Material Transfer Agreements - The University of Tennessee Health

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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
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Service Unit
Serve the faculty
Facilitate research
Help our clients
Protect the University
Provide information to Administration
The UT Puzzle
UTHSC
UTSI
UTK
UTC
PSI
Ag
Martin
Vet
The HSC Puzzle
Memphis
COM – Chattanooga
UTGSM-K
Others
Research Administration Staff
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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
Business
Business&&Finance
Finance
Development
Gifts; Private
Grants
Research
Administration
Grants & Contracts
For Research &
Other Sponsored
Activity
Business &
Finance
Service contracts;
Affiliation
Agreements
Mechanisms of External
Research Funding
• Gifts
• 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 conducts research
PI gets ACUC, IRB, etc.
approvals and routes grant and
submits for agency review
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 ) and routes
grant for campus signatures:
– 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
1
R01
New
Source: NIH/Ganguly
Serial
Number
CA
Institute
123456
Amended
01
Grant
Year
A1
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; midJuly
• 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
– dsmith@uthsc.edu
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
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
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–
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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 4481562
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
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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
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
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