THE NIH SUBMISSION AND ASSIGNMENT PROCESS Suzanne E. Fisher, Ph.D Director, Division of Receipt and...
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Transcript of THE NIH SUBMISSION AND ASSIGNMENT PROCESS Suzanne E. Fisher, Ph.D Director, Division of Receipt and...
THE NIH SUBMISSION AND ASSIGNMENT PROCESS
Suzanne E. Fisher, Ph.D
Director, Division of Receipt and Referral
Center for Scientific Review
January 2002
WHAT’S 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
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
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…
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
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
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
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
LOADING DOCK
Receive packages Unwrap
The step we know goes away with electronic submissions!
APPLICATION RECEIPT
– Date stamp– Accession number– Open and count letters– Separate bulky appendices– Identify RFAs, other applications for
special handling
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)
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
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
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
NONCOMPLIANT APPLICATIONS Fix directly if possible
– Shorten title– Match letters, other material received
separately Contact IC
– $500k– Supplements that do not match parent
grant
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)
POST SUBMISSION INTERACTIONS WITH INVESTIGATORS
Add missing information Replace sections Assignment suggestions Assignment changes On time information
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/clarification at various stages of process
ELECTRONIC SUBMISSION – OPPORTUNITIES AND CHALLENGES
Completeness/Compliance Research Plan Investigator requests Receipt dates Equity Shorten submission to award cycle
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)
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.
INVESTIGATOR REQUESTS
Identification of mechanism and any special requirements
“Self Referral” - suggestions for assignment for review and potential funding IC(s)
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)
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
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
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