1. Writing NIH Grants Writing for Success: NIH R- series Grants Jane Douglas Faculty, CTSI Associate Professor, Center for Management Communication Warrington College of Business

2. Writing NIH Grants NIH R-series Grants Research Project Oriented: Most common are: –R03 Small Research Grants (preliminary, short-term) –R21 Exploratory/Developmental Grants (Develop new research in categorical areas; short-term, restricted support)

3. Writing NIH Grants NIH R-series Grants Research Project Oriented: Most common are: –R01: historically oldest grant mechanism in NIH –Can be investigator-initiated or in response to specific RFAs –But R01 plan must relate to program goals of NIH Institute or Center –Renewable, focuses on multiple experiments to realize complex aims.

4. Writing NIH Grants Be Aware of Shifting Deadlines R01 deadlines occur in cycles, as do other R awards, but –Deadlines for new submissions differ from renewal applications –Applications under specific RFAs also have different deadlines –As do R21s and other R-series grants –Always check relevant RFAs at http://grants1.nih.gov/grants/funding/fu nding_program.htm#RSeries

5. Writing NIH Grants Another Caveat: Institutes and Centers Not all Institutes and Centers accept applications for all types of R-series grants Eligibility criteria may vary widely, as well as deadlines for submission Look up Funding Opportunity Announcements (FOAs) to see which criteria and deadlines apply.

6. Writing NIH Grants R21 Grants Novel, exploratory or developmental research projects Support for early stages, including pilot or feasibility studies Limited to 2 years of funding Budgets: Limited to $275K (direct costs) No preliminary data required (but always helpful).

7. Writing NIH Grants R21 Grants Currently, no grants pertaining to National Heart, Lung, Blood Institute (NHLBI) Also no submissions under National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

8. Writing NIH Grants R03 Grants Currently, no grants pertaining to NHLBI, NIDDK unless pertinent to specific FOAs: Also applies to National Eye Institute (NEI) National Center for Advancing Translational Sciences (NCATS) And others. See Center-specific FOAs, which tend to be highly limited in scope

9. Writing NIH Grants R-series Grants Caveats Never just assume you can submit an R03 or R21 without consulting specific FOAs from the NIH center relevant to your research Despite stated guidelines, preliminary data is always persuasive in establishing feasibility and potential outcomes.

10. Writing NIH Grants Plan WAY Ahead Consult different types of FOAs: –Parent Announcements Broadest category, investigator-initiated, established deadlines for submissions, just needs to fit within NIH overall mission –IC-Specific Program Announcements (PAs) Broadly defined but still investigator-initiated, tied to IC’s scope. –Requests for Applications (RFAs) Well-defined scope and area, reviewed within an IC by a Special Emphasis Panel.

11. Writing NIH Grants What the NIH Looks for Originality –Conduct thorough lit review to ensure idea isn’t duplicative of other research Innovation –Build off “black boxes” in understanding of processes, etiology –Address an established problem using a novel mechanism or approach Advancing knowledge –Capitalize on recent discoveries or poorly understood mechanisms

12. Writing NIH Grants NIH’s Stated Goals Foster discoveries and innovative research strategies to ultimately protect and improve health Develop resources to prevent disease Expand knowledge base in medical and associated sciences to enhance national economic well-being and a high return on investment in research

13. Writing NIH Grants What This Means: Translation Research that addresses public health costs associated with widespread or chronic disease Reduces public health costs or anticipates and addresses increases in costs associated with treatment of disease Indirectly addresses costs of lost productivity from chronic disease.

14. Writing NIH Grants What This Means: Pragmatic Translation Focus on $$ in terms of –Population numbers afflicted with disease –Costs of treatment –Losses in working days –Costs of complications or co-morbid conditions Benefits of prevention, early diagnosis, or treatment in avoiding all of above.

15. Writing NIH Grants What This Means: Your Focus In an R21 or R03: 1. Accounting for disparities in healthcare outcomes from prostate disease between African-American and other populations 2. How minocycline targets gut microbiota implicated in development of T2D 3. Using biomarkers to assess differing impacts of long-term pain among different racial and ethnic populations.

16. Writing NIH Grants Tracing these back to NIH pragmatic aims 1.Racial disparities in outcomes from prostate disease? 2.Targeting gut microbiota linked with T2D? 3.Establishing ethnic and racial disparities in biomarkers for chronic pain?

17. Writing NIH Grants Plan Early! eRA Commons accounts require PI at least one month prior to grant submission. On-campus approvals can take months (IRB, budgetary) Line up collaborative team –Letters of commitment delineate their roles Establish necessary resources (labs, diagnostics, expertise)

18. Writing NIH Grants As You Begin… Ensure your hypothesis hasn’t already been (a) published or (b) funded. Check funded NIH projects via RePORTER: http://report.nih.gov/http://report.nih.gov/ RePORTER also displays associated publications and can be useful lit review resource. Be sure your hypothesis is compelling, novel, innovative, and addresses NIH and IC central aims.

19. Writing NIH Grants As You Begin… Scrutinize FOA Get feedback from colleagues/mentors/available experts Find an already existing R01, R03, or R21 application as a model Ensure your college, department or division will give you protected time promised in grant Familiarize yourself with NIH peer review criteria, based on IC.

20. Writing NIH Grants Bear in Mind R01s are the most complex and competitive grants you will ever write. Let your ideas germinate for months, if not years, prior to submitting an R01. If you’re not passionate about the central hypothesis, don’t start until you are.

21. Writing NIH Grants Hypothesis and Specific Aims Make or break a grant application Hypothesis should be expressible in 2-3 sentences, max. Break down into realizable specific aims –Better Aims 1, 2, 3 rather than extensive sub-aims: Aim 1a, 1b, 1c –Unless you require a subsidiary aim(s) to realize one aim.

22. Writing NIH Grants Hypotheses – R01s Expect to generate multiple experiments to realize even one specific aim (4-5 is not uncommon) Be prepared to pre-empt questions about your experimental design (direct questions as subheadings can be helpful) with rationale(s). Provide anticipated results that acknowledge potential pratfalls, challenges in statistical analyses.

23. Writing NIH Grants Enlist Collaborators If you haven’t already done so, seek out mentors at meetings. –Include association heads, last authors in influential studies, established authorities –Recruit mentors as collaborators or use them as sounding boards for your hypotheses –Mentors can have influence on decisions of NIH study sections. –You may request specific experts/reviewers in your cover/letter of transmittal.

24. Writing NIH Grants Collaborators Can also provide access to labs, methodologies, expertise you lack. Can provide feedback on hypothesis, specific aims, and methodologies. Can reassure NIH that your team has appropriate expertise and resources to complete project. Can act as advocates for your research—if you’re lucky.

25. Writing NIH Grants Primary Peer Review Criteria 1.Significance 2.Investigators 3.Innovation 4.Approach 5.Environment Plus: Independence and Leadership Appropriate Resources Institutional Support

26. Writing NIH Grants Additional Peer Review Criteria 1. Protections for Human Subjects 2. Inclusion of Women, Minorities, & Children 3. Treatment of Vertebrate Animals 4. Biohazards 5. Resubmission 6. Renewal 7. Revision

27. Writing NIH Grants NIH Writing Priorities Applications should be written as clearly and accessibly as possible Primary gate-keepers won’t be subject matter experts Ensure title, abstract, background/public relevance are –Comprehensible to lay public –Use plain, accessible language, explain terminology –Focus on potential impacts on public health

28. Writing NIH Grants As You Begin Create an outline Follow the suggested organization of application Craft one sentence for each main point in outline Focus on persuading reviewers why –A) hypothesis is worth funding –B) you’re the person to carry out study –C) you have the institutional support to complete it.

29. Writing NIH Grants Write Clearly! Reviewers are most likely to read carefully easy-to-read submissions. Avoid jargon and spell out all acronyms on first reference. Even NIH recommends using active construction over passive construction in sentences: –“We will achieve this aim by…” NOT –“This aim will be achieved by…”

30. Writing NIH Grants Write Clearly! To bolster readability: –Short paragraphs, one idea per paragraph –Use transitions, especially causal (as a result, consequently, therefore, because) to strengthen ties between ideas –Enlist readers outside your specialization to assess ideas are accessible.

31. Writing NIH Grants Ultimate Focus on Writing Get help if you’re not a strong writer! Use an independent expert to provide objective critique of application, if possible. Zero tolerance for any typos, misspellings, grammatical or diction errors, or poor formatting –Can lead reviewers to conclude sloppiness in preparation will carry over to research.

32. Writing NIH Grants Questions? Or objections? Or a bloody good argument?