Processing Grants and Research Documents

Deborah L. Smith, Ed.D.

Research Administration UT Health Science Center

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.

Research Administration

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

The UT Puzzle

UTHSC UTK UTC Martin UTSI PSI Ag Vet

The HSC Puzzle

Memphis UTGSM-K COM – Chattanooga Others

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)

Research Administration Personnel (cont’d)

• Clinical Trials Unit: • Melanie Luchs (901 448-3303) • Ruthie Ruston (901 448-3126)

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)

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

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

UT Research Policy

• • UT policies specifically applicable to research projects can be found at: http://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.

Responsibility for UT Funds

Development Gifts; Private Grants Research Administration Grants & Contracts For Research & Other Sponsored Activity Business & Finance Service contracts; Affiliation Agreements

Mechanisms of External • Gifts Research Funding • Grants • Contracts

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

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.

Categories of Grants

Sponsor: • Federal – NIH, NSF, DOD, NASA • Private – AHA, ACS, ALA, NKF • State Type: • Research • Training • Other

Grant Process

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

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)

Grant process (cont’d)

• PI prepares route sheet (available at http://www.uthsc.edu/research/researc h_administration/forms.php

grant for campus signatures: ) and routes – 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

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)

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

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)

Sample NIH Grant Application Number

Type of Grant Serial Number Amended 1 R01 CA New Source: NIH/Ganguly Institute 123456 01 A1 Grant Year

• Links to NIH Activity Codes/Institutes http://grants2.nih.gov/grants/funding/ac .pdf

• www.nih.gov

(click on Institutes link)

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.)

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)

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)

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

Grants – NIH Deadlines

• See handout

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

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 – [email protected]

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 • [email protected] 901 448-5541

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.

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)

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/ • 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/

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/ • Clinical Trials (see CT web page http://www.uthsc.edu/research/research_ad ministration/clinical_trials/index.php

)

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

• Form letter is available in ORA

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”)

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

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

Project Extensions

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

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

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

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

Inventions

• Inventions that result from UT work must be disclosed to the University.

• Forms are available at http://utrf.tennessee.edu/ • UTRC handles inventions and other “intellectual property” for UT.

• Contact Richard Magid at 901 448 1562

Reminders

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

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 [email protected]

Research Web Site

• • UTHSC Office of Research http://www.uthsc.edu/research/vc_research.php

• ORA: http://www.uthsc.edu/research/research_administra tion/ • Contacts • Policy Links • Agency Links • Forms • Information and FAQs