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An Overview of NIH: Supporting Public Health Through Research Terry S. Yoo Office of High Performance Computing and Communications National Library of Medicine National Institutes of Health U.S. Department of Health and Human Services United


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An Overview of NIH: Supporting Public Health Through Research Terry S. Yoo

Office of High Performance Computing and Communications National Library of Medicine National Institutes of Health U.S. Department of Health and Human Services United States of America, North American Continent, Earth

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Chance favors the prepared mind.

  • Louis Pasteur

Luck is when preparation meets

  • pportunity.
  • Roy Williams
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Acknowledgements: NSF: Debbie Crawford CRA: Jay Vegso Phil Bernstein Lori Clarke Slides: Helen Fraser Lee Rosen

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The Government is a very big place. NIH is a pretty big place. Give a basic introduction to the National Institutes of Health. Give a basic introduction to the NIH funding picture and some basic differences from NSF

DARPA: $3.085 Billion NSF: $5.901 Billion NASA: $17.3 Billion DOE: $24.26 Billion NIH: $28.7 Billion

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SLIDE 5

An experiment:

1. Raise your hand. 2. If I get to a term you don’t know, please lower your hand. Grant RFP (Request for Proposals) Research Contract Cooperative Agreement PAR (Program Announcement) BAA (Broad Agency Announcement) SBIR STTR R01 P41 CRADA P01, R03, R21, R33, U01, U54, T32, T15, K13, …

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SLIDE 6

Which way is up?

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NIH Mission Improve human health through biomedical and behavioral research, research training and communications.

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A mistaken view…

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NIH is 27 separately funded Institutes and Centers…

Bethesda, MD:

NIH Campus

Rockville, Poolesville, MD

NCI, NINDS, NIBIB, NIMH, NCRR

Baltimore, MD

Bayview Campus: NIDA, NIA

Frederick, MD

Frederick Cancer Research Center

Research Triangle Park, NC

NIEHS

Hamilton, MT

Rocky Mountain Laboratory

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National Institutes of Health

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SLIDE 11

Another view… Check out:

http://www.thebudgetgraph.com

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A Little more reality?

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QuickTime™ and a TIFF (Uncompressed) decompressor are needed to see this picture.

A zero sum game?

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Mission of the NIH

Promoting the nation’s health through research.

1. Intramural research (NIH labs) - 10% of the budget, 6,000 scientists 2. Extramural research (grants) - 80-90% of the budget

Not a monolithic Agency - 28 Institutes and Centers

NCI NIAID NHLBI NIDDK NINDS NIMH NIGMS NCRR NHGRI NLM NIBIB CC CIT CSR NICHD NIA NIDA NEI NIEHS NIAMS NIAAA NIDCD NIDCR NCMHD NCCAM NINR $4.7B $4.3B $2.9B $1.8B $1.5B $1.3 $1.9B $1.0B $0.4B $0.3B $0.2B $1.2B $1.0B $0.9B $0.6B $0.6B $0.5B $0.4B $0.3B $0.3B $0.1B $0.1B $0.1B FIC OD

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NIH COMPETING RPG* APPLICATIONS: TRENDS IN NUMBER, AWARDS AND SUCCESS RATES: FY 1998-2007

5 10 15 20 25 30 35 40 45 50 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Number of Applications and Awards (in thousands) Fiscal Year

0% 5% 10% 15% 20% 25% 30% 35% 40%

Success Rate

Number Reviewed Number Awarded Success Rate

*RPG activity code in R00, R01, R03, R15, R21, R22, R23, R29, R33, R34, R35, R36, R37, R55, R56, RL1, RL5, RL9, P01, P42, PN1, UC1, UC7, U01, U19, U34, DP1, DP2, RL1, RL2, RL5, RL9. Also includes RPG’s from NLM as of FY07.

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School or Other Research Center (Applicant)

Principal Investigator Initiates Research Idea

Conducts Research

Submits application

Allocates Funds $$

Center for Scientific Review Scientific Review Group

Institute

Advisory Council or Board Institute Director Assign to IC and IRG Review for Scientific Merit Evaluate for Relevance Recommends Action

Takes final action for NIH Director

Research Grant Application (PI) National Institutes of Health

REVIEW PROCESS FOR NIH RESEARCH GRANTS

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Some basic notes across Feds: 1. Grants - Proposals

– Panel has less time to think through your idea than you do. – Proposal writing as story telling – Volunteer

2. Budgets - rising in science and technology

– DOE is optimistic – NSF is optimistic – NIH is cautious – Funding is a zero sum game (10%?)

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CSR Study Sections

  • 1. Each CSR standing study

section has 12-24 members who are primarily from academia

  • 2. CSR standing study

sections convene face-to- face meetings

  • 3. As many as 60-100

applications are reviewed by each study section

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Perceived Study Section

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CSR Standing Study Sections

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CSR Standing Study Section Rosters

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CSR: Mail room , circa 2000

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Applications Submitted to NIH

1. Approximately 80,000 grant applications were submitted to NIH in FY2003, of which 25- 30% are funded 2. Competing grant applications are received for three review cycles per year 3. Applications are now sent online: grants.gov

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NIH COMPETING R01-EQUIVALENT* APPLICATIONS: TRENDS IN NUMBER, AWARDS AND SUCCESS RATES: FY 1998-2007

5 10 15 20 25 30 35 40 45 50 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Fiscal year

0% 5% 10% 15% 20% 25% 30% 35% 40% Reviewed Awarded Success Rate

* R01-Equivalent Grants include R01, R23, R29, and R37 mechanisms

Success Rate

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Regarding NIH…

If it was up to the NIH to cure polio through a centrally directed program instead of an independent investigator driven discovery, you'd have the best iron lung in the world, but not a polio vaccine. Samuel Broder

Former Director of the National Cancer Institute

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Types of NIH Grants

  • Mentored Quantitative Research Career Development Award

(K25)

  • NIH Research Project Grant (Investigator Initiated) (R01)
  • NIH Small Business Innovation Research (SBIR)
  • NIH Small Business Technology Transfer (STTR) Programs
  • NIH Small Grant Program (R03)
  • NIH Support for Conferences and Scientific Meetings (R13

and U13)

  • NIH Project Grants (P01)
  • NIH Biotechnology Resource Grant (Biotechnology Resource

Center) (P41)

  • NIH Cooperative Agreements (U01 and U54)
  • NIH Academic Research Enhancement Award (AREA) Grants -

(R15)

  • NIH Exploratory/Developmental Research Grant Award (R21)
  • NIH Clinical Trial Planning Grant (R34) Program
  • NRSA Institutional Research Training Grants (T32)
  • NRSA Short-Term Institutional Research Training Grants

(T35)

  • NRSA Predoctoral Fellowship Minority Students (F31)
  • NRSA Predoctoral Fellowship Students w/Disabilities (F31)
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Peer Review of NIH Support Mechanisms

CSR CSR Institutes Institutes

Research Project Grant (R01) Program Project Grant (P01) Postdoctoral Fellowship (F32) Center Grant (P30, P50, P60) Senior Fellowship (F32) Institutional Fellowship (T32) Fogarty International Center Academic Career Award (K07) Fellowship (F05, F06) Mentored Clinical Scientist Short-Term Training (T35) Development Award (K08) Small Business Grants (R41, R42 Conference Grant (R13)* R43, R44) Marc Fellowships (F34, F36, T34) Academic Research Enhancement Minority Biomedical Support Award (R15) Grant (S06) Biomedical Research Support Resource Grant (P40, P41, R24, Shared Instrumentation R26, R28) Grant (S10) RFA - Request for Applications R&D - Contracts

Who Reviews What ?

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STANDARD RECEIPT DATES AND REVIEW AND AWARD CYCLES

TYPES OF APPLICATIONS CYCLE I CYCLE II CYCLE III

Application Receipt Dates * All (new, competing, revised, and supplemental) Program Project and Center Grants February 1 June 1 October 1 Competing Continuation, Supplemental, and Revised Grants March 1 July 1 November 1 Individual NRSA (Standard) *** April 5 August 5 December 5 Review and Award Schedule Scientific Merit Review June-July October-November February-March Advisory Council Review September-October January-February May-June Earliest Project Start Date December April July

Deadlines

http://grants1.nih.gov/grants/funding/submissionschedule.htm

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Overall Timeframe from Submission to Award There are three overlapping cycles per year :

JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL

Review Council

Cycle 1

Receipt Referral Award Review Council

Cycle 3

Receipt Referral Award Review Council

Cycle 2

Receipt Award Referral

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Individual Serial Amended Research Number Grant

1 R01 CA 123456 01 A1

New National Grant Application Cancer Support Institute Year

Sample Application Number

You get a letter with your grant number, Institute, Study Section

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Summary statements & priority score

  • What does that score mean?

1. Program Officer can help interpret 2. Funding based on percentile 3. Also based on mission, etc

  • Summary statements

1. Parts will sound familiar (copied from application) 2. Summarizes problems and weaknesses in grant 3. Presents reviews written before study section mtg

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SLIDE 32

Center for Scientific Review Scientific Review Group

Institute

Advisory Council or Board Assign to IC and IRG Review for Scientific Merit Evaluate for Relevance Recommends Action National Institutes of Health

Institute Council makes funding decision Score Relevance Mission concerns Program Officer often in room, but non-voting

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If you win: you get an award letter 1. Start date might be flexible

– At times sooner is better for the Institute

2. If you don’t win: you get a sad letter

– Revise or start over? – Introduction is key (3 pg summary of revision)

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So who are the people who help you through this process at the NIH?

–Program Officer –SRA

Your number one goal must be to become a face or name, rather than a proposal number!

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How do you decide where to send your grant?

1. Many institutes to choose from

Which one is right? Look at mission statements of likely institutes Does your research fit?

2. Is there a PA or RFA on your research area?

How to find out about these? 1. Use the NIH website to search them 2. http://grants.nih.gov/grants/funding/funding_program.htm 3. http://www.bisti.nih.gov/bistic_funding.cfm

3. Speak with Program Officers

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There’s no PA or RFA for my topic 1. OK if no RFA (“Investigator Initiated”) 2. Which institute(s) is right?

1. Mission statements 2. How to narrow them down?

  • Look at portfolio for those institutes

3. Perhaps it is better not to narrow them down

  • Paylines and priorities differ

3. Speak with Program Officers

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Ask ADVICE from the Program Officer 1. Tell him/her about your research goals

– What type of grant are you going for?

2. Ask:

– Is this the right institute? – Should I have a dual funding assignment? – What study section would be good for my grant? – Any comments on the science?

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Investigate study section 1. Make sure that someone on that panel knows your field and the techniques you will be using 2. If no one is available on panel

Once you get your SRA and study section assignment, write a letter asking for someone in a particular field or area of expertise to be added to the study section

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CSR personnel decide Institute & study section

1. From your cover letter, keywords and abstract

(remember your abstract will go on CRISP once you are funded…so be discreet about prelim results and details)

2. Your cover letter can have a big impact

– Present rationale for a particular request – Suggest, don’t demand – Whenever plausible request double assignment (allows two different Councils to consider your grant application)

3. Program Officer assigned in Institute

– May have been defined in RFA or RFP – Often helps to send a copy of the proposal in parallel to PO (they can then request assignment) – Best if there has been contact with PO before submission

4. SRA goes with the Panel

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Talk to the Program Officer

  • PO can tell you if you are way below the funding

line

  • Way above the funding line
  • Or close to the edge (is it worth a letter to Council?)

Most Important things PO can tell you

1. Translate the score 2. Was there anything not in the summary statement that happened during review? (PO’s are often in the room when IRG review happened - can listen but not comment) 3. If something else was pointed out and you need to revise--this is critical to know before submitting

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Council meeting 1. What happens?

Giant binders with reviews, correspondence

2. How are new PIs helped?

1. On your PHS398, check the box for new investigators You are new until you get your first RO1, smaller grant don’t count 2. If you have a good relationship with Program officer and he/she needs your app to fill in a gap in his portfolio You might get rescued from the no fund pile and put in for funding even with a worse score than others

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What not to do? 1. Never Demand 2. Never ask for snap decision (ask advice) 3. Never contact IRG members! 4. Never assume that the IRG member you don’t like did you in in the meeting. 5. Never ignore comments, even from “stupid” reviewers

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School or Other Research Center (Applicant)

Principal Investigator Initiates Research Idea

Conducts Research

Submits application

Allocates Funds $$

Center for Scientific Review Scientific Review Group

Institute

Advisory Council or Board Institute Director Assign to IC and IRG Review for Scientific Merit Evaluate for Relevance Recommends Action

Takes final action for NIH Director

Research Grant Application (PI) National Institutes of Health

REVIEW PROCESS FOR NIH RESEARCH GRANTS

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National Institutes of Health

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SLIDE 45

The best way to predict the future is to invent it.

  • Alan Kay

http://www.nlm.nih.gov