New Investigators/Early Stage Investigators • New Investigator (NI): PD/PI who has not yet competed successfully for a substantial NIH research grant o For multiple PD/PIs-all PD/PIs must meet requirements for NI status • Early Stage Investigator (ESI): PD/PI who qualifies as a New Investigator AND is within 10 years of completing the terminal research degree or is within 10 years of completing medical residency (or equivalent) • • Applies only to R01 applications New Investigators/Early Stage Investigators will be clustered together for review 22
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Early Stage Investigators NIH created a new ‘Early Stage Investigator’ (ESI) category designed to accelerate the early transition of new scientists to research independence by receiving their first R01 earlier. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-121.html A Program Director/Principal Investigator who qualifies as a New Investigator is considered an Early Stage Investigator (ESI) if he/she is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent). 7
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Implementation of ESI definition (cont’d) • Applications from ESIs and New Investigators are identified to reviewers so that appropriate consideration of their career stage can be applied during review. • Applications from ESIs and New Investigators are “clustered” during review to enable evaluation as a group and distinguish from Established Investigators. • An application with more than one Principal Investigator is identified for consideration of ESI/NI by reviewers only if ALL of the listed Principal Investigators qualify as New Investigators. • Staff in the NIH institutes and centers are apprised of ESI and New Investigator status and this factor is considered when applications are selected for award. • New Investigators are eligible for the “Full Implementation to Shorten the Review Cycle for New Investigator R01 Applications Reviewed in Center for Scientific Review (CSR) Recurring Study Sections”. ( http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-083.html ) 9
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RESEARCH PROPOSAL PREPARATION Suggested Suggested timeline timeline with with major major milestones milestones outlined. outlined. Key Key Partners Partners Mentors, Mentors, Collaborators Collaborators Dept DeptChairs Chairs&& Senior SeniorFaculty Faculty PI CCoonntin tinuuoouus fe s feeeddbac backk Review concept and provide feedback to investigator Review draft budget and proposal application and provide feedback to investigator Develop research concept. Discuss and circulate. Monitor funding alerts. Develop proposal based on feedback and discuss project with AA. 6+ 6+ Months Months AA AA // RA RA RA RA // OSP OSP Review funding alerts and announcements for possible support for investigator. NOTE: Planning and communication are key to working with Central Admin Offices Discuss upcoming research project with investigator notify central of intent to submit. Review guidelines and compliance requirements. Develop budget with AA. Complete proposal. 22 Months Months 44 Weeks Weeks Help investigator develop budget and seek commitments, resources and required approvals. Consult with AA and investigator to develop timeline that addresses proposal development, resources, protocols, required approvals, and budget. Complete admin. part of proposal. Review budget Submit proposal to OSP. Complete all protocols and compliance requirements with assistance of RA. 11 Week Week Help investigator complete all protocols and compliance requirements. Reviews proposal, certifies compliance requirements and provides institutional signature Investigator makes submission- Final Final Proposal Proposal Submitted Submitted to to Sponsor Sponsor Sponsor’s Funding Decision Not Not Funded Funded Funded Funded No go decision Investigator decides whether to revise Revise Reviseproposal proposalfor forresubmission resubmission/address /addressreviewers’ reviewers’concerns concerns Investigator Investigator reviews reviews critique critique&& recommenrecommendations dations Investigator Investigator decides decides whether whetherto to resubmit resubmit PI = Principal Investigator; AA = Department/Center/Institute/College Staff; RA = Research Administrator; OSP = Office of Sponsored Program Adapted from ‘The Funding Toolkit’ presented at NCURA 51 by Susan Gramling (UNC) and Natalie Goodwin-Frank (UW) OSP OSP Staff Staff negotiates negotiatesaward award Investigator Investigator manages manages research research project project
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NIH Expedited Reporting • Requirements for reporting vary by institute Institute NCCAM: NCI: NEI: NHLBI: NIA: NIAID: NIAMS: NICHD: NIDA: NIDCR: NIDDK: NIMH: NINDS: Data and Safety Monitoring Policies http://nccam.nih.gov/research/policies/datasafety/ http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm http://www.nci.nih.gov/clinical_trials/conducting/ http://www.nei.nih.gov/funding/policy/policy6.htm http://www.nhlbi.nih.gov/funding/policies/dsmb_est.htm http://rover2.nhlbi.nih.gov/funding/policies/dsm-12.htm http://rover2.nhlbi.nih.gov/funding/policies/dataqual.htm http://www.nhlbi.nih.gov/funding/policies/dsmb_othr.htm http://www.nia.nih.gov/funding/policy/humint.htm http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf http://www.niams.nih.gov/rtac/clinical/dsmb3.html http://www.niams.nih.gov/rtac/funding/grants/datasafe.htm http://www.nichd.nih.gov/funding/datasafety.htm http://www.nida.nih.gov/Funding/DSMBSOP.html http://www.nidcr.nih.gov/research/ctp/data_safety_monitoring_boards.pdf http://www.niddk.nih.gov/patient/patient.htm#policy http://www.nimh.nih.gov/research/safetymonitoring.cfm http://www.ninds.nih.gov/funding/ninds_patient_safety_guidelines.htm
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Early Stage & New Investigator support • ESI support in Commons Personal Profile – Users can enter area of medical residency and date residency training ended • Specific application eligibility – ESI & NI eligibility are system-calculated and status flags are displayed on the grant application’s Status Information screen Attention: PIs Update degree & medical residency info in your PPF (prior to submitting an application) to ensure ESI & NI status are calculated accurately. 8
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RDA Responsibilities Post – Award / Compliance Obtain approval/signatures on all post-award grant documents through execution of LSC approval process Serve as primary point of contact for grant documents, negotiations and correspondence with grant funders and auditors In conjunction with Grants Accounting, monitor LSC subrecipients to ensure proper documentation of transactions and follow up of rules and regulations Ensure compliance of post-award documents with applicable rules and regulations as well as LSC policies and procedures Collect and submit audit documents prepared by the grant program team Work with the grant program team, RDA Development and all affected departments to design and submit continuation funding proposals Conduct mock interviews to prepare the grant program team for external audit meetings Summarize the approved grant proposal, grant contract, and applicable rules into Deliverables Worksheets that support and facilitate grant orientation and grant management Communicate to Grants Accounting the approved grant budget and relevant information to establish the grant budget in iStar Make formal applications for amendments, including no-cost extensions, budget revisions, and modification of terms of award Conduct internal checks to ensure grant programs adhere to grant management requirements (ie.: desk reviews, time & effort checks, etc.) Administer LSC IRB*applications and ensure LSC IRB has the required representation and maintains appropriate records *IRB: Institutional Review Board Provide technical assistance to the grant program team to review regulations, answer questions, and resolve issues related to their grants Retain post-award grant documents and applicable notes in ServiceNow for LSC records
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Implementation of ESI Definition • The NIH modified the collection of information on degree dates and medical residency within the personal profile of the eRA Commons. • PD/PIs must update their personal profile in the eRA Commons in order to be considered for the ESI classification. Investigators who enter degree and residency completion dates will be notified of their ESI status by email. • A procedure and guidelines for requesting an extension of the period of ESI eligibility is in place to accommodate individuals with various medical concerns, disability, pressing family care responsibilities, or active duty military service (instructions in Commons). 8
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RDA Responsibilities Obtain approval/signatures to develop grant programs as per LSC policies Submit completed grant programs to the funders and execute LSC approval process Work collaboratively with all stakeholders to develop grant budgets that support the program design and meet RFP requirements Provide technical advise to the grant program team regarding rules, regulations and requirements as per grant RFP and other documents Pre – Award / Grant Development Transform data, research, and program team discussion into a proposal that meets grantor’s specifications Facilitate the development of grant program evaluation plans in conjunction with the grant program team, as per RFP guidelines Work with the grant program team, RDA Compliance and all affected departments to design and submit continuation funding proposals Provide support and technical guidance on LSC policies and procedures for grant partnerships Inform the grant program team of costs-share requirements, and document/obtain approvals of costshare sources when applicable Facilitate the screening and identification of qualified external evaluators based on RFP guidelines and LSC policies and procedures Provide technical support to the grant program team with the development of all components of the grant application and supplemental documents Work with the grant program team in the draft of letters of support for designated partners when applicable Retain pre-award grant documents and applicable notes in ServiceNow for LSC records
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You Fall Before You Learn to Walk My Rejections: (National acceptance rates 10-20%) • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Reducing Magnetic Dead Layers in Complex Oxides for Increased Interface Coupling, DOE Early Career, 2010 Controlling Interface Valency in Complex Oxides for Increased Magnetoelectric Coupling, DARPA Young Faculty Award, 2010 Optimizing Interface Physics to Magnetize Students and Materials (M. Holcomb, PI), NSF-Career Award, 2010 High-Resolution and Low-Temperature Magnetic/Ferroelectric Microscopy for Nonlinear Optical Imaging of Multifunctional Oxide Nanostrucutures (M. Holcomb, PI, David Lederman and Stuart Wolf), DOD DURIP, 2010 Interface Engineered Multilayer Thin Films for Room-Temperature Precision Magnetic Sensing, Air Force Young Investigator, 2010 Interface Engineered Complex Oxides for Room-Temperature Precision Magnetic Sensing, ONR Young Investigator Program, 2010 MRI-R2: High-resolution and Low-temperature Magnetic Microscopy for Nonlinear Optical Imaging of Complex Nanostructures (M. Holcomb, PI, A. Bristow, F. Ganikhanov, S. Wolf, N. Wu), NSF, 2011 MRI-R2: Acquisition of a Field Emission Scanning Transmission Electron Microscope for West Virginia University (X. Song, PI, D. Lederman, E. Sabosky, S. Urazdin, N. Wu), NSF, 2011 Rural Workforce Development in STEM Fields (E. Toth, PI, Z. Dinu, R. Hensel, M. Holcomb, and D. Simien, Co-PIs), NSF, 2011 Depth-Dependent Studies of Factors Influencing Magnetic Dead Layers (M. Holcomb, D. Lederman and N. Tolk), NSF, 2011 Reducing Magnetic Dead Layers in Complex Oxides for Increased Interface Coupling (M. Holcomb, PI), DOE Early Career, 2011 Material Interfaces for Efficient, Novel Generation and Conversion of Energy (M. Holcomb, PI), Petroleum Research Fund, 2011 Optimizing Interface Physics to Magnetize Students and Materials (M. Holcomb, PI), NSF Career Award, 2011 Improving Device Energy Efficiency and Speed by Optimizing Interfacial Coupling (M. Holcomb, PI), ARO, 2012 Rural Workforce Development in STEM Fields (E. Toth, PI, Co-PIs: C. Dinu, M. Holcomb, and D. Simien), NSF/ATE, 2012 Strategic Approach to Identifying Coupling Mechanisms at Heterostructure Interfaces (M. Holcomb, PI), NSF/CMP, 2012 Depth-Dependent Studies of Interfacial Mechanisms in Complex Oxides (Holcomb, Lederman, Stanescu, and Tolk), DOE, 2012 Improving Device Energy Efficiency and Speed by Optimizing Coupling (M. Holcomb, PI), NSF/EPMD, 2012 Center for Strongly Correlated Oxides for Revolutionary Electronics (SCORE) (S. Wolf, PI, R. Averitt, B. Butler, G. Dionne, J. Eckstein, J. Floro, A. Ghosh, L. Harriott, M. Holcomb, D. Lederman, S. Levitan, A. Lukaszew, J. Lu, C. Mewes, T. Mewes, J. Poon, C. Ross, K. Smith, M. Stan, B. Weikle, J-M Zuo, Co-PIs), SRC/DARPA,, 2012 3D Architecture from 2D Devices (A. Ramirez, PI, E. Andrei, A. Bristow, S.-W. Cheong, M. Chhowalla, L.C. Feldman, L. Fu, E.L. Garfunkel, G.-H.Gweon, D. Heiman, J. Heremans, M. Holcomb, S.M. Kang, N. Kobayashi, D.V. Lang, D. Lederman, J. Moodera, S. Oh, K. Pedrotti, W.E. Pickett, T. Siegrist, T. Stanescu, M.A. Subramanian, D. Vanderbilt, Co-PIs), SRC/DARPA, 2012 Critical Mechanisms Responsible for Magnetic Dead Layers in Complex Oxides (M. Holcomb, PI, Collaborator: S. Satpathy), NSF-CMP, 2013 Rural Workforce Development in STEM fields (Toth, PI, Holcomb Co-PI), NSF/ATE, 2013 Magnetizing Students and Materials by Investigating Science at Its Boundaries (Holcomb PI), Research Corporation, 2013 MRI: Acquisition of High Resolution and Low Temperature Magnetic Microscopy for Nonlinear Optical Imaging of Complex Nanostructures (M. Holcomb, PI; A. Bristow, C. Cen, P. Gannett and D. Lederman, Co-PIs), NSF/MRI, 2013 Project/Proposal Title: DMREF: Searching for Emergent Electronic Phenomena at Interfaces in Fluoride-Based Materials (A. Romero, PI; C. Cen, M. Holcomb, D. Lederman, and T. Stanescu, CoPIs), NSF/DMREF, 2013 Electronic and Optical Properties of Stacked Two-Dimensional Materials (D. Lederman, PI; Y. Glinka J. Heremans, M. Holcomb, C. Tao, Co-PIs), ERFI 2-DARE, 2013 Chemistry at Low Symmetry Interfaces (M. Holcomb, PI), Chemical Society, 2014 Depth-Dependent Studies of Interfacial Mechanisms in Complex Oxides (M. Holcomb, PI; D. Lederman and T. Stanescu, Co-PIs), DOE, 2014 OP: Optical Measurements of Capping Layer Effects on Strongly Correlated Oxides (M. Holcomb, PI), NSF,, 2014 Reanimating Magnetic Dead Layers: Enhancing Magnetism in Strongly Correlated Oxides (M. Holcomb, PI), DOE Early Career, 2015 Interfacial Properties of Designed Peptides Coated onto Metal Nanostructures (PI: Lewis; Co-PIs: Holcomb and Guillion), NSF-CBET, 2015 Point: Lots of them
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Clustering • NI/ESI R01 applications will be clustered together in review. ESI applications will not be separately clustered within the NI\ESI group. o NI/ESI applications will be identified for reviewers so there can be appropriate review in context of career stage. o Expectations of preliminary data and publication track record less than for established investigators.
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