1. Processing Grants and Research Documents Deborah L. Smith, Ed.D. Research Administration UT Health Science Center

2. Research Administration ORA Mission: To support the faculty and staff of the Health Science Center in their efforts to obtain external funding for research and other sponsored projects, while ensuring compliance with UT policy, sponsor policy, and applicable law.

3. Research Administration Service Unit Serve the faculty Facilitate research Help our clients Protect the University Provide information to Administration

4. The UT Puzzle UTHSC UTKUTC Martin UTSIPSIAgVet

5. The HSC Puzzle MemphisUTGSM-K COM – ChattanoogaOthers

6. Research Administration Staff Monica Orange (901 448-5587) Ginny Geer (901 448-1668) Connie Bozant (901 448-4188) Carlisa Jackson (901 448-5532) Ruthie Ruston (901 448-5985) Wanda Donato (p/t 901 448-2037) Debbie Smith (901 448-4823)

7. Research Administration Personnel (cont’d) Clinical Trials Unit: Melanie Luchs (901 448-3303) Ruthie Ruston (901 448-3126)

8. Vice Chancellor’s Office Leonard R. (Rusty) Johnson, Ph.D. –Lisa Bronte (901 448-7125) Jane Poulos (901 448-3746) Jeanne Hermann (901 448-5043)

9. Services Provided by ORA Review and approval of grants & related documents Information on UT and sponsor policies, forms, compliance, and procedures Contract negotiation & facilitation Clinical trials facilitation Institutional signatures Grant and contract data base Non-financial close-out

10. Services (cont’d) Liaison with UTRF re: inventions Liaison with sponsors and subcontractors Liaison with compliance committees Information on external funding Training re: grant/contract processing

11. UT Research Policy UT policies specifically applicable to research projects can be found at: http://www.uthsc.edu/research/researc h_administration/policy.phphttp://www.uthsc.edu/research/researc h_administration/policy.php NOTE: Other UT policies (e.g., fiscal policy, personnel policy, etc.) are also applicable to research.

12. Responsibility for UT Funds Business & Finance Development Gifts; Private Grants Research Administration Grants & Contracts For Research & Other Sponsored Activity Business & Finance Service contracts; Affiliation Agreements

13. Mechanisms of External Research Funding Gifts Grants Contracts

14. Funding Mechanisms Gifts –unrestricted funds given to the University with no expectation of the donor’s receiving anything in return; may be designated for a specific research area, lab, PI, or other specific purpose –handled by Development Office

15. Funding Mechanisms (Grants) Grants - Funds received by the University for a specific project but for which the sponsor does not receive anything in return (except reports); no scientific involvement with the sponsor is expected.

16. Categories of Grants Sponsor: Federal – NIH, NSF, DOD, NASA Private – AHA, ACS, ALA, NKF State Type: Research Training Other

17. Grant Process PI has an idea for project PI writes grant PI gets ACUC, IRB, etc. approvals and routes grant and submits for agency review Peer reviewers and agency make funding decisions Funds are provided to the institution PI conducts research

18. Grant Process PI develops idea for research project PI locates potential source of funding PI writes grant and completes required application forms PI submits protocol for review and approval by compliance committees (IRB, ACUC, rDNA, etc.) Note: Grants may be submitted in response to RFA (request for applications)

19. Grant process (cont’d) PI prepares route sheet (available at http://www.uthsc.edu/research/researc h_administration/forms.php ) and routes grant for campus signatures: http://www.uthsc.edu/research/researc h_administration/forms.php –Department head –Dean – Check with business officer re: additional forms that may be required (CoM) –ORA –NOTE: ORA will take care of institutional signatures required

20. Grant Signature Process Documents needed to process a grant: –Original grant + 1 copy (copy only for g.g submissions) –IRB/ACUC approval letter –ORA route sheet –Cost-sharing document (for Business & Finance, if applicable)

21. Grant Process (cont’d) ORA Review of Grant: –Forms –Budget –Policy –Signatures –Compliance Issues Institutional Signatures – including final submission to agency if submitted electronically by Institution

22. Grant process (cont’d) ORA calls department to pick up signed originals, if applicable, or scans signed route sheet ORA enters proposal into sponsored research data base and files proposal as “pending” Department prepares final w/copies and transmits grant to sponsor (for paper submissions)

23. Sample NIH Grant Application Number Type ofSerial GrantNumber Amended 1 R01 CA12345601A1 Grant New Institute Year Source: NIH/Ganguly

24. Links to NIH Activity Codes/Institutes http://grants2.nih.gov/grants/funding/ac.pdfhttp://grants2.nih.gov/grants/funding/ac.pdf www.nih.gov (click on Institutes link)www.nih.gov

25. Grant Process (cont’d) Sponsor notifies PI or institution of receipt and assignment # Sponsor reviews grant and makes a determination regarding funding Sponsor notifies PI and/or institution of final funding decision (Note: Time from submission to funding can range from a few weeks to a year or more.)

26. Grant Process (cont’d) Grants & Contracts Accounting receives award notice, sets up account, and notifies PI and department of account # PI/Department Business Manager should read award notice carefully for special terms and conditions (see sample)

27. Grant Process (cont’d) ORA enters data into sponsored research data base and files proposal as “active” PI begins work on project and files required interim and final reports with sponsor w/cc to ORA PI maintains current IRB, ACUC, etc. protocols (usually annual renewal)

28. Grant Process (cont’d) Annually, or as required, PI prepares progress reports and other required reports Business Office prepares financial reports annually or as required Subawards (out) need to be prepared or amended

29. Grants – NIH Deadlines See handout

30. Grant Deadlines - Other AHA – National – mid-January; mid- July AHA – Regional – mid-January ACS – April 1, October 15 Children’s Foundation – mid-March Others - whenever

31. Grant Signatures Who signs grants? –Deborah L. Smith, Ed.D. –Assistant Vice Chancellor for Research –Research Administration –910 Madison, Suite 823 –Memphis, TN 38163 –901 448-5587; fax 901 448-7600 –dsmith@uthsc.edu

32. Grant signatures (cont’d) Alternate: Alt: Leonard R. Johnson, Ph.D. Vice Chancellor for Research If Fiscal Officer Signature Required: Anthony A. Ferrara, Vice Chancellor, Finance & Operations, 62 S. Dunlap, Suite 300, Memphis, TN 38163 gbussell@uthsc.edu 901 448-5541

33. Funding Mechanisms (Contracts) Contracts are binding agreements covering the exchange of: –Something of value ($, scientific material, information, etc.) for –Something else of value (research activity, promises of confidentiality, IP rights, etc.) –Significant involvement of the sponsor in the scientific activity is expected.

34. Types of Research Contracts Contracts –Research Contracts (including clinical trials) –Grant “Agreements” –Confidentiality Agreements –Material Transfer Agreements –Subcontracts under grants (UT may be prime or sub) –Note: Contract proposals may be submitted in response to RFP (request for proposals)

35. Compliance IRB – All projects involving the use of human subjects in research (including information and/or tissue) must be approved by the UT IRB BEFORE work begins http://www.uthsc.edu/research/research_co mpliance/IRB/ http://www.uthsc.edu/research/research_co mpliance/IRB/ ACUC – All projects involving the use of laboratory animals must be approved by the ACUC before work begins http://www.uthsc.edu/research/research_co mpliance/IACUC/ http://www.uthsc.edu/research/research_co mpliance/IACUC/

36. Compliance (cont’d) rDNA – All projects involving the use of recombinant DNA or other hazardous materials must comply with UT policy. Please refer to the Institutional Biosafety web page: http://www.uthsc.edu/research/research_co mpliance/IBC/ http://www.uthsc.edu/research/research_co mpliance/IBC/ Clinical Trials (see CT web page http://www.uthsc.edu/research/research_ad ministration/clinical_trials/index.php) http://www.uthsc.edu/research/research_ad ministration/clinical_trials/index.php

37. Human Subjects Certification All NIH-funded projects involving the use of human subjects require proof of training in the use of human subjects. All UT projects involving use of human subjects require certification before IRB approval. Directions for accessing the course are at http://www.uthsc.edu/research/research_co mpliance/IRB/training.php http://www.uthsc.edu/research/research_co mpliance/IRB/training.php Form letter is available in ORA

38. Facilities & Administrative Costs (Indirect costs) Facilities & Administrative Costs (F&A), formerly called “indirect costs” are those expenses associated with a sponsored project that are difficult to account for directly. Examples are costs of the space, utilities, administrative support (accounting, purchasing, ORA), etc. (aka “overhead”)

39. F&A (cont’d) Federal F&A rates are negotiated with the federal government periodically. Current F&A rates for federal on-campus research is 48.0% MTDC. Private rates are 20% of TOTAL costs—or published sponsor rates. Current info on F&A rates, including a reference table, is available on the ORA web site: http://www.uthsc.edu/research/research_administra tion/docs/F&A%20info%20for%20web%207%2014 %2008.pdf http://www.uthsc.edu/research/research_administra tion/docs/F&A%20info%20for%20web%207%2014 %2008.pdf

40. Fringe Benefits Fringe Benefit rates used for grants and contracts are estimated based on average costs for UT employees. Current fringe benefit rates are published on the ORA web site at http://www.uthsc.edu/research/research_ administration/fringe_benefits_rates.php

41. Project Extensions Grants –No-cost extensions of NIH grants – contactGerri Bussell –Other grants – Submit letter of request to sponsor (may need ORA and/or B&F signature) Contracts – Check contract language; may need amendment

42. Transfer of PI with Grant/Contract NIH grants – PHS Relinquishing Statement (available on the web), listing date of transfer, equipment to be transferred, institutional signatures; Final invention statement; new 398 application at new institution Other grants – contact sponsor & ORA Contracts – Do NOT transfer; will terminate contract here and initiate new one with new institution

43. Closing Out a Project Notify IRB/ACUC and ORA Notify department business person and Gerri Bussell, who will prepare final financial report Prepare final scientific report and submit to sponsor w/cc to ORA Prepare final invention statement, if required Records maintenance

44. Collaborative Projects(Grants w/subcontracts) Require budgets & other documents from both institutions Require collaboration letter signed by institutional official

45. Inventions Inventions that result from UT work must be disclosed to the University. Forms are available at http://utrf.tennessee.edu/ http://utrf.tennessee.edu/ UTRC handles inventions and other “intellectual property” for UT. Contact Richard Magid at 901 448- 1562

46. Reminders Ethical conduct of research – Misconduct policy is at https://academic.uthsc.edu/faculty/facu ltysenate.php?module_id=38&pnum=5 0 https://academic.uthsc.edu/faculty/facu ltysenate.php?module_id=38&pnum=5 0 Confidentiality of Patient information and Sponsor proprietary information

47. Research Administration Office of Research Administration (ORA) UT Health Science Center 910 Madison, Suite 823 Memphis, TN 38163 (901) 448-5587 (901) 448-7600 fax dsmith@uthsc.edu

48. Research Web Site UTHSC Office of Research http://www.uthsc.edu/research/vc_research.php ORA: http://www.uthsc.edu/research/research_administra tion/ http://www.uthsc.edu/research/research_administra tion/ Contacts Policy Links Agency Links Forms Information and FAQs