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September 17, 2019 ovpr.uconn.edu ovpr.uchc.edu Draft FDA Guidance - PowerPoint PPT Presentation

September 17, 2019 ovpr.uconn.edu ovpr.uchc.edu Draft FDA Guidance in regards to diversity in clinical trials With Dr. Wesley Byerly ovpr.uconn.edu ovpr.uchc.edu Fringe Benefits Pool Proposed Final FY20 Fringe benefit rates Faculty


  1. September 17, 2019 ovpr.uconn.edu ovpr.uchc.edu

  2. Draft FDA Guidance… in regards to diversity in clinical trials With Dr. Wesley Byerly ovpr.uconn.edu ovpr.uchc.edu

  3. Fringe Benefits Pool Proposed Final FY20 Fringe benefit rates Faculty 45.5% 40.9% for Faculty and UHP: UHP 71.5% 59.9% • In dollar terms: $2M of the $33.2M allocated to UCH by the State for deficit mitigation was used to buy down the Faculty and UHP rates for FY20 only. • Real money in grants to advance work, not money to be saved or rolled over. USE IT OR LOSE IT? • How did this infusion benefit the research mission of UCH? • An opportunity to demonstrate with facts how lower fringe costs increases UCH productivity. • Send schwager@uchc.edu how you made use of these funds. ovpr.uconn.edu ovpr.uchc.edu

  4. Fringe Benefits – Cont. Information to help you anticipate the FB relief funds • Example of information available: • Dollars will accumulate as each pay period posts • When is a re-budget necessary? ovpr.uconn.edu ovpr.uchc.edu

  5. Use of Research Labs • What is External Entity use of Research lab space or equipment? • Why is facility use by an external entity problematic? • What do I do if asked about allocating space to an external entity? ovpr.uconn.edu ovpr.uchc.edu

  6. UConn Health OVPR Costs ovpr.uconn.edu ovpr.uchc.edu

  7. Training Updates • CRA Study Group - meets weekly • NIH Book Club – once a month • SPA Series – Minutes, Moments, Meetings, and Movies • Introduction to Research Administration • NCURA Videos on the Website ovpr.uconn.edu ovpr.uchc.edu

  8. Pre-Award Updates Website Quick Facts New IPR Form First Stop for all ?s ovpr.uconn.edu ovpr.uchc.edu

  9. Pre-Award Updates SPS adheres to an efficient, trackable request processing method where each request is logged in and assigned appropriately. To ensure the best possible service, please remember:  All transactions must be accompanied by an IPAS or IPR.  Send all IPAS, IPR, and contract documents to sps@uchc.edu, not just your project officer. ovpr.uconn.edu ovpr.uchc.edu

  10. Pre-Award Updates • Change to the timeline for streamline route: • SPS requires a streamline route 5 days prior to submission (previously 3 days). • Final applications are due noon the day prior to the sponsor’s deadline. • • This information is included on the Quick Facts sheet on the SPS website. ovpr.uconn.edu ovpr.uchc.edu

  11. NIH Update – Other Support NIH reminds applicants and recipients: -other support includes all resources made available to a researcher in support of and/or related to all of their research endeavors , -regardless of whether or not they have monetary value and -regardless of whether or not they are based at the institution the researcher identifies for the current grant https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-114.html ovpr.uconn.edu ovpr.uchc.edu

  12. NIH Update – Other Support In addition to UConn Start-up funds Lab space, materials and staff Sponsored Projects, received from entities available to you at other institutions other than UCONN documentation includes: Gifts directly used to subsidize expenses related to Grants and contracts through your NIH-funded project Affiliations (even if described (other gifts do not need to be other institutions, including disclosed) as honorary or adjunct) with foreign countries regardless of foreign entities or whether or not you are Visiting faculty, scholars, governments, including talent post-docs or scientists receiving salary or similar programs supported from foreign compensation resources who are participating in your NIH project ovpr.uconn.edu ovpr.uchc.edu

  13. NIH Update – HFT Use Human Fetal Tissue Use Applications that propose HFT: • Must include a justification within the Research Strategy • Use a detailed budget with additional information in the budget justification Prior approval is required before use if HFT is not included and approved in the proposal https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-128.html ovpr.uconn.edu ovpr.uchc.edu

  14. ORCID iD ORCID iD SOON TO BE REQUIRED • NIH, CDC, and AHRQ will begin requiring an ORCID iD (Open Researcher and Contributor Identification) linked to eRA Commons account. • iD will be required for individuals supported by training fellowship, career development and other research education awards. • xTrain appointments WILL NOT BE ACCEPTED if potential appointees do not have an ORCID iD linked to their eRA personal profile – effective OCTOBER 1, 2019. • Will apply to individual fellowship and career development applications submitted for receipt dates on or after January 25, 2020. • NIH encourages everyone from graduate students to senior scientists to register for an ORCID account and link it to their eRA Commons personal profile ovpr.uconn.edu ovpr.uchc.edu

  15. Post-Award Updates Sponsor Invoicing email change: grantaward@uchc.edu dlarkin@uchc.edu This information is included on the Quick Facts. ovpr.uconn.edu ovpr.uchc.edu

  16. Post-Award Updates-Cost Transfers Requires Director Level Approval  Over 90 Days  >$5,000 Be proactive , work with PI to review all charges, including payroll, regularly ovpr.uconn.edu ovpr.uchc.edu

  17. Post-Award Updates New Team Structure in SPS!  SPS reviewed workloads and shuffled some department assignments  Each department is assigned an SPS contact for Proposals, Fund Setup, and Financial Reporting  Check out the website for your team contact information ovpr.uconn.edu ovpr.uchc.edu

  18. Policy Updates Sponsored Award Closeouts Effort on Sponsored Program Activities Governing and Cost Accounting Standards Cost Sharing ovpr.uconn.edu ovpr.uchc.edu

  19. Next SPA and Questions October 15, 2019 ARB Large November 19, 2019 ARB Large December 17, 2019 ARB Large January 14, 2020 ARB Large February 18, 2020 ARB Large March 17, 2020 ARB Large April 14, 2020 TBD May 19, 2020 TBD All meetings are at 10:30 am Have a question or topic you would like covered at the SPA Meetings? Email brenda.lowther@uchc.edu ovpr.uconn.edu ovpr.uchc.edu

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