gco information session: you ask, we answer nih r01 a pplication b asics p resented by : m ichelle h...
TRANSCRIPT
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?
2
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:
3
• 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
4
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?
5
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.
6
NIH R01 APPLICATION BASICS
SF424: Mandatory vs. Optional Forms
7
NIH R01 APPLICATION BASICS
NIH Application Basics
8
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
9
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
10
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
11
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
12
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
13
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
14
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
15
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
16
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
17
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
18
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
19
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
20
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
21
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)
22
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
23
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
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
25
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
26