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Grants 101: An Introduction to NIH Grants. Lynn Clemow, Ph.D. Overview. Outline the organization of the National Institutes of Health Program Announcements and RFAs Describe commonly-used grant mechanisms Application and Review Process. Structure of the NIH. Intramural Research

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overview
Overview
  • Outline the organization of the National Institutes of Health
  • Program Announcements and RFAs
  • Describe commonly-used grant mechanisms
  • Application and Review Process
structure of the nih
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
nih budget
NIH Budget

Intramural

Grants & Contracts

slide6

Offices of: Women’s Health

AIDS Research - Disease Prevention

Behavioral & Social Science Research (OBSSR)

institutes and annual budgets 2007
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
institutes and budgets 2007
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
centers and budgets
Centers and Budgets
  • NCCAM - Complementary and Alternative Medicine - $121 million
  • NCMHD – Minority Health & Health Disparities - $190 million
  • NINR – Nursing Research - $135 million
other federal entities
Other Federal Entities
  • Agency for Healthcare Research & Quality (AHRQ)
  • Centers for Disease Control & Prevention (CDC)
  • Health Resources and Services Administration (HRSA)
grant application overview
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.
grant submission rules
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)
grant budgets
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

grant budgets14
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).
nih grant mechanisms
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)
grant mechanisms
Grant Mechanisms
  • R – Research grants – Awarded to fund a specific objective or study in the area of the principal investigator’s 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)
grant mechanisms17
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
career development grants
Career Development Grants

Many K-award mechanisms:

  • Great career step, at whatever level.
  • Must devote >75% 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
  • Can’t 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
career development award
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 others…Important to note that each I/C uses these mechanisms differently – important to check

r series grants
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 @$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.

r series grants21
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
r series grants22
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: <$500,000 direct costs per year, up to 5 years
  • Supplements and amendments are allowed.
p series
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

minority supplements
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.
stimulus plan arra funding
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
grant development process
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
new nih grant scoring domains
New NIH Grant Scoring Domains
  • OVERALL IMPACT (Summary score)
  • SCORED REVIEW CRITERIA:
    • Significance
    • Investigators
    • Innovation
    • Approach
    • Environment
grant outline formatting
Grant Outline / Formatting
  • For R01 – 12 pages of science for the project.
  • For R21 and some other mechanisms – shorter format (6 pages)
grant outline
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

grant outline30
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
grant submission
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

grant review process
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.
scoring
Scoring
  • Approximately half of grants don’t 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

new scoring criteria
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.

percentiles
PERCENTILES
  • Also get a percentile rank
  • Percentile lets you compare your grant’s 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

Can’t be absolutely sure until the Council meets (3 times/year) and confirms payline.

Later: Notice of Grant Award is issued (that’s the actual money)

paylines differ
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
resubmission
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 didn’t 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
resubmission38
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