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Office of Sponsored Program ll rights reserved GTRC Working with the NIH

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Working with the NIH. Introduction to the NIH History Mission & Organization Funding Facts Fundamentals of NIH Grants Types of Grants Roles & Responsibilities (handout) Decoding the NIH Funding sources Applications & Scientific Review Budgets Program & Grants Staff Actions - PowerPoint PPT Presentation

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Page 1: Working with the NIH

Office of Sponsored ProgramsAll rights reserved GTRC

Working with the NIH

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Today’s TopicsIntroduction to the NIH– History– Mission & Organization– Funding Facts

Fundamentals of NIH Grants– Types of Grants– Roles & Responsibilities (handout)

Decoding the NIH Funding sourcesApplications & Scientific ReviewBudgets– Program & Grants Staff Actions– The Notice of Award (and after)

Web & GT Resources

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Introduction to NIH

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Administration forChildren and Families

(ACF)

Administration forChildren and Families

(ACF)

Food and DrugAdministration

(FDA)

Food and DrugAdministration

(FDA)

Health Resourcesand Services

Administration(HRSA)

Health Resourcesand Services

Administration(HRSA)

Secretary of Health and Human Services

Secretary of Health and Human Services

Administration onAging(AoA)

Administration onAging(AoA)

Center for Medicare &

Medicaid Services

(CMS)

Center for Medicare &

Medicaid Services

(CMS)

Indian HealthServices

(IHS)

Indian HealthServices

(IHS)

National Institutesof Health

(NIH)

National Institutesof Health

(NIH)

Centers for Disease Controland Prevention

(CDC)

Centers for Disease Controland Prevention

(CDC)

Substance Abuse andMental Health Services

Administration(SAMHSA)

Substance Abuse andMental Health Services

Administration(SAMHSA)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

Agency for Healthcare

Research and Quality(AHRQ)

Agency for Healthcare

Research and Quality(AHRQ)

U. S. Dept. of Health and Human Services

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NIH Founded in 1887One agency of 11 within U.S. Department of Health and Human Services (HHS)

Comprises 27 Institutes and Centers (IC)

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NIH Mission

NIH is the steward of medical and behavioral research for the Nation

Our mission: to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability …

… from the rarest genetic disorder to the common cold

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NIH Organizational Structure

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis and

Musculoskeletaland Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Allergy and

Infectious Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacialResearch

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

National Centerfor Complementary

and AlternativeMedicine

FogartyInternational

Center

National Centerfor ResearchResources

National Instituteof Biomedical Imaging and

Bioengineering

NIHClinical Center

Centerfor Information

Technology

Center for Scientific

Review

National Center on Minority Health

and Health Disparities

Office of the Director

No funding authority

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Fulfilling the Mission

Support research by non-Federal scientists across U.S. and abroad

Help train research investigators

Conduct research in our own labs

Foster communication of medical and health sciences information

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What Stays at NIH? What Goes Elsewhere?

$24.7

$4.7

Spending at NIH

Spending Outside

84% Outside NIH> 325,000 Scientists > 3,000 Organizations Worldwide

16% Inside NIH $2.9 B Intramural Research (10%)$1.2 B Staff & Buildings (4%)$0.6 B Other (2%)

Total FY 2008 Budget: $29.46 Billion

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Success Rates ofCompeting Research Progress

Grant (RPG) ApplicationsFY 2007 Reviewed Awarded Success $$$

All Competing RPG Appls 47,455 10,100 21.3% 3.72 BNew Appls 40,256 7,320 18.2% 2.51 BContinuing Appls 7,018 2,719 38.7% 1.20 B

Reviewed Awarded Success $$$ Original Appls 32,854 3,935 12.0% 1.58BA1 Appls 10,333 3,727 36.1% 1.30BA2 Appls 4,241 2,428 57.3% .83B

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Fundamentals of NIH Grants

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PrincipalInvestigator

Authorized Organizational

Reps

ResearchAdministrator

Grantee Institution Team

Grants are awarded to institutions as represented by AORs.

PD/PIs manage and perform the science

Research Administrators support business aspects of the grant

Successful grants require close coordination between all members of the grantee team.

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The Grantee Institution

Actual recipient of awardLegally responsible for proper conduct and execution of grantProvides fiscal management Provides oversight on allocation decisionsAssures compliance with Federal, NIH, and organization-wide requirements

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Georgia Tech Source of Awards

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Decoding the NIH

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NIH Activity Codes

An activity code is a three-character code identifying a specific category of extramural activity.

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Award MechanismsResearch Grants

Traditional – R01Exploratory/Development Grants – R03/R21/R33/R34Program Project – P01Research Center Grants – P50Small Business – R41, R42, R43, R44

Cooperative Agreements (U)Specialized Grant mechanismSubstantial NIH staff involvement in program and scienceTypically initiated by NIH

Research Training and Career Awards

Training Grants – T

Institutional

Pre-doctoral and Postdoctoral

Fellowships – F

Individual

Pre-doctoral – F31

Postdoctoral – F32

Career Development Award – K

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Sample Application Number

1 R01 GM 012345 10 A1/S1

Application Type

Activity Code

Institute/Center

Serial Number

Year of Support

Suffixes

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

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Select the FOA number to open the announcement

Find Grant Opportunities in NIH GuideFind Grant Opportunities in NIH Guide

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Find Opportunity & Download FOA

Read the FOA carefully for specific application instructions!Within the announcement – Click the Apply for Grant Electronically button

This will take you directly to Grants.gov to download the package

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NIH Scientific Review

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NIH Organizational Structure

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis and

Musculoskeletaland Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Allergy and

Infectious Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacialResearch

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

National Centerfor Complementary

and AlternativeMedicine

FogartyInternational

Center

National Centerfor ResearchResources

National Instituteof Biomedical Imaging and

Bioengineering

NIHClinical Center

Centerfor Information

Technology

Center for Scientific

Review

National Center on Minority Health

and Health Disparities

Office of the Director

No funding authority

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Receipt and Referral of Applications

CSR assigns application to Integrated Review Group

Paper PHS 398 delivered to CSR

CSR Referral Office

CSR assigns application to NIH Institute

CSR assigns application number

1st Month

2nd Month

Application assessed for completeness & eligibility

Notice of assignment available in eRA Commons in 4 weeks.

Electronic SF424 R&R submitted through grants.gov

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2 Level System for Application Review

National Advisory Council Assesses Quality of SRG Review Makes Recommendation to Institute Staff on Funding

Evaluates Program Priorities and Relevance

Advises on Policy

Scientific Review Group (SRG) Independent outside reviewers Evaluate scientific merit & significance Recommend length and level of funding

1st Level

2nd Level

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1st Level Review

Standing study section typically has 12-24 members

3 face-to-face meetings each year

Review 60 - 100 applications at each meeting

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New Priority Score

The NIH grant application scoring system uses a 9-point scale A score of 1 indicates an exceptionally strong application with essentially no weaknesses. A score of 9 indicates an application with serious and substantive weaknesses with very few strengths; 5 is considered an average score Ratings are in whole numbers only (no decimal ratings) This scale is used by all eligible (without conflict of interest)

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Pay Line

Conservative funding cutoff point for grant applications set at the beginning of a fiscal year. Institutes determine pay lines by balancing projected grant numbers, grant budgets, and monies in the budget.

The lower numbers represent better scores.

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Video

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Review of Applications

•23 CSR Integrated Review Groups • 220 standing Study Sections• 300 + Special Emphasis Panels

• Review groups at each IC• Dozens of standing Study Sections • Several hundred SEP meetings

3rd Month 4th Month

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After 1st Level Review

Priority Scores recorded

Summary Statements prepared– Overall Resume and Summary of Review Discussion– Essentially Unedited Critiques– Priority Score and Percentile Ranking– Budget Recommendations– Administrative Notes

Viewable 4-6 weeks after review meeting– Only available through the eRA Commons

5th Month 6th Month

7th Month

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2nd Level Review

National Advisory Council or Board assesses quality of 1st level review– Concurs with or modifies SRG action – Reads summary statements only

Can also designate application as “High” or “Low” program priority

8th Month

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Timeline: New Applications

ReceiptDate

February 5June 5

October 5

ScientificReview

JulyOctoberMarch

CouncilReviewOctoberJanuary

May

AwardDate

December AprilJuly

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Do I Contact NIH Before Applying?

Mandatory:Application with budget >$500,000 direct costs for any single year

R13 Conference Grants

Optional:

When RFA’s request a Letter of Intent

Recommended:

When you think about applying for any grant

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Who Makes Actual Funding Decisions?

The Institute DirectorFactors they considered:

– Scientific Merit– Contribution to Institute Mission– Program Balance– Availability of Funds

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Award Negotiation & IssuanceThere are still many steps after a funding decision is made before a grant is awarded.Grants management staff work closely with grantee and NIH program staff to complete this final process.

9th Month 10th Month

Funding approval

from Program

Award Issued

Final review &

Negotiations

Congressional Liaison Notified

Award Received

by Grantee

Investigator Begins Work

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Grants Management IssuesAssurances in Place– Office of Human Research Protections (humans)– Office of Laboratory Animal Welfare (animals)

Financial Status Report (FSR)– (SF 269-long form) – if applicable

Human Subjects EducationPerformance Site(s)/Consortium(s) informationChecklist completenessJust-In-Time Information

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Just-In-Time Information

Information not required to review the application but which is necessary to implement the grant.

Certification of Education on Human SubjectsInstitutional Review Board (IRB) approval – Required within 1 year and before any human subjects

research begins.Institutional Animal Care and Use Committee (IACUC) Approval – Required within 3 years and before animal research

begins.Information on “Other Support” received by Key Personnel

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Grants Management: Special Issues

For Example:

Is there a “foreign component” to the grant?– Includes grants to foreign organizations and

grants with activities or consortium partners in foreign countries.

– Require State Department Clearance prior to award.

Are there bars to the award?– Human subjects and animal subjects concerns– Are there research integrity issues?

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Budget

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Budgetary IssuesCorrectly apply modular and categorical budgets– Modular budgets reduce burden by eliminating the need

for specific budget numbers– Available for grants at or below $250,000 per year– Grantees awarded grants in “modules” of $25,000

Budget Justification Adjustments may be applied to individual grant awards based on IC financial policies– Caps on certain types of costs specific to that funding

opportunity– Limits on overall grant funding due to NIH budget

constraints.

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Modular Budget

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Modular Budget Sections A&B: Personnel

Determine the amount of time (effort) that you will spend on this project.– Calendar, Academic, or Summer Months

Determine the number, qualifications and amount of time needed for other personnel– Technicians

– Postdoctoral Fellows

– Graduate Students

– Undergraduate Students

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There are no magic numbers regarding the qualifications and/or number of individuals needed for each aim.

Be realistic about what each individual can accomplish, and the time necessary to complete the work.Remember the current NIH Salary cap is $191,300

Modular Budget Sections A&B: Personnel

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Modular Budget Section C: Do you need new equipment?

If you need additional equipment, this is the time to consider it.Equipment should be project specific – be sure to include a written justification.Most equipment is requested during the first year of the grant.If you use a modular budget format, you may ask for extra module(s) to cover equipment.

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Modular Budget Section D: Travel funds

This amount is usually small: – $1,000 - 2,000 per meeting per individual

per year

Generally supports one meeting per year for 2-3 individuals

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Modular Budget Section E: Participant/Trainee Support Costs

Unless stated in the FOA, this section should be left blank for NIH applications

– Include tuition remission under Section F: Other Direct Costs

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Modular Budget Section F: Other Direct Costs

Estimate the materials and supplies needed for the personnel involved

It may be reasonable to estimate a supply budget of ~$12,000–15,000/year for each FTE

This number will vary depending on the nature of the research proposed.– Animal intensive studies and studies involving human

subjects tend to be more costly.– In silico studies tend to be less costly for supplies.

Consider stage of career of personnel involved

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Modular Budget Section F: Other Direct Costs

This category also includes funds needed for things such as:– Publication costs – Equipment maintenance– Consortium/subcontracts– Tuition remission.

Estimate these expenses realistically.

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Example Modular BudgetCal Req. Fringe FundsMon Salary BenefitsReq.

A. Senior/Key PersonPI 2 15,333 4,293 19,626

B. Other PersonnelPostdoc Assoc 12 38,976 10,913 49,889Grad Student 12 20,772 5,454 26,226Grad Student 12 20,772 5,454 26,226

C. Equipment – Microscope 19,000D. Travel - (2 meetings) 4,000E. Participant/Trainee usually left

blankF. Other Direct Costs

Materials/Supplies 25,533Publication Costs 1,500Subaward/Consortium/Contractual costs noneTuition Remission 7,000

G. Total Direct Costs 179,000

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Calculate the direct costs for the first year.– (for example, Year 1 budget = $179,000)

Calculate the direct costs for subsequent years taking into account salary increases and changes in funds requested for equipment.– Year 2 = $164,800– Year 3 = $169,744– Year 4 = $174,836– Year 5 = $180,081

Example Modular Budget

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Do I need to submit a modular budget?

Calculate the total direct costs for all years– Total direct costs for 5 years = $868,461

Divide total by the number of years requested– Average direct costs = $173,692/yr

Investigator-initiated R01s up to $250,000/yr must use modular format

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Convert Your Average Direct Costs to the Modular Format

Round up to the next module (number divisible by $25,000)– In the example, $173,692/yr rounds up to

$175,000/yr

No yearly increases for inflationFirst year may include additional modules for one-time expenses like equipment– In the example, add one additional module

to year 1 = $200,000

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Reminder for BudgetAll budget requests to NIH for R01

applications use:– the modular format when requesting direct

costs of $250,000 or less each year

– the non-modular format when requesting direct costs greater than $250,000 in any year

Consortium F&A costs are not factored into the modular direct cost limit

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R01 Budget with Consortium CostsPrepare an itemized budget for the parent

awardPrepare an itemized budget for

consortium/subcontract costs, including:Personnel – salary and benefits

Travel – professional or investigator meeting

Other Direct Costs– Materials and Supplies

Total Direct Costs = $38,300

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Total Consortium Costs

Consortium Direct Costs = $38,300

Consortium F&A– consortium institution (at 50%) = $19,150

Consortium Total Costs = $57,450Remember you may round to the nearest $1,000

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Should you request a modular budget?

Example Modular Budget

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R01 Grant with Consortium Budget

Submit as a modular budgetwhen requesting Direct Costs at or

below $250,000 per year…

… excluding Consortium F&A costs.

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Modular Grant with Consortium BudgetIn our example,

Year 1 – Itemized Total DC = $256,124minus Consortium F&A = $ 19,150

Year 1 – Itemized DC excluding F&A = $236,974

Year 2 – Itemized DC excluding F&A = $224,513Year 3 – Itemized DC excluding F&A = $231,249Year 4 – Itemized DC excluding F&A = $238,186Year 5 – Itemized DC excluding F&A = $245,332

Avg Direct Cost per yr (excluding F&A) = $235,251

Round up to the next module = $250,000

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Record Modular Budget with Consortium: PHS 398 Modular Budget, Period 1

A. Direct Costs Funds Requested ($)*Direct Cost less Consortium F&A $250,000

Consortium F&A $ 19,150 *Total Direct Costs $269,150

The total direct costs requested are allowed to exceed the modular maximum ($250,000) by the amount of F&A associated with the subcontract.

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Money…money… and more money?

Applications requesting > $500,000 DC in any single year – applicants must seek agreement to accept assignment from Institute staff at least six weeks prior to submission.

Multiple principal investigator R01 is intended for projects that clearly require a “team science” approach. The Multiple PI option should not be used as a means to justify a large budget request.

Well-funded investigators should consult with Institute staff regarding policies for support of new research in well-funded laboratories.

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Notice of Award (NoA): Overview

LEGALLY BINDING DOCUMENT

Award Data & Fiscal InformationAward Data & Fiscal Information

Grant Payment InformationGrant Payment Information

OIG* Hotline InformationOIG* Hotline Information

Terms and ConditionsTerms and Conditions

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Grantee Acceptance

The grantee indicates acceptance of the terms and conditions of the

award by drawing down funds against the grant from the

Payment Management System.

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After the Award…

Administrative and Fiscal Monitoring Requirements– Annual Progress Report

(PHS 2590)– Annual Financial Status Reports (FSR)– Invention Reporting– Yearly Audits (as applicable)– Final Closeout Reports

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Tools and Resources

CRISP

Finding NIH funding

PubMed Central

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Crisp

Computer Retrieval of Information on Scientific ProjectsSearchable database of federally supported biomedical research Locate experienced NIH-funded investigators in your area of interest Potential mentors/collaboratorsIdentify the IC that supports research you want to doAnalyze current IC portfolioResearch areas with few funded projectsResearch areas with many funded projects

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CRISP

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eRA Will Check to Ensure…

Once NIH retrieves the application from Grants.gov, eRA systems check the application against NIH business rules.– Detailed check against the instructions in the

application guide– Validates against the instructions in the FOA– For a detailed list of NIH validations:

http://era.nih.gov/ElectronicReceipt/prepare_app.htm#5

Remember, the SF424 (R&R) forms are used by many agencies, so unfortunately NIH cannot build our specific rules into the forms.

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If You Receive Errors & Warnings from NIH…

Errors must be addressed for the application to move on to NIH Receipt & Referral.

– An application must be error-free in order for eRA systems to generate an image of the application for viewing.

Warnings may be fixed at the applicant’s discretion but do not require action for the application to move on.

If the PI corrects any Warnings or Errors, they should contact the AOR/SO. The AOR/SO must submit the entire ‘Changed/Corrected’ application again through Grants.gov.

– Use changed/corrected check box on SF424(R&R) form

NOTE: Reviewers/NIH Staff do not see notifications provided to applicants about errors/warnings.

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Submitting Changed/Corrected Application: Cover Letter

If submitting a changed/corrected application during the 2-business day error correction window after the receipt date, the cover letter must explain changes.

– If your original submission included a cover letter then you must include all previous cover letter text in the revised cover letter attachment.

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Check Status in Commons – PD/PI

Select Recent/Pending eSubmissions link

Or provide Grants.gov tracking number from email notification

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71

View Errors/Warnings

Check Status

Select to show errors/warnings

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Check Assembled Application

The AOR/SO has a 2-business day (excluding federal holidays) viewing window to reject an application that has system formatting errors. If the application is not rejected within the 2 business days it will automatically proceed to Receipt & Referral.

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Deposit

PubMed Central http://www.pubmedcentral.nih.gov/

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Publisher Deposit

Some publishers automatically deposit the published article in PMC http://publicaccess.nih.gov/submit_process_journals.htm

Some publishers deposit the final peer-reviewed manuscript in PMC– PIs must approve the submission in the NIH

Manuscript Submission System [NIHMS]). http://www.nihms.nih.gov/

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Library Services Offered

Answer questions related to the NIH Public Access Policy and how to comply. Offer NIH Public Access Policy informational sessions to departments, research groups, and individual faculty.Deposit manuscripts in PubMed Central and SMARTech on behalf of authors. Provide hands-on PubMed Central submission training. Suggest tools that help researchers retain rights to deposit in repositories like PubMed Central. Contact us at: [email protected]

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Including PMCIDs in Citations

After May 25, 2008, “NIH applications, proposals, and progress reports must include the PubMed Central reference number when citing a paper that falls under the policy and is authored or co-authored by the investigator, or arose from the investigator’s NIH award. This policy includes applications submitted to the NIH for the May 25, 2008 due date and subsequent due dates.”

http://publicaccess.nih.gov/

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Closeout Final Report

Submit Closeout document electronically through the eRA Commons

Documents are due within 90 days of project period end date– Final Financial Status Report (Required electronically)– Final Invention Statement & Certification– Final Progress Report

Failure to submit timely reports may affect future funding to the organization

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CornerstoneCornerstone of the NIH Extramural of the NIH Extramural MissionMission

Standard of Excellence WorldwideStandard of Excellence Worldwide

Collaboration between NIH Extramural Collaboration between NIH Extramural Staff and Scientific CommunityStaff and Scientific Community

NIH Peer Review SystemNIH Peer Review System

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Facilitate changing nature of science

Identify and encourage new and early stage investigators

Ease burden on research enterprise

Streamline time to award

Fund the best science, by the best scientists, with the least amount of administrative burden

Enhancing NIH Peer ReviewEnhancing NIH Peer Review

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Changes Happening NOW Changes Happening NOW January 2009 (and beyond) January 2009 (and beyond)

Due Dates Due Dates Potential FY2010 fundingPotential FY2010 funding

New Policy on ResubmissionsNew Policy on Resubmissions

Identification of Early Stage Investigator (ESI) Identification of Early Stage Investigator (ESI) ApplicationsApplications

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Goals of New Resubmission Goals of New Resubmission PolicyPolicy

Fund meritorious science earlierFund meritorious science earlier

Enhance success rates of new and Enhance success rates of new and resubmitted applications by resubmitted applications by decreasing the number of allowed decreasing the number of allowed grant application resubmissions grant application resubmissions (amendments) from two to one(amendments) from two to one

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New Policy on New Policy on ResubmissionsResubmissions

For January 25, 2009 due dates and For January 25, 2009 due dates and beyond, NIH will accept only a single beyond, NIH will accept only a single amendment to the original applicationamendment to the original application– original new applications (i.e., never original new applications (i.e., never

submitted)submitted)– competing renewal applicationscompeting renewal applications

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Early Stage Investigator Early Stage Investigator (ESI) Policy(ESI) Policy

NIH will support New Investigators at success NIH will support New Investigators at success rates comparable to those for established rates comparable to those for established investigators submitting new applicationsinvestigators submitting new applications

ESIs will comprise a majority of the NIs ESIs will comprise a majority of the NIs supported (FY 2009 funding and beyond). supported (FY 2009 funding and beyond). To ensure appropriate consideration for ESI To ensure appropriate consideration for ESI eligibility, all NIs will need to update their eRA eligibility, all NIs will need to update their eRA Commons profiles, and will now see their Commons profiles, and will now see their eligibility displayed in eRA Commonseligibility displayed in eRA Commons..

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Goals of Identifying Early Goals of Identifying Early Stage Investigators (ESIs)Stage Investigators (ESIs)

Encourage transition to independence Encourage transition to independence for investigatorsfor investigatorsCounter trend of increasing time spent Counter trend of increasing time spent in training phase of careerin training phase of careerStrongly encourage New Investigators Strongly encourage New Investigators (NIs), particularly ESIs, to apply for (NIs), particularly ESIs, to apply for R01 grants when seeking first-time R01 grants when seeking first-time NIH funding NIH funding 

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Early Stage Investigator Early Stage Investigator (ESI) Implementation(ESI) Implementation

Beginning with the traditional R01 grant Beginning with the traditional R01 grant applications received for the February 5, applications received for the February 5, 2009 receipt dates, NIH will identify grant 2009 receipt dates, NIH will identify grant applications from NIs and ESIsapplications from NIs and ESIs

NI and ESI applications will be clustered NI and ESI applications will be clustered for review beginning with the May 2009 for review beginning with the May 2009 review meetingsreview meetings

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Changes Coming SOONChanges Coming SOON May 2009 Review Meetings May 2009 Review Meetings Potential FY2010 fundingPotential FY2010 funding

New 1-9 Scoring SystemNew 1-9 Scoring System

Scoring of Individual Core CriteriaScoring of Individual Core Criteria

Templates for Structured CritiquesTemplates for Structured Critiques

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1-9 Scoring System1-9 Scoring System

The new scoring system will use a 9-The new scoring system will use a 9-point scale point scale (1 = exceptional, 9 = poor)(1 = exceptional, 9 = poor)

This scale will be used for overall This scale will be used for overall impact/priority scores AND for impact/priority scores AND for individual criterion scoresindividual criterion scores

Preliminary impact/priority scores will Preliminary impact/priority scores will help determine which applications are help determine which applications are discusseddiscussed

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Scoring of Individual Review Scoring of Individual Review CriteriaCriteria

Assigned reviewers will use the 9-point Assigned reviewers will use the 9-point scale for five review criteriascale for five review criteria– Each assigned reviewer’s criterion scores will be Each assigned reviewer’s criterion scores will be

reported in the summary statementreported in the summary statement– Criterion scores will be reported for ALL Criterion scores will be reported for ALL

applicationsapplications

Reviewers will consider criterion scores Reviewers will consider criterion scores as appropriate for each application in as appropriate for each application in determining overall impact/priority determining overall impact/priority scorescore

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Templates for Reviewer Templates for Reviewer CritiquesCritiques

Templates contain a box for reviewers to Templates contain a box for reviewers to write their comments for:write their comments for:– each of the core review criteriaeach of the core review criteria– overall impactoverall impact– other review criteria and additional considerations other review criteria and additional considerations

Comments will be in the form of bullet Comments will be in the form of bullet points or short narrativespoints or short narrativesThe template will be uploaded to become The template will be uploaded to become part of the summary statementpart of the summary statement

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Changes Coming LATERChanges Coming LATER

Restructuring of the application will begin with the FY 2011 funding cycle (applications submitted for January 2010 due dates and later)– shorter length– realignment of the application sections with

the review criteria

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Definition of Early Stage Definition of Early Stage InvestigatorInvestigator

A Program Director/Principal Investigator A Program Director/Principal Investigator who qualifies as a New Investigator is who qualifies as a New Investigator is considered an Early Stage Investigator considered an Early Stage Investigator (ESI) if he/she is  within 10 years of (ESI) if he/she is  within 10 years of completing his/her terminal research completing his/her terminal research degree or is within 10 years of completing degree or is within 10 years of completing medical residency (or the equivalent). medical residency (or the equivalent). 

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Definition of New Investigator Definition of New Investigator In general, a Program Director/Principal Investigator (PD/PI) is In general, a Program Director/Principal Investigator (PD/PI) is

considered a New Investigator if he/she has not previously considered a New Investigator if he/she has not previously competed successfully as PD/PI for a significant NIH independent competed successfully as PD/PI for a significant NIH independent research award.  Specifically, a PD/PI is identified as a New research award.  Specifically, a PD/PI is identified as a New Investigator if he/she has not previously competed successfully Investigator if he/she has not previously competed successfully for an NIH-supported research project other than the following for an NIH-supported research project other than the following small or early stage research awards:small or early stage research awards:– Pathway to Independence Award-Research Phase (R00), Pathway to Independence Award-Research Phase (R00),

Small Grant (R03), Academic Research Enhancement Award Small Grant (R03), Academic Research Enhancement Award (R15), Exploratory/Developmental Grant (R21), Clinical Trial (R15), Exploratory/Developmental Grant (R21), Clinical Trial Planning Grant (R34), Dissertation Award (R36), Small Planning Grant (R34), Dissertation Award (R36), Small Business Technology Transfer Grant-Phase I (R41), Small Business Technology Transfer Grant-Phase I (R41), Small Business Innovation Research Grant-Phase I (R43), Shannon Business Innovation Research Grant-Phase I (R43), Shannon Award (R55), NIH High Priority, Short-Term Project Award Award (R55), NIH High Priority, Short-Term Project Award (R56), Competitive Research Pilot Projects (SC2, SC3), (R56), Competitive Research Pilot Projects (SC2, SC3), Training-Related and Mentored Career Awards, Training-Related and Mentored Career Awards,

Training-Related and Mentored Career Awards – All Fellowships (F awards), All career awards (K awards), All Fellowships (F awards), All career awards (K awards),

Loan repayment contracts (L30, L32, L40, L50, L60) Loan repayment contracts (L30, L32, L40, L50, L60) Instrumentation, Construction, Education, Health Disparity Instrumentation, Construction, Education, Health Disparity

Endowment Grants, or Meeting Awards Endowment Grants, or Meeting Awards – G07, G08, G11, G13, G20, S10, S15, S21, S22 G07, G08, G11, G13, G20, S10, S15, S21, S22

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http://grants.nih.gov/grants/peer/reviewer_guidelines.htm