THE NIH SUBMISSION AND ASSIGNMENT PROCESS

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THE NIH SUBMISSION AND ASSIGNMENT PROCESS

• Suzanne E. Fisher, Ph.D
• Director, Division of Receipt and Referral
• Center for Scientific Review
• January 2002

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WHATS IN A NAME?

• NIH perspective - Receipt and Referral
• Applicant perspective - Submission and Assignment
• Multiple activities involving a variety of
  procedures, policies, and decisions critical to
  the NIH Extramural process

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SUBMISSION

• The Division of Receipt and Referral,CSR receives
  all competitive applications for NIH, also
  applications for AHRQ, SAMHSA, NIOSH, and small
  business applications for CDC and FDA
• Twenty-four funding components of NIH
• More than 46,000 applications/year
• Three Receipt/Review/Award cycles per year

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THREE FAVORITE TOPICS FOR DRR

• I would like permission to submit my application
  late.
• Did you receive my application? I sent it Fed
  Ex.
• I sent my application and then I looked at it

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OPPORTUNITIES ABOUND A BLESSING AND A CURSE

• Many different grant mechanisms used by the
  Institutes/Centers
• Support ranges from individual predoctoral level
  to very large resources
• Each Institute/Center uses a different array of
  mechanisms and may have special requirements
• Investigator-initiated and solicited applications
  (RFAs)
• Application kits and deadlines vary

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NIH FUNDING COMPONENTS

• NCI
• NEI
• NHLBI
• NHGRI
• NIA
• NIAAA
• NIAID
• NIAMS
• NICHD
• NIDCD
• NIDCR
• NIDDK

• NIDA
• NIEHS
• NIGMS
• NIMH
• NINDS
• NINR
• NLM
• NIBIB
• NCCAM
• NCRR
• NCMHD
• FIC

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COMMON GRANT MECHANISMS

• C06
• F31, F32, F33
• K01, K02, K08, K07, K12, K23, K24, K25
• P01
• P20
• P30, P40, P50, P60
• M01

• R01
• R03
• R21
• R25
• R41, R42
• R43, R44
• T32
• U01

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STAGES IN PROCESSING OF APPLICATIONS

• Loading Dock
• Application Receipt
• Project Control Unit 1
• Referral
• Project Control Unit 2
• Scanning/Duplication/Delivery to review group/IC

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LOADING DOCK

• Receive packages
• Unwrap
• The step we know goes away with electronic
  submissions!

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APPLICATION RECEIPT

• Date stamp
• Accession number
• Open and count letters
• Separate bulky appendices
• Identify RFAs, other applications for special
  handling

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PROJECT CONTROL - UNIT 1

• Record data from page 1, budget, Checklist,
  Personal Data page
• Match any ARAs (Awaiting Receipt of Application)
• Identify noncompliant budgets (500k, modular)
• Identify noncompliant forms
• Identify potential duplicates
• Screen for format compliance
• Print PI application history (sponsor history for
  fellowships)

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REFERRAL PROCESS

• Make sure application is in compliance with
  policies and should be assigned
• 500k
• Modular budget
• Format
• Revised application
• A2/2 year limit
• Duplicate applications
• Virtual A3s
• Supplement time period matches parent grant
• HESC
• Next policy

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REFERRAL PROCESS (cont.)

• Determine if NIH or other agency application
• CSR or IC review
• Assign
• New, competing, supplement
• Mechanism
• Review location
• Primary and secondary ICs

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PROJECT CONTROL UNIT 2

• Final data quality check
• Final check for compliance (format, budget, etc.)
  and matching of any ARAs
• Generation of unique number for new applications
• Prepare application for scanning/duplication and
  distribution to review and ICs

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NONCOMPLIANT APPLICATIONS

• Fix directly if possible
• Shorten title
• Match letters, other material received separately
• Contact IC
• 500k
• Supplements that do not match parent grant

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NONCOMPLIANT APPLICATIONS (cont.)

• Contact PI to correct
• Form
• Format
• Missing reference letters
• Modular Budget
• Supplements
• Return to PI
• Not corrected/or not corrected in time
• 500k
• Not appropriate for NIH (mechanism/IC)

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POST SUBMISSION INTERACTIONS WITH INVESTIGATORS

• Add missing information
• Replace sections
• Assignment suggestions
• Assignment changes
• On time information

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CURRENT PAPER SUBMISSION PROCESS

• Poor track record of compliance in many areas
• Vertebrate Animals, Human Subjects
• Considerable interaction with PIs, institutions,
  ICs in process
• Applications may be held for correction/clarificat
  ion at various stages of process

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ELECTRONIC SUBMISSION OPPORTUNITIES AND
CHALLENGES

• Completeness/Compliance
• Research Plan
• Investigator requests
• Receipt dates
• Equity
• Shorten submission to award cycle

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COMPLETENESS/COMPLIANCE

• Facilitate the submission of complete
  applications avoid errors of omission
• Facilitate the submission of applications that
  comply with NIH procedures and policies (and
  accommodate changes in policies)
• Include other materials letters of reference,
  collaboration, etc.
• Minimize post submission corrections
• Allow post submission additions
• Integrate on-time information
• Facilitate administrative review by NIH staff at
  many levels (referral, review, program, grants
  management)

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RESEARCH PLAN

• Enable investigators to present scientific
  information in a way that they feel makes the
  best case, shows necessary information in
  figures, tables, etc.
• Apply appropriate limits for text size, font,
  margins, etc.

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INVESTIGATOR REQUESTS

• Identification of mechanism and any special
  requirements
• Self Referral - suggestions for assignment for
  review and potential funding IC(s)

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RECEIPT DATES

• Handle large volume
• 47,000 or more a year
• 4,000 in one day
• Application and Appendix materials
• Reasonable flexibility for late applications
  (study section members, natural disasters, family
  emergencies)

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EQUITY

• Accommodate wide range of application types
  (fellowship, small business, research, centers)
• Accommodate range of applicant organizations
• Referral, review, award processes will be using
  both electronic and paper modes for some time
• Need to be sure that neither mode is advantaged
  or disadvantaged

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SHORTEN CYCLE

• Elimination of paper handling, data entry, etc.
  will eventually allow change in receipt dates,
  less time for receipt and referral stages
• May not lead to significant changes in time
  allowed for recruitment of reviewer or homework
  by reviewers
• Still expect to convene study section meetings

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CONCLUSION

• Change to electronic submission provides an
  opportunity to re-engineer grant application
  practices and improve the process
• This will require a lot of hard thinking and
  work in advance