NIH Grants: Strategies to Improve Your Competitiveness

NIH Grants: Strategies to Improve Your

Competitiveness

Silvia da Costa, Ph.D.Director of Faculty Research Relations

Office of Research

Research Grants Competing Applications and Awards

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 reviewCouncil

Funding decision IC Director

Award!

Research to address the needs of the Funding Institute

CRISP RePORTER

Choosing the right study section

Grant Sections

Early Stage Investigator

Strategies to Improve Your Competitiveness

Research to address the needs of the funding institute

Award!Research to address the needs of the funding

institute

Research to address the needs of the funding

institute

The NIH is not interested in funding good science

The NIH is interested in funding good science that meets the needs of the of the funding institute

“Small business” mentality: Your proposal as an “investment”

To which Institute should you submit your grant?

institute

Awards by Institutesorted by average number

institute

2010 Funding Success Rate per NIH IC

0% 10% 20% 30% 40% 50% 60% 70% 80%

Chart Title

$- $200,000 $400,000 $600,000

Award Amount (‘000s)

institute

NIH RePORT

http://report.nih.gov/reports.aspx

institute

Institute Strategic Plan

http://report.nih.gov/reports.aspxResearch to address the

needs of the funding institute

http://report.nih.gov/strategicplans/index.aspx

institute

IC Area of Interest

http://www.nih.gov/icd/index.html

institute

Any Questions

institute

Award!

CRISP RePORTER

CRISP RePORTER http://projectreporter.nih.gov/reporter.cfm

Who will be reviewing your grant?

Identifying potential members of your

Scientific Review Group

http://public.csr.nih.gov/Pages/default.aspx/

Center for Scientific Review (CSR)

http://public.csr.nih.gov/StudySections/Pages/default.aspx

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

Any Questions

Grant sections

Good Grantsmanship

Grant writing is a learned skill!

Grant sections

Porter, R. Why Academics Have a Hard Time Writing Good Grant Proposal. J Res Admin XXXVIII(2):37-43,2007

Scholarly pursuit:Individual passion

Past oriented:Work that has been done

Theme-centered:Theory and thesis

Expository rhetoric:Explaining to reader

Impersonal tone:Objective, dispassionate

Individualistic:Primarily a solo activity

Few length constraints:Verbosity rewarded

Specialized terminology:“Insider jargon”

Sponsor goals:Service attitude

Future oriented:Work that should be done

Project-centered:Objectives and activities

Persuasive rhetoric:“Selling” the reader

Personal tone:Conveys excitement

Team-focused:Feedback needed

Strict length constraints:Brevity rewarded

Accessible language:Easily understood

Academic Writing Grant Writing

Grant sections

Approach: Restructured Research Plan

Previous Application New Application

Background and Significance

a. Significanceb. Innovationc. Approach

• Preliminary Studies for New Applications

• Progress Report for Renewal/Revision

Research Design and MethodsPreliminary 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

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. 2003. PUBLIC HEALTH: Grand Challenges in Global Health. Science 302(5644): 398–399. PMCID: PMC243493

http://publicaccess.nih.gov/citation_methods.htm

Grant sections

Specific Aims Page - OutlineBackground informationRelevance (medical/clinical)Gap in knowledge/Current

knowledgeLong-term goal (of your lab)Objective of the proposalHypothesis - Basis for hypothesisRational for studySpecific Aims

HypothesisHow it will be testedExpected Results

Why proposal is innovative SignificancePI / EnvironmentPositive Impact“Payoff” for the

Institute/FoundationGrant sections

Specific Aims Page – Target Audience

Grant sections

Specific Aims – Diagrams

Diabetic conditions

XXX YYY

WW abc

Diabetic Neuropathy

CVCV WSWS

Hypothesis: text text text text text text text text texttext text text text text text text text text text text texttext text text text text text text text text text text text

Aim 1 Aim 2

Grant sections

Specific Aims Page

Background informationRelevance (medical/clinical)Gap in knowledge/Current knowledgeLong-term goal (of your lab)Objective of the proposalHypothesis - Basis for hypothesisRational for studySpecific Aims

HypothesisHow it will be testedExpected Results

Why proposal is innovative SignificancePI / EnvironmentPositive 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

HypothesisRationalePreliminary DataExperimental approachMethodsInterpretation of resultsPotential pitfalls Alternatives

Old format:

HypothesisRationaleExperimental approachMethodsInterpretation of resultsPotential pitfalls Alternatives

InnovationSignificance

TimelineGo/No-Go & Milestones

Significantly reduced Preliminary Data

New format:

Grant sections

Preliminary

Hypothesis

Assay 1 Expected Results Go/No-Go

Quantitatable dataMilestone (M1);

Hypothesis Strengthened

Alternatives&

Pitfalls

AlternativeAssays

Assay 2

Assay 3

Associated to M1,not necessarily to

individual assays.

Milestone (M1)

Assay 4No need for extensive detail

Grant sections

Alternatives & Pitfalls

Grant sections

Alternatives & Pitfalls

Alternatives&

Pitfalls

AlternativeAssays

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.

Aim Timeline Yr.1 Yr.2 Yr.3 Yr.4 Yr.5

1 Assay 1 & 2 x

Assay 3 x x

Milestones M1 M2 M3

Go/No-Go Gi Gii

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 FigureGrant sections

Response to Reviewers

Choosing the right study sectionGrant 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 sectionGrant 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

http://grants.nih.gov/grants/new_investigators

48.0Ag

Fiscal Year

Figure 1. Average Age of Principal Investigators with MD, MD-PhD, or PhD at the time of First R01 Equivalent Award from NIH, Fiscal Years 1980 to 2011

MD-PhD

MD Only

PhD Only

R01-Equivalent investigatorsNumber supported on competing awards, by career stage of investigator

NIH Priority: Continued Focuson 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.

http://grants.nih.gov/grants/new_investigators/investigator_policies_faqs.htm#2649Early Stage Investigator

NIH Priority: Continued Focuson 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.

http://grants.nih.gov/grants/new_investigators/investigator_policies_faqs.htm#2649Early Stage Investigator

New Funding Policy for New and Early Stage Investigators

http://grants.nih.gov/grants/new_investigators/investigator_policies_faqs.htm#2649

• For R01 applications as of FY2009, NIH expects to support New Investigators at success rates equivalent to that of established investigators submitting new applications.

• The majority of New Investigators are expected to be Early Stage Investigators

• This will apply to R01 grants only & is intended to discourage need to apply for R21 or R03 before R01

ting A

t Prin

Fiscal Year

Figure 2. Number of New and Experienced Investigators on R01 Equivalent Grants and New Investigators as a Percentage of All Competing R01 Awardees (FY 1962 - 2011)

Established Investigators

New Investigators

Percent New

http://grants.nih.gov/grants/new_investigatorsEarly 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.

Special Programs for NIs & ESIs

• 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

How does the NIH Recognize NIs & ESIs?

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 ESIVerify your degree completion date in your

NIH Commons Profile (eRA Commons)

Extension of ESI Status

http://grants.nih.gov/grants/new_investigators/esi_extension_add.htm

ESI extensions will be considered only after the terminal research degree and/or the residency end date has been added to the eRA Commons Profile.

NIH will consider requests to extend the ESI period for reasons that can include medical concerns, disability, family care responsibilities, extended periods of clinical training, natural disasters, and active duty military service.

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.

Word Reduction & Editing Suggestions

Methods – Keep it Brief

A total of 1 x 107 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% CO2 for 40–48 hours.

Cells (1 x 107 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% CO2, 40 - 48 h).

A total of 1 x 107 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% CO2 for 40–48 hours.

The power of parenthesis…

78 to 58 words…

Methods – Keep it Brief

Cells (1 x 107 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, 40 - 48 h).

Cells will be transfected by electroporation with the reporter plasmid, Renilla luciferase control and expression vector, then transferred into growth medium and cultured (40 - 48 h).

Cells (1 x 107 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, 40 - 48 h).

58 to 23 words…

Figure Legends… Keep it briefFigure 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

Values are mean ± SD

(see Experimental Procedures)

of four independent experiments repeated twice each.

(n=4, in duplicate)

94 to 62 words…

Spell-check

First: Go to EDIT on the Word tool bar, choose SELECT ALL

Then: Go to TOOLS, LANGUAGE, SET LANGUAGEChoose English

Uncheck “Do not check spelling or grammar”Then click OK

“What is written without effort is, in general, read without pleasure.”

Samuel Johnson

Question marks from Stock images

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