Agreements 101 - UNC Research · 2018-08-10 · Agreements 101 Liz Thornberry Moore, Assistant...
Transcript of Agreements 101 - UNC Research · 2018-08-10 · Agreements 101 Liz Thornberry Moore, Assistant...
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Agreements 101
Liz Thornberry Moore, Assistant Director of Contracting
2018 OSR Symposium
Bettina Lampkin, Sponsored Projects Accounting Manager
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What does OSR do?
How can OSR help?
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Role of OSR in Contract Negotiations
• OSR Research Administration (including Industry Contracting) has the responsibility of negotiating agreements for sponsored projects on behalf of the University– Signature authority
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• Contract negotiation requires collaboration with Principal Investigators and departments
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I know I need an agreement, but don’t know what type.
What are the different types of agreements?
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Types of Agreements
• Confidential Disclosure Agreement (CDA)/Non-Disclosure Agreement (NDA)– Activity: to share information confidential in nature for a
particular purpose BEFORE any other relationship occurs– Purpose: to protect confidential information being shared– Example: a pharma company wants to share a clinical trial
protocol with a PI so she can determine if she wants to participate in the trial
– Note: these terms are normally embedded in other agreements
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Types of Agreements
• Data Use Agreement (DUA) (also Data Transfer Agreement/Data Sharing Agreement)– Activity: to share data collected from another source for a
particular purpose– Purpose: to protect the information being shared and
outline the terms and conditions of the transfer– Example: a PI wishes to receive data from outside of UNC to
conduct an analysis as part of a research project– Note: these terms can be embedded in other agreements
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Types of Agreements
• Material Transfer Agreement (MTA) – Activity: acquisition or sharing of biological and research
materials– Purpose: govern the use of the shared materials – Example: a PI wishes to receive research materials from
outside of UNC to conduct research– Notes:
• these terms can be embedded in other agreements• With or without funding
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Types of Agreements
• Clinical Trial Agreement (CTA) – Activity: to conduct a clinical trial testing an investigational
drug or device– Purpose: manages the relationship between the sponsor
and the site– Example: a PI is conducting an industry sponsored clinical
trial on an investigational cancer drug
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Types of Agreements
• Sponsored Research Agreement (SRA) – Activity: to conduct a specified research project during a
defined timeframe– Purpose: to govern the terms of the research project, such
as publication, deliverables, intellectual property, funding, etc.
– Example: a PI develops a research plan and a sponsor wants to fund the project
– Notes: this research does not usually involve human subjects, but can
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Types of Agreements
• Research Services Agreement– Activity: to conduct a specified task or service related to
research– Purpose: to govern the deliverables and payment– Example: a sponsor wants a PI to perform particular testing
services– Notes:
• unlikely to result in the creation of new IP• Core/recharge center agreements fall under this category
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Types of Agreements
• Federal contracts – Activity: to support research in areas of significant scientific
interest, to further scientific knowledge, or to achieve a specific research goal
– Purpose: to allow a federal agency to acquire goods or services for the direct benefit or use for the government
– Example: DOD has a research idea and procures the services of an academic partner
– Notes:• Difference between federal contract and a federal grant
– Federal contracts designed to comply with the provisions of the Federal Acquisition Regulation (FAR)
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Types of Agreements
• Subcontracts, subawards, site agreements – Activity: to engage with a subcontractor to perform a
portion of a research plan or protocol– Purpose: to flow down the terms and conditions of the
prime agreement– Example: a UNC PI wishes to have another researcher at
another university assist in the analysis for their research project
– Notes:• It is best to note the use of subs when we are negotiating the
prime award or submitting the proposal
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Types of Agreements
• Collaboration Agreements– Activity: to conduct a research program with two or more
organizations – Purpose: to describe the actions that each organization has
agreed to undertake and defines the obligations of each party
– Example: a researcher has developed a research protocol with an outside organization and each party is performing a portion of the research and funding the project internally
– Notes: typically no transfer of funds
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Types of Agreements
• Teaming agreements– Activity: binds one or more organizations that are joining to
propose a research program to a prime sponsor in response to a request for a proposal (RFP)
– Purpose: to specify the objectives of each member and the actions and deliverables required from each party
– Example: a PI is collaborating with an outside entity to submit a proposal to NIH
– Notes: • specific to a collaboration to submit a proposal• May limit the University or key personnel to not compete with the
RFP
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Types of Agreements
• Miscellaneous– Memorandums of Understanding (MOUs)– Fellowships/training agreements– Master agreements– Consortium agreements– Gifts
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Where to submit?
Type System
CDA – Clinical CRMS
CDA – Non-clinical ALICE
DUA ALICE
MTA – without funding BLUE (OTC)
MTA – with funding RAMSeS
CTA* CRMS and RAMSeS
SRA/Research Services Agreements RAMSeS
Federal contracts RAMSeS
Subcontracts/subawards/site agreements ALICE and RAMSeS
Collaboration agreements ALICE
Teaming agreements RAMSeS
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Why does OSR keep asking for additional documentation?
What documents need to be submitted for a complete review?
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Documents to Accompany Agreement Request
• Whether submitting in CRMS, ALICE, or RAMSeS, the following documents are required:– Scope of work/protocol/research plan– Budget and budget justification
• Must include appropriate F&A rate– Draft agreement (if available)– Contact information for sponsor/external entity for
negotiation
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What are the responsibilities of the PI and/or department?
Why do I care about the agreement?
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PI Responsibilities
• PI is the subject matter expert on the research project• Also has other contractual obligations
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PI Responsibilities
• Statement of Work/Research Plan/Protocol– Feasibility– Timeline
• Personnel actions (hiring specific expertise)• IRB/IACUC approvals• Ancillary agreements (MTAs, CDAs, etc.)• Subaward/subcontract/site agreements
– Deliverables/outcomes
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PI Responsibilities
• Project Resources– Staffing plan – Do I have the necessary people for the study and
the timeframe?• Staff allocation• Training/certification
– Budget/Payment terms• Burn rate – sometimes used as a method of program progress• Deliverable based payments – Are they reasonable?• Required purchases and/or travel• Cost share or matching requirements – Where are the funds coming
from?
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PI Responsibilities
• Reporting Requirements– When are the reports due? Am I able to meet the
deadlines?– Am I required to have weekly/monthly conference calls or
provide monthly status reports?• Can I comply?
– Are the reporting deliverables reasonable?
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PI Responsibilities
• Other responsibilities to consider:– Confidentiality obligations– Site visits – Are there scheduled site visits?– Contingency plans
• What happens if I do not accomplish all the required deliverables or meet enrollment goals?
• Personnel actions – What are the impacts on timeline?– Communicate and coordinate with department business
managers and OSR if any changes need to be made to the contract (amendments, etc.)
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What can hold up negotiations?
Why is my agreement taking so long?
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Common Sticking Points in a Contract
• Indemnification• Governing Law• Publication• IP• Payment terms• FAR clauses in a federal contract
More discussion in Agreements 102
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Questions?
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