Judith Podskalny, Ph'D'

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Overview of the National Institutes of Health

• Judith Podskalny, Ph.D.
• NIDDK, NIH

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Why do this?

• Get you up to speed
• NIH- 101 based on first meeting of NMRI
• 2 day meeting (now condensed into 1 hour)

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Topics from 1st meeting

• Overview of NIH
• Roles of different NIH staff (program, review,
  grants management)
• Funding mechanisms
• Grant-writing
• Budgets (modular vs non-modular, NGAs, terms and
  conditions)
• Review Process
• Career advice from mentors and from peers
• Regulatory issues (HS, FDA regulations)

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Preamble

• First
• dont let me, or anyone else at these
  meetings, talk in acronyms

• Second see list of acronyms

• Third ask questions

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Topics

• Who\when to contact
• How to navigate the NIH grants process
• What type of grant
• Loan Repayment Programs

• Where to start

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NIH fact sheet

• Part of the Dept. of Health and Human Services
  (DHHS)
• Budget for 2004 28 billion
• 27 Institutes or Centers (ICs)
• 18,000 employees
• gt 60,000 extramural grantees

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National Institutes of Health (Institutes or
Centers)

• National Institute of Diabetes and Digestive and
  Kidney Diseases (NIDDK)
• National Institute on Aging (NIA)
• National Institute on Alcohol Abuse and
  Alcoholism (NIAAA)
• National Institute of Allergy and Infectious
  Diseases (NIAID)
• National Institute of Arthritis and
  Musculoskeletal and Skin Diseases (NIAMS)
• National Institute for Biomedical Imaging and
  Bioengineering (NIBIB)
• National Cancer Institute (NCI)

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• National Institute of Child Health and Human
  Development (NICHD)
• National Institute on Drug Abuse (NIDA)
• National Institute on Deafness and Other
  Communication Disorders (NIDCD)
• National Institute of Dental and Craniofacial
  Research (NIDCR)
• National Institute of Environmental Health
  Sciences (NIEHS)
• National Eye Institute (NEI)
• National Institute of General Medical Sciences
  (NIGMS)

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• National Heart, Lung and Blood Institute (NHLBI)
• National Human Genome Research Institute (HGRI)
• National Institute of Mental Health (NIMH)
• National Institute of Neurological Disorders and
  Stroke (NINDS)
• National Institute of Nursing Research (NINR)
• National Center for Complementary and Alternative
  Medicine (NCCAM)
• National Center for Research Resources (NCRR)
• National Library of Medicine (NLM)
• Fogarty International Center (FIC)

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Therefore --

• You may have interests that could be funded by
  more than just NIDDK
• Identify the several most likely Institutes for
  funding based on your specialty/scientific
  interests
• Become familiar with those Institutes websites
• Contact appropriate staff early in the process of
  applying for any grant

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If you do NOTHING else ---

• Sign up for the NIH GUIDE ListServe
• http//grants1.nih.gov/grants/guide/listserv.htm

once a week receive a Table of Contents with
links to PAs, Notices, and RFAs
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Topics

• Who\when to contact
• How to navigate the NIH

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Grants Process
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Program staff
A

• aka Program Director or Program
  Administrator or Project Officer
• Work for an Institute or Center
• Handle pre-application questions
• Manage portfolio of grants
• Develop RFAs and PAs
• Observers at study section meetings
• Handle post-review issues
• Send out summary statements
• Initiate funding plans
• Review yearly progress reports

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• (see handout)

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Scientific Review Administrators
B

• Equivalent to program staff on the referral and
  review side (some SRAs are also referral
  officers)
• Work either for the CSR or for an Institute (most
  ICs have their own Review Branch)
• Manage study sections
• Recruit members
• Assign applications
• Responsible for meetings
• Prepare summary statements

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Grants Management staff
C

• Grants Management Specialists (non-scientific
  staff)
• Review budgets AND Administrative notes/codes in
  summary statements in preparation for issuing
  awards
• Work with applicants, program staff, and OER to
  resolve issues
• Prepare Notice of Grant Awards

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• (see handout)

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Schedule

• Jan-April
• May-Aug Receipt Dates
• Sept-Dec
• June-July
• Oct-Nov Review Dates
• Feb-Mar
• Sept-Oct
• Jan-Feb National Advisory Council Board Dates
• May-June
• Dec 1
• Apr 1 Earliest Possible Beginning Date
• July 1

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Review Outline
Applications received by Center for Scientific
Review (CSR)

• Assigned to (1) Institute and, often, (2) Study
  Section

Copies sent to IC
Copies sent to SRA
Letter mailed to applicant with assignment
SRA assigns reviewers and mails out applications
IC assigns application to a Program
3 months
.4-6 weeks later.
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Review Outline -- continued
Study Section meets and reviews scores
applications
SRA enters score into computer
1 week
Letter mailed to applicant with priority score (
Program Director name)
SRA generates Summary statement
IC Program staff notified
Program staff sends summary statement to applicant
2-8 weeks
Funding decision
Second level review
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• Questions?

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Topic

• What type of grant

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Types of support (extramural)

• Grants
• Cooperative Agreements
• Contracts
• Interagency agreements

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Grants are by far the major mechanism
used --
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Sample Application Number
Mechanism Activity Code
Identifying number
Amended

• 1 R01 DK 123456 - 01 A1

Institute
Grant Year
Type 1 new 2 renewal
5 progress report
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Activity code groups

• F Fellowships (all levels)
• G Resource programs
• K Research Career
• M M01 GCRCs
• P Research Program Projects Centers
• R Research Projects
• S Research-related
• T Training Programs
• U Cooperative Agreements

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R-series awards

• R01s regular research project grant
• R03s only in response to PAs or RFAs
• R21s only in response to PAs or RFAs
• R34s only in response to PAs or RFAs

NIH issued ?45,000 awards in FY2003
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Features of R01s

• Major grant mechanism
• Renewable
• Budget requested is up to investigator
• Must get prior approval if gt500,000 in any 1
  year

Remember ---
Budget awarded is up to the NIH (peer review,
Institute policy, funds available)
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Features of R21s

• Exploratory grants
• Institute-specific
• Not renewable
• Budgets limited to no more than 275,000 for a 2
  year period
• Reviewed in standard study sections in CSR

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Features of R03s

• Small grants
• 50,000 per year for 2 years
• Not renewable
• Reviewed (usually) in Institute study sections
• some Institutes use 100,000 for some R03s

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Features of U01s

• Big awards
• Only in response to RFAs
• Need special internal NIH clearance
• NIH staff is involved
• Multiple sites large scale clinical trials

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Cooperative Agreements

• R01

NIH staff
U01
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Request for Applications (RFA)

• One receipt date
• Money is committed AND amount is indicated in
  RFA
• Review usually organized by Institute
• Scores not percentiled
• Often
• More than one Institute involved (i.e. more
  chances, more money)

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Program Announcement (PA)

• Multiple receipt dates
• Active for 3 years (unless otherwise stated)
• Shows Institute has an interest in area
• Funds are not set-aside, but PA is considered
  when making funding decisions
• Review usually in CSR study sections
• Sometimes more than one Institute

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Program Announcement(PAR)

• the R means additional Referral guidelines
  USUALLY it means the review is in the Institute
  study sections

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Definitions

• Unsolicited applications
• Solicited applications

• submitted for one of the standard receipt
  dates
• everything else

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Definitions

• Unsolicited applications
• Solicited applications

• most R01s
• most PAs
• RFAs
• some PAs

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• Every application submitted to the NIH should
  include a COVER LETTER.

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Application cover letter

• Request an Institute MORE THAN ONE
• Request a study section
• Indicate areas of expertise needed to review your
  application
• Indicate any individual or group with a major
  conflict of interest
• NEVER--
• Name desired reviewers

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Assignment Considerations

• Institute guidelines
• IRG guidelines and Competency roster of study
  section
• if amended application, previous assignment
  history
• conflict of interest
• workload balance in CSR
• APPLICANT REQUESTS (cover letter)
• ARAs (Awaiting Receipt of Application)

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Review of Research Grants

• REVIEW CRITERIA
• Significance
• Approach
• Innovation
• Investigator
• Environment

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Review Criteria (continued)

• Significance Does the study address an important
  problem? How will scientific knowledge be
  advanced?
• Approach Are design and methods well-developed
  and appropriate? Are problem areas addressed?
• Innovation Are there novel concepts or
  approaches? Are the aims original and
  innovative?
• Investigator Is the investigator appropriately
  trained?
• Environment Does the scientific environment
  contribute to the probability of success? Are
  there unique features of the scientific
  environment?

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• Other mechanisms have different review criteria.

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Elements reviewed in K applications

• Qualifications of candidate (prior training,
  letters of recommendation, publications)
• Mentors (previous mentoring experience, expertise
  in area of research)
• Research project (hypothesis driven, preliminary
  data, reasonable in time frame, logical sequence
  of studies, appropriate safeguards)
• Career development plan and Environment
  (enrichment, training, future plans)

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Resources

• NIH Guide for Grants and Contracts
• Institute web pages
• Grants Net (http//www.grantsnet.org)
• Mentors and colleagues
• NIH staff
• Also..

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Who else is working in my area of research?
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Do a search

• Using ----
• Computerized Retrieval of Information on
  Scientific Projects (CRISP)
• http//crisp.cit.nih.gov

Abstracts of funded grants
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Topic

• Loan Repayment Programs

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LRP features

• Up to 35,000 per year for 2 years
• NIH pays the taxes on this amount directly to IRS
• Institutes prioritize their own applications

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Several Programs

• Clinical Research
• Clinical Researchers from Disadvantaged
  Backgrounds
• Contraception and Infertility Research
• Health Disparities
• Pediatric Research

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LRP Eligibility 2003

• Bona fide educational loan

DO NOT refinance

• Dependent upon indebtedness

Debt gt 20 of yearly income

• Recipient agrees to complete
  2 years of research

(concurrent with loan repayment)

• Engaged in research ? 50

Verified 4x a year

• NIH-funding NOT a prerequisite

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LRP information

• www.lrp.nih.gov

• Sign up to receive information

NIDDK in 2002 63 applications 55 contracts
NIDDK in 2003 171 applications 89
contracts
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If you do NOTHING else ---

• Sign up for the NIH GUIDE ListServe
• http//grants.nih.gov/grants/guide/listserv.htm

once a week Table of Contents with links to
PAs, Notices, and RFAs
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Take home messages --

• Sign up for the GUIDE List Serve
• Keep your program directors phone number and
  email address handy
• Your goal is to be FUNDED AND
• You have to be persistent to succeed!

• Judith Podskalny, Ph.D.
• 301 594-8876
• jp53s_at_nih.gov