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Dec 3/09. National Institutes of Health. Presented by: Van Nhan Senior Grants Advisor Health Research Services Faculty of Health Sciences HSC 1B7 Phone: (905) 525-9140, Ext. 22057 Email: [email protected] Discussion Topics.

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National institutes of health

Dec 3/09

National Institutes of Health

Presented by:

Van Nhan

Senior Grants Advisor

Health Research Services

Faculty of Health Sciences

HSC 1B7

Phone: (905) 525-9140, Ext. 22057

Email: [email protected]


Discussion topics

Discussion Topics

  • About NIH - Basics, Deadlines, Foreign Eligibility, Advantages/Disadvantages as Foreign Institution

  • NIH’s Electronic Application Process http://era.nih.gov/ElectronicReceipt/process.htm

  • Major Changes for Due Dates on or after January 25, 2010 – Restructured Application Forms and Shorter Page Limits http://enhancing-peer-review.nih.gov/docs/application_changes.pdf

  • Tips on getting funded by the NIH


What is nih

What is NIH?

  • The National Institutes of Health is the United States’ medical research agency

  • It is part of the larger U.S. Department of Health and Human Services (DHHS)

  • The NIH funds research both internally and externally

  • Externally funded research managed by the Office of Extramural Research

  • The NIH is not one body, but is comprised of 27 different Institutes and Centers (IC), each with its own specific research agenda.

  • A listing of those institutes & centers http://www.nih.gov/icd/


Office of extramural research

Office of Extramural Research

http://grants.nih.gov/

BASICS

NIH GUIDE

INITIATIVES

eRA, Commons,eSubmission

GET CONECTED

GLOSSARY, FAQS

POLICY

FORMS & INSTRUCTIONS,

SUBMISSION DATES


National institutes of health

Grants Foreign Institutions Are Most Commonly Eligible For:


Nih standard receipt dates application deadlines

NIH Standard Receipt Dates/Application Deadlines

http://grants.nih.gov/grants/funding/submissionschedule.htm


Foreign eligibility

Foreign Eligibility

  • Foreign institutions must be able to provide research that does not have comparable work  being conducted in the U.S.  If it is, the grant will likely not be funded.

  • If you are a highly qualified foreign investigator with unique expertise or resources not available in the U.S., the likelihood of obtaining an NIH award increases.

  • Foreign applicants are strongly encouraged to review Section III. Eligibility Information of the FOA.


Applying as a foreign institution

Applying as a Foreign Institution


Discussion topics1

Discussion Topics

  • About NIH - Basics, Deadlines, Foreign Eligibility, Advantages/Disadvantages as Foreign Institution

  • NIH’s Electronic Application Process http://era.nih.gov/ElectronicReceipt/process.htm

  • Major Changes for Due Dates on or after January 25, 2010 – Restructured Application Forms and Shorter Page Limits http://enhancing-peer review.nih.gov/docs/application_changes.pdf

  • Tips on getting funded by the NIH


Nih s electronic application process

NIH’s Electronic Application Process

  • The majority of competing applications now require electronic application submission.

  • In order to successfully submit an electronic application, investigators must follow both NIH and University-specific procedures


Esubmission process

eSubmission Process

Prepare to Apply

Find Opportunity and Download Application Package

Prepare Application

If errors, correct & submit again

Submit Application to Grants.gov

Check Submission Status

Check Assembled Application

Submission Complete


Two systems working together

Two Systems Working Together

  • eRA Commons – electronic Research Administration system that allows applicants, grantees and Federal staff to access, share and transmit information related to their applications and grants

    • Used by NIH and a few other HHS components

  • Grants.gov – the Federal government’s

    single online portal to find and apply for Federal grant funding

    • Used by all 26 Federal grant-making agencies

IMPORTANT:Each system has its own registration and validations requirements


Applying to the nih first step get registered

Applying to the NIHFirst Step – Get Registered

All Principal Investigator’s applying to the NIH must have two things:

  • an NIH eRA Commons ID

  • Authorized Organization Representative

    status on grants.gov


How to obtain an era commons id

How to obtain an eRA Commons ID

  • Contact your research administration office:

    • For all other Faculties, contact

  • What we need:

    • Name and e-mail address of person requesting ID

  • After requesting ID, PI will receive e-mail from eRA Commons indicating how to proceed with account set-up

    Applications without an eRA Commons ID for the PI will be automatically rejected


  • Aor on grants gov

    AOR on Grants.gov

    • An AOR is an individual authorized to submit applications on behalf of your organization (i.e. McMaster University)

    • If you are not designated as an AOR you will not be able to submit an application via grants.gov

    • You cannot be designated an AOR without authorization from the University’s E-Business Point of Contact (E-Biz POC)

      • Van Nhan in HRS

      • Sonya Strohm in ORS


    Register on grants gov http apply07 grants gov apply orcregister

    Register on Grants.gov http://apply07.grants.gov/apply/OrcRegister

    McMaster’s DUNS


    Internal process considerations

    Internal Process Considerations

    For FHS

    • Send electronic copy of application to HRS at [email protected] and submit hardcopy of completed HRS Checklist (signed by Dept. Chair) along with any ethics/biohazard approvals that may be applicable

    • Once reviewed, HRS will authorize PI as an AOR on grants.gov and PI will be able to submit application electronically

      Note: HRS deadline is two weeks in advance of NIH

      This process must be followed with every application as AOR status will be removed once application process is complete


    Esubmission process1

    eSubmission Process

    Prepare to Apply

    Find Opportunity and Download Application Package

    Prepare Application

    If errors, correct & submit again

    Submit Application to Grants.gov

    Check Submission Status

    Check Assembled Application

    Submission Complete


    Find opportunity download package

    Find Opportunity & Download Package

    • ALL applications must be submitted in response to a Funding Opportunity Announcement (FOA)

    • NIH simultaneously posts FOAs on:

      • NIH Guide for Grants and Contracts http://grants.nih.gov/grants/guide/index.html

        • Announcements include button to download package and instructions from Grants.gov

      • Grants.gov


    National institutes of health

    Finding FOAs in NIH Guide

    NIH Guide for Grants & Contractshttp://grants.nih.gov/grants/guide/

    Enter search string or click Advanced Search


    Announcement notes

    Announcement Notes

    • FOAs in the NIH Guide include button to download app from Grants.gov

    Click Apply for Grant Electronically

    Click download

    Verify information


    Esubmission process2

    eSubmission Process

    Prepare to Apply

    Find Opportunity and Download Application Package

    Prepare Application

    If errors, correct & submit again

    Submit Application to Grants.gov

    Check Submission Status

    Check Assembled Application

    Submission Complete


    Grant application package screen

    Grant Application Package Screen

    Mandatory Grants.gov fields highlighted; Check App Guide

    for additional NIH required fields

    Save locally

    Header info is pre-populated and not editable

    Complete the SF424 (R&R) first –populates fields in other forms

    Check Application Guide to determine which Optional Documents to submit


    Application guide

    Application Guide

    • Read and follow application guide instructions

    • Agency-specific instructions are marked with the HHS logo


    Announcement

    Announcement

    • Read and follow announcement instructions

    • Pay special attention to Section IV. Application and Submission Information

      • Includes any FOA-specific submission instructions

      • Instructions in FOA trump instructions in the application guide


    Esubmission process3

    eSubmission Process

    Prepare to Apply

    Find Opportunity and Download Application Package

    Prepare Application

    If errors, correct & submit again

    Submit Application to Grants.gov

    Check Submission Status

    Check Assembled Application

    Submission Complete


    Submit application

    Submit Application

    • Save & Submit button will not become active until:

    • All fields marked as mandatory on the forms are completed

    • All Mandatory Documents are moved to Mandatory Documents for Submission box and completed

    • The application is Saved

    Check Package for Errors only checks Grants.gov errors.

    You must Submit the application for it to go through the NIH validation process. NIH errors will be shown in the eRA Commons.


    Submit application1

    Submit Application

    Enter your Grants.gov username and password – you must be fully registered to successfully submit.

    Only the AOR can Submit application.


    Submit application2

    Submit Application

    Click Sign and Submit Application button to record electronic signature and initiate submission process to Grants.gov


    Upon submission grants gov will check to ensure

    Upon Submission Grants.gov Will Check to Ensure:

    • All Grants.gov mandatory fields have been completed

    • All mandatory documents have been completed and moved to the Completed Documents box (Submission List)

    • The validity of the organizational DUNS #

    • Date format, e-mail address format, and virus-free


    E mail notifications grants gov

    E-mail Notifications – Grants.gov

    AOR receives Grants.gov e-mails

    • Submission Receipt – app received and

      is being validated (Grants.gov validations only)

      2.Rejection Notice – app is not validated because of Grants.gov errors

      OR

      Submission Validation Receipt – app has been validated (Grants.gov validations only)

      3.Grantor Agency Retrieval Receipt – app has been retrieved by the agency

      4.Agency Tracking Number – app has been assigned a tracking number by the grantor agency (NIH)


    Back to nih

    Back to NIH

    You’re not done yet! Make sure you follow the application through to NIH.


    Esubmission process4

    eSubmission Process

    Prepare to Apply

    Find Opportunity and Download Application Package

    Prepare Application

    If errors, correct & submit again

    Submit Application to Grants.gov

    Check Submission Status

    Check Assembled Application

    Submission Complete


    Application processing in era commons

    Application Processing in eRA Commons

    • eRA system retrieves applications from Grants.gov and checks them against NIH business rules defined in application guide instructions and FOA

      • Complete list of NIH validations: http://era.nih.gov/ElectronicReceipt/prepare_app.htm#5

    • Remember, the SF424 (R&R) forms are owned by Grants.gov and used by many agencies, so unfortunately NIH cannot build agency-specific business rules into the forms


    E mail notifications era commons

    E-mail Notifications - eRA Commons

    AOR/SO, PD/PI and Contact receive

    e-mails


    Check status in commons pd pi

    Check Status in Commons – PD/PI

    Select Recent/Pending eSubmissions

    Or provide Grants.gov tracking number from email notification

    36


    Status esub errors warnings

    Status – eSub Errors/Warnings

    Indicates eSubmission Error

    Grants.gov Tracking #

    Grants.gov tracking # and date are displayed followed by the list of errors/warnings for each submission attempt


    Status esub errors warnings1

    Status – eSub Errors/Warnings

    • Errors stop application processing and must be corrected

    • Warnings do not stop application submission and are corrected at the discretion of the applicant

    Helpful LinksAvoiding Common Errors page:http://era.nih.gov/ElectronicReceipt/avoiding_errors.htm

    Full list of Commons Validations

    http://era.nih.gov/ElectronicReceipt/files/SF424RR_Validation.pdf


    On time submission

    On-time Submission

    • All registrations must be completedprior to initial submission

    • Submission must be accepted by Grants.gov with a timestamp on or before 5:00 p.m. local time of applicant organization on submission deadline date

    • Errors/Warnings must be corrected within the 2-business day error correction window


    Error correction window

    Error Correction Window

    • NIH currently allows applicants to correct errors/warnings during the two (2) business days after the submission deadline

      • Referred to as “error correction window”

      • Your original application submission must have been submitted on time with all appropriate registrations in place

      • Cover letter attachment must be included identifying the system - identified errors/warnings that have been corrected.

    See Notice in NIH Guide for Grants & Contracts (11/30/2007):

    http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-018.html


    Correcting esub errors warnings

    Correcting eSub Errors/Warnings

    Make changes to address the error/warning messages in the local copy of the application

    • Select Changed/Corrected on SF424 (R&R) cover (box #1)

      • Federal Identifier on SF424 (R&R) cover (box #4) is a required field when Changed/Corrected is selected

        • If New is selected in box #8, use Grants.gov tracking number for original submission

        • Otherwise, continue to use the Institute/Center and serial number from original grant award (ex. CA123456)

    • Include cover letter if after submission deadline

    • AOR must submit the entire changed/corrected application to Grants.gov

    • Track submission through to Commons

    NOTE:Reviewers do not see applicant errors/warnings.


    Esubmission process5

    eSubmission Process

    Prepare to Apply

    Find Opportunity and Download Application Package

    Prepare Application

    If errors, correct & submit again

    Submit Application to Grants.gov

    Check Submission Status

    Check Assembled Application

    Submission Complete


    Status view application image

    Status – View Application Image

    • Once an error-free application is received, the eRA system will:

      • Assemble the grant application image

      • Insert headers (PI name) & footers (page numbers) on all pages

      • Generate Table of Contents and bookmark important sections

      • Post the assembled application image in the PI’s eRA Commons account


    Application viewing window

    Application Viewing Window

    • Applicants have two (2) business days to view the assembled application before it automatically moves forward to NIH for further processing

    • SO (Institution) can Reject application within viewing window to address Warnings (if within error correction window) or to address a system issue affecting the application image

      • If Rejected after deadline for any other reason, application is subject to late policy

      • PI will receive email notification if SO rejectsapplication

    If you can’t VIEW it, NIH can’t REVIEW it!


    Status view application image1

    Status – View Application Image

    Status is Pending Verification

    Follow link to detailed status info

    Follow e-Application

    link to view assembled

    application image

    View Appendices and Cover Letter


    Status e application

    Status – e-Application

    TIP:Carefully review the entire application.

    This is your first chance to view/print the same application image that will be used by Reviewers!


    Reject application

    Reject Application

    Must have SO role

    Enter Search Criteria

    Click Search

    Select Recent/ Pending eSubmissions


    Reject application1

    Reject Application

    Select Reject eApplication

    Enter comment to be sent with email notification

    Click Reject


    Esubmission process6

    eSubmission Process

    Prepare to Apply

    Find Opportunity and Download Application Package

    Prepare Application

    If errors, correct & submit again

    Submit Application to Grants.gov

    Check Submission Status

    Check Assembled Application

    Submission Complete


    Discussion topics2

    Discussion Topics

    • About NIH - Basics, Deadlines, Foreign Eligibility, Advantages/Disadvantages as Foreign Institution

    • NIH’s Electronic Application Process http://era.nih.gov/ElectronicReceipt/process.htm

    • Major Changes for Due Dates on or after January 25, 2010 – Restructured Application Forms and Shorter Page Limits http://enhancing-peer review.nih.gov/docs/application_changes.pdf

    • Tips on getting funded by the NIH


    Major changes to applications

    Major Changes to Applications

    Major changes for due dates on or after January 25, 2010

    • Restructured application forms

    • New instructions including shorter page limits

      For ALL competing applications:

      New, Renewal, Resubmission, and Revision


    Goals of restructured applications

    Restructured Application Forms

    Goals of Restructured Applications

    • Align the structure and content of the forms with review criteria

      • To focus the applicants and reviewers on the same elements

      • To help ensure a more efficient and transparent review process


    Overview of the changes

    Overview of the Changes

    • Application forms will be revised in three sections:

      • Research Plan

      • Biographical Sketch

      • Resource and Facilities


    New research plan components

    New Research Plan Components

    Introduction

    Specific Aims

    Background and Significance

    Preliminary Studies/Progress Report

    Research Design and Methods

    Inclusion Enrollment Report

    Progress Report Publication List

    Human Subjects Sections….

    protections, women/minorities, enrollment, children

    Other Research Plan Sections….

    animals, select agents, MPI, consortium, support, resource sharing

    Appendix

    Research Strategy


    New research strategy section

    New Research Strategy Section


    Revisions to biographical sketch

    Revisions to Biographical Sketch

    • Personal Statement added:

      • Briefly describe why your experience and qualifications make you particularly well-suited for your role in the project

    • Publications revised:

      • Limit the list of publications or manuscripts to no more than 15

      • Make selections based on recency, importance to the field, and/or relevance to the application


    Goals of shortened page limits

    New Instructions Including Shorter Page Limits

    Goals of Shortened Page Limits

    • Reduce the administrative burden

    • Focus on the essentials of the science

    • Avoid information overload


    Page limit revisions

    Page Limit Revisions

    Note: Follow FOA page limit requirements if different from the application instructions.


    What has not changed

    What Has Not Changed

    • Need to have a good idea about how to answer an important question

    • Reviewers need to be able to understand WHAT you want to do, WHY it is important, and can YOU do it?

    • Need to align YOUR goals with the funding agency goals.


    Discussion topics3

    Discussion Topics

    • About NIH - Basics, Deadlines, Foreign Eligibility, Advantages/Disadvantages as Foreign Institution

    • NIH’s Electronic Application Process http://era.nih.gov/ElectronicReceipt/process.htm

    • Major Changes for Due Dates on or after January 25, 2010 – Restructured Application Forms and Shorter Page Limits http://enhancing-peer review.nih.gov/docs/application_changes.pdf

    • Tips on getting funded by the NIH


    Tips on getting funded

    Tips on Getting Funded

    • Foreign Justification

      • Although it is not specifically mentioned in an application it is very important that applicants from foreign institutions submit a foreign justification with their application

      • What should you address in the justification?

        • Why the work can only be done here

        • The strengths and unique qualities of McMaster’s research environment

        • Why you are the best person to conduct this research


    Tips on getting funded1

    Tips on Getting Funded

    • Foreign Justification cont’d

      As mentioned earlier…

    • Foreign institutions must be able to provide research that does not have comparable work  being conducted in the U.S.  If it is, the grant will likely not be funded.

    • If you are a highly qualified foreign investigator with unique expertise or resources not available in the U.S., the likelihood of obtaining an NIH award increases.

    • Foreign PD/PI’s and/or research involving a foreign institution are highly encouraged to contact an NIH program officer as soon as possible in the planning and writing stages.


    Tips on getting funded2

    Tips on Getting Funded

    • Collaborators

      • Many have found it helpful to have American collaborators on the grant

      • Helps reviewers with the idea of the NIH keeping some money in the country

      • Also, American collaborators are generally very experienced with regards to NIH applications


    Tips on getting funded3

    Tips on Getting Funded

    • Project of High Scientific Caliber that fits within NIH research priorities

      • Important to keep in mind with investigator-initiated projects

      • Once you identify the institute that would best support your research, check their website to determine if idea matches their high-priority research areas

      • Or call a Program Official (PO) at the institute and discuss your ideas with them

      • There are also NIH-wide initiatives to consider


    Tips on getting funded4

    Tips on Getting Funded

    • Originality

      • The NIH really focuses on funding original work

      • Check the NIH Research Portfolio Online Reporting Tool (RePORTER) http://projectreporter.nih.gov/reporter.cfm to minimize overlap with existing studies

      • Assess the competition. See what other projects in your field are being funded, and consider turning competitors into collaborators to improve the strength of your proposal

      • Carve out a niche that will allow you to significantly advance knowledge in your respective field


    Nih peer review criteria

    NIH Peer Review Criteria

    1 . Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventive measures that drive this field?

    2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

    3. Innovation. Is the project original and innovative? For example, does the project challenge existing paradigms or clinical practice? Does it address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

    4. Investigators. Are the PD/PI (s) and other key personnel appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI(s) and other researchers? Do the PD/PI (s) and investigative team bring complementary and integrated expertise to the project, if applicable?

    5. Environment. Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?


    A note on budgets

    A Note on Budgets

    • Most NIH applications will state that a modular (non-detailed) budget is required

      • NOT SO FOR FOREIGN INSTITUTIONS

      • YOU MUST COMPLETE A DETAILED “RESEARCH & RELATED” BUDGET

  • For NIH Grants, full F&A costs will not be allowed. NIH provides limited F&A costs (8 percent of total direct costs less equipment) to foreign institutions to support the costs of compliance with NIH requirements

  • Be realistic. Ask for the funds you need! Don’t be modest.


  • Application support

    Application Support

    • eRA Commons Help Desk Web: http://ithelpdesk.nih.gov/eRA/ (Preferred method of contact)Toll-free: 1-866-504-9552Hours: Mon-Fri, 7a.m. to 8 p.m. Eastern Time

    • Grants.gov Contact Center Toll-free: 1-800-518-4726Hours: Mon-Fri, 7 a.m. to 9 p.m. ESTEmail: [email protected] the resources available on the Grants.gov website first (http://grants.gov/)

    • Grants InfoPhone: 301-435-0714TTY: 301-451-5936Fax: 301-480-0525Email: [email protected]


    Websites and institutional numbers

    Websites and Institutional Numbers

    • Register on Grants.gov http://apply07.grants.gov/apply/OrcRegister

    • McMaster DUNS 207510108

    • Electronic Submission of Grant Applications http://era.nih.gov/ElectronicReceipt/support.htm

    • Application Changes - http://enhancing-peer-review.nih.gov

    • Video – What Applicants Need to Know Now, November 19, 2009

      http://enhancing-peer-review.nih.gov/application_changes_video.html

    • Foreign Grants Information http://grants.nih.gov/grants/foreign/index.htm


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