Preparing an NIH Research Grant Proposal - From A to Z - PowerPoint Presentation

Slide1

Preparing an NIH Research Grant Proposal - From A to Z

Wilfried Karmaus

School of Public Health

University of Memphis

Slide2

Flow of ideas, passion, and dreams

Scientific work: Curiosity, ambition, passion

Flow of data/analyses (preliminary data), experience)

Development of capacities, collaboration, teams, tools

Flow of publications (publication record)

Window of opportunities

Windows of opportunities

RFA or investigator initiated application

Flow of applications (R03, R21, R01, program grant)

Window of opportunities

Creativity is intelligence having fun.

Slide3

Bridge between multiple other disciplines

(mixed method approach) and institutions

Collaboration -- basic science,

-- clinical science

-- social science

-- biostatistics -- ……

Build a network, contact people: Small Universities: not all disciplines at one placeBuild trust

Build reputation (expertise – do not slip into the role of

auxiliary/support science)

Show that you can implement – reliability (analyses,

publication, lead authorship, etc.)

Slide4

Where do you get the idea from?

Request for Information (

RFI

): Inviting Comments and Suggestions on a Framework for the NIH-wide Strategic Plan

Notice Number: NOT-OD-15-118

Key Dates

Release Date:

July 22, 2015

Response Date

: August 16, 2015

Related Announcements

None    

Issued by

National Institutes of Health (

NIH

)

Request for Information (

RFI

): Inviting Comments and Suggestions on the Environmental influences on Child Health Outcomes (ECHO) Program (the National Children's Study Alternative)

Notice Number: NOT-OD-15-117

Key Dates

Release Date:

  July 13, 2015

Response Date

: August 14, 2015

Slide5

Where do you get the idea from?

Request for applications

(RFA):

Expert meetings

Concepts = early planning stages for requests for applications, and solicitations.

https://www.niaid.nih.gov/grants-contracts/potential-opportunities

Often special study sections (problems!)

Investigator initiated

application:https://grants.nih.gov/grants/grants_process.htm

The investigator has a novel idea

Has to tell the storyLess competition if the idea is goodRegular study sections (look the reviewer up:

http://www.csr.nih.gov/committees/rosterindex.asp)

Slide6

Where do you get the idea from?

Work with other PIs / in research projects.

Help to identify additional questions:

For instance, volunteer to determine what is know/what is unknown for some of the questions that cannot fully addressed by an ongoing grant.

Keep a list of additional/open/unaddressed questions

Slide7

See what has been addressed before:

NIH reporter:

https://projectreporter.nih.gov/reporter.cfm

(This tool is also useful to see whether people who stated that they were involved in 24 grants really were involved in 24 grants.)

Slide8

Grant types: R01, R21, R03, F15, …..

R01

Investigator-initiated or can be solicited via a request for

applications.

R03

Support small research projects that can be carried out in a short

period of time with limited resources

.

R21 Encourage exploratory/developmental research by providing support

for the early and conceptual stages of project development.

R15 Support small research projects conducted by undergraduate and/

or graduate students and faculty in institutions of higher education that have not been major recipients of NIH research grant funds.

F31 Predoctoral individuals with supervised research training in specified health and health-related areas leading

toward the research degree (e.g., Ph.D.). Often: no non-residents

F32

Same for post-doctoral individuals Often: no non-residents

K (K00-K99, KM1)

research training DP1

Funding opportunities for exceptionally creative scientists

proposing pioneering approaches (no citizenship or residency

requirements)DP2 Support highly innovative research projects by new investigators in

all areas of biomedical and behavioral research

(non-residents)

https://grants.nih.gov/grants/funding/funding_program.htm

Slide9

Grant types: R01, R21, R03, F15, F32

RFA – if not funded



one chance to resubmit

However:

re-submit a RFA proposal rejected by a

special study section asInvestigator-initiated grant  one re-submission

This way: totally 2 resubmissions (

change title and revise approach  endless number of resubmissions)

Chance of funding: 5% for investigator-initiated

applications (

payline: 10% or less of 50% reviewed) R21, R01Chance for F32: High if it is part of a project

Often: no non-residents

Slide10

For all R01 grants, the NICHD sets a baseline for new competing applications:

~ 14th percentile

For R01 applications from New Investigators and Early Stage Investigators:

~18th percentile

The 2019

payline

for competing R03s and R21s:

31th percentile, with no budget reduction.The 2015

payline for F30 and parent F31 Fellowship applications:

20th percentile The 2015

payline for Diversity F31 Fellowship applications:

19th percentileThe 2015 payline for F32 Fellowship applications is the

24th percentilehttps://writedit.wordpress.com/nih-paylines-resources/

https://www.einstein.yu.edu/administration/grant-support/nih-paylines.aspx

NICHD Funding Strategies for Fiscal Year 2019

Slide11

Research Project Success by NIH Institute for 2014

http://

report.nih.gov/success_rates/Success_ByIC.cfm

DEFINITION:

Success rates are defined as the percentage of reviewed grant applications that receive funding.

Slide12

NIH Institute/Center

Number of Applications Reviewed

Number of Applications Awarded

Success Rate

Fiscal Year

 FIC

78

23

29.5%

2016

 NCI

10,210

1,230

12%

2016

 NEI

1,294

332

25.7%

2016

 NHLBI

4,052

979

24.2%

2016

 NIA

2,742

624

22.8%

2016

 NIAID

6,058

1,452

24%

2016

 NIAMS

1,570

251

16%

2016

 NICHD

3,492

462

13.2%

2016

 NIDA

2,002

308

15.4%

2016

 NIDCD

817

218

26.7%

2016

 NIDDK

3,649

734

20.1%

2016

 NIEHS

1,154

164

14.2%

2016

 NIGMS

3,915

1,159

29.6%

2016

 NIMH

2,565

587

22.9%

2016

 NINDS

4,247

842

19.8%

2016

Slide13

Objective:

Five applications per faculty per

year



4 years to get funding

Synchronize your science work

Network and collaborate: Discuss SA page with all partners early in the development

Discuss your SA page with program officialsDiscuss your research strategy with your mentor and colleagues

Enthuse reviewers

Help reviewers: write in a way as if you review your application

Significance: Not the importance of the disease or public health, but what can be changed.

Creativity is intelligence having fun.

Slide14

Review Criteria

Overall Impact/Priority

Reflects the reviewers’ assessment of the likelihood for the project to exert a sustained, notable influence on the research field(s) involved

5 Core Review Criteria:

Significance

Investigator(s)

Innovation

Approach

Environment

Reviewers rank grants, but do not decide

Slide15

Core Review Criteria

Significance

Important problem or barrier to progress

If successful:

What will be the impact on the field?

What will be the effect on concepts, technology, prevention/ intervention that drive the field?

Describe the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of your application. 

Review Criteria

Slide16

Core Review Criteria

Innovation

Change/Paradigm

shift

Concepts, approaches or

methodologies, technical

developments or interventions novel

to field or novel in broad sense.

Review Criteria

Slide17

Core Review Criteria

Approach

Are the overall strategies, methods

& analyses well-reasoned and appropriate to accomplish aims?

Are potential pitfalls, alternative strategies and benchmarks for success presented?

If in early stage, will strategy establish feasibility and will risks be managed?

If clinical research, are the plans for

1) protection of human subjects from research

risks, and

2) inclusion of Gender, Minorities and Children,

justified in terms of the scientific goals and

research strategy proposed?

Slide18

Core Review Criteria

Approach

 

Describe the experimental design and methods proposed and how they will achieve robust and unbiased results. 

Explain how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans.

For example, strong justification from the scientific literature, preliminary data, or other relevant considerations, must be provided for applications proposing to study only one sex.

Slide19

Review Criteria

Overall Impact

Overall impact/priority score

Likelihood for project to exert sustained

powerful influence on research field.

Take into account five review

criteria…but not average of their scores.

Slide20

9-point Scoring Descriptions

Not discussed

Possible Funding

Slide21

Typical negative review points

Reviewers did not find the scientific question

interesting (

Did you tell the story?

)

To ambitious (discrepancy between capacities

and aims)Unfocused

House of cards (what if aim 1 fails, will aims 2-5

still be important/feasible?)Lack of experience

Review Criteria

Slide22

New Criterion: Rigor and Reproducibility

Scientific rigor and transparency

in conducting biomedical research is key to the successful application of knowledge toward improving health outcomes.   

The 

scientific premise

 for an application is the research that is used to form the basis for the proposed research.

NIH expects applicants to describe the general strengths and weaknesses of the prior research being cited by the applicant as crucial to support the application.

NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies.

Slide23

Grant writing

Passion

Start small

Check eligibility

What is known – what is unknown

Get to know project officers/concept papers

Get a mentor or a team (& biostatistical advice)

Tell a story

Clearly describe what will be improved if we knew the results of the proposed study

Show how the project will fill the knowledge gap

Slide24

Grant writing:

Specific Aims page

There is a

gap of knowledge

regarding the mechanisms …The

rationale of the proposed investigation …Our

long-term goal is …

The short term goal of this application,

The central hypothesis is …The specific aims are: Specific Aim 1:

XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX -

This aim will test the working hypotheses that …Expected outcomes of …Positive impact of these aims are…Our team includes …. with experience in…

Slide25

Specific Aims

(1. page):

What is known? (focus)

What is unknown? – Gap of knowledge

What will this application add?

- one aim per year

- Aim 1 is important

Significance

(2. page)

State of the art (focus on what you want to do, this is not a review)

What can be improved if we fill the gap of knowledge?

Innovation

(2. part- 0.5 page)

State all innovations:

Prevention in public healthImprovements in treatments

Connect with the Specific Aims

Specific Aims

(p. 2.5-6/12)

Describe your team

Provide preliminary data

Repeat the aims (verbatim)

Rationale for the aim

Procedures to achieve the aim

Alternative approaches and expected results

Slide26

What to do when?

Assisted Referral Tool (ART):

Cover letter

Find the study section

Biosketches

for PI and Co-Investigators

Project summary (30 lines)

Project narrative (3 sentences)Specific Aims (1 page)

Research Strategy (6 or 12 p.)Bibliography & Reference Cited

Consortium/Contractual ArrangementsAny additional Letters of Support

Facilities & Other Resources

EquipmentResource Sharing PlanBudget Justification

Are human Subjects involved?  If so, you will need the following (whichever pertains to your proposal)

Protection of Human SubjectsInclusion of women and minorities

Targeted/planned Enrollment table

Inclusion of children

Slide27

Find the study section

Assisted Referral Tool (ART)

https://art.csr.nih.gov/ART/index.jsp?tabID=995E34E3AD85E014E624BB2DD0C9109D7095100

Then check the

members

of the ‘recommended’ study section (your friends and enemies) and the

expertise

of each study section.(Example:

Is epigenetic aging related to exposure to PCB and DDE? DDE

PCBepigenetics

DNA methylationAging)

Slide28

Time line

(in months)

Initial SA page, partners,

Access, IRB

Month 1

2

3

4-4.5

4.5-5

Develop the research strategy, partners

Consensus,

biosketches

, preliminary budget

Budget development,

Process the backbone

SCIENCE PART

ADMINISTRATIVE PART

Budget development, Resources, Human subjects,

Finalize SA page, and research strategy

Add all pieces into

the backbone,Submit

Slide29

“The only real failure is the failure to try, and the measure of success is how we cope with disappointment.” (19 of 20 submissions)

BUT

“Everything will be all right in the end. 

If it's not all right then it's not the end.”

(

Both: “

The Best Exotic Marigold Hotel”

)

Thank you.

Questions