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HOW TO WRITE THE NEW, SHORTER NIH RESEARCH GRANTS

HOW TO WRITE THE NEW, SHORTER NIH RESEARCH GRANTS. Maureen E. Goode, PhD, ELS Administrative Director 713-500-7924 Maureen.Goode@uth.tmc.edu Main CCTS number: 713-500-7900 Offices: UTBP 1100 Web site: http://ccts.uth.tmc.edu.

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HOW TO WRITE THE NEW, SHORTER NIH RESEARCH GRANTS

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  1. HOW TO WRITE THE NEW, SHORTER NIH RESEARCH GRANTS

  2. Maureen E. Goode, PhD, ELSAdministrative Director713-500-7924Maureen.Goode@uth.tmc.eduMain CCTS number: 713-500-7900Offices: UTBP 1100Web site: http://ccts.uth.tmc.edu

  3. Starting January 25, 2010, the format and length of the Research Plans of NIH grants will change

  4. Should you wait to see how NIH study sections like the proposals to be written? No, unless you can wait up to a year or more. It will take that long before study sections review the new proposals.

  5. If you’ve already started working on anNIH proposal due January 25, 2010, or later, reread the Funding Opportunity Announcement (FOA) and see if anything has changed.

  6. READ THIS NOTICE Now Available: Restructured Application Forms and Instructions for Application Due Dates on or after January 25, 2010 http://grants.nih.gov/grants/ guide/notice-files/NOT-OD-10-016.html

  7. Use version 6/2009 forms and instructions http://grants1.nih.gov/grants/forms.htm (The previous versions were 11/2007) READ THE NEW INSTRUCTIONS!

  8. The application has been brought into line with the review criteria: CriteriaSection changed Significance Significance Innovation Innovation Approach Approach Investigator Biosketch Environment Facilities/Resources

  9. Changes in forms OSP will have a session for UTHSC-H administrators in January on the changes in the forms, but here are three you should address now: Biosketches Facilities/Resources All Personnel Report

  10. Biosketches now have a Personal Statement “Briefly describe why your experience and qualifications make you particularly well suited for your role (e.g., PD/PI, mentor, participating faculty) in the project that is the subject of the application.” This means you’ll need a different Personal Statement for each proposal—you can no longer use the same biosketch for every proposal.

  11. “A. Personal Statement • [I am the PI of this proposal.] The goal of the proposed research is to investigate the interaction between drug abuse and normal aging processes. Specifically, we plan to measure changes in cognitive ability and mental and physical health across a five-year period in a group of older drug users and matched controls. I have the expertise, leadership and motivation necessary to successfully carry out the proposed work. I have a broad background in psychology, with specific training and expertise in key research areas for this application. As a postdoctoral fellow at Berkeley, I carried out ethnographic and survey research and secondary data analysis on psychological aspects of drug addiction. At the Division of Intramural Research at the National Institute on Drug Abuse (NIDA), I expanded my research to include neuropsychological changes associated with addiction. As PI or co-Investigator on several previous university- and NIH-funded grants, I laid the groundwork for the proposed research by … In summary, I have a demonstrated record of successful and productive research projects in an area of high relevance for our aging population, and my expertise and experience have prepared me to lead the proposed project.”

  12. Resources • Describe how the scientific environment will help you successfully complete the project • Early Stage Investigators (those with no previous major NIH funding who completed their terminal degree or residency less than 10 years ago) must describe how the institution has invested in their success • (Mention the CCTS! We can give you a letter of support!)

  13. All Personnel Report Check whether you need to include it (probably only renewals do). It replaces the Senior/Key Personnel Report. Anyone working on the project for a least 1 calendar month (8.3% effort or more) in the previous year (whether or not they were paid from the grant itself) has to be included in the All Personnel Report.

  14. All Personnel Report(con’t) For each person listed, you must include eRA Commons User name (“when applicable”—ask your program officer what that means for your proposal) Name Degrees Role on Project Last 4 digits of Social Security number Date of birth Effort (calendar months)

  15. Research Plan Old format: Specific Aims Background and Significance Preliminary Studies/Progress Report Research Design and Methods Maximum 25 pages (15 for R21s) New format: Specific Aims Research Strategy Significance Innovation Approach (strategy and methods, plus Preliminary Studies/ Progress Report) Maximum 13 pages (7 for R21s)

  16. If your FOA states other formats or page limits, use those.

  17. Organizing the Research Plan • Specific Aims • Research Strategy • B.1. Significance • B.2. Innovation • B.3. Approach • B.3.1. Methods • B.3.2. Preliminary Studies/Progress Report • Or, • B.3.1. Preliminary Studies/Progress Report • B.3.2. Methods • (the order will be clarified by NIH soon)

  18. Specific Aims “State concisely the goals of the proposed research and summarize the expected outcomes, including the impact that the results of the proposed research will exert on the research fields involved. List succinctly the specific objectives of the research proposed, e.g., to 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. Specific Aims are limited to one page.”

  19. So, the Specific Aims section has not changed significantly.

  20. Features of Specific Aims Section Is the most important section of the proposal Has an introductory paragraph describing the field, the gap in the knowledge the proposed work will fill, and why filling the gap is important States the hypothesis being tested

  21. Features of Specific Aims Section (Con’t.) Lists the Specific Aims, which should be phrased as hypothesis-oriented (rather than methods-oriented) infinitives (for example, “To determine whether the X gene is overexpressed in the disease Y” rather than “To perform PCR on patients with Y” or “To study X gene expression in Y”) Should end with a statement on how the proposed work will further the field

  22. Research Strategy Significance Innovation Approach Strategy and Methods Preliminary Studies/Progress Report

  23. “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.”

  24. Significance (con’t) Why is this study important? How will your findings change science or medicine? Examples: lives will be saved or quality of life improved (state how), new rationales for treatment tested (state why they’re needed) 1 page may be sufficient. Start with enough background information to support the conclusion that the study is important.

  25. Sample Significance Outline Incidence and severity of the disease being studied Why the current treatment or diagnostic system doesn’t work well, so lots of people are dying or living poor-quality lives We propose trying X, which we believe will work better for the following reasons… If our hypothesis is correct, we will have a more effective treatment/diagnosis system for X that will save lives or improve the quality of lives (estimate numbers of people affected from disease incidence)

  26. Sample Significance Section In 2009, at least 25% of Americans were obese (with a body mass index (BMI) of 25 or greater), and the percentage is predicted to continue to rise…. Obesity is the second leading cause of preventable death in the United States, because it is a risk factor for many chronic diseases, including diabetes (2), heart disease (3), and many forms of cancer, including breast and prostate cancer (4,5)…. Alleviating obesity could reduce the incidence of these diseases and so save lives, but current obesity reduction strategies are not effective… We therefore will identify the factors that most strongly influence obesity, so that individual weight-loss strategies can be devised… This could save X lives…

  27. “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 interventions to be developed or used, and any advantage over existing methodologies, instrumentation or interventions. Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions.”

  28. Innovation (con’t.) What’s new about your proposed study? New hypotheses? New methods or approaches? Not all studies have to be innovative… (maybe the timing is right…) Half a page should be sufficient

  29. Sample Innovation Statement Our study is innovative because instead of using the same treatment for every patient, we will determine which of the many obesity factors affect a specific patient and use those factors to tailor treatment for that individual…

  30. “Approach [strategy and methods] 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.”

  31. Approach [strategy and methods con’t] Use each Specific Aim as a subheading, and under each, describe how you will achieve that aim: B.3.1. Methods B.3.1.1. Specific Aim 1: To ascertain the relationships… B.3.1.2. Specific Aim 2: To construct a profile…

  32. For each Specific Aim, state how you will achieve the Aim, including: How samples or subjects will be accrued Sample size calculation Assays, tests, etc. to be conducted—why you chose them and how they’ll be performed (describe as succinctly as possible—cite references (your own, if you can) wherever possible) How the data will be analyzed Possible pitfalls and how you’ll address then

  33. “Preliminary Studies for New Applications. For new applications, include information on Preliminary Studies as part of the Approach section. Discuss the PI’s preliminary studies, data, and/or experience pertinent to this application. Except for Exploratory/Development Grants (R21/R33), Small Research Grants (R03), Academic Research Enhancement Award (AREA) Grants (R15), and Phase I Small Business Research Grants (R41/R43), preliminary data can be an essential part of a research grant application and help to establish the likelihood of success of the proposed project. Early Stage Investigators should include preliminary data. (However, for R01 applications, reviewers will be instructed to place less emphasis on the preliminary data in applications from Early Stage Investigators than on the preliminary data in applications from more established investigators.)”

  34. This section is called Preliminary Studies, not Preliminary Data. Include: Evidence that the Aims can be achieved and the hypothesis tested Evidence that you’re the right person to do the study Brief descriptions of relevant previous studies Prior work relevant to the proposed study Logistical arrangements for the proposed study (e.g., system for notification about potential subjects arriving in ED)

  35. Describe published studies briefly: Only enough background and methods to make the study understandable (1-2 sentences) Only enough results to be convincing Emphasize the conclusions (interpretation of results) Write the descriptions backwards: What were the conclusions that support your proposed study? What data are essential to support those conclusions? What background information has not already been presented in your application? Then, arrange the sentences in background—data—conclusions order.

  36. If possible, organize Preliminary Studies by Specific Aims: use each Specific Aim as a subheading, and under each one state what you’ve done already to achieve the aim. If that’s not possible, make the relationship between the aims and the preliminary studies clear: Technique X “Aim 2 calls for technique X, which we recently established in our laboratory. An example is shown in Figure 1.”

  37. “Progress Report for Renewal and Revision Applications. For renewal/revision applications, provide a Progress Report as part of the Approach section. Provide the beginning and ending dates for the period covered since the last competitive review. Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement. Explain any significant changes to the specific aims and any new directions including changes resulting from significant budget reductions. A list of publications, manuscripts accepted for publication, patents, and other printed materials should be included in 5.5.5; do not include that information here.”

  38. The Progress Report should be organized by Specific Aims, using each one as subheading and under it describing everything that has been done to achieve the aim. Use the strategy for describing Preliminary Studies. State whether the aim has been achieved or how much work remains to be done on it and why you didn’t finish it. If you didn’t complete an aim because your findings made you change direction, say so. Reviewers like to see investigators respond to new information and challenges.

  39. A final bit of advice: Do your very best on your proposal— You are now allowed only one revised application. If the revision is not funded, you must submit your idea as a new application.

  40. REMEMBER Use CCTS services and programs to leverage your grant applications Check our web site for information http://ccts.uth.tmc.edu/ Contact the CCTS to discuss what we can do for you 713-500-7900 CCTS@uth.tmc.edu

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