gco information session: you ask, we answer nih r01 a pplication b asics p resented by : m ichelle h...

GCO INFORMATION SESSION: YOU ASK, WE ANSWER

NIH R01 APPLICATION BASICS

PRESENTED BY: MICHELLE HUMPHREYS

GRANTS ANALYST IIGRANTS AND CONTRACTS OFFICE

NIH R01 APPLICATION BASICS

Q: Why isn’t there a GCO Procedure Guide for NIH R01 Applications?

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Short Answer: Because there are too many possible variables that can occur in an R01.

Long Answer: NIH R01 applications have some of the broadest guidelines allowable in NIH grant mechanisms; the number of variables that can be proposed in an R01 and “if-then” instructions make it impossible to reduce to a 1-2 page guide.

NIH R01 APPLICATION BASICS

NIH R01 Resources:

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• R01 Funding Opportunity Announcement (FOA) Instructions

• NIH Grants Policy Statement (GPS) (417 pages)

• Supplemental Grant Application Instructions guide (102 pages)

• NIH SF424 (R&R) Application Guide (253 pages)

NIH R01 APPLICATION BASICS

Different types of FOAs

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1. Parent Announcements (PARs)2. IC-Specific Program

Announcements (PAs)3. Request for Applications (RFAs)

How to find an R01 FOA:

1. http://www.grants.nih.gov/grants/guide/index.html 2. NIH IC websites (e.g. NIDDK, NHLBI)3. Google

NIH R01 APPLICATION BASICS

What is the R01 Funding Mechanism?

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NIH R01 APPLICATION BASICS

What are the SF424 Research & Related (R&R) forms?

The SF424 is a formset used by the federal government, including NIH, to accept applications for grant funding. NIH uses a combination of the federal-wide SF424 R&R forms and agency-specific (PHS) forms in application packages.

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NIH R01 APPLICATION BASICS

SF424: Mandatory vs. Optional Forms

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NIH R01 APPLICATION BASICS

NIH Application Basics

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Details are important!• Adhere to guidelines for font, margins,

format of attachments• All attachments must be PDFs; do not use

“Bundling” or “Portfolio”• Naming rules for attachments – only

include acceptable characters, do not use “&” or double spaces

• Watch out for invalid page sizes

NIH R01 APPLICATION BASICS

NIH Application Basics

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Carefully follow all attachment page limits

R01 Standard Page Limits

Specific Aims 1Research Strategy 12Biosketch 5Project Summary 30 lines of textProject Narrative 2-3 sentences

NIH R01 APPLICATION BASICS

NIH Application Basics

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Personnel Roles• PD/PI: Leader of the project• If multiple PIs on the application, all

need the same role of PD/PI; one must be designated the Contact PI

• Multi-PIs can be from different institutions; NIH will make a single award to the Contact PI’s institution

• Application must contain a Multi-PI Leadership Plan

• NIH does not recognize the term “Co-PI”

NIH R01 APPLICATION BASICS

NIH Application Basics

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Personnel Roles

• Senior/Key Personnel: presented as having quantifiable effort that is necessary and integral to the project

• Usually given the role of Co-Investigator• NIH will name all sponsor-identified Key

Personnel in the Notice of Award (NOA)

NIH R01 APPLICATION BASICS

NIH Application Basics

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Personnel Roles

• Other Significant Contributor (OSC): individual with no measurable or paid effort on the grant but whose contribution is important for the project in an advisory capacity

• OSCs are listed in the SF424 Senior/Key Personnel form and Biosketch is included

NIH R01 APPLICATION BASICS

NIH Application Basics

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Personnel Roles

• Consultant: individual with an advisory and short-term role on the project

• If the Consultant is to be paid and is a faculty member at another institution, this is covered via a Subaward

• Refer to the MCW Corporate Policy on Proposal Budget Preparation for details

NIH R01 APPLICATION BASICS

NIH Application Basics

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Biosketch• Required for all Senior/Key Personnel

and OSCs• New format required as of May 25, 2015• New resource for assistance: SciENcv• 5 pages (previously 4) with 4 sections:

A. Personal StatementB. Positions and HonorsC. Contributions to ScienceD. Research Support

NIH R01 APPLICATION BASICS

NIH Budget Forms

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Two types of budget forms accepted for an R01 application

1. Modular • Used if total direct costs are

between $25,000 - $250,000• Must be in increments of $25,000• No line item detail provided• 3 part budget justification as

applicable: Personnel, Consortium, and Additional Narrative sections

NIH R01 APPLICATION BASICS

NIH Budget Forms

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Two types of budget forms accepted for an R01 application

2. R&R Detail • Direct costs $250,001 - $500,000• Over $500,000 requires prior

approval from NIH or allowed if specified in the RFA

• Provides line item detail for each budget category

NIH R01 APPLICATION BASICS

NIH Budget Forms

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2. R&R Detail • Single detailed budget justification

required; each category must be well justified and future year increases and changes addressed

• Personnel: List all Key Personnel, with base salary, calendar months effort, fringe benefit amount

• Non-Key Personnel positions can be grouped

NIH R01 APPLICATION BASICS

NIH Budget Forms

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2. R&R Detail • Travel costs: identify travel to domestic

versus foreign sites• Provide details on supply costs; if

office supplies are included, must have detailed justification

• Justify any increases or changes in future budget periods

NIH R01 APPLICATION BASICS

NIH Budget Forms

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2. R&R Detail • If consortium sites are included,

R&R detail budget forms and justifications must be completed for each site

• If site is foreign, F&A is capped at 8%

• If site has no negotiated federal F&A rate agreement, new default F&A rate allowed is 10%

NIH R01 APPLICATION BASICS

NIH Budget

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Indirect Costs (F&A)• Determined by MCW’s Federally

Negotiated Rate Agreement• Rate based on where at MCW the

majority of the research is taking place• Most common default rates:

On-Campus: 53%; 7/1/16 54%

FMLH: 38%CRI: 52%Off-campus: 26% (CHW, clinics,

etc.)

NIH R01 APPLICATION BASICS

Compliance Areas

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Need to identify use of Human Subjects Research (HSR)and/or Vertebrate Animal Research in the application• If HSR is Exempt or requires designation

by the IRB that it is Non-HSR, this should be determined by the IRB at application

• If using animals, detailed information is required in the Vertebrate Animals plan; identify all species

NIH R01 APPLICATION BASICS

Consortium Site(s)

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If the project involves collaboration with faculty at another institution, a Consortium must be proposed in the application• Consortium Plan should detail the roles

and relationship between sites• Letter of Intent required for all sites at

the time of application• If R&R detail budget, need same level of

detail for each Consortium site as MCW

NIH R01 APPLICATION BASICS

R01 Submission Process

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1. The R01 is assembled in eBridge.2. After the FP is routed to GCO and

approved by AOR, GCO generates the final version of the SF424 and it is submitted to Grants.gov.

3. The application is reviewed in Grants.gov and if it passes all validations, moves to eRA Commons.

4. R01 is validated in eRA Commons; if there are no Errors, there is the 2-day review window up until application deadline.

NIH R01 APPLICATION BASICS

The End

Questions?

Email aor@mcw.edu

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NIH R01 APPLICATION BASICS

NIH R01 and Application Resources

NIH R01 Information: http://grants.nih.gov/grants/funding/r01.htm

SF424 (R&R) Application Guide and Supplemental Instruction guide: http://grants.nih.gov/grants/funding/424/index.htm

NIH Grants Policy Statement (GPS): http://grants.nih.gov/grants/policy/nihgps/index.htm

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NIH R01 APPLICATION BASICS

GCO Resources

Visit the GCO website:http://www1.mcw.edu/Grants-Contracts-Office.htm

GCO FAQshttp://www1.mcw.edu/Grants-Contracts-Office/FAQ.htm

MCW Corporate Policy – Proposal Budget Preparationhttp://infoscope.mcw.edu/Corporate-Policies/Research/Grants-Contracts.htm

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