Grants 101: NIH Structure
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Transcript of Grants 101: NIH Structure
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
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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)
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Training Grant Awards—Clinical Track
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Training Grant Awards—PhD Track
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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
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‘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.
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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
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K Career Awards—Clinical Track
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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
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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
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K Career Awards—PhD Track
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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
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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
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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)
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UW Institutional K Awards
K12Jan Abkowtiz, HematologyWilliam Bremner, Male Reprod Health ResDavid Eschenbach, Women’s Reprod Health Res
KL2Nora Disis, ITHS
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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 [email protected] – WRHR: Susan Reed [email protected]
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
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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