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