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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 l.jpg

PREPARING ANDSUBMITTINGASUCCESSFUL 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


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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


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Today’s 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


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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.htm


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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.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


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

[email protected]


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ADDITIONAL RESOURCES



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“THE RULES”for 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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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


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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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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



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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 (R&R) 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 government’s “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/registrationinstructions.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_AC135.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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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 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


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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 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


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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.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


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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


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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


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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/guide/index.html


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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.


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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/


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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/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


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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


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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


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