nih grant writing workshop n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
NIH Grant Writing Workshop PowerPoint Presentation
Download Presentation
NIH Grant Writing Workshop

Loading in 2 Seconds...

play fullscreen
1 / 72

NIH Grant Writing Workshop - PowerPoint PPT Presentation


  • 108 Views
  • Uploaded on

NIH Grant Writing Workshop. Susan McHale Professor of Human Development; Director, SSRI Douglas M. Teti Professor of Human Development, Psychology, and Pediatrics; Associate Director, SSRI Rhonda BeLue Associate Professor of Health Policy and Administration Kristin Buss

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

NIH Grant Writing Workshop


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
nih grant writing workshop

NIHGrant Writing Workshop

Susan McHale

Professor of Human Development; Director, SSRI

Douglas M. Teti

Professor of Human Development, Psychology, and Pediatrics; Associate Director, SSRI

Rhonda BeLue

Associate Professor of Health Policy and AdministrationKristin Buss

Professor of Psychology, College of the Liberal Arts

Michelle Frisco

Associate Professor of Sociology and Demography,

College of the Liberal Arts

workshop outline
Workshop Outline
  • NIH Organization
  • NIH Funding Mechanisms
  • The Grant Writing Process
    • Focus on the R01
  • The NIH Review Process
    • Overview of Review Meeting
    • The Scoring Process
    • A Penn State example
  • Workshop Evaluation
thanks to
Thanks to:
  • Lori Francis, Associate Professor of Biobehavioral Health and Center for Family Research in Diverse Contexts, PSU
  • Donna Panasiti, Social Science Research Institute
i the nih
I. The NIH
  • Department of Health and Human Services
    • National Institutes of Health
      • 25 Awarding Institutes/Centers aka ICs (e.g., NICHD, NIMH, NIDA, NIA)
      • Center for Scientific Review
      • Office of the Director
the nih extramural team

The NIH Extramural Team

A. Program

B. Grants Management

C. Review

a the program institute staff program administrator
A. The Program/Institute StaffProgram Administrator
  • Maintains knowledge of scientific area
  • Attends study section meetings
  • Makes funding recommendations
  • Monitors scientific progress
  • Identifies scientific area of importance
  • Reports to senior staff
  • Development of programs and initiatives
b grants management
B. Grants Management
  • Interprets Federal regulations and policies
  • Assures compliance with Federal regulations and policies
  • Monitors financial aspects of projects
  • Interprets regulations and policy
c review scientific review group 1 st level
Center for Scientific Review (CSR) or NIH Institute & Center (IC)

Scientific Review Group (SRG)

Non-federal scientists with relevant expertise

Led by a Scientific Review Officer (SRO)

http://www.csr.nih.gov/Roster_proto/sectionI.asp

C. Review:Scientific Review Group (1st Level)
c review advisory council or board 2 nd level
C. Review:Advisory Council or Board (2nd Level)

The potential awarding IC performs the second level of review.

Comprised of scientists from the extramural community and public representatives.

NIH program staff examine applications for impact (formerly “priority”) scores, percentile rankings, & summary statements against the IC’s needs.

Program staff provide grant funding plan to Advisory Council or Board.

Advisory Council or Board advises the IC director.

Director makes final decision.

nih grant application cycle
NIH Grant Application Cycle

Investigator

Institution

NIH

InitiatesResearch

Peer Review

Submits Application

Council Review

Allocates Funds

Funding Decision

ConductsResearch

grant application it s a process not an event
Grant Application: It’s a process, not an event
  • Communicate with Program Officer
    • Introducing ideas, getting feedback, pre-review

2. Get your proposal to the right review committee

    • Review the rosters and talk to colleagues
    • Effectively wording the abstract
    • Make a written request

3. Seek feedback from colleagues and consultants on drafts of the grant (prepare ahead!)

4. Consider who is likely to review your grant (review the rosters) and make sure to know and cite their work when relevant

5. Recognize that funding on first submission is rare

ii nih grant mechanisms
II. NIH Grant Mechanisms
  • Ks: NIH Career Development Awards (K01, K02, K05, K07, K08, K22)
  • P01: Research Program Project Grant
  • P30: Center Core Grants
  • R01: NIH Research Project Grant Program
  • R03: NIH Small Grant Program
  • R13: NIH Support for Conferences and Scientific Meetings (R13, U13)
  • R15: NIH Academic Research Enhancement Award (AREA)
nih grant mechanisms continued
NIH Grant Mechanisms (continued)
  • R21: NIH Exploratory/Developmental Research Grant Award
  • R34: NIH Clinical Trial Planning Grant
  • T series: NRSA Training Grants (T32, T34, T35, T90, etc.)
  • U series: Research Project Cooperative Agreement
  • Diversity Supplements: Research Supplements to Promote Diversity in Health-related Research
  • Roadmap: NIH Roadmap Initiatives (Director’s Pioneer Award; Director’s New Innovative Program
pre doctoral and post doctoral training awards f series
Pre-doctoral and Post-doctoral Training Awards (F-series)
  • Focuses on the training environment, research training plan, and the candidate’s strengths
  • Research strategy is 6 pages
  • F31 covers doctoral study tuition and living stipend (levels set by NIH). Up to 60 months of support.
  • F32 covers living stipend and funds for research/professional development
career awards k series
Career Awards (K-series)
  • Nine different Career Development (K) Awards
    • Body of application is 12 pages for most
  • Support individuals after they have completed clinical training and have accepted a faculty position
  • Provide for release time for research and monies for research/faculty development
slide16
R03
  • Small research grant
    • Research strategy is 6 pages
  • Can be used to collect pilot data, conduct feasibility studies
  • Often analysis of an existing dataset
  • May be used to develop new research technology
  • $50K per year for 2 years
slide17
R21
  • Exploratory or Developmental Grant
    • Research strategy is 6 pages
  • Often little or no pilot data
  • Feasibility study
  • 2 years of funding (Total of $275K)
  • Not necessarily the first step for new investigators
slide18
R34
  • Supports the development of Phase III clinical trials
      • Establishment of the research team
      • Development data management tools
      • Definition of recruitment strategies
      • Finalization of the protocol
    • Research strategy is 6 pages
  • The planning grant is designed to lead to an application for support of a full-scale trial
r15 area award
R15 Area Award
  • Used to stimulate research in educational institutions that have not been major recipients of NIH support
    • Research strategy is 12 pages
  • Opportunity to conduct research; strengthen the research environment of the institution; and benefit the student through exposure to and participation in research
  • Limited to up to three years of funding for total of $150,000
  • Preliminary data generally not required
r01 primary focus today
R01 (primary focus today)
  • Used to support a discrete, specified, circumscribed research project
  • NIH’s most commonly used grant program
    • Research Strategy is 12 pages
  • Advance permission required for $500,000 or more (direct costs) in any year
  • Generally awarded for 3 to 5 years
research center grants p series
Research Center Grants (P-series)
  • Established by ICs to meet special needs
  • May support research and/or core facilities
  • Usually initiated by the IC
    • Request for Applications (RFA)
  • P30, P50, P60, U54
  • P01 Center grants are investigator-initiated, linked R01s with an additional core of funding
research supplements to promote diversity in health related research
Research Supplements to Promote Diversity in Health-Related Research
  • Administrative supplement to R01 grants and many other types
  • Need to have at least 2 years of funding left on the grant
  • Contact project officer for permission to submit
  • Can be used for students, doctoral students, junior investigators
new and early stage investigators a competitive edge
New and Early Stage Investigators:A Competitive Edge
  • New Investigator has not previously served as a PI for an R01; may have been an investigator or received other smaller, developmental or research training awards
  • Early Stage Investigator (ESI) is within 10 years of completing his/her terminal research degree, or is within 10 years of completing medical residency
iii the grant writing process
III. The Grant Writing Process
  • Grant writing is:
    • A skill like any other…
    • But not the same skill as article writing
    • Instead, more of a problem-based writing activity (theory and practice problem)
a few preliminary tips
A few preliminary tips
  • Start early, make a timeline and STICK TO IT
    • Should allow time for serious pre-submission review & subsequent revision
  • Develop a relationship with project officers
  • It is not possible to overdo clarity
  • Let your passion come through in your proposal
  • Take advantage of early stage and new investigator opportunities
getting ready to write
Getting ready to write
  • Know what has been done
  • Know what has been funded
    • NIH website
  • Decide on the problem
    • Important enough to get funded but simple enough to explain as clean design in 12 pp (for the R01; less for other mechanisms)
    • Mediators and moderators, mechanisms of change
  • Assemble team--CAREFULLY
  • Preliminary research (R01)
getting ready to write1
Getting ready to write
  • Communicate with program officer
    • Establish a relationship and trust (funding decision)
    • Acquire information on mechanism and priorities
    • Obtain input on aims/proposal
main sections of the nih application see francis et al for example
Main Sections of the NIH Application(see Francis et al. for example)
  • Face Page
  • Table of Contents
  • Performance Sites
  • Other information
    • Project Summary/Abstract (Description)
    • Public Health Relevance Statement
    • Facilities & Resources
more sections
More Sections
  • Key Personnel
    • Biosketches --with personal statements
  • Budgets (for each study year)
    • Budget Justification
  • Clinical Trial and Human Embryonic Stem Cell (HESC)
  • List of Research Plan Attachments
main sections of the r01 specific research plan
Main Sections of the R01: Specific Research Plan
  • [Introduction – revisions only]
  • Specific Aims: The basis for the proposal’s organization
  • Research Strategy
    • Significance and Innovation
    • Approach
      • Preliminary studies
      • Design
      • Sample/recruitment/power analyses
      • Procedures & measures
      • Analyses
page limit guide plan your proposal with these limits in mind
Page Limit Guide: Plan your proposal with these limits in mind

Page limits may vary for other funding mechanisms.

Check Funding Opportunity Announcement: http://grants.nih.gov/grants/guide/search_results.htm?scope=pa&year=active

and more sections
And More Sections
  • Protection of Human Subjects
    • Women and Minorities
    • Planned Enrollment Table
    • Children
  • References Cited
  • Letters of Support
  • Resource Sharing Plan
  • Checklist

SO START EARLY!

keys to r01 success
Keys to R01 Success
  • Impact and Significance
    • Practice (2-3 sentences)
      • Prevalence of problem in population
      • Important social concern
    • Theory (model)
      • Building, testing, using
  • Innovation
      • New directions, value added
  • Importance of Preliminary Research
keys to success methods
Keys to Success - Methods
  • Methods are very important
    • Overall -- clarity and detail
    • May include a table that traces aims to hypotheses to constructs to measures (table/s)
    • Is the design feasible?
    • Are there gaps in the methods (e.g., fidelity for interventions)
    • Stats are very, very important (methodologist team member)
    • Include a detailed timeline
more methods issues
More Methods - Issues
  • Community-based participatory research -- very strict about how this is done.
  • Lab versus field
  • Focus groups, interviews, analyses
and more methods the sample
And More Methods: The Sample
  • Preference for representative samples
    • Students only if relevant to age/situation (e.g., college drinking)
  • Generalizability from a single entity (university, clinic, state)
  • Unit of assignment is unit of analysis
budgets
Budgets
  • Direct Costs
    • Senior Personnel (PI, co-Is, project director) (PSU fringe at 36.5%)
    • Other Personnel (full time staff, RAs, part time wages) (PSU fringe 36.5% for full time staff, 13.2% for Grad Assts AY; 7.9% for part time wages and summer)
    • Equipment
    • Travel
    • Participant/Trainee Support Costs
budgets 2
Budgets.2
    • Other
      • Materials and supplies
      • Publication costs
      • Consultant services
    • Subawards/Consortium/Contractual Fees
    • Other
  • Indirect Costs (> 45% at PSU, but does not include all expenses)
  • Budget justification
receiving the summary statements the hardest part
Receiving the Summary Statements: The Hardest Part!
  • Reviews critical, even harsh
  • Reviewers usually find grant’s weaknesses, while recognizing strengths
  • Summary statements spend much more time on critique than praise
  • Many investigators experience a mixture of rage and depression when they read their summary statements and easily lose perspective
  • Take a day or two (or more!) and then read again with a cooler head
receiving the summary statements bouncing back
Receiving the Summary Statements: Bouncing Back!
  • Ask experienced colleagues to read reviews
  • Don’t interpret criticism as hopeless
  • Program Officer may be helpful in clarifying critique
  • If “discussed” (rather than triaged), you have a chance of funding in next round
  • The lower the initial score, the fewer problems and more likely to be successful after revision
resubmission resilience and flexibility
Resubmission:Resilience and Flexibility!
  • Persistence pays off in the grant process!!
  • Second submission must respond to the critiques through revision or clearly defending reasoning
  • Same reviewers may or may not review resubmission, but will see critique
most common reasons for a poor score in priority order
Most Common Reasons for a Poor Score (in priority order)
  • Lack of impact or significance
  • Lack of new or original ideas – show your passion!
  • Hypotheses ill-defined, superficial, lacking, unfocused, or unsupported by preliminary data
  • Methods unsuitable, not feasible, not rigorous or not likely to yield results; methods don’t clearly link to aims
  • Design not logical, inappropriate instrumentation, poor timing or conditions; doesn’t link well to aims
  • Data management and analysis vague, not rigorous; analyses don’t clearly link to aims
  • Inadequate expertise or knowledge of field for PI; too little time to devote to the work
  • Poor resources or facilities; limited access to appropriate population
when to revise
When to Revise
  • Basic idea was significant and innovative or these can be bolstered
  • Design/measurement/analysis problems can be clarified (more information) or fixed
  • Need preliminary data
  • Problem is poor writing
iv the nih review process
IV. The NIH Review Process
  • A. The Review Meeting
  • B. Review Discussion
  • C. The Scoring Process
  • D. A Penn State Example
a the review meeting the sro s role prior to meeting
A. The Review Meeting: The SRO’s Role Prior to Meeting
  • Point of contact until review group meets (then project officer)
  • Analyze submissions for completeness and conflicts
  • Recruit ad hoc reviewers as needed
  • Schedule 1-2 day meeting
  • Assign applications to reviewers (at least 3)
    • Primary, secondary, discussant
  • Create review order based on preliminary impact scores from best to worst within categories
reviewers role prior to meeting
Reviewers’ Role Prior to Meeting
  • Familiarize self with criteria, mechanisms, and scoring
  • Review assigned applications
    • Assign scores to each criteria and other areas
    • Write bulleted strengths and weaknesses for each criteria
    • Reviews are advice to institutes for funding decisions, not advice to PI
  • Post scores and comments on NIH Commons
  • Read other reviews of assigned applications
  • Prepare presentation of reviews
  • Skim/read non-assigned applications
format of the review meeting
Format of the Review Meeting
  • SRO opening remarks
  • Chair orientation
  • New investigator R01 grants
  • Other R01 grants
  • Other grant types (R03, R15, R21, R34)
    • Applications discussed in order of Impact Score; bottom 50% are not discussed
sro opening remarks
SRO Opening Remarks
  • Confidentiality
  • Review order
  • Proposals below median within each category may not be discussed
chair orientation
Chair Orientation
  • Start with reviewer impact scores
    • May differ from posted scores
  • Goal of discussion is to clarify not reach agreement
  • If scores are similar, shorter discussion
  • If scores are dissimilar, longer discussion
  • Recommended time
    • Primary – 5 minutes
    • Secondary – 3 minutes
    • Discussant – 2 minutes
b review discussion
B. Review Discussion
  • Identify proposal
  • Members in conflict leave
  • Reviewers provide preliminary impact scores
  • Reviews
    • Impact, Significance, Investigators, Innovation, Approach, Environment
    • Stress main points, do not repeat previous points
    • Non-reviewers typically ask questions to clarify
  • Human Subjects issues affecting scoring
  • Open discussion to entire committee
review discussion continued
Review Discussion (continued)
  • Ask for reviewers impact scores again
  • Identify the reviewers’ recommended range
  • Ask if anyone wants to score outside the range
  • Entire committee records impact score
  • Discuss budget and other issues
c the scoring process
1. Overall Impact Score: likelihood project will “exert a sustained, powerful influence on the research field(s) involved (1-9 scale)

2. A separate 1-9 score for each of 5 core criteria (Significance, Investigators, Innovation, Approach, Environment)

3. Additional review criteria help determine scientific and technical merit BUT are not scored separately

4. Additional review considerations are addressed by reviewers, but are not scored & are discussed after group scores.

C. The Scoring Process
score criteria
Overall Impact: will project exert a sustained, powerful influence on the research field(s) as indexed by 5 core review criteria

1. Significance: important problem addressed; how will this improve scientific knowledge, technical capability, and/or clinical practice

Score Criteria
what is the difference between impact and significance
What is the Difference Between Impact and Significance ?
  • Impact Addresses:
    • Probability of whether the research will exert a sustained, powerful influence on the research field
  • Significance Addresses:
    • Does the project address an important problem or a critical barrier to progress in the field?
    • If the aims are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?
score criteria continued
2. Investigators: PI & other researchers well suited to the project; appropriate experience & training; ongoing record of accomplishments; complementary & integrated experience; leadership approach, governance, and organizational structure appropriate for project

3. Innovation: the work challenges and seeks to shift current research or practice paradigms; utilizing noveltheory, approaches or methods, instrumentation, or interventions; the work is novel

Score Criteria (continued)
score criteria continued1
4. Approach: strategy, methodology, analyses are well-reasoned and appropriate; potential problems & alternative strategies thought through; benchmarks set; risk is managed

5. Environment: the environment will contribute to the project’s success; institutional support, equipment, & other resources sufficient; unique features of the environment, subject population, collaborative arrangements

Score Criteria (continued)
additional review criteria not scored
Human Subjects:

Protection of human subjects

Data safety monitoring plan (clinical trials only)

Inclusion of women, minorities, children

Vertebrate animals

Biohazards

Additional Review Criteria (not scored)
additional review considerations
Budget and period of support

Select agent research (infectious agents)

Applications from foreign organizations

Resource sharing plans

Additional comments to applicant

Additional Review Considerations
criteria scoring system
CRITERIA SCORING SYSTEM

HIGH

  • Exceptional: Exceptionally strong with essentially no weaknesses
  • Outstanding: Extremely strong with negligible weaknesses
  • Excellent: Very strong with only some minor weaknesses

MEDIUM

  • Very Good: Strong but with numerous minor weaknesses
  • Good: Strong but with at least one moderate weakness
  • Satisfactory: Some strengths but also some moderate weaknesses

Low

  • Fair: Some strengths but with at least one major weakness
  • Marginal: A few strengths and a few major weaknesses
  • Poor: Very few strengths and numerous major weaknesses
criteria scoring system continued
CRITERIA SCORING SYSTEM (continued)
  • 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
criteria scoring system continued1
CRITERIA SCORING SYSTEM (continued)

Final Overall Impact Score:

Mean of all reviewers’ final impact scores X 10

Range = 10 (high impact) -- 90 (low impact)

NOTE: New scoring likely to produce more applications with identical scores (“tie” scores). Thus, other factors (e.g., mission relevance, portfolio balance) will be considered when all other things are essentially equal

key sections in r01 proposal format
Key Sections in R01 Proposal Format
  • Research Plan Components
    • Specific Aims
      • Includes language about the impact of the research
    • Research Strategy
      • Includes Background & Significance; Preliminary Studies/Progress Report; Research Design & Methods
  • Facilities and Equipment
    • Reflects the Environment criterion
    • For ESIs describes the institutional investment in the success of the investigator
  • Biographical Sketch
    • Requires Personal Statement; no more than 15 pubs based on recency, importance to field, and/or relevance to the application
slide63

Key sections (cont’d)

Innovation

  • Does application challenge/seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?
  • Concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?
  • Refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
  • Not all applications need to be innovative!
slide64

Key sections (cont’d)

Approach

  • Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the Specific Aims of the project?
  • Are potential problems, alternative strategies, and benchmarks for success presented?
  • If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
slide65

Key Sections (cont’d) Investigators

  • Personal Statement:
    • Why their experience and qualifications make them particularly well-suited for their roles in the project
  • Publications:
    • Recommended: no more than 15---up to five of the best; up to five of the most relevant to the proposed research; up to five of the most recent
  • If Early Stage Investigators or New Investigators, do they have appropriate experience and training?
  • If Established, have they demonstrated ongoing record of accomplishments that have advanced their field(s)?
d a penn state example
D. A Penn State Example
  • Rhonda BeLue, Associate Professor of Health Policy and Administration, College of Health and Human Development
  • Kristin Buss, Professor of Psychology, College of the Liberal Arts
  • Michelle Frisco, Associate Professor of Sociology and Demography, College of the Liberal Arts
slide67

Links of Interest

Enhancing Peer Review Criteria: http://grants.nih.gov/grants/guide/notice-files/not-od-09-025.html

Page Limits: http://grants.nih.gov/grants/forms_page_limits.htm

Human Subjects: http://grants.nih.gov/grants/policy/hs/index.htm

SF424 guidelines for submission: http://grants.nih.gov/grants/funding/424/index.htm

Glossary: http://grants.nih.gov/grants/glossary.htm

general resources
General Resources

NIH RePorter (formerly CRISP)

https://libraries.ucsd.edu/info/resources/nih-reporter-formerly-crisp

Revised Applications

http://grants.nih.gov/grants/policy/amendedapps.htm

NIH Grant Writing Tip Sheets

http://grants.nih.gov/grants/grant_tips.htm

Getting an RO1

http://sciencecareers.sciencemag.org/career_development/previous_issues/articles/1190/getting_an_nih_r01

more general resources
More general resources

NSF Proposal Writing

http://www.cs.cmu.edu/~sfinger/advice/advice.html

Other Proposal Writing Guides

http://www.learnerassociates.net/proposal/

Reasons Proposals Fail

http://chronicle.com/article/How-to-Fail-in-Grant-Writing/125620/--let

new and early stage investigator resources
New and Early Stage Investigator Resources

New and Early Stage Investigators

http://grants.nih.gov/grants/new_investigators/

nih websites
NIH Websites

http://public.csr.nih.gov/Pages/default.aspx

http://grants.nih.gov/grants/oer.htm (forms, grant search, etc.)

ssri listserv
SSRI Listserv
  • New subscribers can join the SSRI listserv by sending mail to:
  • mailto:L-SSRI-subscribe-request@lists.psu.edu