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  1. Getting Started as a New Investigator Anthony Carter, Ph.D. Program Director NIGMS/NIH/DHHS April 27, 2009

  2. Who is a New Investigator? • Has not previously served as PI on any PHS grant • Exceptions: R00, R03, R15, R21 or mentored K awards • Recipient of Independent Scientist or other non-mentored career award is not new investigator

  3. Early Stage Investigators (ESI)New for 2009 NOT-OD-09-021 • Meets definition of New Investigator • Within 10 years of completion of terminal research degree or medical residency • Must update eRA Commons profile Extension of ESI Status can be considered when there has been a lapse in research or research training

  4. Good Grantsmanship, like research, involves teamwork • Investigators conducting the research • Officials at your home institution • NIH staff

  5. Good Grantsmanship requires good preparation At your home institution • Refine your thinking with your mentor(s) • Get outside opinions as you proceed • Seek a critical evaluation • Show draft a colleague outside your field • He/she should understand what you intend • If not, reviewers may not understand either • Leave enough time to revise your draft!

  6. Some Homework before Contacting NIH Staff • Research Portfolio Online Reporting Tool (RePORT) • Check NIH Computer Retrieval of Information on Scientific Projects (CRISP) • Check NIH Guide for Grants and Contracts • Check web information for the relevant Institute or Center – e.g. • Identify Appropriate Staff Contacts – e.g. “About NIGMS”

  7. Research Portfolio Online Reporting Tool (RePORT)

  8. CRISP • Searchable database of federally supported biomedical research • Analyze current Institute portfolio • Areas with few funded projects • Research areas already well funded • Locate experienced NIH funded investigators in your area of interest • Potential mentors/collaborators • Due to be replaced by RePORTER in 2009

  9. Coming in 2009RePORT Expenditures and Results (RePORTER) system

  10. NIH GUIDE for Grants and Contracts • Official notification of NIH policies, notices and availability of funds • Contains all PAs, RFAs, RFPs and other solicitations • Sign up on-line to receive weekly NIH Guide publication

  11. Identifying Staff Contacts – About NIGMS

  12. The NIH Extramural Team Grants Management Review Program

  13. When Preparing an Application the Program Officer is an Important Contact • Call early … and often! • Helps to match your scientific interests with mission of NIH Institute • Can provide information about special initiatives • Suggests appropriate grant mechanism(s) • Provides guidance in application preparation • Helps to navigate peer review process

  14. First Contact with the Program Officer • Scientific meetings • E-mail • Draft of abstract or specific aims • Phone number • Biosketch, if applying for F32 or K award • Telephone

  15. Typical Questions for the Program Officer • Is my project appropriate for your Institute? • Is my project appropriate for this PA (or RFA)? • Do you accept small grant (R03 or R21) applications? • Should I ask for a dual assignment? • What is your payline?

  16. “I do not have much preliminary data.” Should I start with a small grant and work up to an R01?

  17. Research Career Development Timetable Career Stage Support Mechanism GRADUATE/ MEDICAL STUDENT Predoctoral Training Awards: F30, F31, T32 Postdoctoral Training Awards: F32, T32 POST DOCTORAL Mentored Career Development Awards: K01, K08, K22, K23, K25, K99/R00 Small Grant: R03 EARLY Exploratory/Developmental Grant: R21 New Innovator Award: DP2 Research Project Grant: R01, EUREKA, R15 CAREER Independent Scientist Award: K02 MIDDLE Midcareer Investigator Awards: K24, K26 Pioneer Award: DP1 SENIOR Senior Scientist Award: K05

  18. NIH Mechanisms of Special Interest to New Investigators • K awards (K01, K08, K22, K23, K25,K99/R00) • Small grant (R03) • Exploratory/developmental grant (R21) • Academic Research Enhancement Award (R15) • NIH Director’s New Innovator Award (DP2) • Researchproject grant (R01)

  19. Mentored Career Development Awards (mK) • K01 Mentored Research Scientist Development • K08 Mentored Clinical Scientist Development • K22 Research Career Award for Transition to Independence • K23 Mentored Patient-Oriented Research Development • K25 Mentored Quantitative Research Development • K99/R00 Pathway to Independence

  20. Small Research Grant Program (R03) • Support for small research projects • Up to 2 years and $50K per year • Not all ICs support this mechanism • PA-06-180

  21. Exploratory/Developmental Research Grant (R21) • Foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies • Break new ground or extend previous discoveries toward new directions or applications • Up to 2 years and $275K total direct costs • PA 06-181

  22. Academic Research Enhancement Award (R15) • Small-scale health-related research projects at eligible domestic institutions • $150K total direct costs for up to 3 years • PA 06-042 Recovery Act Limited Competition: Academic Research Enhancement Award (R15)

  23. NIH Director’s New Innovator Award (DP2) • New investigators of exceptional creativity • Bold and highly innovative new research approaches • Up to $300,000/yr for 5 years Reissued yearly

  24. “I am not quite ready for an R01, but I can not find an appropriate grant at NIH.” Do not overlook support from other agencies • Federal agencies – e.g. NSF • State and Local sources • Private foundations

  25. When the Application is Received by the Center for Scientific Review The application • Receives an Institute/Center (IC) assignment • You can make suggestions • Receives a Study Section assignment • You can make suggestions

  26. From receipt of the application until the review is completed The Scientific Review Officer (SRO) is an important contact. • Manages the peer review process • Checks applications for completeness • Analyzes content • Recruits and assigns reviewers • Provides technical advice to applicant -- beforethe review

  27. First Contact with the Scientific Review Officer • Scientific meetings • E-mail • Draft of abstract or specific aims • Phone number • Biosketch, if applying for F32 or K award • Telephone

  28. Address Questions About the Review Process to the SRO • What scientific areas are covered by the study section? • What expertise is on the study section? • May I ask for a specific study section? • What happens if I have a conflict with someone on the study section? • May I submit an update after the application is submitted?

  29. Are New Investigators given special consideration during the review?

  30. General Considerations when Reviewing New Investigator R01s • Keep in mind the experience of PI and resources available • More emphasis on demonstrating feasibility than on preliminary data • More emphasis on training and potential of PI • Evaluate evidence of institutional commitment

  31. Grant Application Tips for New Investigators

  32. What Makes a Great Idea? • Does it address an important problem? • Will scientific knowledge be advanced? Will this work drive the field forward? • And especially for new investigators … … Is it feasible for you to do? • Engage collaborators that complement your expertise and training

  33. Good Presentation • Provide a well-focused research plan • Keep specific aims simple • Link hypotheses to specific aims • Link methods to each specific aim • Stay on the main theme • Use timelines and conceptual models

  34. Good Presentation • Be realistic … not overly ambitious • Be self-critical. Discuss potential problems • Discuss alternative interpretations and possible solutions • Explain rationale for your decisions • Reviewers cannot read your mind … Don’t assume they know what you intend

  35. Coming Summer 2009Enhanced Peer Review • 9 point scale scoring system • Scores for each criterion • Enhanced review criteria • Formatted reviewer critiques • Percentile rankings will be calculated new • Preliminary impact score will determine which applications are discussed • Clustering of New Investigator applications during review

  36. New 2009 Reviewer Critique Template Application #: 1R01HL123456-01 Principal Investigator(s): Doe, Jane Overall Impact Scored Review Criteria Additional Review Criteria The following review criteria are not scored individually, but should be considered when determining the overall impact/priority score

  37. After the Study Section Review ... • Priority score/percentile within 3 working days – available through eRA Commons • SRA prepares the Summary Statement • National Advisory Council review • Final funding decisions

  38. After the Study Section Review ...things you can do before Council • Wait for the Summary Statement • Read the Summary Statement carefully • Contact the program officer with questions about the review of your specific application

  39. “Am I likely to be funded?”“Should I revise and resubmit?” Contact your program officer • May provide additional insights regarding the discussion at the study section • Discusses summary statement • Understanding the written reviews • Responding to reviewer concerns • Revising and resubmitting

  40. Shortened Review Cycle for New Investigators

  41. Are New Investigators given special consideration in funding decisions? NHLBI, as an example: • Separate payline for ESI and New PIs that is 5 percentile points above the regular RPG payline (FY 2009) • ESI applications >5 but ≤10 percentile points above the regular R01 payline may undergo an expedited review to resolve comments in the summary statement • Funds new investigators for all years recommended • Separate payline for ESI first renewal applications that are 5 percentile points above the regular RPG payline (FY 2009)

  42. Are New Investigators given special consideration in funding decisions? NIGMS, as an example: • New Investigator status is a criterion for funding decisions • Staff are encouraged to identify and give special consideration • R01 grants can be awarded for 5 years (instead of 4)

  43. If funding seems likely • Just-in-Time information • Human subjects • Animal welfare • Budget • Administrative requirements Consult with program officer and/or grants management officer on key issues:

  44. Grants Management Officer • Only NIH official authorized to obligate funds or establish terms and conditions of award • Assures that applications meet all administrative requirements prior to award • Assures compliance with Federal laws and NIH policies and procedures • Reviews and responds to grantee requests that require prior approval • Responsible for official grant files