Writing NIH Grants Writing for Success: NIH R- series Grants Jane Douglas Faculty, CTSI Associate...
Transcript of Writing NIH Grants Writing for Success: NIH R- series Grants Jane Douglas Faculty, CTSI Associate...
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ts Writing for Success: NIH Writing for Success: NIH R-series GrantsR-series Grants
Jane DouglasFaculty, CTSI
Associate Professor, Center for Management Communication
Warrington College of Business
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tsNIH 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)
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tsNIH 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.
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tsBe 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/funding_program.htm#RSeries
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tsAnother 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.
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tsR21 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).
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tsR21 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)
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tsR03 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
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tsR-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.
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tsPlan 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.
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tsWhat 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
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tsNIH’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
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tsWhat 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.
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tsWhat 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
conditionsBenefits of prevention, early
diagnosis, or treatment in avoiding all of above.
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tsWhat This Means: Your
Focus
• In an R21 or R03:1. Accounting for disparities in healthcare outcomes from prostate disease between African-American and other populations2. How minocycline targets gut microbiota implicated in development of T2D3. Using biomarkers to assess differing impacts of long-term pain among different racial and ethnic populations.
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tsTracing 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?
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tsPlan 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)
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tsAs You Begin…
• Ensure your hypothesis hasn’t already been (a) published or (b) funded.
• Check funded NIH projects via RePORTER: 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.
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tsAs 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.
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tsBear 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.
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tsHypothesis 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.
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tsHypotheses – 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.
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tsEnlist 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.
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tsCollaborators
• 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.
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tsPrimary Peer Review
Criteria1. Significance2. Investigators3. Innovation4. Approach5. Environment
Plus: Independence and LeadershipAppropriate ResourcesInstitutional Support
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tsAdditional Peer Review
Criteria
1. Protections for Human Subjects2. Inclusion of Women, Minorities, & Children3. Treatment of Vertebrate Animals4. Biohazards5. Resubmission6. Renewal7. Revision
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tsNIH 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
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tsAs 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.
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tsWrite 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…”
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tsWrite 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.
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tsUltimate 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.