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P REPARING AND S UBMITTING A S UCCESSFUL G RANT A PPLICATION. Priti Mehrotra, Ph.D. Chief, Immunology Clinical Review Branch National Institute of Allergy and Infectious Diseases National Institutes of Health. July 22, 2007. To Build or Maintain a Sustainable Research Career.

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p reparing and s ubmitting a s uccessful g rant a pplication


Priti Mehrotra, Ph.D.

Chief, Immunology Clinical Review Branch

National Institute of Allergy and Infectious Diseases

National Institutes of Health

July 22, 2007

to build or maintain a sustainable research career
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
today s discussion
Today’s Discussion
  • Application Preparation
  • Application Submission
  • NIH Peer Review Process
  • Additional Resources
    • Grantsmanship Tips
    • Electronic Submission
    • Review Criteria
    • Internet Resources
  • 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


choosing the right mechanism
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)
choosing the right mechanism cont
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
strategies for success
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
strategies for success cont
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
strategies for success cont10
Strategies for Success (cont.)
  • Prepared according to NIH standard review criteria
    • Significance
    • Innovation
    • Approach
    • Investigator
    • Environment
  • Initiative specific review criteria, if applicable
  • Proof read
elements of unsuccessful applications
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
elements of unsuccessful applications cont
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
elements of unsuccessful applications cont13
Elements of Unsuccessful Applications (cont.)
  • Lack of attention to details
  • Lack of institutional support
  • Inadequate attention to the submission requirements
advice for new investigators
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.htm
why include multiple principal investigators
Why Include Multiple Principal Investigators?
  • To promote multi-disciplinary team science
    • Complement expertise
  • To recognize collaborators
  • To define responsibility and accountability of each PI

Electronic Submission is Happening!





key elements of electronic submission
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.gov/)
  • 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

avoid having your application returned
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
receipt and referral
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
  • Competitive process
  • Managed by Scientific Review Administrator(s)
  • Follows NIH/NIAID policies and procedures
  • Follows Office of Extramural Research for Peer Review policy
the two step process
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
nih staff roles
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



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

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
nih staff roles cont
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
what happens prior to the review meeting
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)
what happens during a review meeting
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
what happens during a review meeting cont
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

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)

Contact Information

Priti Mehrotra, Ph.D.

Chief, Immunology Clinical Review Branch

Division of Extramural Activities


6700-B Rockledge Drive, Room 3138, MS 7616

Bethesda, MD 20892-7616

Phone: 301-435-9369 / Fax: 301-480-2310


application must be complete
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
application must be complete cont
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

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
be straightforward
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
don t work alone
Don’t 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
be aware of changes in science and policies
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

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/
don t give up
Don’t 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

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 (R&R) application form
  • The transition is in progress and may end in 2008-2009 for all mechanisms
must be done for electronic submission
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 government’s “Central Contractor Registry” CCR
    • Identify the Point of Contact
must be done for electronic submission cont
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)

must be done for electronic submission cont49
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/registrationinstructions.jsp
must be done for electronic submission cont50
Must be Done for Electronic Submission (cont.)
  • ERA Commons and Grants.gov registration can be done simultaneously
  • Allow 2-4 weeks to complete
registration process
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.
registration process cont
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.

registration process cont53
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.
registration process cont54
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_AC135.asp
registration process cont55
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.
  • 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
  • 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?
approach cont
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
  • 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


  • Address each PI’s 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
  • 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

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


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


Electronic Databases

  • US National Library of Medicine’s PubMed http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed
  • USDA National Agricultural Library’s AGRICOLA http://agricola.nal.usda.gov
  • ISI Web of Knowledge (may need to subscribe)isiwebofknowledge.com

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

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.mil
  • DoE Office of Scientific & Technical Information (OSTI) http:/www.osti.gov
  • DoE Biological and Environments Research (BER) http://www.osti.gov/oberabstracts/index.jsp
peer review policy
Peer Review Policy
  • Video of a Peer Review Meeting http://cms.csr.nih.gov/ResourcesforApplicants/PolicyProcedureReview+Guidelines/OverviewofPeerReviewProcess/InsidetheNIHGrantReviewProcessVideo.htm
  • NIH Peer Review Policy http://grants.nih.gov/grants/peer/peer.htm
peer review policy cont
Peer Review Policy (cont.)
  • NIH Recombinant Advisory Committee http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
  • Human Subjects in Clinical Research http://www.niaid.nih.gov/ncn/clinical/default_human.htm
  • Animal Welfare http://grants.nih.gov/grants/olaw/olaw.htm
  • NIH Conflict of Interest Guidelines http://www.niaid.nih.gov/ncn/sop/coi.htm
niaid funding mechanisms
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.

niaid funding opportunities
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/guide/index.html
niaid grants preparation guidance
NIAID Grants Preparation Guidance
  • All About Grants Tutorials http://www.niaid.nih.gov/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.


Other Resources for Grantsmanship

  • NIH Grants Policy http://grants.nih.gov/grants/policy/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/findingpeople/
  • U.S. Civilian Research & Development Foundation http://www.crdf.org/
actual applications and summary statements
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)
nih electronic application submission
NIH Electronic Application Submission
  • Pre-Application http://www.grants.gov/resources/download_software.jsp
  • The Application Process http://era.nih.gov/electronicreceipt_app.htm#1
    • Check SF-424 General Instructions Guide and prepare to apply http://era.nih.gov/electronicreceipt/preparing.htm
    • Find FOA and download application package http://era.nih.gov/electronicreceipt/find_app.htm
nih electronic application submission cont
NIH Electronic Application Submission (cont.)
  • The Application Process (cont.)
    • Prepare Application http://era.nih.gov/electronicreceipt/prepare_app.htm
    • Submit Application to Grants.gov http://era.nih.gov/electronicreceipt/submit_app.htm
    • Check Submission status in Commons http://era.nih.gov/electronicreceipt/check_submission.htm
    • Check Assembled Application http://era.nih.gov/electronicreceipt/check_submission.htm

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/guide/index.html