National Institutes of Health

National Institutes of Health Presented by:

Van NhanSenior Grants AdvisorHealth Research ServicesFaculty of Health SciencesHSC 1B7Phone: (905) 525-9140, Ext. 22057Email: [email protected]

Dec 3/09

mailto:[email protected]

2

Discussion Topics

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

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

3. 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

4. Tips on getting funded by the NIH

3

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/

44

Office of Extramural Research

eRA, Commons,eSubmission

POLICY

NIH GUIDE

FORMS & INSTRUCTIONS,SUBMISSION DATES

GLOSSARY, FAQS

INITIATIVES

GET CONECTED

http://grants.nih.gov/

BASICS

5

Grants Foreign Institutions Are Most Commonly Eligible For:

RO1 – Research Project Grant

RO3 – Small Grant Program

R21 - Exploratory /Developmental Research Grant Award

• Used to support a discrete, specified, circumscribed research project

• NIH's most commonly used grant program

• No specific dollar limit unless specified in the FOA • Advance permission required for $500K or more (direct costs) in any year

• Generally for 3 -5 yrs

• All ICs utilize

• Limited funding for a short period of time to support a variety project types: pilot or feasibility studies, collection of preliminary data, secondary analysis of existing data, small, self-contained research projects, development of new research technology, etc.

• Limited to 2 yrs of funding

• Direct costs generally up to $50,000 per year

• Not renewable

• Utilized by more than half of the NIH ICs

• Encourages new, exploratory and developmental research projects, support for the early stages of project development. Sometimes used for pilot and feasibility studies.

• Up to 2 yrs of funding

• Combined budget for direct costs for the 2 yr project period usually may not exceed $275,000.

• No preliminary data required

• Most ICs utilize

6

Grant Type Deadline (3 cycles)

RO1 – Research Project GrantNEW Application

Feb 5, Jun 5, Oct 5

R01 – Renewal, Resubmission, Revision

Mar 5, Jul 5, Nov 5

R03 - Small Grant Program R21 - Exploratory /Developmental NEW Application

Feb 16, Jun 16, Oct 16

R03, R21 – Renewal, Resubmission, Revision

Mar 16, Jul 16, Nov16

NIH Standard Receipt Dates/Application

Deadlines

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

7

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.

Foreign Eligibility

8

Applying as a Foreign Institution

Advantages Disadvantages

U.S. Exchange Rate (not so much now)

Exchange rate fluctuationOnce an award is made, NIH will not compensate foreign grantees for currency exchange fluctuations

Salary• The NIH will pay for portions of the investigator’s salary (including PIs and Co-Is)• Amount of salary paid is equivalent to amount of time dedicated to research project• Because of this component we ask that all investigator’s discuss this with their departments when applying to NIH

Highly competitive

Note: FHS at McMaster University externally reported over $7 million CDN dollars in NIH funding for 08/09

Dollar Figures•Generally, the NIH funds larger budgets than many other funding agencies•Budgets should accurately reflect the actual costs of running a project

9

Discussion Topics



3. 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


10

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

1111

eSubmission ProcessPrepare to Apply

Find Opportunity and Download Application

Package

Submit Application to Grants.gov

Prepare Application

Check Submission Status

Check Assembled Application

Submission Complete

If errors, correct & submit again

12

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

13

Applying to the NIHFirst Step – Get

Registered

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

1. an NIH eRA Commons ID

2. Authorized Organization Representative

status on grants.gov

14

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

FHS All Other Faculties

Health Research ServicesVan NhanSenior Grants [email protected]

Office of Research ServicesSonya StrohmSenior Grants [email protected]

15

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

16

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

McMaster’s DUNS

17

Internal Process Considerations

1. 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

2. 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

For FHS

1818



Package


Prepare Application



Submission Complete


19

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

20

Finding FOAs in NIH Guide

Enter search string or click Advanced Search

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

21

Announcement Notes FOAs in the NIH Guide include button

to download app from Grants.gov

Click Apply for Grant Electronically

Click download

Verify information

22



Package


Prepare Application



Submission Complete


23

Grant Application Package Screen

Save locally

Check Application Guide to determine which Optional Documents to submit

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

Mandatory Grants.gov fields highlighted; Check App Guidefor additional NIH required fields

Header info is pre-populated and not editable

24

Application Guide Read and follow application guide instructions

Agency-specific instructions are marked with the HHS logo

25

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

26



Package


Prepare Application



Submission Complete


27

Submit Application

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.

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

28

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

Only the AOR can Submit application.

Submit Application

29

Submit Application

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

30

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

31

E-mail Notifications – Grants.govAOR receives Grants.gov e-mails

1. 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)

32

Back to NIH

You’re not done yet! Make sure you

follow the application through to NIH.

33



Package


Prepare Application



Submission Complete


34

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

35

E-mail Notifications - eRA Commons

AOR/SO, PD/PI and Contact receive

e-mails

Validations Complete/Check Assembled Application

Validations Complete/Check Assembled Application – Warnings Only

Action Required: Errors and/or Warnings, Missing or Invalid Commons Username, System Error

SO has refused application – SO rejected the application

363636

Check Status in Commons – PD/PI

Select Recent/Pending eSubmissions

Or provide Grants.gov tracking number from email notification

3737

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

3838

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 Links Avoiding Common Errors page:

http://era.nih.gov/ElectronicReceipt/avoiding_errors.ht

m

Full list of Commons Validationshttp://era.nih.gov/ElectronicReceipt/files/SF424RR_Validation.pdf

39

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

40

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

4141

Correcting eSub Errors/Warnings

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

1. 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)

2. Include cover letter if after submission deadline

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

4. Track submission through to Commons

NOTE: Reviewers do not see applicant errors/warnings.

42



Package


Prepare Application



Submission Complete


4343

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

4444

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!

45

Status – View Application Image

View Appendices and Cover Letter

Status is Pending Verification

Follow e-Application link to view assembledapplication image

Follow link to detailed status info

46

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!

47

Reject ApplicationMust have SO role

Select Recent/ Pending eSubmissions

Click Search

Enter Search Criteria

48

Reject Application

Select Reject eApplicationEnter comment

to be sent with email notification

Click Reject

49



Package


Prepare Application



Submission Complete


50

Discussion Topics





51

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

52

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

Restructured Application Forms

53

Overview of the Changes

Application forms will be revised in three sections:

– Research Plan– Biographical Sketch– Resource and Facilities

54

New Research Plan ComponentsIntroduction

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

55

New Research Strategy SectionCurrent Application New Application

Background and Significance

Research Strategy

a. Significance

b. Innovation

c. Approach• Preliminary Studies

for New Applications

• Progress Report for Renewal/Revision

Research Design and

Methods

Preliminary Studies/Progress Report

56

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

57

Goals of Shortened Page Limits Reduce the administrative burden

Focus on the essentials of the science

Avoid information overload

New Instructions Including Shorter Page Limits

58

Page Limit Revisions

Current Page Limit (Section 2-5 of the

Research Plan)

New Page Limit (Research Strategy)

<25 6

25 12

>25 Follow FOA Instructions

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

59

What Has Not Changed

Need to have a good idea about Need to have a good idea about how to answer an important how to answer an important questionquestion

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

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

60

Discussion Topics





61

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

62

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.


63


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

64


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

65

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


66

NIH Peer Review Criteria1 . 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?

67

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.

68

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] Check 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]

69

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

Date post:	17-Jan-2016
Category:	Documents
Upload:	domani
View:	40 times
Download:	0 times