NIH Grants: Strategies to Get Funded Silvia da Costa, Ph.D. Director of Faculty Research Relations Office of Research

Research Grants Competing Applications and Awards

Strategies to Improve Your Competitiveness

Research to address the needs of the funding institute

The NIH Peer Review Process Application received Assignments made Initial peer review Funding considerations Scientific Review Group Institutes or Centers (ICs) (Study section) (Duals possible) Scientific Review Officer Program Officer Second level of review Council Funding decision IC Director Award! Research to address the needs of the funding institute

The NIH is interested in funding good science that meets the needs of the of the funding institute “Small business” mentality Strategies to Improve Your Competitiveness The NIH is not interested in funding good science

Strategies to Improve Your Competitiveness To which Institute should you submit your grant? Research to address the needs of the funding institute

Awards by Institute sorted by average number Research to address the needs of the funding institute

2010 Funding Success Rate per NIH IC Research to address the needs of the funding institute

NIH RePORT Research to address the needs of the funding institute

Institute Strategic Plan Research to address the needs of the funding institute

Institute Strategic Plan Research to address the needs of the funding institute

Institute Strategic Plan Research to address the needs of the funding institute

Institute Strategic Plan Research to address the needs of the funding institute

IC Area of Interest Research to address the needs of the funding institute

Any Questions Research to address the needs of the funding institute

The NIH Peer Review Process Application received Assignments made Initial peer review Funding considerations Scientific Review Group Institutes or Centers (ICs) (Study section) (Duals possible) Scientific Review Officer Program Officer Second level of review Council Funding decision IC Director Award!

Strategies to Improve Your Competitiveness CRISP RePORTER

CRISP RePORTER Keyword “Cancer”, first few pages of search… NCINational Cancer Institute NIBIBNational Institute of Biomedical Imaging and Bioengineering NIANational Institute on Aging NIGMSNational Institute of General Medical Sciences NIMHDNational Institute on Minority Health and Health Disparities NINRNational Institute of Nursing Research NHGRINational Human Genome Research Institute NIAMSNational Institute of Arthritis and Musculoskeletal and Skin Diseases NCCAMNational Center for Complementary and Alternative Medicine NIEHSNational Institute of Environmental Health Sciences NIAIDNational Institute of Allergy and Infectious Diseases NCATSNational Center for Advancing Translational Sciences ODOffice of the Director

Strategies to Improve Your Competitiveness Choosing the right study section

Who will be reviewing your grant? Identifying potential members of your Scientific Review Group Strategies to Improve Your Competitiveness Choosing the right study section

Center for Scientific Review (CSR) Choosing the right study section

s/default.aspx Center for Scientific Review (CSR) Choosing the right study section

Center for Scientific Review (CSR) Choosing the right study section

Center for Scientific Review (CSR) Choosing the right study section

Any Questions Choosing the right study section

Strategies to Improve Your Competitiveness Early Stage Investigator

NIH Priority: Continued Focus on New Investigators New Investigator is an NIH research grant applicant who has not yet competed successfully for a substantial, NIH research grant. Example: a PI who has previously received a competing NIH R01 research grant is no longer considered a New Investigator. However, a PD/PI who has received a small grant (R03) or an Exploratory, Developmental Research Grant Award (R21) retains his or her status as a New Investigator. stigator_policies_faqs.htm#2649 Early Stage Investigator

NIH Priority: Continued Focus on New Investigators Early Stage Investigators: ESIs are New Investigators who are within 10 years of completing their terminal research degree or within 10 years of completing their medical residency at the time they apply for R01 grants. stigator_policies_faqs.htm#2649 Early Stage Investigator

Funding Policy for NIs & ESIs Applications from ESIs, like those from all New Investigators, are given special consideration during peer review and at the time of funding. Peer reviewers are instructed to focus more on the proposed approach than on the track record, and to expect less preliminary information than might be provided by an established investigator. Applications will be clustered during initial peer review to the extent possible. Early Stage Investigator

Special Programs for NIs & ESIs stigator_policies_faqs.htm#2649 Pathway to Independence Award (K99-R00) provides support as a postdoctoral scholar transitions from a training position to a faculty position Director’s New Innovator Award (DP2) provides support to highly innovative research approaches Early Stage Investigator

How does the NIH Recognize NIs & ESIs? stigator_policies_faqs.htm#2649 NI and ESI status is determined automatically by the functionality built into eRA Commons, based on the investigator’s record of receiving NIH grants and the date of their terminal degree and/or completion of medical residency. Make sure you are correctly designated as an ESI Verify your degree completion date in your NIH Commons Profile (eRA Commons) Early Stage Investigator

Loss of ESI Status Status applies only to R01s If you are applying for an R01 with another non-ESI, the proposal will not be reviewed as an ESI application. If awarded, you will lose your ESI status. Need to balance use of experienced collaborator with loss of ESI status. Early Stage Investigator

Strategies to Improve Your Competitiveness Grant sections

Good Grantsmanship Grant writing is a learned skill! Grant sections

Approach: Restructured Research Plan Previous ApplicationNew Application Background and Significancea.Significance b.Innovation c.Approach Preliminary Studies for New Applications Progress Report for Renewal/Revision Research Design and Methods Preliminary Studies/Progress Report Grant sections

Significance (1/2 page) Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Innovation (1/2 page) Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Grant sections Important to differentiate between the two!

Biographical Sketch Personal Statement –what experience and qualifications make the applicant particularly well- suited for the project. Limited to 4 pages (per person) Publications limited to 15 –5 most recent –5 best –5 most relevant to the application Grant sections

Biosketch: Include the PMCID Example Varmus H, Klausner R, Zerhouni E, Acharya T, Daar A, Singer P PUBLIC HEALTH: Grand Challenges in Global Health. Science 302(5644): 398–399. PMCID: PMC Grant sections

Specific Aims Page - Outline Background information Relevance (medical/clinical) Gap in knowledge/Current knowledge Long-term goal (of your lab) Objective of the proposal Hypothesis - Basis for hypothesis Rational for study Specific Aims Hypothesis How it will be tested Expected Results Why proposal is innovative Significance PI / Environment Positive Impact “Payoff” for the Institute/Foundation Grant sections

Specific Aims Page – Target Audience Grant sections

Specific Aims – Diagrams Diabetic conditions TGF XXX YYY WW abc Diabetic Neuropathy CVCV WSWS Hypothesis: text text text text text text text text text text text text text text text Aim 1Aim 2 Aim 3 Grant sections

Specific Aims Page Background information Relevance (medical/clinical) Gap in knowledge/Current knowledge Long-term goal (of your lab) Objective of the proposal Hypothesis - Basis for hypothesis Rational for study Specific Aims Hypothesis How it will be tested Expected Results Why proposal is innovative Significance PI / Environment Positive Impact “Payoff” for the Institute/Foundation What is not known is … It is relevant because… The objective of the proposal is.. The rational is based on the need to… This proposal is innovative because… The research is significant because.. It will have a positive impact due to… Our unique research environment specializing in XYZ will assure the success of the proposed project… It helps the XX institute fulfill it’s mission towards… or is in line with the goals of the institute in that… Your job is to make the reviewer’s work easier! Grant sections

Specific Aims Page Abstract Grant sections

Experimental Design Hypothesis Rationale Preliminary Data Experimental approach Methods Interpretation of results Potential pitfalls Alternatives Old format: Hypothesis Rationale Experimental approach Methods Interpretation of results Potential pitfalls Alternatives Innovation Significance Timeline Go/No-Go & Milestones & Preliminary Data Significantly reduced New format: Grant sections

Preliminary data Hypothesis Assay 1Expected Results Go/No-Go Go Quantitatable data Milestone (M1); Hypothesis Strengthened No-Go Alternatives & Pitfalls Alternative Assays Assay 2 Assay 3 Associated to M1, not necessarily to individual assays. Milestone (M1) Assay 4 No need for extensive detail Grant sections Alternatives & Pitfalls

Grant sections Alternatives & Pitfalls Alternatives & Pitfalls Alternative Assays Anticipated Results and Alternative Approaches: “There are no perceived obstacles to completing this aim with results as predicted.” Demonstrate to the reviewer that you have thought of, and planned for, all possibilities.

AimTimelineYr.1Yr.2Yr.3Yr.4Yr.5 1Assay 1 & 2x Assay 3xx 2xx MilestonesM1M2M3 Go/No-GoGiGii Summarize with the Timeline Go/No-Go identified in Alternatives & Pitfalls M1: text, text, text; M2, text, text text Milestones identified either in the main text or with the Table Your entire proposal summarized in one Table and one Figure Grant sections

Grant Proposal Cover Letter Application title FOA # and title Request: Place SRG & IC review requests on separate lines Place positive & negative requests on separate lines Include name of IC or SRG, followed by a dash and acronym Provide explanations for each request in a separate paragraph You can ask for a specific study section but it is not necessarily guaranteed… Check eRA Commons regularly to see confirm to where it was assigned. Contact the PO immediately if it was not assigned to the section you wanted - they usually will try to accommodate your request Choosing the right study section

Response to Reviewers Choosing the right study section Grant sections Q: What if you know that you are “Right” and the reviewers are “Wrong”, is it appropriate to argue your position in your resubmission? A: NO! Never be Argumentative ! Never be Abrasive ! Do not do long term damage to yourself Always address all comments and critiques Thank the reviewer for their effort Remind them of the good comments

Response to Reviewers Choosing the right study section Grant sections The reviewer’s comments regarding the proposed mode of action of XXX are frankly astonishing and somewhat disturbing as they suggest a view biased in favor of the more conventional mode of action for antibody. Clearly this reviewer is not familiar with the anti-inflammatory properties of XXX and apparently did not read the background sections on ‘Antibody prophylaxis and therapy’ (section 3.3) and ‘Anti- inflammatory Activity of XXX’ (section 3.4) in which XXX mechanisms of action were discussed. How to shoot yourself in the foot…

Any Questions Grant sections

Word Reduction & Editing Suggestions Early Stage Investigator

Methods – Keep it Brief A total of 1 x 10 7 cells in 0.4 ml of serum-free RPMI 1640 medium was transfected with 2  g of the reporter plasmid, 0.5  g of the Renilla luciferase control vector (pRL-TK; Promega), and 30  g of the expression vector by electroporation (250V and 950  F). Following electroporation, cells were incubated for 10 minutes at room temperature and then transferred into growth 10 ml of medium and cultured at 37 C and 5% CO 2 for 40– 48 hours. Cells (1 x 10 7 in 0.4 ml of serum-free RPMI 1640 medium) were transfected with the reporter plasmid (2  g), Renilla luciferase control (0.5  g, pRL-TK; Promega), and expression vectors (30  g), by electroporation (250 V, 950  F), incubated (10 min, room temperature), transferred into growth medium (10 ml) and cultured (37 C, 5% CO 2, h). A total of 1 x 10 7 cells in 0.4 ml of serum-free RPMI 1640 medium was transfected with 2  g of the reporter plasmid, 0.5  g of the Renilla luciferase control vector (pRL-TK; Promega), and 30  g of the expression vector by electroporation (250V and 950  F). Following electroporation, cells were incubated for 10 minutes at room temperature and then transferred into growth 10 ml of medium and cultured at 37°C and 5% CO 2 for 40–48 hours. The power of parenthesis… 78 to 58 words…

Methods – Keep it Brief Cells (1 x 10 7 in 0.4 ml of serum-free RPMI 1640 medium) will be transfected with the reporter plasmid (2  g), Renilla luciferase control (0.5  g, pRL-TK; Promega), and expression vectors (30  g), by electroporation (250 V, 950  F), incubated (10 min, room temperature), transferred into growth medium (10 ml) and cultured (37 C, 5% CO2, h). Cells will be transfected by electroporation with the reporter plasmid, Renilla luciferase control and expression vector, then transferred into growth medium and cultured ( h). Cells (1 x 10 7 in 0.4 ml of serum-free RPMI 1640 medium) will be transfected with the reporter plasmid (2  g), Renilla luciferase control (0.5  g, pRL-TK; Promega), and expression vectors (30  g), by electroporation (250 V, 950  F), incubated (10 min, room temperature), transferred into growth medium (10 ml) and cultured (37 C, 5% CO2, h). 58 to 23 words…

Figure Legends… Keep it brief Figure 2. Protein spots in 2-D gels for (A) DR0099, DR2340 and DRA0346: SsB, RecA and PprA, respectively; (B) DR0307 and DR1082: elongation factor G and light-repressed protein A, respectively and (C) DR1473 and DR2128: phage shock protein A and DNA-directed RNA polymerase alpha subunit, respectively. Figure 2. (A) The spots of proteins in the 2-D gels: DR0099, DR2340 and DRA0346: SsB, RecA and PprA, respectively. (B) The spots of proteins in the 2-D gels: DR0307 and DR1082: elongation factor G and light- repressed protein A, respectively. (C) The spots of proteins in the 2- D gels: DR1473 and DR2128: phage shock protein A and DNA- directed RNA polymerase alpha subunit, respectively. (D) Relative protein expression levels of proteins. Protein expression was calculated as described in experimental procedures. The values are the mean ± standard deviation (D) Relative protein expression levels (mean ± SD) (see Experimental Procedures) of four independent experiments repeated twice each. (n=4, in duplicate) 94 to 58 words…

Spell-check First: Go to EDIT on the Word tool bar, choose SELECT ALL Then: Go to TOOLS, LANGUAGE, SET LANGUAGE Choose English Uncheck “Do not check spelling or grammar” Then click OK

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