Research Agreements

Report
Research Agreements
Jeff Cheek – Sponsored Programs & Regulatory Compliance
Services
Guiding Principles
1. Facilitate the research enterprise
2. Protect the interests of the
University, individual faculty
and students
3. Abide by University policy,
state and federal regulations
and laws
4. Keep all parties informed of
status (RADAR Progress Journal)
Sponsor Categories
• Federal Government
e.g., National Science Foundation
• Quasi Governmental Entities
e.g., Oak Ridge National Laboratory
• State Government
e.g., NC Department of Transportation
• Private
– Companies like DuPont, CREE Research, or
Battelle
– Foundations like Morris Animal Foundation
Federal Government
Award Types
(Direct Sponsorship or Flow-through)
•
•
Assistance Awards = Public
Purpose (fundamental research)
-Grants
-Cooperative Agreements
Operational Requirements =
Government Purpose (e.g., study effects
of sonar on marine mammals)
-Contracts
-Purchase Orders
Grants & Cooperative Agreements
Grants are assistance awards. Generally some
flexibility in scope of work; spending and outcomes
are unknown. A deliverable is not always specified
other than routine and final reports. If federal,
OMB A-110 and A-21 apply for now (new
omnicircular effective 12/26/2014).
A cooperative agreement is an award of financial
assistance that is used to enter into the same kind
of relationship as a grant; and is distinguished from
a grant in that it provides for substantial
involvement between the sponsor and the recipient
in carrying out the activity contemplated by the
award.
What is a Contract?
• A contract is a legally enforceable agreement
between two or more parties with mutual
obligations. An offer is made and accepted,
and each party benefits.
• Prime contract (the contract between the
government and its contractors) is subject to the
federal law; i.e., the Federal Acquisition
Regulations (FAR)
• Industry contracts that are flow through are also
governed by FAR. Other industry contracts are
governed by other laws and codes, e.g. Uniform
Commercial Code (UCC).
What is a Gift?
• A Gift is a “non-reciprocal transfer with
no implicit or explicit statement of
exchange, procurement of services or
provision of exclusive information”
• There is no Quid Pro Quo and benefits
would accrue to the general public.
• The Gift’s purpose or use may be
restricted or unrestricted.
Mechanisms for Industry and Private Sponsor Funded Research
Agreement
Types →
Issues &
Concerns ↓
Memorandum
of Agreement
(MOA)
Development
Work Order
(DWO)
Sponsored
Project
Agreement
(SPA)
Bilaterally
negotiated
Contract
(Sponsor's
template)
Clinical Trial for
VetMed Clinical
Sciences
NCSU ownership,
Undefined,
NCSU ownership, NCSU ownership, Sponsor Owned
Intellectual
sponsor option to Defaults to US sponsor option to sponsor option to if Derived from
Property Terms negotiate royalty- Patent Law, No IP negotiate royalty- negotiate royaltySponsor's
bearing license
Generated
bearing license
bearing license
Protocol 1
NCSU Retains
NCSU Retains
NCSU Retains
Single-Site Study
NCSU Retains
Publication
Full Publication Full Publication Full Publication
- yes; Multi-Site
Full Publication
Terms
Rights
Rights
Rights
Study - with
2
Rights
(No Review)
(No Review)
(With Review)
some delays
Detailed SOW
Detailed/Well Detailed/Well
Detailed/Well
Description of
with specific
Scope of Work
Defined
Defined
Defined
Project
timelines and
Deliverable
Deliverable
Deliverable
deliverables
Specified
Maximum
Final Technical Final Technical
Specified
Technical
Case Reports
Deliverable
Report
Report
deliverables
Reports
Typical Payment
Mechanism
Advance
Payment
Cost
Cost
Reimburseable,
Reimburseable
Fixed Priced
Cost
Reimburseable
Cost
Reimbursable
Legally binding
NCSU Standard
NCSU Sponsored
NCSU Standard
NCSU Standard
contract (std.
Documentation
MOA
Project
Clinical Trial
DWO
and negotiated
with no changes
Agreement (SPA)
Agreement
clauses)
Min/Max
Funding
$25,000 per
None
None
None
Number of
Restriction
company, per PI
Subjects
F&A
15% of Total
Award
NCSU Federally NCSU Federally NCSU Federally
Negotiated
Negotiated
Negotiated
Rate*
Rate*
Rate*
Charitable
Contribution or
Gift (via NCSU
Foundations)
None
(NCSU Owns)
None
(No Restrictions)
None (PI Conducts
“Dept. Research"
per A-21)
None-Gift
Acknowledgement
Only
Advance Payment
Company Letter
Stating Gift or
Charitable
Contribution
28% of Total
Award
None
None
(1) If not sponsor owned, then NCSU owns; sponsor has option to negotiate royalty-bearing license
(2) if applicable, with removal of defined Confidential Information and/or negotiated delay for protection of patent rights
(*) Rate determined based on activity, i.e., Research (51.5% on campus, 26.9% adjacent to campus, 26% off campus); Instruction
(52% on campus, 26% off campus); Other Sponsored Activities (33.6% on campus, 20% off campus)
Pre-Proposal Review
• Does a Proposal need a SPARCS
Review? A PINS record is critical!
– Some Solicitations include terms and
conditions (T&C)
– Must be reviewed by SPARCS prior to
proposal submission
– If no exceptions are given, the Sponsor
assumes its T&Cs are acceptable
• SPARCS Needs Your Help!
Award T&C
• Terms and Conditions
– Define business relationship between
Sponsor and University
– Time of performance and consideration
– Clarify each party’s obligations & rights
– How to handle changes and unexpected
situations
– Assign risk or liability to parties
Problematic T&C
• Publication
– Retain right to publish and disseminate
results
– Acceptable alternative
•Sponsor’s prior “review & comment”
rather than “review and consent”
Problematic T&C
• Intellectual Property (IP)
– Patents, copyrights, trademarks, trade
secrets
– Must retain ownership to any IP
developed under sponsored project
– “Work-for-hire” agreements require
results to be owned by Sponsor
Award Review Process
• Award document reviewed in detail
• Identify terms that are problematic
• Risk Assessment (prioritize high/low risk)
• Prepare a letter of exception or “redline” Sponsor’s agreement
• Record status in the RADAR
Progress Journal
When the Agreement Arrives…
• If milestone payment method is used, is
the schedule reasonable?
• Can I meet the reporting requirements?
• Is it cost reimbursable or fixed price?
What about unexpended funds at close
of the project?
• Who owns any equipment purchased?
• Do the Intellectual Property terms fit my
project?
Arrives con’t…
• Do I need to have any publication
reviewed (not approved) by the sponsor?
• Are there any confidentiality
requirements?
• Are there any spending restrictions? Can
I re-budget or do I need approval?
• The Scope of Work is generally fixed and
firm, so is there any flexibility in the
work plan? Do I need approval if I
modify scope or method?
• Is the sponsor offering direct payment of
travel? If so, NC State personnel could
end up with additional personal liability.
Best Practices
• Review the terms carefully: discuss with
your CRO and/or Dept. Administrator
before the project begins.
• If it is a contract, it is not a grant or a gift.
• Make note of special conditions.
• Submit reports exactly as committed in
the contract, these are deliverables!
• Follow agreed upon timelines and
methodology.
…or request IN WRITING a change in
scope, timelines or reporting.
More Best Practices
• Do not charge expenses to the project unless
they directly relate to the contracted work.
• If the company has title to the equipment, don’t
use any NC State funds to purchase it.
• If you have an MTA, be sure to understand the
conditions imposed.
• Closely monitor subawards. New OMB
omnicircular imposes much stricter
requirements on risk assessment prior to
issuance and subrecipient monitoring.
• Remember that while verbal agreements may
constitute a contract, they are nearly impossible
to prove.
Questions?
• SPARCS Website Policies & Forms
• SPARCS Office Contacts
• SPARCS Phone - 515.2444
Jeffrey M. Cheek
[email protected]
513.2148

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