1. EARLY STAGE INVESTIGATOR (ESI): THE FIRST YEAR PRAC/ January 2010 National Institutes of Health U.S. Department of Health and Human Services Walter Schaffer, Ph.D.Suzanne E. Fisher, Ph.D. Senior Scientific Advisor Director for Extramural Research Office of Extramural ResearchDivision of Receipt and Referral 1

2. Development of the ESI Policy Concern about the number of New Investigators Related concern about increasing age at first award Search for age-independent policy Develop ESI policy Modeled on NIH Director’s New Innovator Award – Announced March 9, 2007 oTen years from most recent doctoral degree or medical residency Enrich the applicant pool with enough ESIs to reduce the average age at first award Designed to encourage individuals and institutions to accelerate the period of training leading to independence Policy decision and electronic systems development – accelerated Direct and active involvement of several EPMC members with systems experts from eRA Moved from bare policy framework to systems development and complete implementation in less than six months. 2

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4. ESI Polices NOT-OD-08-121 (September 2008) Set the definition of NI and ESI oNI: PD/PI who has not yet competed successfully for a substantial, competing NIH research grant oESI: NI within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent) NOT-OD-09-013 (October 2008) Set expectations for FY2009: oNew and established investigators to be supported at equivalent success rates oMajority of NIs to be ESIs 4

5. ESI Extension Policy NOT-OD-09-021 (November 2008) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-021.html eRA Commons profiles will be used to determine ESI status based on degree and residency dates Investigators are responsible for Working with their institution to establish an eRA Commons account Entering necessary data (degrees, end of residency) and updating as necessary 5

6. ESI Extension Implementation NOT-OD-09-034 (December 2008) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-034.html Set process for requesting an extension of the ESI 10-year period Established web based application form Described factors to be considered Frequently Asked Questions developed http://grants.nih.gov/grants/new_investigators/investigator_policies_faqs.htm First extension requests received on January 16, 2009 First meeting of ESI Extension Committee on January 21, 2009 6

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8. New and Early Stage Investigator Policy for FY 2010 NOT-OD-10-039 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-039.html Reprise 2009 policy Continue to equilibrate success rates for established and new Investigators submitting type 1 R01 applications Should enable support for 1,650 new investigators A majority of the new investigator will be ESIs 8

9. ESI Extension Request Form http://grants.nih.gov/grants/new_investigators/esi_extension_add.h tm 9

10. ESI Extension Committee Joint Effort of the Office of Extramural Research and Division of Receipt and Referral (DRR), CSR Members Judith Cooper, PhD (NIDCD) Rene Etcheberrigaray, MD (CSR) Lisa Evans, JD (OER) Suzanne Fisher, PhD (CSR) James Hyde, PhD (NIDDK) Terry Nesbitt, DVM, PhD (NIEHS) Walter Schaffer, PhD (OER) Michael Small, PhD (NCI) Administrative and Analytic Support Mary Kalra (CSR) Jennifer Pohlhaus, PhD (OER) 10

11. Committee Process All members have access to requests via internet site. DRR confirms baseline status and communicates with requesters as needed: Enter or correct data in eRA Commons Profile Provide further information/details Committee meets every other week to discuss requests and requester responses. Consent lists are circulated between meeting weeks and approved requests processed. 11

12. Committee Outcomes Most cases are resolved within 1-2 weeks (complicated cases take longer). Requestor notified via email. Data is changed in NIH system and visible in eRA Commons Profile. Extra step needed to change status for pending R01 application; best if applicants make requests before R01 submission. Though formal appeal not possible, committee will reconsider if more information provided. 12

13. Extension Requests by Month 13

14. Demographics of Requestors and Requests More requests from females than males but 25% of requestors have not indicated sex in eRA Commons profile (not a required field) Frequency of requests from MDs plus MD/PhDs about the same as from PhDs but 14% are other degrees Females ask for a slightly longer extension than males Length of request is longer for MDs than PhDs and both are longer than MD/PhDs 14

15. Reasons for Granted Extensions 15

16. Committee Actions 72% of requests are granted (full or in part) 12 % of the requests are handled by administrative action Requestor enters data in eRA Commons Profile Inherited R01 16% of requests are denied Less than 1% of requests are abandoned; individual does not respond to multiple requests for further information. 16

17. Denied Requests Life Choice Work in industry Choose clinical practice Choose to stay at home for an extended period for child care MBA degree Change of research field Desire to be eligible for upcoming R01 submission 17

18. Misperceptions My tenure clock was extended by 1 year so my ESI status should be extended. Clinical responsibilities associated with a faculty appointment are eligible for an extension. In order to be with my spouse I took an inferior research position and that should count for an extension. Time of a Career Award (K series) is eligible for extension. FAQs are constantly evolving to address these and other issues. http://grants.nih.gov/grants/new_investigators/investigator_policies_faqs.htm 18

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21. Future Efforts in Analysis Consolidating data between eRA Commons Profile and ESI requests Reconciling requestor data discrepancies Capturing reason codes for denied requests Capturing months requested for each reason code More detailed analysis of data from first year and ongoing analysis of requests and results 21

22. QUESTIONS?