Grants 101: NIH Structure

Thomas HawnJuly 28, 2011

Fellows Survival Course

OutlineJuly 28I. NIH Structure

1. NIH Hx & Funding Trends2. NIH Nuts & Bolts3. Grant Mechanisms

July 29II. Writing a Grant

Sheila LukehartIII. Behind the Scenes at Study Section

Bill Parks

National Institutes of HealthUS Department of Health and Human Services

Director of NIHFrancis Collins, MD PhD

Kathleen Sabelius - H&HS

The Boss

Responses toYellow Fever

1879 • Yellow fever destroyed the Mississippi Valley• A $30,000 bid (RFA) from the US Army for

Universities• 1st peer-reviewed applications for research.

NIH History

Adapted from slide From Toni Scarpa, head NIH CSR

1887 • Marine Hospital Service established, NIH roots started• Director Joseph Kinyoun

1930 • NIH officially named

The Fundamental Tenets for NIH (1946)

1. The only possible source for adequate support of our medical research is the taxing power of the federal government.

2. The federal government and politicians must assure complete freedom for individual scientists in developing and conducting their research work.

3. Reviews should be conducted by outside experts essentially without compensation.

4. Program management and review functions should be separated.

Surgeon General Thomas Parran, Jr.

Slide From Toni Scarpa, head NIH CSR

NIH Funding Stats

Getting the Facts

`

Department of Health and Human ServicesTotal = $592 Billion Total =

$52.6 Billion

FDA 3%

Other 24 %

Discretionary Programs 9%

Medicare

58%

Medicaid

33%

HRSA11% CDC

8%

NIH54%

The Bulk (~85%) of the NIH Budget Supports Extramural Research & Training

IntramuralResearch

9.7%

R&D Contracts9.6%

Research Centers9.9%

Other Research(Including K Awards)

5.9%

All Other 5.5%

Research Mgmt. &Support 3.9%

Training 2.7%

Research Project Grants 52.9%

*~4% of DOD budget

FY 2011 NIH Budget -- $30.7 Billion

SpendingOutside NIH

$24.1 B

Spendingat NIH$4.5 B

2007 data

2003: $27.1 billion2004: $28.0 billion (+3.1%)2005: $28.6 billion (+2.2%)2006: $28.6 billion (-0.2%)2007: $29.2 billion (+2.1%)2008: $29.2 billion (0%)2009: $30.4 billion (+4.1%) 2010: $30.8 billion (+1.4%)2011: $30.7 billion (-0.3%)

NIH Grew with Clinton and Fell with Bush

Change in NIH Appropriations, FY 1995 - 2007

0

5

10

15

20

25

30

1995Pre-Doubling

1996 1997 1998Period ofDoubling

1999 2000 2001 2002 2003 2004Post

Doubling

2005 2006 2007*

Fiscal Year

AppropriationsBillions $

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

PercentChange

$30

$25

$20

$15

$10

$5

$0 1977197819791980198119821983198419851986198719881989199019911992199319941995199619971998199920002001200220032004200520062007

Current Dollars

Constant Dollars

Growth Wasn’t That Great Anyway

Billions

More Applications + Flat Budget = Reduced Paylines

Top Recipients of Taxpayers Largesse 2007

• 2816 institutions/companies/organizations ranked

Source of Research Funds at UW~2/3 of Research Funds at UW Are Federal

• Gold standard of extramural funding

• Essential for advancement and promotion• Your salary support

• Most important:

• Indirect Costs: $1 = $0.54

Source of Research Funds at UWDHHS is the predominant UW source of Federal Money

Scenario—Who to Ask

You are ready to apply for a grant and have many questions. Where do you get information?1. Grants Management Specialist2. Study Section Chairperson3. NIH SRO/SRA4. NIH PO

Solicit Advice Broadly …

MentorFellowsPost-docsColleaguesNIH

The SRO and the Program Officer Scientific Review Officer (SRO)

– 240 SROs in CSR– Legal Responsibility for Study Section Mtg– Selection of Study Section Members– Assignment of Applications– Follow the law, the rules and the regulations– Assisted by Grants Management Specialist

Program Officer– Role before and after review– Key “translator” of summary statements for

investigator– Responsible for programmatic, scientific,

and/or technical aspects of a grant.

NIH Structure

Office of the Director

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis and

Musculoskeletaland Skin Diseases

National CancerInstitute

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacial

Research

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

Center for InformationTechnology

Center for Scientific Review

National Centerfor Complementary

and AlternativeMedicine

National Instituteof Allergy and

Infectious Diseases

FogartyInternational

Center

National Centerfor ResearchResources

Clinical Center

National Institute of Biomedical Imaging and Bioengineering

National Center on Minority Health and Health Disparities

NIH Instituteshttp://www.nih.gov/icd/

No funding authority

Dual Review System for Grant Applications

Second Level of Review NIH Institute/Center Council

First Level of Review= CSR Scientific Review Group (SRG)

The Basic Operating Principles of NIH Peer Review

NIH has ownership of the review process The Scientific Review Officer, a federal employee,

nominates the review panel, assigns applications and is responsible for the meeting

The study section has ownership of the science review

Is composed of the best and most experienced scientists in the field.

~ 20 permanent members, serving 4 years 3 times/year; 10 ad hoc

Hundreds of study sections reviewing different fieldsOwnership of application: - CSR from receipt to posting of Critiques - IC after Critique posting

•Grant: Investigator decides the research to be designed or developed and the approach •~ 84-88% of extramural grants

•Contract: Government decides the research to fill their perceived need and establishes detailed requirements •~ 8-10%

•Cooperative Agreement: Similar to grants, but awarding Institute/Center (IC) and recipient have substantial involvement in carrying out the project’s activities•~ 4-6%

3 Funding Instruments for Extramural Research

Major Grant Activities NIH Uses to Fund Extramural Research

•Grants•Small Research Grant (R03)•Exploratory/Developmental Research Grant (R21/R33)•Traditional Research Project Grant (R01)•Program Project Grant (P01)•Scientific Meeting Support (R13)•Small Business Innovation Research Grant (SBIR: R43/R44)•Small Business Technology Transfer Grant (STTR: R41/R42)

•Grants or Cooperative Agreements•Research Center Grant (P50/P60)

•Contracts

•Investigator-Initiated Research •Unsolicited, from general institute extramural budget•R01, R21, R03•~ 80% of awards

•Request for Applications (RFA)•Solicited; set-aside of funds for a certain number of awards•One-time competition to stimulate research in a priority area•R01, R21, R03, P01, Cooperative Agreement•~ 10% of awards

•Requests for Proposals (RFP) (contracts)•Solicited, with set-aside of funds for a certain number of awards•One-time competition

Mechanisms for NIH to Get Research Proposals

•Program Announcement and Special Review (PAR)

• Solicited, but no set-aside of funds• Reviewed by special emphasis panel

•Program Announcement (PA) • Solicited, but no set-aside of funds• Reviewed by standing study section

Mechanisms for NIH to Get Research Proposals

New Investigator

•A Principal Investigator (PI) who has not yet competed successfully for a substantial, competing NIH research grant (R01 or ‘higher’) is considered a New Investigator• http://grants1.nih.gov/grants/new_investigators/resources.htm

Early Stage Investigator (ESI) An individual who is classified as a New

Investigator and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent)

Extension of ESI Eligibility The 10-year period may be extended to

accommodate special circumstances (e.g. medical concerns, disability, pressing family care responsibilities, or active military duty service)

What Affects NI Status? • PI of an R03 or R21? No

• PI of an NIH contract? No • PI of a grant with another Federal agency? No • PI of an SBIR/STTR? No • PI of a U01, specifically for a foreign investigator?

Receipt of U01 removes NI status. • Inheriting an R01 from a PI who moved away or

died? No

Scenario I

You have just finished your 1st year of fellowship. What grant series should you apply for?1. T 2. F 3. K 4. R, U, or P?

Scenario—What to Apply For

NIH Award Mechanisms

31

Predoctoral Individual NRSA (F31)Predoctoral Individual MD/PhD NRSA

(F30)

Postdoctoral Institutional Training Grant (T32)Postdoctoral Individual NRSA (F32)

Small Grant (R03)

Research Project Grant (R01)

Independent Scientist Award (K02)

Senior Scientist Award (K05)

Stage of ResearchTraining / Career Awards

GRADUATE/MEDICALSTUDENT

POSTDOCTORAL

EARLY

MIDDLE

SENIOR

CA

REE

R

Predoctoral Institutional Training Grant (T32)

NIH Pathway to Independence (PI) Award (K99/R00)Mentored Research Scientist Development Award (K01)Mentored Clinical Scientist Development Award (K08)Mentored Patient-Oriented RCDA (K23)Mentored Quantitative RCDA (K25)

Midcareer Investigator Award in Patient-Oriented Research (K24) Exploratory/Develop-

ment Grant (R21)

Training and Career Timetable

Pre-Bac Pre-Bac Institutional Training Grant (T34)

32

Training Grant Awards—Clinical Track

33

Training Grant Awards—PhD Track

34

T & F Grants• Institutional Awards: T32

– Institution, not the individual, applies for the award– Not available at all schools, departments, divisions

• Individual Awards: F32– Mentored– Independent—can interact with other NIH Awards– Depending on the award, all doctorates or

restricted to clinical doctorates– NIH support varies by Institute

TOTAL YEARS of F and T NIH Grant Support=3 YEARS

F32 NRSA Success Rates

36

‘Career’ Awards = ‘K’ Awards

• Individual Awards:– Mentored– Independent—can interact with other NIH Awards– Depending on the award, all doctorates or restricted to clinical

doctorates

• Institutional Awards:– Institution, not the individual, applies for the award– Curriculum/Program Development

Purpose: To provide protected time for individuals to further develop their research expertise.

37

Mentored K Awards• K01: Mentored Research Scientist Development Award• K08: Mentored Clinical Scientist Development Award• K22: Research Career Award for Transition to Independence• K23: Mentored Patient-Oriented Research Development

Award• K25: Mentored Quantitative Research Development Award• K99/R00: NIH Pathway to Independence (PI) Award

• K12/KL2Institutional Mentored Research Scientist Development Program

38

K Career Awards—Clinical Track

39

K08: For Health Professional Doctorate

• Supervised research experience for individuals with health professional degree who are committed to a career in laboratory research

• Phased award period• didactic experience• “hands-on” research experience

• For individuals intending a career in basic or translational research

40

K23: For Health Professional Degree

• Supervised research for clinically trained professionals with a commitment to focus on patient-oriented research (POR)

• POR is defined as research in which the investigator directly interacts with human subjects

• Must have completed clinical training, including specialty/sub-specialty, if applicable, prior to award

41

K Career Awards—PhD Track

42

K01: For Research Doctorate

• Provides an intensive, mentored research experience

• Candidates normally must have a research doctorate and postdoctoral experience

• Not an extension of postdoctoral training• Varied and limited NIH IC participation

– Used for re-entry– Used for pursuit of new research area

43

K22: For Research or Health Professional Doctorate

• Assists transition to independence• May be activated after identifying a suitable

position at a research institution• Might include mentored and independent

phases• May support an NIH intramural and an

extramural phase

44

K99/R00: For Health Professional or Research Doctorates with Research Experience at the

Postdoctoral Level

• K99: Mentored research experience for up to 2 years• R00: Transition to research independence as junior

faculty for up to 3 years• Applicants: no more than 5 years of postdoctoral

research training at the time of initial application or resubmission

• Non-U.S. citizens may apply, but institution must be domestic

• Transition to R00 phase requires offer and acceptance of tenure-track, full-time assistant professor position (or equivalent)

45

UW Institutional K Awards

K12Jan Abkowtiz, HematologyWilliam Bremner, Male Reprod Health ResDavid Eschenbach, Women’s Reprod Health Res

KL2Nora Disis, ITHS

46

K12: For Institutions

• K12: Institutional Mentored Research Scientist Development Program – Enhance research career development for

individuals, selected by the institution, who are training for careers in specified research areas

– Provides institutions with the capacity for mentoring junior investigators through a programmatic approach

UW’s MRHR/WRHR Programs• Institutional Career Development Award in Men’s

and Women’s Reproductive Health Research• Open to MDs after completion of fellowship or

residency in (Ob/Gyn, Medicine, Pediatrics or Urology)

• 4-5 years of salary support (75% time), up to $100,000 yearly, with $25,000/yr. research funds

• 5-6 Scholars in both programs (~1 new/year)• Contact:

– MRHR, John Amory jamory@uw.edu – WRHR: Susan Reed reeds@uw.edu

UW’s KL2 Program• Institutional Career Development Award in

Clinical/Translational Research • Open to any MD/PhD after completion of fellowship or

post-doc in clinical field• 4-5 years of salary support (75% time), up to $85,000

yearly, with $25,000/yr. research funds• 5-6 Scholars chosen yearly by December (28-24 total

scholars). Applications due in fall.• Weekly research seminars and “works-in-progress”

sessions• Details at http://old.iths.org/education/kl2

49

Research Career Development AwardsNumber of entry-level awards

Other Grant Sources To ConsiderNIH Loan Repayment Program• Ideal for individuals with clinical doctorate degrees working in specified areas of biomedical science, predominantly

patient-oriented research

• Examples of Sources of Non-Federal GrantsAmerican Hearth AssociationInfectious Diseases Society of AmericaCystic Fibrosis FoundationParker B Francis Foundation

If All Else Fails ….

Website References

NIHGrants Page: http://grants.nih.gov/grants/oer.htm

NRSA (T+F Grants): http://grants.nih.gov/training/nrsa.htm

K Career Development Awards:http://grants.nih.gov/training/careerdevelopmentawards.htm