Ralph Nitkin, Ph.D. - RN21E@NIH.GOV

National Center for Medical Rehabilitation Research (NCMRR)

Eunice K. Shriver National Institute of Child Health and Human

Development (NICHD)

National Institutes of Health (NIH)

The NIH is made up of 28 Institutes, The NIH is made up of 28 Institutes, Centers, Divisions:Centers, Divisions:

OD NIDA NCI NIEHS NEI NIGMS NHLBI NIMH NHGRI NINDS NIA NINR

NIAAA NLM NIAID CIT NIAMS CSR NIBIB FIC NICHD NCCAM NIDCD NCMHD NIDCR NCRR NIDDK CC

Majority of funds go to investigator-initiated proposals - rather than responding to program initiativesFunding in any given area is largely driven by number of quality applications that NIH receives in that areaNIH accepts proposals in three annual cycles,

typically: early February, June, and OctoberElectronic submissions – leave time to deal with it!!!From submission to funding: 9 months - probably more for revisionsSupport provided to institutions in name of investigator

Applying to the NIHApplying to the NIH

Research Project Award: R01Research Project Award: R01Investigator-initiated applications

(majority of basic & clinical NIH funding)

Focus on specific set of aims Budget: no boundaries but typically

$200-300,000 per year (direct costs)May request up to 5 years; If funded, and productive, can later

apply for “competitive renewal” for another years

Small Grants: R03 and R21Small Grants: R03 and R21R03: Pilot studies; feasibility studies $50,000 (direct costs) per year for two years

R21: innovative research; high-risk; pushing the envelop; new methodology or technology;

$275,000 (direct costs) spread over two years

Not renewable; may not be used to supplement already-funded projects

AREA (Academic Research AREA (Academic Research Enhancement Award): R15Enhancement Award): R15

Schools that have not been major recipients of NIH funding (< $3 million/yr)

Especially projects that engage undergraduate students

Up to 3 years, aggregate budgets up to $100,000 direct costs, Renewable

http://grants.nih.gov/grants/funding/area.htm

Small Business Tech Transfer (STTR, R41/42) Small Business Tech Transfer (STTR, R41/42) Small Business Innovation Res (SBIR, R43/R44) Small Business Innovation Res (SBIR, R43/R44)

Innovative research, potential for commercialization

STTR (partnership: small business + academic):Phase I: $100,000 (1 year)Phase II: $500,000 (2 years)

SBIR (primarily at small business):Phase I: $100,000 (6 months)Phase II: $750,000 (2 years)

http://grants.nih.gov/grants/Funding/sbir.htm

Midcareer Investigator Award in Midcareer Investigator Award in Patient-Oriented Research (K24)Patient-Oriented Research (K24)

Mid-career (i.e., associate professor-level) clinical investigator

Has grant-funding base

Time and resources to become a better mentor for junior clinical investigators

http://grants.nih.gov/grants/guide/pa-files/PA-09-037.html

Supplements to already-funded Supplements to already-funded NIH research grantsNIH research grants

To add qualified individuals at any career level (high school through beginning investigator) who:are from under-represented minoritiescome from disadvantaged backgroundshave disabilitiesre-entering research after family obligations

Contact NIH program director of funded grant

http://grants.nih.gov/grants/guide/pa-files/PA-08-190.html

Special Research InitiativesSpecial Research Initiatives

Program Announcements (PA)Highlights Institute(s) interest in specific area, but no funds set aside

Request for Applications (RFA)One-time limited set aside for applications in specific area

New and Early-Stage InvestigatorsNew and Early-Stage InvestigatorsNIH encouraging support for new investigators “New investigator” status highlighted in the

peer-review processExtended paylines Shortened review cycleSee NIH websites for specific policy

New Investigator = never been PI on an R01 grantEarly Career = New and within 10yrs of terminal

research degree

Special Kinds of Grants for EngineersSpecial Kinds of Grants for EngineersBRG - Bioengineering Research Grant Can be used for device development-may not

need scientific hypotheses

BRP -Bioengineering Research ProgramAn industrial, multi-project collaborative

program

NIH Bioengineering consortium:http://publicaccess.nih.gov/becon_redirect.htm

NIH Blueprint for NeuroscienceNIH Blueprint for NeuroscienceCooperative effort among the 16 NIH

Institutes and Centers that support neuroscience research

Basic and clinical neuroscientistsDevelopment of new tools; training

opportunities, Neuroscience research initiatives Resources (e.g., animal models, clinical tools,

imaging, neuroinformatics, core facilities, cell/tissue/DNA banks; and gene and protein expression)

http://neuroscienceblueprint.nih.gov/

How an Application becomes a Grant How an Application becomes a Grant – or at least tries– or at least tries

25,000 applications arrive at NIH Central:“Receipt and Referral”Which Institute(s) support this area of research – should it get a top score?

Which study section has the most appropriate expertise?

You can attach a cover letter to suggest appropriate Institute(s) and/or study section assignments

Although R01 applications are generally reviewed in the centralized “Center for Scientific Review” (CSR), study sections within Institutes generally review:

RFAs and other one-time solicitationsTraining & career-development

applicationsR03s & other specialized support

mechanisms

Institute study sections function similar to the peer-review panels of CSR

Also Institute Peer-reviewAlso Institute Peer-review

Study section has about two dozen reviewers, plus ad hoc expertise as needed

Scientific Review Officer (SRO):Checks applications for

administrative issuesMakes reviewer assignmentsAvoids conflicts of interest

(positive/negative)

Typical workload for a study section: 50-80 applications per round

Application gets assigned to a Application gets assigned to a Study SectionStudy Section

Each application assigned to three reviewers:Sometimes, additional outside opinions

soughtPrior to the meeting, assigned reviewers prepare detailed written critiques focusing on strengths and weaknesses for each of the five NIH review criterion:

Significance, Investigator(s), Innovation, Approach, and Environment Note: review criteria re-oriented to shift emphasis from methodological details to potential scientific impact

Assigned reviewers score applications on each of the five review criteria, using new NIH scale 1-9 (whole numbers only). Old NIH scale was 1-5

Prior to the Review MeetingPrior to the Review Meeting

NIH Review CriteriaNIH Review CriteriaIndividual criterion scores in each domains:Significance: important problem? Effect on the field?Investigator: Appropriately trained? Appropriate

experience? Innovation: Potential to shift thinking? Novel concepts,

approaches or methods? Aims original and innovative? Refinement, improvement or new application of approaches?

Approach: Conceptual framework, design, methods, and analyses? Discussed potential problems and alternative strategies? Benchmarks for success?

Environment: Adequate scientific environment(s)? Adequate institutional support? Unique features, subject populations?

Also: Protection of human subjects; Inclusion of women, minorities, and children; vertebrate animal research;

Renewal or revision?

Applications are reviewed in rank order through the upper half; remaining applications are not discussed*

*Do not receive a formal impact/priority score, but get benefit of full written critiques and the five criterion scores

Also, applications from new investigators clustered together

Discussion of applications (~15-20’ each): 3 assigned reviewers highlight strengths and weaknesses Rest of committee joins in discussionEach member votes overall impact: 1 (exceptional) – 9 (poor)Impact scores averaged and multiplied by 10 (thus 10 - 90)

To normalize scoring across study sections, impact/priority scores translated to percentile ranking

At the Review MeetingAt the Review Meeting

Applications get a second level of review from Institute Councils, but are rarely discussed individually

Each NIH Institute has limited amount of funds to support investigator-initiated research applications: Generally fund by percentile ranking, occasionally making minor adjustments right around funding line

Outcomes: Award notice !!!! Revise ?!? Back to the drawing board

Talk to your Program official!

Now only one amended application will be allowed

Meanwhile, back at the Institutes . . .Meanwhile, back at the Institutes . . .

Useful NIH WebsitesUseful NIH WebsitesNIH Home page: www.nih.gov

CRISP (searchable database of all NIH-funded grants): www.commons.cit.nih.gov/crisp/[search by topic or by institution/locale]

Center for Scientific review (study section descriptions and rosters): www.csr.nih.gov

BECON (NIH Bioengineering Consortium):www.becon.nih.gov/becon.htm

You are encouraged to contact NIH staff

• Locate possible “program officials” through Institute websites

• As an introduction, email your abstract and “specific aims” pages

• Discuss potential grant mechanisms, funding initiatives, study section assignments

• Later, program official can help interpret your summary statement

• But funding decisions are largely driven by the priority score you get from study section

Program OfficialProgram OfficialPrimary point of contact prior to submission

and again after summary statement is released

As introduction, email “specific aims” page

Discuss potential grant mechanisms, funding initiatives, and study section assignments

Later, can help interpret summary statement

But funding decisions are largely driven by the priority score you get from peer review

If funded, Program staff administers the grant (e.g., progress reports, subsequent adjustments)

Scientific Review OfficerScientific Review OfficerAssociated with a particular study section –

(usually located in the Center for Scientific Review)

But also SROs within NIH Institutes, to review training, career development, pilot grants, and most RFAs

SRO is the primary point of contact once the application has been submitted to the NIH and up to the release of the summary statement

SRO oversees the review process: recruits and assigns reviewers; checks for completeness of application, necessary certifications, conflicts of interest

Monitors the actual review meeting and later prepares the summary statement