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Competing for Funding in the Biomedical Sciences from the National Institutes of Health

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John Ivy, PhD (Molecular Biology) johnivy_at_tamu.edu ... listserves (last but not least) ... NIH makes a distinction between solicited versus unsolicited proposals ... – PowerPoint PPT presentation

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Title: Competing for Funding in the Biomedical Sciences from the National Institutes of Health


1
Competing for Fundingin theBiomedical
Sciencesfrom the National Institutes of Health
Elsewhere
  • December 12, 2008
  • John Ivy
  • JohnIvy_at_tamu.edu
  • Office of Proposal Development
  • Texas AM University
  • Texas AM Health Science Center

2
Texas AM UniversityOffice of Proposal
Development
  • Unit of Division of Research and Graduate Studies
  • Supports Texas AM faculty in the development and
    writing of research and educational proposals
  • Junior faculty research
  • Individual faculty proposal support
  • Center-level initiatives
  • Multidisciplinary and multi-institutional
    research teams
  • Diversity in the research enterprise
  • List funding opportunities
  • Proposal development resources
  • Grant writing seminars and workshops
  • Agency Toolkits
  • Craft of Grant Writing Workbook

3
OPD Member List
  • Jean Ann Bowman, PhD jbowman_at_tamu.edu
  • Physical Geography/Hydrology, earth, ecological,
    environmental
  • Mike Cronan, PE, BS (Civil/Structures), BA, MFA
  • Center-level proposals, research and educational
    partnerships, new proposal and training
    initiatives mikecronan_at_tamu.edu
  • Lucy Deckard, BS, MS (Materials) l-deckard_at_tamu.ed
    u
  • New faculty initiative, fellowships,
    engineering/physical science proposals,
    equipment, and instrumentation
  • John Ivy, PhD (Molecular Biology) johnivy_at_tamu.edu
  • NIH biomedical and biological science initiatives
  • Phyllis McBride, PhD (English) p-mcbride_at_tamu.edu
  • Proposal writing training, biomedical, editing
  • Libby Pasciak libbyp_at_tamu.edu
  • Scheduling, workshop management, project
    coordination
  • Robyn Pearson, BA, MA (Anthropology) rlpearson_at_tam
    u.edu
  • Social sciences and humanities proposals, editing
    and rewriting

4
Office of Proposal DevelopmentOPD-WEB
http//opd.tamu.edu/
  • For an electronic version of this presentation

5
General Steps for Writing Competitive Proposals
Topics
  • Finding Research Funding Opportunities
  • Analyzing the RFP Its Role in Proposal
    Development
  • Analyzing and Assessing the Agency Culture,
    Mission and Research Priorities
  • Understanding the Review Process Writing to
    Reviewers
  • Overview of How to Write a Competitive Project
    Summary Proposal Narrative

6
Your Research Interests will define funding
sources
  • Your research interests should align with the
    Mission of the Agency
  • Biology
  • Biomedicine
  • Health disparities
  • Behavior
  • Biochemistry
  • Computational science
  • Interdisciplinary studies

7
Know the category of funding in which you are
interested
  • Research
  • Training
  • Fellowship
  • Student retention
  • Student recruitment
  • Diversity
  • Curriculum
  • Loan reimbursement

8
Funding Sources for Biomedical Research
  • National Institutes of Health 29 bill.
  • National Science Foundation 6 bill.
  • Dept. of Health Human Services
  • Department of Defense
  • Foundations
  • Environmental Protection Agency
  • US Department of Agriculture
  • National Aeronautics Space Admin.

9
Where do you find the RFPs? (Who ya gonna call?)
  • Network with colleagues
  • Funding sources cited in literature
    acknowledgements
  • Corporations
  • Professional societies
  • Google searches
  • University posted listings
  • Federal agency web sites
  • Foundation web sites
  • Discussions with Agency and Foundation
    Representatives
  • E-mail listserves (last but not least)

10
Grants.gov
  • The Grants.gov web portal serves as a single
    point of access for all federal agency grant
    announcements. New funding announcements from
    federal agency are posted to this site daily, and
    a range of other features allow subscribing to
    email funding alerts, linking to agency web
    sites, and searching for funding among agencies.

11
http//www.grants.gov/
12
Search Browse Grant Opportunities
  • Searchhttp//www.grants.gov/applicants/search_opp
    ortunities.jsp
  • Browse agencieshttp//www.grants.gov/search/agenc
    y.do

13
Grants.gov Search
14
Vaccine Keyword Results
15
Receive Grants.gov Funding Email Alerts
16
http//foundationcenter.org/pnd/rfp/
17
Identify NIH Funding Opportunities
  • NIH Office of Extramural Research
  • http//grants1.nih.gov/grants/oer.htm
  • NIH Guide for Grants and Contracts
  • http//grants1.nih.gov/grants/guide/index.html
  • Search by keyword
  • Browse by Requests for Applications (RFAs)
  • Browse by Program Announcements (PAs)
  • Automatic funding alerts
  • Institutes and Centers (IC) homepages
  • Listed at http//www.nih.gov/icd
  • Go to IC homepage
  • Browse or search their Research Funding or
    "Extramural Funding section

18
NIH Funding Mechanisms
  • Three principal types
  • Training T F
  • Career K
  • Research Project Grant R

19
NIH Training Awards
  • Institutional awards
  • Individual Training awards for predoctoral
    (F31), postdoctoral (F32), or senior fellowships
    (F33)
  • Limited to US citizens or legal aliens

20
NIH Career Development K Awards
  • Directed at retraining, professional career
    development, or recognition of career success
  • K Kiosk http//grants1.nih.gov/training/careerdeve
    lopmentawards.htm
  • Career Award Wizard http//grants.nih.gov/training
    /kwizard/index.htm
  • Helps you select the right career award
  • Participation may be restricted to certain
    Institutes and Centers
  • K01 Mentored Research Scientist
  • Provide mentored career development in a new
    research area
  • 3-5 yr, 75 effort
  • K08 Mentored Clinical Scientist
  • Provides support and protected time to
    individuals with a clinical doctoral degree for
    an intensive, supervised research career
    development experience
  • Biomedical and behavior research
  • 3-5 yr, 75 effort
  • K23 Mentored Patient-Oriented Research Career
    Development
  • Development of the independent research scientist
    in the clinical area
  • 3-5 yr, 75 effort
  • K99/R00 NIH Pathway to Independence (PI)
  • 2 years mentored postdoctoral research 3 years
    independent research in tenure track position (or
    equivalent)

21
Research Grants for Independent Scientists
  • R01 Large Research Grant
  • 4-5 years, 250,000/yr
  • R03 Small Grant
  • 2 year max, 50,000/yr max
  • R21 Exploratory Research Grant
  • High Risk High Reward
  • Transformational
  • 2 years, 275,000 total
  • R15 Academic Research Enhancement Award (AREA)
  • Primarily undergrad institutions
  • Institute must have received lt3mill/yr in NIH
    funding

22
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23
Unsolicited vs. Solicited
  • NIH makes a distinction between solicited versus
    unsolicited proposals
  • Unsolicited (investigator-initiated) proposals
    (82)
  • Parent Announcements (Program Announcements, PA)
  • Solicited (agency-initiated) proposals (18)
  • Program Announcements (PA)
  • New research programs and updates to ongoing
    programs (renewable)
  • Request for Applications/Proposals (RFA/RFP)
  • One time request to fulfill specific agency
    research objective or need

24
Parent Announcements
25
Identifying NIH Solicitations by Topic
26
Example Sequencing Technology
27
Example Sequencing Technology
28
Funding Opportunity Announcements
29
Application Due Dates
30
Identifying NIH Solicitations by IC
  • Search by Agency (IC)
  • Identify funding opportunities within an agency
  • Steps for searching.
  • Identify Agency (IC)
  • Go to their homepage (http//www.nih.gov/icd)
  • Go to their Research Funding or Extramural
    Funding section
  • Perform search

31
Identifying NIH Solicitations by IC
32
Identifying NIH Solicitations by IC
33
Elements of an NIH FOA
  • A Funding Opportunity Announcement
  • Part I. Overview Information
  • Issuing Organization
  • Participating Organizations
  • Components of Participating Organization
  • Title
  • Announcement Type
  • Program Announcement Number
  • Key Dates
  • Executive Summary

34
Contents of an NIH PAPart II. Full Text of
Announcement
  • Section I. Funding Opportunity Description
  • 1. Research Objectives Section II. Award
    Information 1. Mechanism(s) of Support 2.
    Funds Available Section III. Eligibility
    Information 1. Eligible Applicants     A.
    Eligible Institutions     B. Eligible
    Individuals 2. Cost Sharing or Matching 3.
    Other - Special Eligibility Criteria Section
    IV. Application and Submission Information 1.
    Address to Request Application Information 2.
    Content and Form of Application Submission 3.
    Submission Dates and Times A. Submission,
    Review and Anticipated Start Dates   1. Letter
    of Intent B. Sending an Application to the NIH
    C. Application Processing 4.
    Intergovernmental Review 5. Funding
    Restrictions 6. Other Submission Requirements
  • Section V. Application Review Information 1.
    Criteria 2. Review and Selection Process   A.
    Additional Review Criteria    B. Additional
    Review Considerations    C. Sharing Research
    Data    D. Sharing Research Resources 3.
    Anticipated Announcement and Award Dates
    Section VI. Award Administration Information
    1. Award Notices 2. Administrative and National
    Policy Requirements 3. Reporting Section VII.
    Agency Contact(s) 1. Scientific/Research
    Contact(s) 2. Peer Review Contact(s) 3.
    Financial/ Grants Management Contact(s) Section
    VIII. Other Information - Required Federal
    Citations

35
Program Solicitation
  • From the PA or RPF
  • Determine supporting ICs
  • Identify mechanism (R, T, U, etc.)
  • Determine eligibility
  • Identify review criteria
  • Learn essential information to develop and write
    a competitive proposal that is fully responsive
    to the agencys objectives and review criteria.
  • Continuously use the RPF throughout proposal
    development and writing as a reference point to
    ensure that an evolving proposal narrative fully
    addresses and accurately reflects the goals and
    objectives of the funding agency including the
    review criteria.

36
Staying Informed on NIH FOAs
  • Subscribe to Weekly E-mail LISTSERV

37
Remember, investigator-initiated grants represent
gt80 of those funded by NIH!
38
Identifying funding opportunitiesSUMMARY
  • Develop search protocols to fit research
    interests
  • Know relevant agencies
  • Learn grant cycles

39
Know the Funding Agency NIH Mission
  • NIH is the steward of medical and behavioral
    research for the Nation. Its mission is
  • science in pursuit of fundamental knowledge about
    the nature and behavior of living systems and
  • the application of that knowledge to extend
    healthy life and reduce the burdens of illness
    and disability.

40
NIH 20 Institutes, 7 Centers
41
National Institutes of Health
  • NIH is a basic research agency
  • Each Institute has its own mission
  • Each Institute has its own budget
  • Each Institute has its own activities
  • Each Institute has its own ways of doing things
  • When youre planning to submit a grant, check
    with Program Officers from different institutes
    to determine their specific policies and interest
    in your science.

42
Know your home-base IC's Mission
For Researchers
About NIDA
43
Analyze the Agency NIH Culture
  • Trans-NIH initiatives research that cuts across
    typical agency boundaries of various ICs
  • http//www.nih.gov/about/transnih.htm
  • Model Organisms for Biomedical Research
  • Blueprint for Neuroscience Research
  • Bioengineering Consortium
  • Biomaterials and Medical Implants
  • Bioinformatics at the NIH
  • Mammalian Gene Collection
  • Cognitive Emotional Health
  • Translational Research
  • Part of the NIH Roadmap for Medical Research
  • http//nihroadmap.nih.gov/
  • http//nihroadmap.nih.gov/clinicalresearch/overvi
    ew-translational.asp

44
NIH Funding Investments and Priorities
  • NIH has investment priorities based on past
    research findings and current trends in science
  • Targeted areas (FY 2008 proposed budget)
  • HIV/AIDs
  • Biodefense
  • Roadmap for Biomedical Research
  • Enhanced Support for New Investigators
  • Physical Infrastructure
  • NIH FY2007 budget is 28.8 billion (FY2008
    proposed 28.85 billion)
  • NIH funds research projects inside their own
    laboratories (intramural) and outside their
    laboratories at national and international
    locations (extramural)
  • Extramural funding 85
  • Intramural Funding 10
  • Research Infrastructure 5

45
New Investigator Programhttp//grants.nih.gov/gra
nts/new_investigators/index.htm
46
For New Investigators
  • K99/R00 Pathway to Independence
  • Must have fewer than 5 yr postdoc experience
  • Open to US and non-US citizens
  • 2 yr mentored Post-doc 75 effort required
  • 3 yr independent, tenure-track or equivalent
    position 75 research effort
  • R01 fast review for new investigators
  • Check box on cover page for new investigators
  • Example Oct 5 Submit Mar 1 Summary
    Statement Mar 20 Resubmit (Mar 5, Jul 5, Nov 5)

47
For New Investigators
  • More lenient R01 payline for new investigators
    (varies by IC)
  • In FY07, 500 R01 awards to be made to new
    investigators
  • DP2 Directors New Innovator Award
  • For exceptionally creative work of new
    investigators
  • Requires highly innovative approaches that have
    the potential to produce an unusually high impact
  • Must have completed doctoral degree within 10
    yr
  • Awards up to 300,00

48
A New InitiativeIdentify Early Stage
Investigators
  • Designed to encourage early transition to
    independence
  • the average age at which an investigator first
    obtains R01 funding has increased by more than 5
    years between 1980 to and 2001
  • New Investigator  An NIH research grant
    Principal Investigator who has not yet competed
    successfully for a substantial, competing NIH
    research grant
  • AND
  • Early Stage Investigator (ESI)  An individual
    who is classified as a New or First-Time
    Investigator and is within 10 years of completing
    his or her terminal research degree or is within
    10 years of completing medical residency

49
Details ofEarly Stage Investigators Initiative
  • Early Stage Investigator (ESI) 
  • NIH will collect necessary data from the eRA
    Commons personal profile
  • NIH will eliminate the New Investigator Check Box
    on the application face page
  • New or First-Time Investigators will continue to
    be identified by determining whether the
    individual has had significant, previous NIH
    funding
  • PD/PIs who receive a substantive, competing NIH
    research grant will lose their New Investigator
    status and hence their status as an ESI
  • Applications from ESIs and New Investigators will
    be identified to reviewers so that appropriate
    consideration of their career stage can be
    applied during review
  • New Investigators as well as ESIs will be
    eligible for the Full Implementation to Shorten
    the Review Cycle for New Investigator R01
    Applications Reviewed in Center for Scientific
    Review Recurring Study Sections"

50
Early Stage Investigator New NIH Policy Supports
Transition to Independence
  • Peer reviewers will be instructed to concentrate
    more on the proposed method of research and to
    expect less preliminary data than might be
    provided by an established investigator.
  • In addition, many NIH institutes and centers will
    give special consideration to ESI applications
    while in some cases, grant periods for ESIs may
    be longer.
  • All New Investigators must update their eRA
    Commons profiles to ensure that they are given
    appropriate consideration for R01 applications
    for February, 2009 due dates and beyond.
  • New investigators who do not yet have an eRA
    Commons account should work through the sponsored
    research office or its equivalent at their
    institution to establish an eRA Commons account.

51
RationaleEarly Stage Investigators
  • NIH hopes that providing a focus on ESIs will
    directly encourage earlier application for NIH
    research grant support.

52
What you're competing forFY 2007 Operating
PlanNIH Discretionary Budget Authority 29.228
Billion
  • gt80 awarded to gt325,000 extramural researchers

53
It's competitive out there Historical NIH
Congressional Appropriations
54
New Grant Applications and Success Rates During
and After the Doubling Period
55
Success Rate FY 2007It's competitive out there!
  • Research Project Grant application overall
    success rate
  • 47,455 applications
  • 10,100 funded
  • 21.3 success rate
  • New 18.2
  • Continuation 38.7
  • Supplements 33.7

DP1, DP2, P01, R01, R03, R15, R21, R33, R34,
R36, R37, R55, R56, RL1, RL2, RL5, RL9, U01, U19
56
Dr. William F. Raub, NIH Associate Director for
Research and Training, strategy paper
  • Competition for funds from the NIH and other
    sponsors, intensifying year by year, now stands
    at an unprecedented level, and shows no sign of
    abating. Never before have so many established
    investigators faced so much uncertainty about
    their longevity as active scientists. Never
    before have so many novices faced so many
    disincentives to entering or continuing a
    research career.

1982
57
Assess the CompetitionKnow what was recently
funded
  • Learning about recently funded research in your
    area helps you understand what an agency is
    looking for in the review process
  • Search on-line databases of funded projects
  • Review abstracts of funded proposals on agency
    web sites
  • Talk to the principal investigators of funded
    proposals in your area
  • Obtain copies of funded proposals
  • Ask the PI

58
CRISP http//report.nih.gov/crisp/
  • Computer Retrieval of Informationon Scientific
    Projects
  • A searchable database of federally funded
    biomedical research
  • What similar projects have been funded?
  • Has someone already been funded to pursue my
    idea?
  • Who are my competitors?
  • Who are potential collaborators?

59
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60
CRISP search results
61
Review of NIH Proposals
  • Center for Scientific Review (CSR)
  • Administers and coordinates peer review
  • http//www.csr.nih.gov/default.htm
  • Divisions (4)
  • Integrated Review Groups (IRG) 23
  • Study Sections (SS) 220
  • Scientific Review Officer (SRO)
  • Members (peers with expertise in SS research)
  • Standing members
  • Ad hoc members
  • Study section rosters postedhttp//www.csr.nih.go
    v/Roster_proto/sectionI.asp

62
What happens when you submit an application?
Center for Scientific Review
1) Scientific Review Group or IC Review Branch
2) IC Advisory Council
Institute Director
63
CSR Review Streamlining
  • Proposal received at CSR
  • Assigned to an IRG, then to a Study Section (SS)
  • The Scientific Review Officer (SRO) assigns a
    primary, secondary, and tertiary reviewer
  • Review is a two-step process
  • 1) Peer review is merit-based
  • Investigator-initiated proposals (R01, R03, R21)
    are read by the 1, 2, 3 peer reviewers
  • Bottom 50 of proposals are identified about 1
    week prior to the SS meeting (triaged or
    streamlined)
  • All three reviewers must agree on the streamlined
    proposals in order for the proposal to be triaged
  • Streamlined applications receive summary
    statements verbatim from each reviewer, but are
    not discussed nor scored
  • SS meets to review and discuss applications
  • Primary reviewer presents your proposal to the
    group (reads the abstract)

64
CSR Scoring ProposalsCaution details are
changing!
  • 1) Peer Review (cont.)
  • SS members discuss your application, the primary
    reviewer answers questions about the proposal
  • SS members assign a score to the proposal between
    1-5 (1outstanding, 5forget it)
  • After the meeting the SRO calculates the average
    score for each proposal, multiply by 100 to get a
    3 digit score (100-500)
  • SRO calculates a priority score or percentile
    ranking of the score based on the past 3 cycles
    of grant scores within SS
  • SRO prepares a written critique of your proposal
    based on reviewers comments
  • 2) Advisory Council or Board
  • Meritorious proposals considered against mission,
    needs, and budget
  • IC Program Officer makes recommendation to IC
    Director
  • IC Director makes funding decision

65
Preparing for Changes in Peer Review
  • Scoring
  • Critiques
  • Balanced and Fair Reviews Across Career Stages
    and Scientific Fields
  • Amended Applications
  • Enhanced Review Criteria

66
Preparing for Changes in Peer Review
  • Scoring
  • To improve the transparency of the scoring
    process
  • Before a review meeting, assigned reviewers and
    discussants will score applications on the five
    review criteria using a scale greater than 1-5.
  • Each assigned reviewer and discussant will also
    provide a preliminary overall score using the new
    scale.
  • At the meeting, discussed applications will
    receive an overall score from each eligible
    (i.e., without conflicts of interest) panel
    member and these scores will be averaged,
    multiplied by 10, and called the priority score.
  • The priority scores then will be percentiled
    against the appropriate base. The new scoring
    system will necessitate the establishment of new
    percentile bases. Percentiles will be reported in
    whole numbers

67
Preparing for Changes in Peer Review
  • Critiques
  • To improve the quality of the critiques and to
    focus reviewer attention on the review criteria
  • Before the review meeting, in addition to
    preliminary scoring, assigned reviewers will
    provide written critiques of the application
    through an electronic template that will prompt
    for strengths and weaknesses for each criterion.
  • After the meeting, the critiques will be compiled
    into a summary statement that will be shorter and
    more focused than current summary statements due
    to standardized organization and reporting of
    strengths and weaknesses.
  • Discussed applications also will have a summary
    of the panels discussion at the meeting.
  • Feedback for Streamlined Applications.
  • Currently, applications not considered to be in
    the more meritorious half are streamlined.
    Streamlined applications are not discussed by the
    full review committee and are not assigned
    numerical priority scores, but the applicants do
    receive the reviewers critiques.
  • In 2009, streamlined applications will receive
    scores in addition to the reviewers critiques to
    help applicants assess whether or not they should
    submit an amended application.

68
Preparing for Changes in Peer Review
  • Balanced and Fair Reviews Across Career Stages
    and Scientific Fields
  • The New Investigator Policy was modified to
    identify Early Stage Investigators (ESIs), see
    http//grants.nih.gov/grants/guide/notice-files/no
    t-od-08-121.html, and becomes effective beginning
    with traditional R01 applications received for
    the February 2009 receipt dates.
  • Where possible, NIH will cluster new investigator
    applications (including ESIs) for review.
  • The same clustering approach will be considered
    for clinical research applications

69
Preparing for Changes in Peer Review
  • Amended Applications
  • To speed the funding of meritorious science and
    minimize reviewer burden
  • NIH has issued a policy announcement decreasing
    the number of resubmissions (i.e., amendments)
    permitted from two to one.
  • Beginning with applications intended for the
    January 25, 2009 due date, all original new
    applications (i.e., never submitted) and
    competing renewal applications will be permitted
    only a single amendment (A1).
  • To facilitate this transition, original new and
    competing renewal applications submitted for FY
    2009 or earlier, i.e. prior to January 25, 2009,
    will be permitted two resubmissions.

70
New NIH Policy to Fund Meritorious Science Earlier
  • The new NIH policy decreasing the number of
    amended grant application resubmissions from two
    to one will help ensure earlier funding of high
    quality applications and improve efficiencies in
    the peer review system

71
Your application is reviewed at study section by
  • Experts
  • Non-experts
  • People who are reading lots of grants
  • People who want to be excited by science
  • People who will be irritated by a sloppy
    application
  • So,
  • Submit a high quality, reviewer-friendly
    application!
  • Have people review your application critically
    well before submission

72
For what are Reviewers looking?NIH General
Review Criteria
  • Significance
  • Ability of the project to improve health
  • Approach
  • Feasibility of methods and appropriateness of
    budget
  • Innovation
  • Originality of research
  • Investigator
  • Education, training, relevant experience
  • Environment
  • Suitability of facilities and institution support

73
Preparing for Changes in Peer Review
  • Enhanced Review Criteria
  • The current five scoring criteria will have
    clearer descriptions, with questions for
    reviewers to consider in evaluating each
    criterion.
  • The application instructions will be updated to
    inform applicants of these revised questions.

74
Timeline for Implementation of Key Actions in the
NIH Peer Review System
75
Preparing Proposals
  • All NIH proposals use either the electronic form
    SF424 or the paper PHS398. In transition!
  • The transition to SF424 for F and K awards is
    delayed
  • Step 1 Download the Instructions and Forms via
    the NIH OER website
  • http//grants2.nih.gov/grants/funding/424/
  • http//grants1.nih.gov/grants/funding/phs398/phs39
    8.html
  • Step 2 READ THE INSTRUCTIONS

76
2009 Brings New Adobe-Based Application Forms for
Electronic Submissions
  • Most electronic submissions to NIH on or after
    Jan. 1, 2009 must use Adobe application forms,
    with a few exceptions.
  • Existing FOAs that were released prior to Sept.
    1, 2008, will have PureEdge application forms
    that will remain active and available until they
    are replaced by Adobe forms in the December
    timeframe.
  • New Funding Opportunity Announcements released
    after Sept. 1, 2008, will not have Adobe
    application forms for downloading until December
    2008.
  • Note Although the software program has changed,
    the electronic submission process has NOT.

77
New Adobe-Based Application Forms
  • Adobe-based application packages will become
    available after the first week of December 2008.
  • Everyone who will work on an application must
    download Adobe Reader version 8.1.3 or higher
  • Non-compatible versions of Adobe Reader will
    prevent successful submission to Grants.gov make
    sure to install compatible software before you
    begin your application!
  • A delay in receiving the revised forms has
    prompted us to modify our implmentation schedule.
    There will be two rounds of form updates.
    Applicants will need to return to their
    respective FOAs in April to download the latest
    version of the Adobe-based application forms for
    receipt dates of May 2009 and beyond.

78
NIH Transition to Adobe Forms
Small business and conference FOAs will use
PureEdge forms for receipt dates on or before
Jan. 7, 2009, and Adobe thereafter.
2008
2009
FEB
OCT
JAN
DEC
NOV
NIH pilot of Adobe Forms (mid-late
Oct.) RFA-AI-08-020 RFA-DE-09-001 RFA-DE-09-002
Adobe forms for existing and new FOAs will be
available in early Dec. (Except for small
business and conference FOAs)
Most submissions after Jan. 1, 2009 must use
Adobe forms, with these exceptions
Adobe forms for SBIRs and R13/U13s will be
available in early Feb. 2009
Apr. 2009 2nd update of Adobe forms
New FOAs issued after Sep.1, 2008 might not
contain application forms. ? Adobe forms
will be made available for these FOAs in early
Dec. 2008 ? Adobe forms for small business
and conference FOAs will be available in early
Feb. 2009 Most FOAs with receipt dates on or
after Jan. 1, 2009 must use Adobe forms, except
? Small business applications
(R41,R42,R43,R44) and conference grant
applications (R13/U13) with Jan. 7, 2009 AIDS
submission deadlines ? All FOAs
expiring on or before Jan. 31, 2009 that will
continue to use PureEdge until the expiration
date. See complete list on eSubmission
Web Site at http//era.nih.gov/ElectronicReceipt/
79
Writing for Reviewers
  • Reviewers often have 8 or 10 proposals to read
  • Use white space, underlining, bold, bullets,
    figures, flowcharts to make main points easy to
    find
  • Put main idea of sections and paragraphs up front
  • Write for the reviewers
  • Make it easy for them to assess your proposal
  • Make it easy for them to be your advocate

80
Must Convince Reviewers
  • Your proposed research should be funded
  • Its important and supports the agency mission
    and program goals
  • Its exciting
  • It has a good chance of succeeding
  • You are the person who should conduct the
    proposed research
  • You are knowledgeable and well-qualified
  • You have the support and resources required

81
Albert Einstein on Grant Writing
  • If you can't explain something simply, you don't
    understand it well.
  • Most of the fundamental ideas of science are
    essentially simple, and may, as a rule, be
    expressed in language comprehensible to everyone.
  • Any fool can make things bigger, more complex,
    and more violent. It takes a touch of genius
    and a lot of courage to move in the opposite
    direction.

82
Before you begin . . .
  • Make sure you have identified the following
  • Goal
  • Indicates the purpose for the project as a whole
  • Should be aligned with the agencys mission
  • Aims (Objectives)
  • Indicate the purpose for each specific part of
    your project
  • Should be aligned with your overall goal
  • Should be specific and measurable
  • Rationale
  • Indicates why you want to achieve your purpose
  • Should be clear and logical
  • Expected outcomes
  • Indicate what will change as a result of your
    research(e.g., behavior, performance, process,
    produce)
  • Should include both immediate and long-term
    outcomes

83
Speak with the Program Officer early and often
  • Do your homework first
  • Make an appointment
  • Listen to the response
  • Request clarification
  • Follow up

84
Never be timid about contacting a program officer
for clarification
  • Timidity is never rewarded in the competitive
    grant process.

85
Common Elements of PHS398 R01
  • Cover page/face sheet
  • Description Project Summary (Abstract)
    Relevance
  • Performance site, key personnel
  • Table of contents
  • Budget page(s)
  • Budget justification
  • Biosketch of PI, biosketch of all other major/key
    personnel
  • Resources
  • Research Plan (Items A-D)
  • Other Information under Research Plan (Items E-J)
  • References cited, human or animal research
    subjects, inclusion of minorities/children in
    clinical studies, data sharing plans, etc.
  • Appendix items
  • Checklist

86
Introductory writing tips
  • Title, Summary (Abstract), and Introduction
    (Specific Aims) are key
  • May be all reviewers read
  • Must excite and grab the attention
  • Reviewers will assume errors in language and
    usage will translate into errors in the science
  • Dont be overly ambitious in what you propose,
    but convey credibility and capacity to perform

87
Introductory writing tips
  • Sell your proposal to a good scientist but not an
    expert
  • Some review panels may not have an expert in your
    field, or panels may be blended for
    multidisciplinary initiatives
  • Agencies reviewers fund compelling, exciting
    research
  • Proposals are not journal articles proposals
    must be user-friendly and offer a narrative that
    tells a story that is memorable to reviewers

88
Cover Sheet
  • Requires that you provide basic information about
    yourself, your institution, and your proposed
    research project
  • Often offers you the opportunity to indicate if
    you are a new investigator (until Feb. '09/)

89
Title
  • Used by agency administrators to route your
    proposal to the appropriate reviewers
  • Should provide an accurate representation of
    your proposed project
  • Should generate interest in and enthusiasm for
    your proposed project
  • Should conform to agency requirements
  • Program name
  • Number of characters (NIH 81 incl. spaces)

90
Project Summary (Abstract)
  • One of the most critical sections
  • May be one of only a few elements a reviewer
    reads
  • Communicate excitement and grab the reviewer
  • Used by agency administrators to route your
    proposal to the appropriate reviewers
  • Provides a concise overview of the proposed
    project
  • Requires that you provide a great deal of
    information within a very limited amount of space
    (NIH 30 lines)
  • Becomes public record if the project is funded

91
Project Summary (Abstract)
  • Consider writing the Abstract after you've
    written your Research Plan
  • Use the same elements of the Specific Aims in the
    same order
  • Brief introduction to the topic
  • Gap in knowledge or critical need
  • Broad, long-term goals
  • Specific Aims
  • Describe research design and methods
  • Summarize the Significance of the project
  • Avoid summary of past accomplishments
  • Avoid use of the first person

92
Project Relevance
  • The second component of the Project
    Summary/Abstract is Relevance
  • Corresponds to "Project Narrative" in SF424 forms
  • Using no more than two or three sentences,
    describe the relevance of this research to public
    health
  • Be succinct and use plain language that can be
    understood by a general, lay audience

93
Connect budget to the research narrative
  • Be sure activities discussed in the narrative
    (Research Plan) are reflected in the budget
  • In budget justification, personnel, materials,
    supplies, equipment, travel should reflect that
    necessary to complete Research Plan
  • Base budget on real costs
  • Remember that reviewers know what things cost
  • Factor in both direct and indirect costs
  • Factor in cost escalations for multi-year projects

94
NIH Biographical Sketch
  • Four page maximum use NIH form
  • Emphasize qualifications relevant to the proposed
    project
  • Ability to conduct and manage project
  • Section A. Positions and Honors
  • Section B. Publications
  • List publications reflective of the topic of the
    current proposal (or maximum)
  • Section C. Research Support
  • Current and completed support
  • Begin with projects that are most relevant to the
    research proposed in the application

95
Sample NIH Biosketch (via http//grants.nih.gov/gr
ants/OER.htm)
96
Resources
  • Demonstrate that it is feasible to conduct the
    proposed research project at your institution
  • Laboratory
  • Clinical
  • Animal
  • Computer
  • Office
  • Other

97
Research Plan
  • Introduction (Resubmissions only)
  • A) Specific Aims
  • Long-range goals
  • Hypothesis
  • B) Background Significance
  • C) Preliminary Studies / Progress Report
  • D) Research Design and Methods
  • Structure based on Specific Aims

98
Specific Aims
  • Critically important
  • Must provide a conceptual overview
  • Must outline the project goals, objectives
    (aims), and expected outcomes
  • Must be clearly written leave no room for
    interpretation
  • Must grab the reviewers attentionand generate
    enthusiasm for the project
  • Must be able to stand alone
  • Often Title, Abstract, and Specific Aims may be
    the only three parts that all study section
    members will have an opportunity to read

99
Specific Aims
  • PHS's Instructions
  • "List the broad, long-term objectives and the
    goal of the specific research proposed, for
    example, to test a stated hypothesis, create a
    novel design, solve a specific problem, challenge
    an existing paradigm or clinical practice,
    address a critical barrier to progress in the
    field, or develop new technology. One page is
    recommended."
  • Grants.gov Application Guide SF424 (RR)

100
General organization of the Specific Aims
Introduction to the problem. Identification of
need or gap in knowledge. Long term research goal
and specific project goal Central
hypothesis Specific Aims
Project outcomes benefits
101
Specific Aims
  • Write this section for all your audiencesprimary
    reviewers and other reviewerssince they'll all
    read it.
  • Provide a framework for your research topic
  • State a long-range goal of your research program
  • State a goal of the proposed research
  • Identify a gap in knowledge or critical need
  • State a specific hypothesis or critical need that
    your experiments will address
  • State specific, measurable Specific Aims
  • Aims are not activities, e.g., measure, study,
    evaluate
  • Specific aims are what you plan to accomplish by
    the end of the grant
  • Specify research methods
  • Do not be overly ambitious!
  • Provide a rationale for your approach how
    expected outcomes will fill gap in knowledge,
    satisfy critical need, advance the field, enable
    future progress, etc.
  • Summarize Significance
  • Identify Innovation
  • Tie to program/agency mission and goals
  • One approach organize this section into four
    paragraphs.

102
Specific Aims Paragraph 1
  • Introduce the project.
  • Relate the project to the agencys mission.
  • Educate the reviewer.
  • Summarize the important knowledge.
  • Identify the gap in the knowledge or state the
    critical need.
  • Identify the problem created by the gap or the
    critical need.
  • Adapted from Morrison and RussellGrant
    Application Writers Workbook

103
Specific Aims Paragraph 2
  • Describe your long-range research or career
    goal(s).
  • Ensure that your long-range career goal aligns
    with the agencys mission.
  • State your overall project goal.
  • Ensure that the overall project goal addresses an
    identified gap in knowledge and represents a step
    toward achieving your long-range career goal.
  • Present your central hypothesis (or,
    alternatively, a statement of need).
  • Be sure that you present a true hypothesis one
    that can be objectively tested to determine its
    validity rather than a predetermined
    conclusion.
  • Adapted from Morrison and Russell Grant
    Application Writers Workbook

104
Specific Aims Paragraph 2 (cont.)
  • Explain your rationale for pursuing the project.
  • Indicate what it will be possible to accomplish
    when your research is complete.
  • Describe your qualifications and research
    environment.
  • How you are better prepared than other, equally
    qualified researchers.
  • Identify special training, expertise, experience,
    and, most importantly, relevant preliminary data.
  • Identify access to human and animal subject
    pools to unique equipment and instrumentation
    and to collaborations and partnerships.
  • Why you are the best resercher in the best
    environment to address the research question.
  • Adapted from Morrison and Russell Grant
    Application Writers Workbook

105
Your Central Hypothesis
  • The foundation of your application the
    conceptual underpinning on which the entire
    structure rests.
  • Generally applications should ask questions that
    prove or disprove a hypothesis rather than use a
    method to search for a problem or simply collect
    information.
  • The goal of more applied research may be to
    discover basic biology or develop or use a new
    technology.
  • If your application is not hypothesis-based,
    state this in your cover letter and give the
    reasons why the work is important.

106
Your Central Hypothesis
  • Choose an important, testable, focused hypothesis
    that increases understanding of biologic
    processes, diseases, treatments, or preventions
    and is based on previous research.
  • State your hypothesis in both the Specific Aims
    section and the Abstract.
  • Example of a good research hypothesis
  • Analogs to chemokine receptors can inhibit HIV
    infection.
  • Examples of a poor research hypothesis
  • Analogs to chemokine receptors can be
    biologically useful.
  • A wide range of molecules can inhibit HIV
    infection.
  • NIAID "How to Plan a Grant Application"

107
Specific Aims Paragraph 3
  • Delineate your specific aims in a bulleted list.
  • Ensure that specific aims correlate with your
    central hypothesis.
  • Ensure that all specific aims relate to and
    support your overall project goal.
  • Design your specific aims and experiments so they
    answer the question posed by the hypothesis.
  • Provide conceptual rather than descriptive
    specific aims.
  • Adapted from Morrison and Russell Grant
    Application Writers Workbook

108
Specific Aims Paragraph 3 (cont.)
  • Delineate your specific aims in a bulleted list
    (cont.).
  • Delineate a reasonable number of specific aims,
    presented in a logical order.
  • Why aims are generally stronger than what
    aims.
  • Define a clear purpose, working hypothesis or
    statement of need, and expected outcome for each
    specific aim.
  • Make sure no specific aim is dependent on the
    successful outcome of another aim.
  • Adapted from Morrison and Russell Grant
    Application Writers Workbook

109
Specific Aims Paragraph 4
  • Identify the projects innovation, e.g., a unique
    approach or technology
  • Delineate the projects expected outcomes
  • Should validate central hypothesis and resolve
    gap in knowledge
  • Summarize the projects significance
  • Provides segue to Background and Significance
  • Adapted from Morrison and Russell Grant
    Application Writers Workbook

110
Specific Aims
  • Don't be overly ambitious
  • 2-5 aims for an R01
  • Avoid descriptive aims
  • No fishing expeditions no look-and-see!
  • Use brief, concise, informative, conceptual
    statements (headline style)

111
What vs. Why Aims
  • "What" aims
  • Determine amino acid sequence of protein Y of
    antiviral Z-sensitive wild-type virus X.
  • Determine amino acid residue changes in protein Y
    of 100 natural antiviral Z-resistant virus X
    isolates.
  • In culture, select for virus X variants that
    develop resistance to antiviral Z and identify
    altered protein Y residues.
  • versus
  • "Why" aim
  • Identify virus X protein Y candidate amino acid
    residues responsible for antiviral resistance.

112
Background Significance
  • Consider starting with Significance and tie into
    Specific Aims
  • Explain explicitly why proposed research is
    important
  • Specify how your research will extend and advance
    knowledge in the field
  • Identify what you will be able to do following
    successful research that you cannot now do.
  • Tie to agency and program goals
  • Relate to review criteria (e.g., innovation)
  • Make Significance easy to find
  • Communicate your excitement!

113
Background
  • Background should tie closely to your proposed
    research
  • Describe state of the field
  • Provide context for proposed project
  • Demonstrate your familiarity with the field
  • Nature of the problem and Identification of the
    opportunity
  • Acknowledge alternative hypotheses or models
  • Be thorough and concise
  • Do not be dismissive of previous research

114
Preliminary Data / Progress Report
  • Preliminary data must connect clearly to proposed
    project
  • Determine how much preliminary data to include
  • Can vary with funding mechanism
  • Present the results in a logical order
  • Illustrate your results

115
Research Design Methods
  • Structure based on Specific Aims or Review
    Criteria
  • Include approaches and detailed methods
  • Be clear about how you will accomplish your
    stated goals and objectives. Include details
  • What, specifically, will you do when you get the
    money?
  • Schedules and milestones may be helpful
  • This is especially important if you are a
    relatively new researcher
  • Identify expected, measurable outcomes
  • Identify and address anticipated pitfalls and
    alternate approaches
  • Avoid ambiguous terminologybe specific!

116
Project schedule
  • Delineate the key milestones
  • Incorporate the agency and program requirements

117
Formatting Requirements
  • Font
  • Arial, Helvetica, Palatino Linotype, or Georgia
    typeface
  • Black font color
  • Font size of 11 points or larger
  • Symbol font may be used to insert Greek letters
    or special characters the font size requirement
    still applies
  • Type density, including characters and spaces,
    must be no more than 15 characters per inch
  • Type may be no more than six lines per inch
  • Page Margins
  • At least one-half inch margins (top, bottom,
    left, and right) for all pages
  • Use standard paper size (8 ½" x 11)
  • Figures, legends, tables, graphs, charts, etc.
    may use smaller font

118
The funded proposal
  • The author of a funded proposal has
    accomplished the basic goal of grant writing when
    she has ensured that the reviewers
  • were intrigued and excited about the proposed
    research,
  • understood its significance, and
  • were confident in the researchers capacity to
    perform.

119
Three possible outcomes of proposal review
  • Triaged
  • Discussed, scored, not funded
  • Discussed, scored, FUNDED!

120
Receive review comments
  • If your proposal is not funded
  • Deal constructively with rejection

121
Revisions Resubmission
X Two
  • Three strikes youre out
  • Read the reviewers comments
  • Take a break
  • Re-read the reviewers comments
  • Dont take them personally
  • Read the reviewers comments, AGAIN
  • Call the program officer for more feedback
  • Evaluate if you should resubmit

122
Interpreting Reviews Planning to Resubmit
  • Were certain issues mentioned consistently?
  • Plan how to address those issues
  • Did the reviewers misunderstand your proposal?
  • Plan how to make your text more clear
  • Was no clear issue mentioned?
  • May not have excited reviewers enough
  • May not be an area they wish to fund now
  • May not fit into their research portfolio
  • Begin working on the revisions. Incorporate the
    revisions that you think make your proposal
    better than the previous submission
  • Many funded proposals were funded after multiple
    submissions ? intelligent perseverance is the key!

123
Recap Tips for Success with NIH Grants
  • Identify your "IC home"
  • Get to know your Program Officer
  • Sign up for the Weekly NIH Funding Opportunities
    and Notices
  • Study the "how-to" NIH websites
  • Look for various opportunities to acquire
    funding, e.g., diversity supplements, career
    awards
  • Partner with established NIH investigators
  • Read the solicitation
  • Develop a descriptive title
  • Write a concise, non-ambiguous Abstract/Summary
  • Write Specific Aims that are hypothesis-driven
    with clear, measurable outcomes

124
The Last WordThe proposal is the only reality
  • A proposal is not unlike a novel or a movie. It
    creates its own, self-contained reality. The
    proposal contains all the funding agency and
    review panel will know about your capabilities
    and your capacity to perform. With few
    exceptions, an agency bases its decision to fund
    or not to fund entirely on the proposal and the
    persuasive reality it creates.

125
NIH Web Resources
  • National Institutes of Health http//www.nih.gov/
  • Grant Application Basicshttp//grants.nih.gov/gra
    nts/grant_basics.htm
  • All About Grants Tutorialhttp//www.niaid.nih.gov
    /ncn/grants/default.htm
  • New Investigator Portalhttp//www.niaid.nih.gov/n
    cn/grants/new/portal.htm
  • Annotated R01 Research Plan and Summary
    Statementhttp//www.niaid.nih.gov/ncn/grants/app/
  • Mock Peer Review Videohttp//www.csr.nih.gov/Vide
    o/Video.asp
  • CRISP funded biomedical researchhttp//crisp.cit.
    nih.gov/

126
Life Science Funding Source Listings
  • Grants.gov http//www.grants.gov
  • National Institues of Health
  • Office of Extramural Research http//grants.nih.go
    v/grants/OER.htm
  • Individual Institutes and Centers
  • National Science Foundation http//www.nsf.gov/
  • Find Funding http//www.nsf.gov/funding/
  • Funded Research http//www.nsf.gov/awardsearch/
  • GrantsNet sponsored by AAAS and
    HHMI http//sciencecareers.sciencemag.org/funding
  • Congressionally Directed Medical Research
    Programs http//cdmrp.army.mil/funding/default.ht
    m
  • Philanthropy News Digest RFP listings http//found
    ationcenter.org/pnd/rfp/
  • American Cancer Society http//www.cancer.org/docr
    oot/RES/RES_0.asp
  • American Heart Association http//www.americanhear
    t.org/presenter.jhtml?identifier9713
  • Cancer Research Institute http//www.cancerresearc
    h.org/criprogs.html
  • Life Sciences Research Foundation http//www.lsrf.
    org/geninfo.htm

127
Additional Resources
  • Office of Proposal Development,
    TAMUhttp//opd.tamu.edu/
  • Funding Opportunitieshttp//opd.tamu.edu/funding-
    opportunities
  • Resources for Junior Facultyhttp//opd.tamu.edu/r
    esources-for-junior-faculty
  • The Craft of Grant Writing workbookhttp//opd.tam
    u.edu/the-craft-of-writing-workbook
  • National Science Foundationhttp//www.nsf.gov/
  • Find Fundinghttp//www.nsf.gov/funding/
  • Funded Researchhttp//www.nsf.gov/awardsearch/

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Grant Writers' Seminars and Workshops http//gran
tcentral.com/
131
Questions?
  • Copies of this presentation will be available on
    the OPD websitehttp//opd.tamu.edu/
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