PREPARING AND SUBMITTING A SUCCESSFUL GRANT APPLICATION

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PREPARING AND SUBMITTINGA SUCCESSFUL GRANT
APPLICATION
Priti Mehrotra, Ph.D.
Chief, Immunology Clinical Review Branch
National Institute of Allergy and Infectious
Diseases National Institutes of Health
July 22, 2007
2
To Build or Maintain a Sustainable Research Career

• It is important to
• Choose the right mechanism
• Focus on institute's mission
• Understand the programmatic needs of the IC
• Know NIH peer review policies

3
Todays Discussion

• Application Preparation
• Application Submission
• NIH Peer Review Process
• Additional Resources
• Grantsmanship Tips
• Electronic Submission
• Review Criteria
• Internet Resources

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APPLICATION PREPARATION
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Overview

• Preparing a competitive grant application
• Is challenging
• Is time-sensitive and time-consuming
• Involves
• Planning
• Writing
• Submitting
• Note Mastery of grantsmanship is critical for
  research
• success

6
Choosing the Right Mechanism

• Unsolicited Investigator Initiated Applications
• Capitalize on your strengths
• Find great ideas and concentrate on your
  expertise
• Funding mechanism opportunities
• Research Project Grants (R01)
• Small Grants (R03)
• NIH Exploratory Research (R21)
• Other Funding Opportunities Announcements
  (including multi-project applications)

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Choosing the Right Mechanism (cont.)

• Solicited Initiatives
• Are first approved as concepts and these concepts
  are listed in the
• NIAID Funding Opportunities
• NIAID Newsletter
• Are published in the NIH Guide for Grants and
  Contracts
• Allow time to establish collaboration and
  accumulate data

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Strategies for Success

• Future impact
• New, original ideas
• Innovative and significant
• Brainstorm with colleagues and mentors
• Focused research
• Solid hypothesis-driven approach
• Supported by preliminary data
• Achievable specific aims
• Precise, focused and related to hypothesis

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Strategies for Success (cont.)

• Future directions and contingency plans
• Appropriate plans for data analysis
• Adequate staff with experience/training in
  essential methodology
• Complement expertise with collaborators and
  consultants
• Appropriate resources and facilities
• Knowledge of relevant published scientific
  literature
• Administrative plans for communication and
  interaction

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Strategies for Success (cont.)

• Prepared according to NIH standard review
  criteria
• Significance
• Innovation
• Approach
• Investigator
• Environment
• Initiative specific review criteria, if
  applicable
• Proof read

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Elements of Unsuccessful Applications

• Project not likely to produce useful information
• Failure to describe significance of the proposed
  work
• Lack of focused hypothesis or specific aims
• Insufficient preliminary data and experimental
  detail
• Lack of scientific basis and rationale
• Failure to address experimental pitfalls and
  alternative approaches

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Elements of Unsuccessful Applications (cont.)

• Over-ambitious research plan
• Inappropriate or insufficient expertise of the
  Principal Investigator (PI) and/or key personnel
• Over-commitment of the PI
• Insufficient knowledge of relevant literature and
  research area(s)
• Lack of administrative plan(s) communication,
  interaction, and collaboration

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Elements of Unsuccessful Applications (cont.)

• Lack of attention to details
• Lack of institutional support
• Inadequate attention to the submission
  requirements

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Advice for New Investigators

• Check eligibility, if no previous R01 funding has
  been received
• Utilize available resources
• NIH Office of Extramural Research New
  Investigator Program
• http//grants.nih.gov/grants/new_investigators/
• NIAID Advice for New Investigators
• http//www.niaid.nih.gov/ncn/grants/plan/plan_i1.h
  tm

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Why Include Multiple Principal Investigators?

• To promote multi-disciplinary team science
• Complement expertise
• To recognize collaborators
• To define responsibility and accountability of
  each PI

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APPLICATION SUBMISSION
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Electronic Submission is Happening!

• IMPORTANT CHANGES TO THE
• APPLICATION SUBMISSION PROCESS
• ARE IN PROGRESS!
• http//era.nih.gov/ElectronicReceipt/

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Key Elements of Electronic Submission

• Most types of NIH grant applications are
  submitted electronically via Grants.Gov using
  SF-424 forms
• eRA Commons is a web-based system for secure
  information exchange with applicants and
  applicant organizations (http//commons.era.nih.go
  v/)
• Applicants must establish personal commons
  accounts to track review progress and to retrieve
  scores and summary statements
• Note See Additional Resources section for
  electronic
• submission details

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Avoid Having Your Application Returned

• Follow formatting instructions
• Submit correct forms (PHS 398 or SF-424)
• Know the Deadlines
• Standard Submission dates
• Special Submission dates for AIDS
• Receipt dates for solicited applications
• Contact the Scientific Review Administrator and
  Program Officer, if you have any questions

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Receipt and Referral

• All applications submitted to NIH go to the
  Center for Scientific Review (CSR)
• Referral officers at CSR assign applications to a
  Scientific Review Group (SRG) or institute for
  the review
• Applications may be assigned to one or more NIH
  institutes for funding consideration
• A cover letter can help direct application toward
  appropriate SRG and institute assignments based
  on scientific area

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NIH PEER REVIEW PROCESS
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Overview

• Competitive process
• Managed by Scientific Review Administrator(s)
• Follows NIH/NIAID policies and procedures
• Follows Office of Extramural Research for Peer
  Review policy

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The Two Step Process

• Scientific and Technical Evaluation
• SRGs evaluate scientific merit and assign
  priority scores
• CSR reviews the majority of applications
• Review divisions of funding institutes review the
  rest
• Advisory Councils at funding institutes
• May concur with priority score and recommend
  funding
• Provide special consideration of applications
  that address high program priorities

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NIH Staff Roles

• Scientists administering the research grant
  process
• Scientific Review Administrators (SRA)
• Program Officers (PO)
• Grants Management Specialists (GMS)

Note NIH staff can not influence the evaluation
of applications
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NIH Staff Roles (cont.)

• Scientific Review Administrator (doctoral
  scientist)
• Is an expert on peer-review policy, procedures
  and compliance
• Protects the confidentiality of the applications
• Recruits reviewers, insures scientific expertise
  on the panel, and selects chairperson to moderate
  discussions
• Serves as a point of contact for review related
  issues

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NIH Staff Roles (cont.)

• Scientific Review Administrator (cont.)
• Manages the review meeting as a Federal Official
• Provides scientific, administrative, and
  logistical oversight of the peer-review
• Writes resume of discussion at the review meeting
  and generates final summary statements

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NIH Staff Roles (cont.)

• Program Officer
• Provides scientific stewardship and administer
  grants
• Identifies areas of scientific priorities
• Serves as advocate for investigators
• Provides guidance on resources for research and
  collaboration
• Tip! Contact the PO to discuss science
• Grants Management Specialist
• Is the Government official on fiscal policy
• Negotiates, approves and awards all grants

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What Happens Prior to the Review Meeting?

• Assigned Reviewers provide preliminary scores on
  internet assisted review (eRA commons) website
• Provide a Priority Score to the application
• Outstanding (1.0 - 1.5) in 0.1 increments
• Excellent (1.5 - 2.0)
• Very Good (2.0 - 2.5)
• Good (2.5 - 3.5)
• Acceptable (3.5 - 5.0)
• NRFC (Not Recommended for Further Consideration)

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What Happens During a Review Meeting?

• Streamlining
• Non-competitive among pool of the applications
• Unscored and not discussed
• Receive reviewers critiques
• Competitive Applications
• Discuss and receive a priority score by all
  non-conflicted reviewers

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What Happens During a Review Meeting? (cont.)

• Review of Applications based on
• Review Criteria
• Significance
• Approach
• Innovation
• Investigator
• Environment
• ? Also initiative specific review criteria, when
  applicable

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Post-Meeting

• Summary statements
• Description provided by applicant
• Resume of discussion written by SRA
• Written critiques from assigned reviewers
• Scores and critiques are made available to the
  investigators (eRA Commons) and to the assigned
  institutes for funding consideration (30 days)

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QUESTIONS?
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Contact Information
Priti Mehrotra, Ph.D. Chief, Immunology Clinical
Review Branch Division of Extramural
Activities NIAID, NIH, DHHS 6700-B Rockledge
Drive, Room 3138, MS 7616 Bethesda, MD
20892-7616 Phone [phone] / Fax
301-480-2310 pmehrotra_at_niaid.nih.gov
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ADDITIONAL RESOURCES
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Grantsmanship Tips
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THE RULESfor Navigating the NIH Peer Review
System
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Application Must Be Complete

• Write the application section by section
• Address ALL the review criteria
• Address Special Requirements of award type or
  solicitation
• Include all documents necessary for review
• ONLY the information in the application is
  reviewed
• Applications are NOT compared

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Application Must Be Complete (cont.)

• Make the Description (Abstract) understandable
  and complete
• Helps to orient reviewers
• Needs to be written carefully
• Will be in CRISP, if funded
• Write it last to make it comprehensive
• Describe a clear, concise, and factual synopsis
  of the application
• Do not cut and paste
• Define acronyms
• Fit it in the space

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Make It Easy for the Reviewers

• Present clear overall organization
• Be concise
• Make your application visually appealing charts,
  tables, diagrams, figure legends, and flow-charts
• Use appendices well
• Cross-reference biosketches of key personnel,
  label, and number relevant items
• Organize according to the Review Criteria

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Be Straightforward

• Lay out strengths and weaknesses of experimental
  approaches and techniques
• Identify potential limitations and problems
• Show how you propose to address them
• Don't over- or under-estimate the budget
• Do not assume reviewers will know what you mean
• Do not assume reviewers will ignore review
  criteria
• Don't indulge in blatant self-promotion
• Don't add irrelevant information to biosketches

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Dont Work Alone

• Seek collaborators and consultants
• Network widely
• Find available resources
• Read a successful application and its summary
  statement
• Allow enough time for writing
• Seek advice from senior investigators
• Allow enough time for feedback

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Be Aware of Changes in Science and Policies

• Periodically check NIH and NIAID web page
• Keep abreast of change in policies
• Know NIAID high priority area(s)
• Communicate with Program Officers, Scientific
  Review Administrators, and Grants Management
  Specialist
• Stay in touch with your University / Institution
  Office of Sponsored Programs

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Be Aware of Changes in Science and Policies
(cont.)

• NIH Manual Chapters
• http//www1.od.nih.gov/oma/manualchapters/scripts/
  mcs/browse.asp
• NIAID Standard Operating Procedures
• http//www.niaid.nih.gov/ncn/sop/default.htm
• NIAID Research Funding
• http//www3.niaid.nih.gov/researchFunding/

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Dont Give Up!
Initial failure is common learn from it and
succeed the majority do!

• Read criticisms in the summary statement
• Decide if problems are repairable
• Attend diligently to each criticism
• Keep a positive tone and attitude
• Revise and resubmit
• When resubmitting address reviewers comments

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Electronic Submission Process
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Electronic Submission is Happening!

• The NIH is transitioning from paper submission of
  grant applications to electronic submission
• A phase out from the Form PHS 398 grant
  application is in progress
• Form 398 is being replaced with the SF 424
  Research and Research-related (RR) application
  form
• The transition is in progress and may end in
  2008-2009 for all mechanisms

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Must be Done for Electronic Submission

• Register on Grants.gov
• Non-US institution or organization
• One-time registration
• To obtain EIN (Employer Identification Number)
  from the Internal revenue Service (IRS)
• Request DUNS (Dunn and Bradstreet) number
• Register with the US governments Central
  Contractor Registry CCR
• Identify the Point of Contact

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Must be Done for Electronic Submission (cont.)

• Register the Authorized Organization
  Representatives (AORs)
• Individual who can submit the application
• NOTE This process may take 4-8 weeks. Non-US
• institutions may require additional
  registration with
• a North Atlantic Treaty Organization
  Commercial
• and Government Entity (NCAGE)

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Must be Done for Electronic Submission (cont.)

• ERA Commons (NIH Electronic Research
  Administration System)
• For applicants and grantee
• To receive and transmit information or
  application electronically
• Both applicant and organization must register
• Organization
• One-time registration
• If registered, see institution on the list
  http//era.nih.gov/commons/index.cfm
• If not listed, check the following site
  https//commons.era.nih.gov/commons/registration/r
  egistrationinstructions.jsp

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Must be Done for Electronic Submission (cont.)

• ERA Commons and Grants.gov registration can be
  done simultaneously
• Allow 2-4 weeks to complete

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Registration Process

• A registrant must have a Dun Bradstreet (DUNS)
  number before completing the Central Contractor
  Registration (CCR).
• Step 1 Obtain your DUNS number. The registrant
  can apply through the DUNS webpage via the World
  Wide Web or through a phone call.
• The DUNS process Go to the Dun Bradstreet
  homepage.
• Under Business Name, enter your name. Click on
  Request a New D-U-N-S number
• Enter other pertinent information as requested
  and submit your request.

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Registration Process (cont.)

• Step 2 Register with CCR. This process is done
  electronically as well.
• Important Keep all information. You will need to
  enter the
• exact format and information for
  your name and
• address in the CCR registration
  process.

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Registration Process (cont.)

• The Central Contractor Registration (CCR) is a
  secure, federally controlled database for all
  non-federal persons, companies, or other entities
  doing business with the Federal government.
• The CCR process Access the CCR online
  registration at http//www.ccr.gov and begin a
  new registration.

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Registration Process (cont.)

• Checklist for what you will need to prior
  beginning CCR registration
• DUNS number
• Social Security number (not necessary for non-US
  applicants)
• Financial Institution Name Telephone number
• A North Atlantic Treaty Organization Commercial
  and Government Entity (NCAGE) code must be
  obtained.
• The NCAGE Process To obtain an NCAGE code, go to
  the CCR website and locate Non-U.S. registrants.
  
• NCAGE form http//www.dlis.dla.mil/Forms/Form_AC1
  35.asp

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Registration Process (cont.)

• If your registration was submitted successfully
• A letter will be sent (via either U.S. Postal
  Service or e-mail) to welcome you to CCR and will
  include a copy of your registration.
• You also will receive guidance to obtain your
  Trading Partner Identification Number (TPIN) for
  verification.
• This is a confidential password provided to you
  upon activation in CCR.
• The TPIN is mailed via the U.S. Postal Service or
  access to the TPIN is provided via e-mail to the
  person listed as the CCR Point of Contact.
• The TPIN, in conjunction with your DUNS number,
  gives you access to your entire registration.

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Review Criteria
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Significance

• Convey the significance of the research
• Advancement of scientific knowledge
• Importance to public health
• State clear rationale with focused aims and goals
• Relay the effect of these studies on the
  concepts, methods, technologies, treatments,
  services, or preventive interventions that drive
  this field
• Show your breadth of the scientific knowledge

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Approach

• Develop a conceptual framework, study design and
  methods
• Provide adequate analyses, well integrated, well
  reasoned, and appropriate aims of the project
• Describe experiments to match aims
• Provide limitations of the proposed approaches
• How are they handled?

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Approach (cont.)

• Acknowledge potential problems and consider
  alternative approaches
• Reference methods and concepts
• Include preliminary data
• Discuss how the data will be collected and
  interpreted
• Include a leadership plan, if it is a Multiple PI
  application

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Innovation

• Describe
• What is new and/or innovative including research
  question(s), novel concepts, approaches,
  methodologies, tools, or technologies
• How existing paradigms are challenged
• If the hypothesis is innovative or critical
  barrier to progress the field
• Support the innovative approach with data
• Be persuasive, but be careful of being too
  innovative
• Note Innovation is NOT weighed heavily in some
• contexts

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Investigator

• Address each PIs experience and suitability to
  carry out the project
• List specific responsibilities of each PI and Key
  personnel including percent month effort
• Include training/experience of other personnel
• Describe specific and relevant past
  accomplishments
• Utilize consultants/collaborators expertise to
  complement the project, if applicable

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Environment

• Describe the
• Scientific environment in which the work will be
  done
• Organizational framework
• How does it contribute to success?
• Coordination/communication plans among staff and
  organizations
• Special resources/facilities available/dedicated
  to the project (institutional support)
• Note Also initiative specific review criteria

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Other Criteria

• May affect the score
• Human subjects safety issues
• Data safety monitoring plans
• Plan to insure the participation of women,
  minorities, and children
• Vertebrate animals welfare issues
• Biohazards
• Select agents
• Recombinant DNA
• ?There are NIH policies for each of these

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Other Criteria (cont.)

• Does not impact the score
• Model organisms
• Data sharing plan
• Non-US application justification
• The budget
• Justification
• Appropriateness
• Over- or under-estimated
• ?There are NIH policies for each of these

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Internet Resources
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Electronic Databases

• US National Library of Medicines PubMed
  http//www.ncbi.nlm.nih.gov/entrez/query.fcgi?dbP
  ubMed
• USDA National Agricultural Librarys AGRICOLA
  http//agricola.nal.usda.gov
• ISI Web of Knowledge (may need to subscribe)
  isiwebofknowledge.com

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Electronic Databases- Funded Awards

• NIH CRISP (Computer Retrieval of Information on
  Science Projects) http//crisp.cit.nih.gov
• USDA CRIS (Current Research Information System)
  http//cris.csrees.usda.gov
• NSF FastLane https//www.fastlane.nsf.gov/fastlane
  .jsp
• Centers for Research Libraries (includes
  dissertations) http//www.crl.edu/catalogindex.htm

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Electronic Databases- Funded Awards

• DoD Biomedical Research Database (BRD). Research
  conducted at military institutions
  http//www.dtic.mil/biosys/org/brd/
• DoD Congressionally Mandated Research Programs.
  Research funded by DoD but conducted at
  universities/other institutes http//cdmrp.army.mi
  l
• DoE Office of Scientific Technical Information
  (OSTI) http/www.osti.gov
• DoE Biological and Environments Research (BER)
  http//www.osti.gov/oberabstracts/index.jsp

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Peer Review Policy

• Video of a Peer Review Meeting http//cms.csr.nih.
  gov/ResourcesforApplicants/PolicyProcedureReviewG
  uidelines/OverviewofPeerReviewProcess/InsidetheNIH
  GrantReviewProcessVideo.htm
• NIH Peer Review Policy http//grants.nih.gov/grant
  s/peer/peer.htm

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Peer Review Policy (cont.)

• NIH Recombinant Advisory Committee
  http//www4.od.nih.gov/oba/rac/guidelines/guidelin
  es.html
• Human Subjects in Clinical Research
  http//www.niaid.nih.gov/ncn/clinical/default_huma
  n.htm
• Animal Welfare http//grants.nih.gov/grants/olaw/o
  law.htm
• NIH Conflict of Interest Guidelines
  http//www.niaid.nih.gov/ncn/sop/coi.htm

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NIAID Funding Mechanisms

• NIAID Funding Mechanisms http//www.niaid.nih.gov/
  ncn/grants/mechan.htm
• Note Different ICs may have different specific
  purposes
• for the certain funding mechanism.
  Consult the
• funding IC you plan to apply.

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NIAID Funding Opportunities

• NIAID Funding Opportunities List
  http//www.niaid.nih.gov/ncn/budget/opps.htm
• Updated site
• Lists the approved NIAID initiatives.
• Funding Opportunity Announcements (FOAs)
• Usually RFA, RFPs
• NIH Guide Notices http//grants1.nih.gov/grants/g
  uide/index.html

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NIAID Grants Preparation Guidance

• All About Grants Tutorials http//www.niaid.nih.go
  v/ncn/grants/default.htm
• The NIAID Checklists http//www.niaid.nih.gov/ncn/
  grants/charts/checklists.htm
• Note These tutorials and Checklists help
  biomedical
• investigators, especially new ones,
  plan, write,
• and apply for the basic NIH research
  project
• grant, the R01.

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Other Resources for Grantsmanship

• NIH Grants Policy http//grants.nih.gov/grants/p
  olicy/policy.htm
• NIH Office of Extramural Research (OER)
  http//grants.nih.gov/grants/oer.htm
• NIAID http//www3.niaid.nih.gov/
• NIAID Staff http//www3.niaid.nih.gov/about/findin
  gpeople/
• U.S. Civilian Research Development Foundation
  http//www.crdf.org/

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Actual Applications and Summary Statements

• Center for Scientific Review CSR web pages
  provide descriptions and rosters
  http//cms.csr.nih.gov/
• R03 (Small Grants)
• R01 (Investigator Initiated Research)
• NIAID http//www.niaid.nih.gov/ncn/grants/
• R01 (Investigator Initiated Research)

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NIH Electronic Application Submission

• Pre-Application http//www.grants.gov/resources/do
  wnload_software.jsp
• The Application Process http//era.nih.gov/electro
  nicreceipt_app.htm1
• Check SF-424 General Instructions Guide and
  prepare to apply http//era.nih.gov/electronicrece
  ipt/preparing.htm
• Find FOA and download application package
  http//era.nih.gov/electronicreceipt/find_app.htm

77
NIH Electronic Application Submission (cont.)

• The Application Process (cont.)
• Prepare Application http//era.nih.gov/electronicr
  eceipt/prepare_app.htm
• Submit Application to Grants.gov
  http//era.nih.gov/electronicreceipt/submit_app.ht
  m
• Check Submission status in Commons
  http//era.nih.gov/electronicreceipt/check_submiss
  ion.htm
• Check Assembled Application http//era.nih.gov/ele
  ctronicreceipt/check_submission.htm

78
Electronic Submission Resources

• Instruction Sources
• NIH Electronic Receipt Web Site
  http//era.nih.gov/ElectronicReceipt/
• NIH Electronic Receipt Web Site Map
  http//era.nih.gov/ElectronicReceipt/site_map.htm
• NIH Guide Notices http//grants1.nih.gov/grants/gu
  ide/index.html