue Human embryonic stem cells Data and safety monitoring plan (for clinical trials) Some exemptions Describe use of animals outlined in Section D: species, strains, ages, sex, numbers Justify use of animals, choice of species, and numbers Describe veterinary care Procedures to minimize discomfort, pain, injury Describe methods for euthanasia consistent with Panel on Euthanasia of the American Veterinary Medical Association (AVMA) Must match your research plan Must use NIH budget forms and justify all expenses (OSP can help) Personnel Consultants Supplies Travel Human subject payments For multi-institutional applications, must be separate budgets for each subcontractor Justification: no length requirement, but be succinct and accurate Describe in detail the core facilities (not personnel) used in the study Physical resources—departmental offices, labs, etc. Equipment—describe those used, those needed Other university resources—MRI facilities, testing labs, etc. Provide space description (sq. ft., # offices, labs, etc). Be specific Be sure this section is consistent with budget/justification About 3-4 pages Use specified forms Color illustrations from the grant must be included in all copies Manuscripts (10 max) from your lab supporting the application Protocols and Procedures used in your research Large tables & Figures supporting the application Don‘t include critical information — appendices are not required to be read by reviewers Don‘t include consultant letters (they are in ―Section 16‖) Always discuss potential problem areas and alternative approaches. Never assume that reviewers will know what you mean. Be explicit about what you want the reviewers to know and what they need to know. READ the application instructions carefully. Stay within page limits. Secure collaborators for areas you lack experience and training. There are no competitors in science, only potential collaborators. ―Independent Researcher‖ does not mean that you work in isolation. ―Independent Researcher‖ does mean that you set the direction of the research. Don‘t give the impression of being intellectually ―Isolated‖. If your application is a renewal or supplement request, know that study section members will not have the benefit of your previous application but rather only the previous summary statement. Be sure to explain your progress carefully in the current application. Publish, Publish, Publish - be productive.
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