The NIH: an overview and introduction for foreign researchers

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The NIH an overview and introduction for foreign
researchers
Jennifer Harris, PhD Department of Genes and
Environment Division of Epidmiology The Norwegian
Institute of Public Health
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Overview

• Introduction to the NIH
• NIH Grants
• NIH funding opportunities for foreign researchers
• Paths to a research grant and the NIH funding
  process

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What is the NIH?
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U.S. Department of Health and Human
Services Agencies of the U.S. Public Health
Service
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National Institutes of Health

• US federal government agency
• Mission
• Expand scientific knowledge
• Improve public health
• Founded in 1887 as Laboratory of Hygiene
• gt18000 employees (mostly in Maryland)

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National Institutes of Health

• Primary agency for supporting conducting
  biomedical and behavioral research
• Grants
• Contracts
• Intramural
• 20 Institutes and 7 Centers (IC)
• Each institute has a defined research focus
• 24 of the ICs issue grants

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NATIONAL INSTITUTES OF HEALTH
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The National Institutes of Health
NIAID
NIDDK
NIA
NINDS
NHLBI
NCI
NIGMS
NIMH
NICHD
NIA
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National Institutes of Health

• Support for US and international scientists
• Annually gt 28 billion in medical research
• 83 awarded through 50,000 competitive grants
• gt 325,000 researchers
• gt 3,000 universities, medical schools, research
  institutions in every state and around the world.
  
• 10 of NIH budget supports projects by 6,000
  scientists in NIH (intramural research)

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A TYPICAL INSTITUTE
SCIENTIFIC PROGRAMS
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NIH Centers for

• Information Technology (CIT)
• Scientific Review (CSR)
• Fogarty International Center (FIC)
• Complementary and Alternative Medicine (NCCAM)
• Minority Health and Health Disparities (NCMHD)
• Research Resources (NCRR)
• Warren Magnuson Clinical Center (CC)

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Offices of the Director

• 20 Offices under the NIH director
• Responsible for
• stimulating specific areas of research throughout
  NIH
• planning and supporting research and related
  activities
• program offices fund research through the
  institutes.
• Current program areas are
• minority health,
• women's health,
• AIDS research,
• disease prevention,
• behavioral and social sciences research
• Examples of planning and supporting
• Office of Technology Transfer
• Office of Community Laison

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• NIH Grant Programs

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Overview of Grant Types

• Activity codes (e.g. R01, R03, K99 etc.)
  differentiate between research-related programs
• Research grants (R series)
• Career development awards (K Series)
• Training and fellowships (T F)
• Program project center grants (P Series)
• Resource Grants (various series)
• Trans NIH Programs

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What about foreign applications? foreign
applicants?
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Extramural and Intramural Possibilities

• Extramural
• Applying for research funding
• Various types of grants can be applied for
• Intramural (no extramural grant awarded)
• Visiting programs for training and research
• Intramural training opportunities

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Extramural
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Foreign Awards-I

• Foreign institutions eligible to apply for most
  research project grants
• Typically US citizenship not required
• Typically US affiliation not required
• Exceptions-foreign applications not permitted
  for
• Small business awards (need US citizenship)
• Fellowships
• Most career development awards
• Training awards (need US citizenship or permanent
  resident)

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Foreign Awards-II

• Important to demonstrate
• Special opportunities for furthering research
• Unusual talent
• Unique resources
• Populations
• Unique environmental conditions
• Will augment exisitng US resources

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Foreign Awards-III

• Successful approach partner with a US researcher
• Foreign institutions are often eligible to apply
  for grants that include consortia or subcontracts
  with U.S. institutions
• U.S. institutions may apply for grants that
  include foreign consortia or subcontracts
• Eligibility criteria are always stated on the FOA
• Fogarty International Center

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R01

• NIH Research Project Grant Program (R01)
• Used to support a discrete, specified,
  circumscribed research project
• NIH's most commonly used grant program
• No specific dollar limit unless specified in FOA
• Advance permission required for 500K or more
  (direct costs) in any year
• Generally awarded for 3 -5 years
• All ICs utilize
• See parent FOA at http//grants.nih.gov//grants/
  guide/pa-files/PA-07-070.html
• Requirements for foreign institutes

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R03

• NIH Small Grant Program (R03)
• Provides limited funding, short period of time
• Variety of projects, including pilot or
  feasibility studies, collection of preliminary
  data, secondary analysis of existing data, small,
  self-contained research projects, development of
  new research technology, etc.
• Limited to two years of funding
• Direct costs generally up to 50,000 per year
• Not renewable
• Utilized by more than half of the NIH ICs
• See parent FOA at http//grants.nih.gov/grants/gui
  de/pa-files/PA-09-163.html

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R21

• NIH Exploratory/Developmental Research Grant
  Award (R21)
• Encourages new, exploratory and developmental
  research
• Support for the early stages of project
  development 
• Sometimes used for pilot and feasibility studies.
  
• Limited to up to two years of funding
• Combined budget for direct costs for the two year
  project period usually may not exceed 275,000.
• No preliminary data is generally required
• Most ICs utilize
• See http//grants.nih.gov/grants/guide/pa-files/PA
  -09-164.html

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New and Early Stage Investigators

• NIH committment to attract new researchers
• Explores ways to encourage transition to
  independence
• New Investigators
• Not competed successfully as PD or PI for a
  significant NIH independent research award
• NIH has history of committment through special
  programs
• Early Stage Investigators (ESI)
• New investigators within 10 years of terminal
  degree
• RO1s flagged and stage of career considered in
  review
• Relevant for foreign applicants

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Paylines Vary by Institute

• NIA currently funding research project grant
  mechanisms to approx 11.6 percentile
• New investigator 16.6 percentile
• ESI 23.1 percentile
• NHLBI to 15.0 percentile
• New investigator 20.0 percentile
• ESI 25.0 percentile

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Pathway to Independence Award (K99-ROO)

• PI award program to increase cohort of new
  independent investigators
• Transition at an earlier stage than norm
• Phase I Early mentored research (1-2 yrs)
• Phase II Independent research support (3 yrs)
• Ineligibile if gt than 5 years post-doc
  experience
• 150-200 awards per year
• Open to US and non-US citizens
• Only K-mechanism for foreign applicants
• Foreign institutes NOT eligible

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Eligible individuals include

• NIH intramural postdoctoral fellows
• Foreign citizens who are eligible to work in USA
  country
• Individuals who are in postdoctoral type (i.e.,
  limited term) positions and have fewer than five
  years of postdoctoral research experience

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Intramural
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Foreign Researchers Planning to Conduct Research
at NIH

• The NIH Division of International Services
• Visiting program (training/research)
• gt 2000 foreign scientists annually
• Open to scientists at all career levels
• Visiting Fellows training (usually 2 yrs)
• Visiting Scientists research (renewable to 5
  yrs)
• Letter of request to NIH scientist w/materials
• Letter of invitation needed

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Intramural Training Opportunities

• Variety of NIH Postdoctoral Research Training
  Opportunities
• Many open to any nationality
• http//www.training.nih.gov/
• National Research Council (NRC) Research
  Associateship Program
• For outstanding investigators of any nationality
  who have held their doctoral degree for less than
  five years
• Postdoctoral Visiting Fellowship (VF)
• For foreign national doctoral-level scientists
  within five years of obtaining their doctoral
  degree
• International Research Career Transition Programs
• Opportunities for recent doctoral degree
  recipients from participating countries to pursue
  postdoctoral training at the NIH and then return
  to positions as independent investigators in
  their home countries
• Partership Programs
• The NIH has partnerships with several countries
  that allow foreign postdoctoral fellows to train
  at NIH before returning to their home country.

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Foreign students looking for opportunities to
study in the U.S.

• University fellowship programs-check university
  websites
• NIHs Fogarty International Center maintains a
  directory of other organizations that provide
  student fellowships http//www.fic.nih.gov/fund
  ing/directory_fellowships.htm.  

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The Path to a Research Grant and the NIH funding
process
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Management of Applications Grants at NIH
Program
Grants Management
Review
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Paths to a Research Grant

• Investigator Initiated
• Response to a particular Funding Opportunity
  Announcement (FOA)
• Check funding opportunities and notices on the
• NIH GUIDE (grants.gov)
• Different types of FOAs
• Has implications for
• Application dates
• Review
• Eligibility
• Available funds
• Resubmission

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Anatomy of an FOA
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Program Announcement

• Describes existence of an NIH extramural research
  activity
• May describe new or expanded interest in a
  particular extramural program
• May be a reminder of a continuing interest in an
  extramural program
• Usually has no funds set aside

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Request for an Application (RFA)

• Formal announcement describing an Institute
  initiative in a well-defined scientific area
• Invitation to the field to submit research grant
  applications for a one-time competition
• Set aside of funds for a certain number of awards

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Check Eligibility Information

• Section III. Eligibility Information
• 1. Eligible Applicants 1.A. Eligible
  Institutions The following organizations/institu
  tions are eligible to apply
• Public/State Controlled Institutions of Higher
  Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities
  (HBCUs)
• Tribally Controlled Colleges and Universities
  (TCCUs)
• Alaska Native and Native Hawaiian Serving
  Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than
  Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other
  than Institutions of Higher Education)
• Small Businesses
• For-Profit Organizations (Other than Small
  Businesses)
• State Governments
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign
  Organizations)
• Eligible Agencies of the Federal Government
• 1.B. Eligible Individuals

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Preparations

• NIH Interested in
• High scientific caliber
• Investigator initiated research
• Unique research projects
• Contact program staff
• Familiarize with information on the web
• Complete necessary registration
• Read information Office of Extramural Research
  Foreign grants pre-application requirements
• Give your self good amount of time to prepare
  (pre-grant writing stage is critical)

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Before Submitting

• Obtain program information
• Know what type of grant to apply for
• Contact staff
• Send a prospectus
• Discuss with colleagues

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Writing the Application

• Follow instructions
• Be brief, concise, clear
• Be organized and logical
• Show what is new and innovative
• Be complete
• Provide pilot data

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Common Problems

• Lack of new or original ideas
• Diffuse, superficial, or unfocused research plan
• Lack of knowledge of published relevant work
• Lack of experience in the essential methodology
• Uncertainty concerning the future directions
• Questionable reasoning in experimental approach
• Absence of an acceptable scientific rationale
• Unrealistically large amount of work
• Lack of sufficient experimental detail
• Uncritical approach

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How a Research Grant is Made
Investigator Initiates Research Idea
School or other research center
Submits Application
Allocates Funds
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What happens when an application is delivered?
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Application Review Process

• Recepit and referral (checked for completeness
  etc)
• ScientificReview Adminstrator
• Ensures that each appication receives competent
  review
• Assures that proper review criter are used
• Depending on grant review is administered by
• Center for Scientific Review
• Peer review at the IC
• First level review
• Peer review by scientific review group
• Primarily non-federal scientists, experts in area
• Second level Review
• Grant funding plan proposed
• National advisory council advises the IC director
• IC Director makes final funding decision

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Reviewers

• Receive copies 6 weeks prior to the peer review
  meeting
• Prepare written critique of application
• based on review criteria and judgment of merit
• Make recommendations concerning the scientific
  and technical merit
• written comments and numerical scores
• Make recommendations concerning appropriateness
  of budget requests
• Make recommendations concerning protections for
  human subjects inclusion of women, minorities,
  and children in clinical research welfare of
  vertebrate animals and other areas as applicable
  for the application

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Initial Peer Review Meeting

• Most SRGs convene for 1-2 days
• Core criteria
• Significance
• Approach
• Innovation
• Investigators
• Environment
• Assigned reviewers present critiques to group
• Open discussion
• Final scoring (overall impact and core criteria)

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Summary Statement (1-2 months after review)

• Contact information Program Officer
• Impact or priority score (depending on the fiscal
  year)
• Percentile (if applicable)
• Resume summary of the discussion (if not
  streamlined)
• Reviewer critiques individual criterion scores
• Committee recommendations concerning the budget
• Human subject and vertebrate animal concerns (if
  applicable)
• Additional administrative comments (if
  applicable)
• Official meeting roster

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Study Sections Do Not Fund

• Institutes fund!
• Study Sections judge applications scientific and
  technical merit
• Institutes take these evaluations very seriously
• Scores translated into percentiles and fractiles
• able to
• Rank within set of scores assigned by review
  board
• Rank among all scores assigned by all all review
  boards
• Second level Review
• Grant funding plan proposed
• National advisory council advises the IC director
• IC Director makes final funding decision
• Institutes also consider relevance of application
  to the Institutes research priorities

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After the review...

• Summary sheets made available online
• Discuss with colleagues
• Revise and resubmit?
• Most funded applications are resubmissions

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• Difficult to obtain funding
• Even more difficult if you do not apply!!

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NIH-Funded Norwegian Research Grants

• Institutes involved
• NCI (7,7,5)
• NHGRI (1,1,1)
• NHLBI (1,1,0)
• NIA (1,1,5)
• NIAID (1,1,2)
• NIBIB (2,2,0)
• NICHD (2,2,2)
• NIDA (1,1,0)
• NIDCR (1,1,5)
• NIDDK (1,1,4)
• NIEHS (2,2,1)
• NIMH (2,2,1)
• NINDS (2,2,1)
• NICCAM (0,0,1)
• NIGMS (0,0,4)

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Some Useful Websites

• WWW.NIH.GOV
• NIH homepage directories information gateway
  to parts of NIH
• WWW.GRANTS.NIH.GOV
• Office of extramural research with application
  info
• http//grants.nih.gov/grants/foreign/index.htm
• Foreign grants information
• WWW.GRANTS.GOV
• Grant opportunities
• http//www.nih.gov/Training.htm
• Training at the NIH

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Thank you!