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Grants 101: An Introduction to NIH Grants

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Title: Grants 101: An introductory course Author: Dr. Lynn Clemow Last modified by: Lynn Clemow Created Date: 2/22/2010 11:10:01 PM Document presentation format – PowerPoint PPT presentation

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Title: Grants 101: An Introduction to NIH Grants


1
Grants 101 An Introduction to NIH Grants
  • Lynn Clemow, Ph.D.

2
    

3
Overview
  • Outline the organization of the National
    Institutes of Health
  • Program Announcements and RFAs
  • Describe commonly-used grant mechanisms
  • Application and Review Process

4
Structure of the NIH
  • Intramural Research
  • Research done onsite by NIH scientists
  • 9 of the NIH budget
  • Extramural Research 82 of budget
  • Research grants
  • Training
  • R D contracts
  • Research Management Support

5
NIH Budget
Intramural
Grants Contracts
6
Offices of Womens Health AIDS Research -
Disease Prevention Behavioral Social
Science Research (OBSSR)
7
Institutes and Annual Budgets - 2007
  • National Cancer Institute (NCI) 4.8 billion
  • National Institute of Allergy Infectious
    Disease (NIAID) - 4.5 billion
  • National Heart, Lung Blood Institute (NHLBI)
    2.9 billion
  • National Institute of Diabetes and Digestive and
    Kidney Diseases (NIDDK) - 1.85 billion

8
Institutes and Budgets - 2007
  • National Institute of Neurological Diseases and
    Stroke (NINDS) - 1.5 billion
  • National Institute of Mental Health (NIMH)- 1.4
    billion
  • National Institute on Aging (NIA)- 1.04 billion
  • National Institute of Drug Abuse (NIDA) - 1.0
    billion

9
Centers and Budgets
  • NCCAM - Complementary and Alternative Medicine
    - 121 million
  • NCMHD Minority Health Health Disparities -
    190 million
  • NINR Nursing Research - 135 million

10
Other Federal Entities
  • Agency for Healthcare Research Quality (AHRQ)
  • Centers for Disease Control Prevention (CDC)
  • Health Resources and Services Administration
    (HRSA)

11
Grant Application Overview
  • 3 regular grant submission cycles every year
  • February 1 (/- 2 weeks)
  • June 1 (/- 2 weeks)
  • October 1 (/- 2 weeks)
  • If a resubmission, due 1 month later (Mar, July,
    Nov).
  • Also special one-shot grant opportunities come up
    (Requests for Applications or RFAs) with very
    little notice.

12
Grant Submission Rules
  • Prior to January, 2009, many grant mechanisms
    could be re-submitted twice (i.e., total of 3
    submissions), and that rule still applies to
    grants submitted prior to 1/09
  • As of January, 2009, new grants can only be
    re-submitted once (for a total of 2 submissions)

13
Grant Budgets
  • Budgets include
  • DIRECT COSTS (GO TO THE PROJECT)
  • Personnel costs (salary 36 fringe benefits
    rate) specifying effort for each person
  • Equipment
  • Supplies
  • Subject payments/ incentives
  • Travel (local mileage and conference travel)
  • Each person and item needs to be justified in
    budget justification section of grant

14
Grant Budgets
  • INDIRECT COSTS (GO TO INSTITUTION)
  • Money goes to the institution to provide
    facilities and administrative support to
    researchers
  • Rate calculated by periodic negotiations between
    each institution and the Federal Government at
    UMDNJ currently 56 .
  • For every dollar of direct costs (excluding large
    equipment purchases) UMDNJ gets an additional
    .56.
  • Usually indirect costs are given OVER AND ABOVE
    budget limits. Usually ceilings apply only to
    direct costs.
  • How that money gets divided up within the
    institution varies a great deal from place to
    place. For many medical schools, the
    dean/central admin. gets half, the department
    gets half (in large depts., shared with the
    division and investigator in some way for
    resources).

15
NIH Grant Mechanisms
  • T - Institutional Research Training Grants
    (granted to institutions grad students and
    post-docs appointed by institution) (e.g., NRSA)
  • F Fellowships Individual post-doc fellowships
    for research training in biomedical or behavioral
    science
  • K Research Career Development Awards to
    develop research scientists with clear potential
    (can be early or later career, mentored or to
    support mentoring)

16
Grant Mechanisms
  • R Research grants Awarded to fund a specific
    objective or study in the area of the principal
    investigators interest competence
  • P - Program Grants awarded to more senior
    investigators only, funds a broad-based long-term
    program of research, interacting projects with
    groups of investigators, often 3 or 4 projects
    and shared cores for stats, admin, training,
    instrumentation, etc. Tend to focus on mechanisms
    of disease.
  • P- Center Grants Senior investigators, research
    likely to have a more clinical focus, in response
    to I/C priorities. (MUPS center grant)

17
Grant Mechanisms
  • SBIR Grants made to small business concerns
    that have expertise to contribute to scientific
    mission of NIH
  • Small Business Technology Transfer (STTR) to
    facilitate research between small businesses and
    research institutions.
  • Conference Grants

18
Career Development Grants
  • Many K-award mechanisms
  • Great career step, at whatever level.
  • Must devote gt75 effort to research in most
  • Covers 75 base salary for up to 5 years
  • For mentored mechanisms often want people to be
    with 5 years of end of training, though some
    career transition awards exist
  • For early-career researchers, this kind of award
    is the Holy Grail.
  • Protects the time and space to develop research
    skills, ideas
  • The project is usually of fairly limited scope
  • Cant take any other NIH money for duration of
    award
  • Develops a track record with NIH funding.
  • The mentors and institutional resources are often
    key elements for success

19
Career Development Award
  • Some K grants are more basic-science focused
  • K01 Mentored research scientist award
  • K02 Independent scientist award
  • K05 Senior scientist award
  • K07 Academic career award - curriculum
    development focus
  • Some with more clinical scientist focus
  • K08 Mentored clinical scientist award
  • K23 Mentored patient-oriented research career
    development award
  • K24 - Mid-career investigator award in
    patient-oriented research (must spend 25-50
    effort on pt-oriented research
  • There are many othersImportant to note that
    each I/C uses these mechanisms differently
    important to check

20
R-Series Grants
  • SMALLER/ DEVELOPMENTAL GRANTS Used in different
    ways by different I/Cs
  • R03 Small grant program
  • May request up to 2 years of funding _at_50,000 /
    year. Great for pilot data for larger study.
  • R21 Exploratory/developmental grant
  • May request up to 2 years for project,
    with TOTAL of 275,000. Often used to develop and
    pilot test an intervention.

21
R-Series Grants
  • SMALLER / DEVELOPMENTAL GRANTS
  • R34 Clinical Trial Planning grant- project to
    prepare for a larger clinical trial, (often R-18
    or large R01) which generally is used to
    translate established scientific findings into
    clinical practice.
  • Total of 100,000 / year, 1 or 2 years

22
R-Series Grants
  • R01 Research Project Grant Program
  • To support a discrete, specific project
  • Need to have pilot feasibility data and a
    team with necessary expertise (preferably some of
    whom have worked together before)
  • Budget lt500,000 direct costs per year, up to 5
    years
  • Supplements and amendments are allowed.

23
P-Series
  • Large program-projects or center grants
  • Led by senior investigators (supported by
    collaborative interdisciplinary group)
  • Usually made up of 3-4 interacting projects and
    several shared core functions (biostatistics/
    data management, administration, training,
    instrumentation, laboratories, etc.)
  • Budgets usually 1.5 million/year for 5 years,
    goes up for competitive renewal every 5 years

24
Minority Supplements
  • Trainees and junior investigators who are members
    of under-represented minorities are eligible for
    special minority supplements grants.
  • Generally propose a relatively simple additional
    measure or research question to be added to the
    parent grant covers time at designated stipend
    levels.
  • Benefit to applicant Great opportunity to get
    research experience and funding for that time
  • Benefit to project an extra pair of hands that
    are free to the project, sponsoring minority
    trainees viewed positively by NIH
  • No specific deadlines for applications (usually
    5 pages and admin. paperwork) quick turnaround
    2 months. Issues in working with institutional
    HR, etc.

25
Stimulus Plan (ARRA) Funding
  • Whole bunch of RFAs, used differently by I/Cs.
  • Challenge Grants (RC-1) Each I/C defines
    specific research aims. 12-page application
    format, 500,000 per year x 2 years.
  • Administrative Supplements Again, each I/C
    defines use of these supplements, many institutes
    gave these primarily to new investigators
  • Announcements still emerging
  • Very high level of special reporting and tracking
    of funds

26
GRANT DEVELOPMENT PROCESS
  • Get an idea, discuss with colleagues, mentors
  • Think about appropriate grant mechanisms
  • Adequate pilot data?
  • Scope of project?
  • NIH grant deadline to shoot for?
  • Develop sample size estimates project timeline
    and budget flows from those
  • Develop budget and budget justification, consult
    with administrator regarding budget details, has
    to be in early.
  • Develop grant application

27
New NIH Grant Scoring Domains
  • OVERALL IMPACT (Summary score)
  • SCORED REVIEW CRITERIA
  • Significance
  • Investigators
  • Innovation
  • Approach
  • Environment

28
Grant Outline / Formatting
  • For R01 12 pages of science for the project.
  • For R21 and some other mechanisms shorter
    format (6 pages)

29
Grant Outline
  • Introduction (for resubmission only, 1 page)
  • Specific Aims (1 page)
  • Research Strategy
  • Significance
  • Innovation
  • Approach
  • Preliminary Studies for New Applications
  • Progress Report for Renewal and Revision
    Applications
  • References
  • Human Subjects issues, Environment, etc

Page limits apply to these sections
30
Grant Outline
  • Also need to include
  • Budget/ budget justification
  • Any subcontract paperwork, if including
    co-investigators from other institution
  • Biosketches (4-page limit) for investigators and
    main staff people
  • Letters of support
  • Administrative pages with info on PI,
    investigators, and institution

31
Grant Submission
  • Have to get internal sign-offs
  • Financial disclosure from each investigator
  • Grants office, financial review of budgets.
  • Admin. sign-off from departments, facilities
  • Submissions done electronically in almost all
    cases at this time to grants.gov via grants
    office

32
Grant Review Process
  • Sent to Center for Scientific Review, directed to
    an I/C
  • Assigned to a Study Section (can request specific
    assignment)
  • Can submit 3 pages of supplemental data/ info
    prior to review.
  • Reviewed 4 months later when Study Section
    meets
  • After study section meets (usually a few days)
    get score, summary statement follows within 30
    days.

33
Scoring
  • Approximately half of grants dont get scored and
    are not discussed at the study section meeting.
    So you get reviews, but no discussion and no
    overall priority score.
  • New scoring system gives reviewers ratings of
    each scoring criteria
  • Scored grants (and grant elements) are rated from
    1 - 9
  • 1 perfect score 9 worst possible score

34
NEW SCORING CRITERIA
  • Score Descriptor Additional Guidance on
    Strengths/Weaknesses
  • 1 Exceptional Exceptionally strong with
    essentially no weaknesses
  • 2 Outstanding Extremely strong with negligible
    weaknesses
  • 3 Excellent Very strong with only some minor
    weaknesses
  • 4 Very Good Strong but with numerous minor
    weaknesses
  • 5 Good Strong but with at least one moderate
    weakness
  • 6 Satisfactory Some strengths but also some
    moderate weaknesses
  • 7 Fair Some strengths but with at least one
    major weakness
  • 8 Marginal A few strengths and a few major
    weaknesses
  • 9 Poor Very few strengths and numerous major
    weaknesses
  • Minor Weakness An easily addressable weakness
    that does not substantially lessen impact
  • Moderate Weakness A weakness that lessens impact
  • Major Weakness A weakness that severely limits
    impact
  • The final overall impact/priority score Average
    of OVERALL IMPACT/PRIORITY SCORES OF REVIEW PANEL
    MEMBERS to one decimal point and multiplying by
    ten. Thus, the new scores range from 10-90 in
    whole numbers.

35
PERCENTILES
  • Also get a percentile rank
  • Percentile lets you compare your grants score to
    the likely payline (cutoff percentile score).
    The lower the percentile and the score, the
    better. Fundable scores generally published
    every year by the I/C
  • Example Score 21, 11
  • Payline 15 - grant is
    nearly sure to be funded
  • Cant be absolutely sure until the Council meets
    (3 times/year) and confirms payline.
  • Later Notice of Grant Award is issued (thats
    the actual money)

36
Paylines Differ
  • Year by year, given level of NIH budget
  • Institute by Institute depends on budget level
    and their long-term commitments
  • Depending on the Investigator Advantage given
    to new investigators (sometimes get extra 5
    points). People who have had K awards or small R
    grants are still considered new
  • At some I/Cs, if you get close to the payline,
    can submit a 5-page response to the reviewers and
    undergoes administrative review

37
Resubmission
  • Need to carefully digest the reviews and decide
    how best to respond.
  • May need to strengthen background, study
    rationale, details of methods, statistical
    analysis plan, adjust budget, or collect
    additional pilot data
  • May just need to highlight things you originally
    wrote, but didnt emphasize
  • Always best to be clear that you are being
    responsive to feedback
  • Great to get advice from Program Officer assigned
    to your grant once you get score they were
    generally in the room when it was discussed

38
Resubmission
  • You have up to 2 years to resubmit. Most often
    done sooner.
  • Deadline usually a month later than regular
    intervals, but check about special mechanisms
  • Sooner rather than later is the general rule, but
    totally worth it to wait a cycle and collect
    pilot data if feasibility is questioned.
  • You have 1 additional page up front to respond
    directly to the reviewers comments, and mark
    other revisions in body of grant
  • Generally goes back to the same study section
  • Especially important to get the response right
    when only 1 resubmission is allowed
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