AUA Grant Writing Workshop

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AUA Grant Writing Workshop

• Dr. Gary Smith Dr. James Marshall
• Roswell Park Cancer Institute

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Presenters

• Dr. James R. Marshall
• Senior Vice President for Cancer Prevention and
  Population Sciences
• Co-Leader of the Chemoprevention Program
• Roswell Park Cancer Institute
• Buffalo, New York
• Dr. Gary J. Smith
• Distinguished Professor of Urologic Oncology
• Co-Leader of the Prostate Program
• Roswell Park Cancer Institute
• Buffalo, New York

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I. Grant Preparation
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GRANTSMANSHIP

• For most, grant writing is an acquired skill
• You should test your ideas and generate your
  hypotheses with a senior colleague(s) before you
  begin writing
• Seek out senior faculty colleagues with study
  section experience or who have been successful at
  winning grants
• You should develop your proposal with the
  guidance of a senior colleague(s)
• Grant development is an iterative process
• Initial draft should be ready 4-6 weeks before
  submission dead line

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Before Beginning Your Grant Application

• Select the study section most appropriate to
  review your grant
• Based upon the stated area of expertise of the
  study section and / or the members of the study
  section
• Center for Scientific Review (CSR)
• http//www.csr.nih.gov/
• Select the institute(s) your application should
  be assigned to?
• http//www.nih.gov/icd/
• Prepare a strong cover letter justifying the
  study section and institute you believe is
  appropriate

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Before Beginning Your Grant Application

• After you have identified the institute that you
  feel is most appropriate for your application
• Identify the specific Program within the
  Institute that matches your project and contact
  the Program Officer
• Get advice on
• the priorities of the institute
• PAs and RFAs that match your area of interest
• How to structure a competitive proposal
• What are issues specific to an application from a
  New Investigator

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Preparing your grant application

• The RO1 Grant Application as a Paradigm
• - (eg. DOD, ACS, NSF, contract etc.)

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Essential Elements of a Grant Proposal

• A testable hypothesis
• How you will validate / refute the hypothesis
• Specific aims
• Background and Significance
• Preliminary Results / Progress Report
• Experimental Design

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Face Page
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Face Page
New Investigator?
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Face Page
Response to PA or RFA?
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Face Page
Vertebrate Animals
Human Subjects
Exempt
IACUC
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Face Page
JIT Just in Time
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Face Page
Institutional Agreement
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Description and Performance Sites
The Abstract is now utilized as the description
or summary of the project. Follow the
suggestions. Include -The problem
-Hypothesis -Goals -Specific Aims -Overall
experimental approach for each Aim Do
not include -Literature review -Discussion
of data
Description (Abstract)
Performance Sites
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Key Personnel and Embryonic Stem Cells
Key Personnel
Other Significant Contributors
Human Embryonic Stem Cells
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Table of Contents
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First Year Detailed Budget
Effort Committed to Project
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First Year Detailed Budget
Categorize and Give Cost of Individual
Categories -experienced laboratory
researchers are reviewing
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First Year Detailed Budget
Indirect Costs of Consortium Projects are now
part of Direct Cost of the total project
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Budget for Entire Period
Budget Justification
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Budget Justification

• Propose realistic effort commitments
• Fully justify
• Personnel roles and responsibilities
• Equipment budget year and commitment to this
  project
• Supplies general categories, animal expenses
  and special items
• Other Expenses Fee-for-service costs, animal
  per diems, service contracts, publication and
  communication expenses

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Budget Justification
Modular Budget Increments of 25K
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Biographical Sketch
Yours and all key individuals
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Other Support
Active Pending Completed
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Resources
Describe access to critical pieces of
instrumentation - In your laboratory - In
core facilities
If independence is in question, get letter of
commitment from Dean or Department Chair
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Resubmission

• Rebuttal or Introduction
• Approximately three pages
• Address all major comments in the critique
• Highlight the positive comments
• Agree or disagree with negative comments
• Positive tone, not argumentative

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Page Limits

• Research Plan (Sections A-D)
• Limit 25 pages
• -Including figures, tables, and diagrams

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Research Plan

• Sections A D
• 25 pages total do not exceed
• use 12 point fonts
• observe margins
• not a requirement to fill the entire 25 pages
• General Recommendation
• A. Specific aims
  1 page
• B. Background and Significance
  3 pages
• C. Progress Report / Preliminary Results
  8-10 pages
• D. Experimental Methods
  10-12 pages

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Research Plan

• A. Specific Aims
• B. Background and Significance
• C. Preliminary Studies / Progress Report
• D. Experimental Methods

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A. Specific Aims

• State long-term goals
• Briefly set up the problem
• Provide general goals
• Provide a testable hypothesis
• A yes or no answer
• State specific aims to test hypothesis
• Can provide brief description of general
  experimental approach

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A. Specific Aims

• Aims should be interrelated
• Project should not depend on the successful
  completion of Aim 1
• If you need reagents, expertise or access to
  instrumentation to perform a proposed study, get
  strongly positive letter (not form letter) from
  that investigator / company

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Research Plan

• A. Specific Aims
• B. Background and Significance
• C. Preliminary Studies / Progress Report
• D. Experimental Methods

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B. Background and Significance

• Describe the problem to be investigated
• Describe the state-of-the-art literature in the
  field
• be up-to-date (otherwise, the problem appears
  dated, or the application appears recycled with
  little effort)
• Be focused, do not go off into unrelated areas
• Describe how your relevant studies are consistent
  with, or do not support, the current party-line
• set the stage for the studies to be discussed in
  preliminary results, do not repeat
• Provide a figure/model that summarizes the system
• Demonstrates your grasp of the field and helps
  reviewer
• Restate your objective at conclusion of section
  to keep fresh in reviewers mind

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Background and Significance (contd)

• Do not expect all / any of your assigned
  reviewers to be expert (or even familiar) in the
  field
• Provide them sufficient background to appreciate
  the uniqueness and importance of your project

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Research Plan

• A. Specific Aims
• B. Background and Significance
• C. Preliminary Studies / Progress Report
• D. Experimental Methods

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C. Preliminary Studies (for new grant
applications)

• Present the data relevant to the application, not
  everything you have ever done
• relevant figure(s), summary tables with
  statistics are better than representative
  images
• establish your expertise with the techniques to
  be utilized in the proposed project
• At the end of this section, summarize how your
  work advances the field, or provides new
  paradigms
• in a short paragraph

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C. Preliminary Studies (for new grant
applications) contd

• Do not provide critical data only in the
  appendix, you cannot expect reviewers to look at
• Appendices may be stopped with electronic
  submissions
• Reviewers are established scientists, do not
  present weak data, grossly over interpret data,
  or present data that contradicts your hypothesis

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C. Progress Report (for competing grant
applications)

• Summarize briefly your progress for each of the
  Aims of the funded project
• Organize the presentation of studies according to
  the Aims of the funded project
• You are judged on your completion of the proposed
  aims

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Research Plan

• A. Specific Aims
• B. Background and Significance
• C. Preliminary Studies / Progress Report
• D. Experimental Methods

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D. Research Design and Methods

• For each specific aim
• Restate the specific aim
• Summary or Introduction
• Focus the studies in that aim
• Brief review of critical literature and your
  results
• Describe the research design and procedures as
  subsections, and relate to the focus of the aim
• If you have demonstrated experience with a
  method(s) (ie., published or shown in Prelimary
  Results) dont describe in detail
• Focus on rationales and how the experiments fit
  together to address the goal of the aim
• Filling the space with experimental minutia,
  unless for a unique protocol, suggests
  unfamiliarity with technique(s) or lack of ideas

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D. Research Design and Methods (contd)

• Be concrete We will measure PSA expression
• Describe experiments with sufficient detail so
  the reviewers will understand your intent and
  whether the experiment can be performed
  successfully
• Discuss in a separate subheading
• Statistical Analysis
• Anticipated results
• Potential problems
• Alternative solutions

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D. Research Design and Methods (contd)

• Maintain the level of the presentation throughout
  the aims
• Do not spend 10 pages on Aim 1, and a single
  paragraph each on aims 2 and 3
• Highlight the inter-related nature of the aims,
  but also that failure of a single aim does not
  preclude definitive testing of the hypothesis

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Research Plan

• E. Human Subjects
• (part of review criteria)

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Research Plan

• E. Human Subjects
• (part of review criteria)

U.S. Department of Health and Human
Services Public Health Service Grant Application
(PHS 398) PART II Supplemental Instructions
for Preparing the Human Subjects Section of the
Research Plan
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Human Subjects Section

• For all research involving human subjects, a part
  of the peer review process will include careful
  consideration of protections from research risks,
  as well as the appropriate inclusion of women,
  minorities, and children. The Scientific Review
  Group (SRG) will assess the adequacy of
  safeguards of the rights and welfare of research
  participants, and the appropriate inclusion of
  women, minorities, and children, based on the
  information in the application.
• Item E. of the Research Plan (Human Subjects
  Research) answer the following five questions
• Question 1 Does your proposed research involve
  human subjects?
• Question 2 Does your proposed human subjects
  research meet the criteria for one or more of the
  exemptions in the HHS regulations (45 CFR Part
  46)?
• Question 3 Does your proposed research meet the
  definition of clinical research?
• Question 4 Does your proposed research include a
  Clinical Trial?
• Question 5 Does your proposed research meet
  criteria for an NIH-Defined Phase III Clinical
  Trial?
• Click on the questions and when you can answer
  the five questions, select the scenario that best
  matches your responses, and then follow the
  instructions provided for the scenario you
  choose.

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Research Plan

• F. Vertebrate Animals
• (part of review criteria)
• Detailed description of proposed studies
  (species, strain, age, sex, number)
• Justify use of animals
• Describe methods of analgesia and anesthesia
• Describe method of euthanasia

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Research Plan

• G. Literature Cited

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Research Plan

• H. Consortium/Contractual Arrangements

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Research Plan

• Checklist

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Research Plan

• Personal Data

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Electronic Submissions of NIH Grants

• Department of Defense (CDMRP) pioneered
  electronic submission
• All federal funding agencies are switching to
  electronic submission through www.grants.gov

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Electronic Submissions of NIH Grants

• SF424 Research and Related RR) family of
  forms.
• Information on registering for electronic
  submission is available at http//grants.nih.gov/g
  rants/guide/noticefiles/NOT-OD-05-067.html.
• Updates regarding the transition process are at
  http//era.nih.gov/ElectronicReceipt/

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A Walk Through The SF424 (RR)
Begin Segments of an NIH Slide Presentation http/
/era.nih.gov/ElectronicReceipt/presentations/a_wal
k_through_the_sf424_rr.ppt http//grants.nih.gov/g
rants/funding/424/sf424_rr_guide_general_ver2.doc
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Features of the SF424 (RR)

• The SF424 (RR) is an application form that is
  comprised of common data elements developed for
  use by Federal agencies funding Research and
  Research-Related programs
• Also provides a consistent electronic submission
  process through Grants.gov

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Features of the SF424 (RR)

• SF424 (RR) Components include
• SF424 (RR)An application cover component
• Research Related Project/Performance Site
  Location (s)
• Research Related Other Project Information
• Research Related Senior/Key Person
• Research Related Budget
• Research Related Personal Data (NIH will not
  use)
• RR Subaward Budget Attachment Form

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Features of the SF424 (RR)

• NIH requires additional data collection to
  accommodate the unique information required for
  review of its biomedical research portfolio.
  Therefore, NIH has also developed agency-specific
  components (titled PHS 398)
• PHS 398 Cover Letter File
• PHS 398 Cover Page Supplement (supplements the
  RR Cover)
• PHS 398 Modular Budget
• PHS 398 Research Plan
• PHS 398 Checklist
• Why call them PHS 398?
• Needed a generic term since other HHS agencies
  will use
• Its the OMB-cleared data collection instrument
  that gives us the authority to request these
  additional data elements

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Features of the SF424 (RR)

• Application components include specific data
  fields as well as multiple attachments
• Most attachments are text
• NIH requires PDF for text attachments
• Applicants will need PDF-creation software
• Attachments can be generated using any word
  processing software but will need to be converted
  to PDF before they can be attached to the
  application form
• Do not include headers or footers in the text
  pages

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Features of the SF424 (RR)

• After submission, the eRA system will
• Generate a Table of Contents
• Assemble the grant image
• Include headers (PI name) footers (page
  numbers) on all pages
• Applicants (AOR/SO PD/PI) will have 2 weekdays
  to view this grant image in the eRA Commons

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Component SF424 (RR) A Cover Component

• Similar to the PHS 398 Face Page
• Provides general information about the applicant
  organization, contact information for the PD/PI
  and AOR/SO
• Provides application-specific information (type,
  title etc.)

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SF424 (RR) - A Cover Component A Few Data
Issues

• Item 1, Type of Submission
• Pre-applicationinstructed not to use unless
  specifically noted in FOA
• Changed/Corrected Application To be used only
  when correcting an application that failed system
  validations. This is NOT a resubmission
  (amendment).
• Item 5, Applicant Information This is for the
  applicant organization

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SF424 (RR) - A Cover Component A Few Data Issues

• Item 8, Type of Application--New Terminology
• New is the same
• Resubmission is equivalent to a Revision (a
  revised or amended application)
• Renewal is equivalent to a Competing Continuation
• Continuation is equivalent to a Progress Report.
  For the purposes of NIH and other PHS agencies,
  the box for Continuation will not be used and
  should not be checked.
• Revision is somewhat equivalent to a Competing
  Supplement

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Component Research and Related
Project/Performance Site Locations

• Equivalent to the PHS 398 Form Page 2 Performance
  Site section
• Collects individual data for up to 8 locations
• gt8 locations information is provided in an
  attachment (not structured data, just text)
• Format for the gt8 attachment available on SF424
  (RR) Forms Page http//grants.nih.gov/grants/fun
  ding/424/index.htm

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Component Research and Related Other Project
Information

• Includes information on involvement of Human
  Subjects, Vertebrate Animals, Environmental
  Impact, Foreign Involvement
• Includes separate PDF attachments for
• Project Summary/Abstract (Description)
• Project Narrative
• NIH will use this upload for the Relevance
  section of the Abstract
• Separate component developed for Research Plan
• Bibliography References (previously section G.
  Literature cited)
• Facilities Other Resources
• Equipment Resources

Equivalent to PHS 398 Resources Format Page
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Component Research and Related Senior/Key Person

• Credential Must enter the eRA Commons User Name
  - for the PD/PI, this is a mandatory field for
  NIH submissions. (1 Validation Failure to date)
• Biosketch is attached for each person
• Same data requirements exist however, page
  limits slightly change to just 4 pages
• Eliminated the 2-page limit for subsections
• Note, Attachment for Current Pending Support
  (a.k.a. Other Support) will not be used at time
  of submission unless specified in FOA. For most
  applications, this will continue to be a
  Just-In-Time submission

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Component Research and Related Budget, Sections
A B

• Personnel separated into 2 sections
• A. Senior/Key Person
• Allows 8 as named individuals structured data
• gt8 information is provided in an attachment (not
  structured data, just text)
• Info for PD/PI must be entered, even if 0
• B. Other Personnel
• Postdocs, Grad Students, Undergrads captures
  only
• NIH will request more detail in Budget
  Justification

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Component PHS 398 Research Plan

• Separate PDF attachments for each section
  (designed to maximize benefits of system
  validations to accommodate bookmarking of the
  image)
• Same formatting requirements in the PHS 398
  continue here margins, page limits, etc.
• Appendix Material
• Allows up to 10 separate attachments
• Will be stored separately in the eRA Grant
  Folder, not as a part of the main application
  grant image
• Will be accessible to appropriate NIH staff and
  peer reviewers
• New! Effective for the May 10, 2006 submission
  dates and beyond, use links to on-line journals
  for publication references when available. See
  Guide Notice http//grants.nih.gov/grants/guide/
  notice-files/NOT-OD-06-051.html

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Component PHS 398 Research Plan Helpful Hints

• Create as a single document using any word
  processing software. Separate only at the end
  before uploading.
• Do not include headers or footers
• Do include a section heading as part of the text
  i.e., Specific Aims, Background Significance
• Avoid 2-column format for text
  (difficult for reviewers to read electronically)
• Avoid scanning when text has been generated using
  a word processing tool
  (Specific Aims, etc.)

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What Will a Completed Application Look Like?

• After submission, the eRA system will
• Assemble the grant image
• Generate a Table of Contents
• Include headers (PI name) footers (page
  numbers) on all pages
• Sample Document eRA Assembly of the SF424 (RR)
  Application
• Includes a sample Table of Contents, and
• a chart cross-referencing the location in the
  forms components for each piece of the grant
  image.
• http//grants.nih.gov/grants/funding/424/index.ht
  m

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New TerminologyType of Application
RR Type of Application also includes
Continuation. This is equivalent to our
Progress Report or T-5. NIH will not use the RR
for progress reports.
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New Terminology
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New Terminology
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NIH Planned Transition Dates of Mechanisms for
Electronic Submission using the SF424 (RR)
Resource (G7, G8, G11, G13, G20), Career
Development (K), S11, S21, S22 (Jun. 1, 2007)
SBIR/STTR (Dec. 1, 2005)
R13/U13 (Dec. 15, 2005)
R18/U18, R25, C06/UC6 (Oct. 1, 2006)
Fellowship (F) (Aug. 5, 2007)
R36 (Feb. 17, 2006)
Potential R01 Multi-PI Pilot (Oct. 1, 2006)
R15 (Feb. 25, 2006)
Training (TD), U45, D71/U2R (Sep. 10, 2007)
S10 (Mar. 22, 2006)
X02 (April 18, 2006)
DP1(Jan. 22, 2007)
X01 (May 18, 2006)
Project/Center (P), G12, M01, S06, R10/U10, U01,
U19, U54, U56, R24/U24 (Oct. 1, 2007)
R01(Feb. 1, 2007)
R03, R21/R33, R34(June 1, 2006)
10
08
10
08
12
11
05
07
12
09
01
02
03
04
05
01
02
03
04
06
06
07
09
2006
2007

• Current as of February 2, 2006. Visit the Web
  site for the latest version http//era.nih.gov/El
  ectronicReceipt/

Mechanism Abbreviation Key C06/UC6 Research
Facilities Construction Grants DP1 NIH Directors
Pioneer Award Program D71/U2R International
Training Cooperative Agreement/
Phase 2 of FIC mechanism D71 R01
Research Project Grant Program R03
Small Grant Programs R10/U10 Cooperative
Clinical Research Grants R13/U13 Support for
Conferences Scientific Meetings R15
Academic Research Enhancement Awards
(AREA) R18/U18 Research Demonstration and
Dissemination Projects
R21/R33 Exploratory/Development
Research R24/U24 Resource Related Research
Projects R25 Education Projects R34
Clinical Trial Planning Grant Program R36
Research Dissertation Grant Program SBIR
Small Business Innovation Research STTR
Small Business Technology Transfer S06,S10,S11
Biomedical Research S21,22 Health Disparities
Endowment Grants U Cooperative
Agreement Awards X02 Preapplication
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Rules for Submission

• Applications are accepted by Grants.gov by 500pm
  local time of the applicant organization on the
  submission date
• Only the AOR is allow to submit
• NIHs late application policy still in
  effect

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Next Steps Grantees

• Review Electronic Submission website
  http//era.nih.gov/ElectronicReceipt/
• Familiarize yourself with the forms and
  application guide(s)
• Application guides and sample versions of
  application packages are available at
  http//grants.nih.gov/grants/funding/424/index.htm
  
• Must have PureEdge Viewer installed in order to
  manipulate the sample application packages.
  (Check with your IT folks for permission and
  assistance in downloading this software)
• Review available training resources brochures,
  video library, video webcasts
  http//era.nih.gov/ElectronicReceipt/training.htm
  

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Training Tools

• Registration in the eRA Commons Demo
  http//era.nih.gov/virtualschool/external/c101_Gra
  nteeRegistrationProcess.htm
• Grants.govs How to Complete An Application
  Package Demo http//www.grants.gov/images/Applica
  tion_Package.swf
• SF424 (RR) application guides, sample
  application packages and related resources
  http//grants.nih.gov/grants/funding/424/index.htm
  

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A Walk Through The SF424 (RR)
Conclusion of NIH Slide Presentation
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Successful Grant Applications

• Clearly written
• Proof-read
• Innovative
• Within the capabilities of the investigator
• Address an important problem
• Provide a game-plan for your next five years of
  work

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II. FUNDING SOURCES/MECHANISMS
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POTENTIAL SOURCES OFFUNDING

• National Institutes of Health (NIH)
• Department of Defense (CDMRP)
• VA
• Other PHS divisions CDC, AHRQ, NSF
• Foundations
• Pharmaceutical companies

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More Funding Information

• You can sign on to list serves
• NIH Funding http//nih.gov/grants/oer.htm
• DOD Funding http//cdmrp.army.mil/

82
Types of NIH Grant Awards

• NIH Grants Office of Extramural Research
• http//grants1.nih.gov/grants/oer.htm
• Grant Mechanisms
• National Research Service Awards (F_)
• Pre-and post-doctoral fellowships
• Research Grant Programs (R_)
• Career Development Awards (K_)
• Small Business Development (SBIR, STTR)
• SBIR (R41) Small Business Innovation Res
• STTR (R43) Small Business Tech Transfer

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National Research Service Awards

• Purpose
• NIH Research Training and Career Development
  Programs help ensure that a diverse pool of
  highly trained scientists are available in
  adequate numbers and in appropriate research
  areas to address the Nations biomedical,
  behavioral, and clinical research needs.

84
National Research Service Awards (NRSA)

• Established by the NRSA Act of 1974
• Institutional Training Grants (T32, T35)
• Individual Fellowships (F31, F32, F33)
• Only NIH award that goes to individual
• 5 years support for grad/med students
• 3 years support for post-doctoral fellows
• Must be a U.S. citizen or permanent resident
• Pay back provisions

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NRSA Grant Application

• Scholastic Performance
• Research Experience / Training Plan
• Personal Data Form
• Biographical Sketch
• Facilities and Commitment
• Criteria for evaluation
• candidate,
• training plan,
• success of training program

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Individual NRSA Grants

• F31 Ruth L. Kirschstein National Research
  Service Award Predoctoral Fellowship
• support for research training leading to a Ph.D.
  (or the equivalent research degree) or a combined
  M.D./Ph.D. (or other combined professional
  research doctoral degrees) in the biomedical or
  behavioral sciences.
• F32 Ruth L. Kirschstein National Research
  Service Award Postdoctoral Fellowship
• support for postdoctoral research training to
  individuals to broaden their scientific
  background and extend their potential for
  research in specified health related areas

87
Institutional NRSA Grants

• T32 National Research Service Award
  Institutional Training Grants
• support training opportunities at the predoctoral
  or postdoctoral level at qualified institutions
• Program Director is responsible for selecting the
  trainees and administering the program
• T36 - Minority Access to Research Careers (MARC)
• support to increase the number of well-trained
  minority scientists in biomedical disciplines and
  strengthen the research and teaching capabilities
  of minority institutions

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NIH Research Grant Program (R_)

• Purpose
• The NIH Research Grant Program is to
  support investigator initiated research at not
  for profit and for profit institutions

89
Most Common Research Grants

• P01 Research Program Project Grant
• support integrated, multi-project research
  approach involving a number of independent
  investigators
• each project should contribute or be directly
  related to the common theme
• R01 Research Project Grant
• support discrete, specified research projects
  performed by the named investigator(s) in an area
  representing his/her specific interest and
  competencies

90
Small Research Grants

• R03 Small Research Grant
• support specifically limited in time and amount
  for initiating studies that are generally
  preliminary short-term projects
• R21 Exploratory/Developmental Grant
• support the development of pilot projects or
  feasibility studies to support creative, novel,
  high-risk/high-payoff
• levels of support and time are restricted.
• R33 Exploratory/Developmental GrantPhase II
• Second phase of support of research activities
  initiated under the R21 mechanism.

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Small Business Research Grants

• R43 Small Business Innovation Research (SBIR)
  GrantPhase I
• Support research efforts by for-profit, domestic,
  small businesses.
• Limited in time and amount
• used to establish the technical merit and
  feasibility of ideas that have a potential for
  commercialization.
• R44 Small Business Innovation Research (SBIR)
  GrantPhase II
• Continue support for efforts initiated in Phase
  I, with the ultimate goal of achieving
  commercialization
• Only Phase I awardees are eligible for Phase II
  awards.

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Program Announcement (PA)

• Invites grant applications in a research area of
  interest to the institute, an area that does not
  attract many grants or of a new / expanded
  interest in a particular extramural program
• Funds not set aside to support projects
• Applications reviewed by CSR along with
  unsolicited grant applications

93
Requests for Applications (RFA)

• Institute based-initiative for studies in a
  well-defined area
• Applications are for a one-time competition
• Funds are set-aside for a limited number of
  awards
• Applications are reviewed within the institute

94
NIH Career Development Awards (K_)

• Purpose
• The Career Development Awards are designed to
  provide mentored development of research careers,
  transitions of career emphasis, protected time
  for research by clinicians, and support for
  outstanding scientists with a sustained level of
  high productivity

95
NIH Career Development Programs

• Thirteen Different Mechanisms
• Match with the stage of career
• Mentored, Mid-career, Senior
• Can be interactive with other NIH Awards

96
Mentored Research Grants

• K01 Mentored Research Scientist Development
  Award
• provide research scientists with a sponsored
  research experience that will help the applicant
  gain expertise in a new research area or
  demonstrably enhance the applicants scientific
  career
• Sunsets July 2, 2006 Replaced by the NIH Pathway
  to Independence
• K25 Mentored Quantitative Research Career
  Development Award
• support the career development of investigators
  with quantitative scientific and engineering
  backgrounds outside of biology or medicine who
  have made a commitment to focus their research
  endeavors on behavioral and biomedical research
  (basic or clinical)
• K22 Career Transition Award
• support newly trained investigators (basic or
  clinical) to develop their independent research
  skills through a two phase program.
• initial period involves an intramural appointment
  at the NIH
• final period of support is conducted at an
  extramural institution.
• research in Cancer Prevention Control

97
NIH Pathway to Independence Award K99/R00

• Postdoctoral scientists receive both mentored
  independent research support from the same award
• 1-2 year mentored phase (K99)
• independent phase, occurs in years 3-5 (R00)
• Goal to facilitate awardee
• secure an assistant professorship (or equivalent)
• establish and independent research program
• apply for an investigator-initiated grant

98
Mentored Clinical Grants

• K08 Mentored Clinical Scientist Development
  Award
• support the development of outstanding clinical
  research scientists
• Provide specialized study for clinically trained
  professionals who are committed to a career in
  research and have the potential to develop into
  independent research scientists
• K12 Mentored Clinical Scientist Development
  Program Award
• Support newly trained clinicians appointed by an
  institution for development of independent
  research skills and experience in a fundamental
  science within the framework of an
  interdisciplinary research and development
  program.
• K23 Mentored Patient-Oriented Research Career
  Development Award
• support for the career development of
  investigators who focus their research endeavors
  on patient-oriented research
• provides support for a period of supervised study
  and research for clinically trained professionals

99
Other Award Mechanisms

• R15 Academic Research Enhancement Award (AREA)
• support small-scale research projects conducted
  by faculty in domestic institutions that
  primarily award baccalaureate degrees.
• S06 Minority Biomedical Research Support (MBRS)
• provide funds to strengthen the biomedical
  research and research training capability of
  ethnic minority institutions, thus creating a
  more favorable environment for increasing the
  involvement of minority faculty and students in
  biomedical research.
• K07 Academic Career Award
• support
• junior candidates who are interested in
  developing academic and research expertise in a
  specific area
• senior individuals with acknowledged scientific
  expertise and leadership skills who are
  interested in improving the curricula and
  enhancing research capability within an academic
  institution.

100
Department of Defense Prostate Program

• Congressionally Directed Medical Research Program
  (CDMRP)
• Funds added to the DOD budget by Congress
• Grants are funded in full upon award
• Emphasis is adapted yearly to accommodate rapid
  change
• Highly flexible model to address research gaps
• Consumer advocate participation
• Two-tiered formal review of proposals

101
Department of Defense Applications

• The First TierScientific Peer Review
• Peer Review Panels
• 21 panels covering multiple broad scientific
  disciplines
• The Second TierProgrammatic Review
• comparison-based process that takes into account
  scientific evaluations across all disciplines and
  specialty areas.
• carefully scrutinizes all assigned proposals to
  allocate the limited funds available for each
  award mechanism
• criteria ratings and evaluations of the peer
  reviewers (scientists and consumers)
  programmatic relevance relative innovation and
  impact program portfolio balance and adherence
  to the intent of the award mechanism. After
  programmatic review,
• the Commanding General of the USAMRMC approves
  funding for the proposals recommended during
  programmatic review.

102
PROSTATE CANCER RESEARCH PROGRAM (PCRP)

• Research Awards
• Idea Development
• New Investigator
• Health Disparity Research
• Exploration Hypothesis Development
• Clinical Trial
• Clinical Consortium
• Training/Recruitment Awards
• Physician Research Training
• Prostate Cancer Training
• Health Disparity Training Prostate Scholar
• Collaborative Undergraduate HBCU1 Student Summer
  Training Program
• HBCU Collaborative Partnership

103
Department of Defense Grant Application

• Abstract
• Lay Abstract
• Statement of Work
• Main Body
• Background
• Experimental Problem
• Pertinent Preliminary Data
• Hypothesis/Rationale
• Objectives/Specific Aims
• Methods
• Abbreviations
• References

104
Veterans Administration

• VA Merit Award Must have 5/8ths appointment.
• Research Career Development Award
• 5/8ths appointment not required.
• Goal is to attract new investigators to VA system
• Clinical Research Career Development Program-
• training in clinical research
• http//www1.va.gov/resdev/

105
Foundations

• American Urological Association Foundation
• http//www.auafoundation.org
• grants_at_auafoundation.org
• American Cancer Society
• http//www.cancer.org
• Prostate Cancer Foundation Association for cure
  of cancer of the prostate
• http//www.prostatecancerfoundation.org/
• National Kidney Foundation
• http//www.kidney.org
• American Diabetes Association
• www.diabetes.org

106
American Urologic Association

• AUA Foundation Programs for Career Development
  Awards
• AUA F / NIDDK / NCI Surgeon-Scientist Award
• AUA Foundation / Astellas Rising Stars in
  Urology Awards
• Support for grants that fail to make pay line but
  can be resubmitted
• Supported in part by proceeds from Run for
  Research

107
III. The Grant Review Process
108
Grant Review Process
YOU
CSR
NIH PROGRAM
INSTITUTE COUNCIL
109
III.A. Center for Scientific Review (CSR)
110
IDEA
PROPOSAL SUBMITTED TO eRA COMMONS
NIH REFERRAL OFFICER
CENTER FOR SCIENTIFIC REVIEW (CSR)
INTEGRATED REVIEW GROUP (IRG)
Score and Summary Statement
NIH PROGRAM DIRECTOR
STUDY SECTION
SCIENTIFIC REVIEW ADMINISTRATOR (SRA)
SECRET VOTE
PEER REVIEWER
DISCUSSION IN REVIEW PANEL
111
The Dual Review Process

• Before the review process starts
• Institute and SRG are assignment by an NIH
  Referral Officer based on
• Title
• Abstract
• Cover Letter
• Electronic record of the
• Referral number -- 1 R01 CA012345-01
• Institute - can receive a dual assignment
• SRG assignment (CSR)
• Program Director (NIH Institute)

112
Center for Scientific Review (CSR)

• Application assignment based upon topic of
  proposal and expertise of the members of the
  Review Panel (Study Section)
• Review Panels are independent of the NIH
  Institutes
• Each panel reviews proposals assigned to multiple
  Institutes
• NIH Institute-based Program Directors have no
  role in the peer review process
• Program Directors may attend Review Panel
  Meetings to listen to the review of proposals
  assigned to their program
• Program Directors do not participate in the
  review
• Program Directors do not have access to the
  written reviews or private scores essentially
  until available to the PI

113
Center for Scientific Review (CSR)

• Scientific Review Administrators (SRAs) are the
  leader of each Review Panel (Study Section)
• Recruit peer reviewers
• With Panel Chair assign applications to
  individual peer reviewers
• Prepare Summary Statements (Pink Sheets)
• Your contact for any matter through the
  conclusion of the review
• Receives supplemental data and distributes
• When review completed, your contact switches to
  the NIH Program Directors assigned to the
  application

114
Center for Scientific Review (CSR)

• Review activities are organized into Integrated
  Review Groups (IRGs).
• Each IRG represents a cluster of study sections
  around a general scientific area. Applications
  generally are assigned first to an IRG, and then
  to a specific study section within that IRG for
  evaluation of scientific merit.
• CSR Provides links to
• the IRGs and a general description, specific
  research areas covered
• list of study sections within that IRG and the
  specific areas covered
• shared interests with other study sections and
  IRGs
• email access to its Scientific Review
  Administrator (SRAs)
• membership and meeting rosters of a study section
• meeting dates
• CSR http//grants.gov
• IRG http//www.csr.nih.gov
• Study Section Roster http//www.csr.nih.gov/Commi
  ttees/rosterindex.asp

115
The Department of Health and Human Services (HHS)

• The HHSs mission is to enhance the health and
  well-being of Americans by providing effective
  health and human services and by fostering
  strong, sustained advances in the science
  underlying medicine, public health, and social
  services.
• HHS has 11 operating divisions
• Administration for Children and Families (ACF)
• Administration on Aging (AoA)
• Agency for Healthcare Research and Quality (AHRQ)
• Agency for Toxic Substances and Disease Registry
  (ATSDR)
• Centers for Disease Control and Prevention (CDC)
• Centers for Medicare and Medicaid Services (CMS)
  (formerly the Health Care Financing
  Administration HCFA)
• Food and Drug Administration (FDA)
• Health Resources and Services Administration
  (HRSA)
• Indian Health Service (IHS)
• National Institutes of Health (NIH)
• Substance Abuse and Mental Health Services
  Administration (SAMHSA)

116
CSR Integrated Review Groups
AARR - AIDS and Related Research BBBP -
Biobehavioral and Behavioral Processes BCMB -
Biological Chemistry and Macromolecular
Biophysics   BDA - Biology of Development and
Aging BST - Bioengineering Sciences and
Technologies BDCN - Brain Disorders and Clinical
Neuroscience CB - Cell Biology   CVS -
Cardiovascular Sciences DIG - Digestive
Sciences EMNR - Endocrinology, Metabolism,
Nutrition and Reproductive Sciences   GGG -
Genes, Genomes and Genetics HOP - Health of the
Population HEME - Hematology IMM - Immunology IDM
- Infectious Diseases and Microbiology IFCN -
Integrative, Functional, and Cognitive
Neuroscience MDCN - Molecular, Cellular, and
Developmental Neuroscience   MOSS -
Musculoskeletal, Oral and Skin Sciences ONC -
Oncological Sciences   RES - Respiratory
Sciences RPHB - Risk, Prevention and Health
Behavior RUS - Renal and Urological Sciences SBIB
- Surgical Sciences, Biomedical Imaging, and
Bioengineering

117
ONC - Oncological Sciences IRG

• Study Sections
• Cancer Etiology Study Section CE
• Cancer Genetics Study Section CG
• Molecular Oncogenesis Study Section MONC
• Cancer Molecular Pathobiology Study Section
  CAMP
• Tumor Cell Biology Study Section TCB
• Tumor Microenvironment Study Section TME
• Tumor Progression and Metastasis Study Section
  TPM
• Chemo/Dietary Prevention Study Section CDP
• Cancer Biomarkers Study Section CBSS
• Radiation Therapeutics and Biology Study Section
  RTB
• Cancer Immunopathology and Immunotherapy Study
  Section CII
• Drug Discovery and Molecular Pharmacology Study
  Section DMP
• Developmental Therapeutics Study Section DT
• Basic Mechanisms of Cancer Therapeutics Study
  Section BMCT
• Clinical Oncology Study Section CONC
• Oncological Sciences Small Business Activities
  SBIR/STTR Special Emphasis Panels ONC Small
  Business SEPs
• Oncological Sciences Fellowship Study Section
  F09
• Oncological Sciences IRG ONC

118
RUS - Renal and Urological Sciences IRG

• Study Sections
• Cellular and Molecular Biology of the Kidney
  CMBK
• Pathobiology of Kidney Disease PBKD
• Urologic and Kidney Development and Genitourinary
  Diseases UKGD
• Renal and Urological Sciences Small Business
  Activities SBIR/STTR Special Emphasis Panel
  RUS (10)
• Renal and Urological Sciences IRG RUS

119
The Urologic and Kidney Development and
Genitourinary Diseases UKGD Study Section

• Reviews grant applications concerning
• Normal and abnormal development of the kidney,
  urinary tract, and male genital system and
  physiologic and pathophysiologic processes of
  cells and tissues of the bladder, prostate,
  ureter, urethra, male reproductive organs, penis
  and male and female pelvic floor. 
• This encompasses
• 1) responses of uroepithelial tissues and cells
  to infectious bacteria and other pathologic
  insults
• 2) mechanisms of renal stone formation and
  prevention
• 3) normal development of the kidney, urinary
  tract, and male genital system
• 4) normal and pathophysiological processes of the
  urinary tract and male genital system
• 5) application of new technologies and
  methodologies to the diagnosis and treatment of
  urologic diseases
• 6) novel approaches to regeneration and tissue
  engineering of the kidney, urinary tract and male
  genital system
• 7) clinical assessment of genitourinary diseases
  including urinary incontinence and pelvic floor
  dysfunction. 

120
UKGD has the following shared interests outside
the RUS IRG

•  
• With the Biological Chemistry and Macromolecular
  Biophysics BCMB IRG
• With the Genes, Genomes and Genetics GGG IRG 
• With the Biology of Development and Aging BDA
  IRG
• With the Bioengineering Sciences and Technologies
  BST IRG
• With the Health of the Population HOP IRG 
• With the Immunology IMM IRG 
• With the Infectious Diseases and Microbiology
  IDM IRG
• With the Oncological Sciences ONC IRG
• With the Endocrinology, Metabolism, Nutrition and
  Reproductive Sciences EMNR IRG 
• With the Musculoskeletal, Oral and Skin Sciences
  MOSS IRG
• With the Surgical Sciences, Biomedical Imaging,
  and Bioengineering SBIB IRG   
•  With the Integrative, Functional and Cognitive
  Neuroscience IFCN IRG 
• With the Brain Disorders and Clinical
  Neuroscience BDCN IRG 

121
The Peer Review Process

• The Scientific Review Group (SRG) Study Section
• Scientific Review Administrator (SRA) Exec
  Sec
• Chairperson
• Reviewers
• Observers (Program Representatives from NIH
  Institutes)
• Historically have convened in a single room
• Experimenting with Asynchronous Review by
  Computer
• Program Officers are excluded from reviews and
  scores

122
The Peer Review Process (2)

• The application is assigned to
• One primary reviewer
• One or two secondary reviewer
• readers (one to several)
• Mail in reviewers to provide additional expertise
• An application can be submitted three times
• 01, A1 and A2
• Often some of the reviewers of resubmissions were
  reviewers of earlier submissions
• There is a strong corporate memory in the panel
  that must be addressed and won over in
  resubmissions

123
The Peer Review Process (3)

• Scientific reviewers consider in scoring
• Scientific and technical merit of proposed
  research / training
• Response to critique in resubmission
• Qualifications of PI and research team
• Availability of resources
• Human Subjects / Animal welfare
• Issues considered outside of score
• Budget
• Administrative issues

124
The Peer Review Process (4)

• Review Criteria
• Significance
• Approach
• Innovation
• Investigator(s)
• Environment
• Human Subjects
• Vertebrate Animals
• Summary
• Budget
• Administrative notes

125
The Peer Review Process (5)

• The first task of the panel is to identify the
  proposals that represent the bottom half of the
  application in that panel session
• The UNSCORED list
• This task is to allow more detailed discussion of
  the competitive applications for determination of
  the best applications
• Applications can be triaged, or indicated not to
  be reviewed again, if dangerous to the
  researchers, clinical study subjects or research
  animals

126
The Peer Review Process (6)

• Level of Enthusiasm from each assigned reviewers
• Outstanding 100-149
• Excellent 150-199
• Very Good 200-249
• Good 250-299
• Acceptable 300-500

127
The Peer Review Process (7)

• Primary Reviewer
• Summary of Project (panel follows the ABSTRACT)
• Critique of Project based upon criteria in
  previous slide
• Overall summary
• Second Reviewer
• Summarizes strengths and weaknesses
• If overall evaluation is significantly different
  from the Primary Reviewer, provide rationale to
  support the different point of view
• Additional Reviewers
• Attempt to help establish a consensus
• Discussion opened to all members of the panel

128
The Peer Review Process (8)

• Discussion continues ideally until all reviewers
  reach a consensus
• The reviewers are polled periodically to
  determine if the scores are converging
• If a consensus cannot be achieved, the panel
  members are asked to vote their conscience
• If a reviewer(s) wish to vote more than 0.5
  outside of the final range of scores of the
  assigned reviewers, they can, but must submit a
  minority review that will be included in the
  summary statement

129
The Peer Review Process (9)

• The discussion concludes with evaluation of
• Budget
• Administrative issues

130
The Peer Review Process (10)

• Review and Scoring
• Your application will either have a score (gt300)
  or be unscored (lt300)
• However, with discussion, some scores are
  increase to over 300
• If you have a score
• Suggests that application was in the lower half
  of all grants reviewed
• You will get an integrated summary statement to
  describe the panel discussion in addition to the
  written critiques
• If unscored, the application was viewed as not
  competitive (upper 50)
• You only get the raw written reviews of the SRG
  members

131
The Peer Review Process (11)

• Summary Statement
• Priority Score (100-500)
• Percentile Ranking (1-100)
• Normalize between the multiple SRA panels to
  assist Institutes
• Percentiles derived from score distributions
  across multiple previous panel meetings
• Critique

132
III.B. PROGRAMMATIC REVIEW
133
PROGRAM DIRECTOR
INSTITUTE PROGRAM LEVEL
INSTITUTE LEVEL
INSTITUTE COUNCIL
FUNDING
134
Funding Decisions

• At the beginning of a new Federal fiscal year,
  the Institute Executive Committee discusses
  program priorities and preliminary funding
  allocations for the coming fiscal year. In order
  to determine the program allocations, the
  following considerations are taken into account
• Congressional mandates
• New scientific opportunities
• New initiatives
• Program priorities
• Previous commitments, such as non-competing
  continuations
• Other projected needs
• Anticipated availability of funds
• Final allocations and funding decisions cannot be
  made until the actual amount of the appropriation
  is known.

135
Role and Responsibilities of NCI Program Directors

• The Program Director is responsible for the
  programmatic and scientific
• aspects of his/her portfolio, including
• Providing leadership and coordination in the
  medical and scientific communities for research
  groups carrying out investigations in a
  particular program area.
• Visiting grantee institutions to promote and
  explain the objectives of the program and to
  exchange information.
• Reviewing and evaluating the state of the art of
  research in a specific program area and
  stimulating scientific investigations in that
  field through the issuance of RFAs and PAs and
  recommending exception funding.
• Making recommendations to the NCI, NIH, and HHS
  policymakers on subjects related to his/her
  individual expertise.
• Serving as a liaison member on reviewing panels
  and as a participant in national and
  international symposia and other meetings called
  to discuss research in a specific program field.
• Program Directors collaborate with Grants
  Management Specialists in providing oversight of
  the NCI grants program.

136
National Cancer Advisory Board

• The NCAB is composed of 18 members, who by virtue
  of their training, experience, and backgroundare
  especially qualified to evaluate the programs of
  the NCI. These members serve overlapping terms of
  6 years. The President also designates one of the
  appointed members to serve as Chair for a term of
  2 years.
• Ex officio members of the Board include the
• Secretary of HHS.
• Director of the Office of Science and Technology
  Policy.
• Director of the NIH.
• Chief Medical Director of the Department of
  Veterans Affairs.
• Director of the National Institute of
  Environmental Health Sciences.
• Secretary of Labor.
• Commissioner of the Food and Drug Administration.
• Administrator of the Environmental Protection
  Agency.
• Chair of the Consumer Product Safety Commission.
• Assistant Secretary of Defense for Health
  Affairs.
• Director of the