Office of Research Integrity & Compliance (oric) Office of Sponsored Programs (osp) Office of Technology Transfer (ott) Guidance on Issuance, Review, Negotiation

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Office of Research Integrity & Compliance (ORIC)

Office of Sponsored Programs (OSP)

Office of Technology Transfer (OTT)
Guidance on Issuance, Review, Negotiation, and Execution

of Research-Related Data Use Agreements (DUAs)

and Material Transfer Agreements (MTAs)

I. Background: In Research and Development (R&D) collaborations, East Carolina University may provide research data generated or tangible material collected or developed at ECU to another party, as well as be the recipient of research data or material from another entity. To protect the interests of ECU, the exchange of data and/or material with another entities must only occur with an agreement that provides the limitations placed by the Provider that are acceptable to the Recipient. The purpose of this guidance document is to clarify the responsibilities of the Office of Research Integrity & Compliance (ORIC), The Office of Sponsored Programs (OSP), and the Office of Technology Transfer (OTT) for initiation, review, negotiation, and/or execution of these agreements for the exchange of data and/or materials.
II. Definitions: For the purpose of this guidance, the following definitions apply:
A. Research and Development (R&D): The components of R&D are defined as follows:
1. Research: A systematic study directed toward fuller scientific knowledge or understanding of the subject studied;
2. Development: The systematic use of knowledge and understanding gained from Research directed toward the production of useful materials, devices, systems, or methods, including design and development of prototypes and processes
B. Provider: The party providing data and/or material to another entity
C. Recipient: The party receiving data and/or material from another entity
D. Data: Recorded information
E. Human Data: Recorded information from or about a human obtained through observation, intervention, or interaction with the individual. Such data may be in a de-identified dataset, a limited dataset, from a registry, or fully identifiable
F. Data Use Agreement (DUA): A formal agreement, issued by a Provider, that is between the Provider and the Recipient that establishes terms and conditions for provision, use, maintenance, protection, and/or disposition of data
G. Material: Tangible matter. May be Human Material or proprietary material.
H. Human Material: Any material (tissues, blood, sputum, excreta, cells, etc.) that is obtained from a human
I. Material Transfer Agreement (MTA): A formal agreement, issued by the Provider, between the Provider and the Recipient that establishes terms and conditions for provision, use, maintenance, protection, and/or disposition of material
J. Business Affiliate Agreement (BAA): A formal agreement, issued by the Provider, between the Provider and the Recipient that establishes terms and conditions of Data use when the Recipient is acting as a contractor/vendor of services rather than as a research collaborator.


III. Responsibilities for Issuance, Review, Negotiation, and Execution of Data Use Agreements and Material Transfer Agreements: The role of ECU (as Provider or Recipient) and the nature of the Data and/or Material (Human or Non-Human) determine which ECU office is responsible for issuing, reviewing, negotiating, and executing DUAs and MTAs. The following matrix identifies responsible offices/parties.


Type of Agreement

Initiation

Review

Negotiation

Execution

DUA Covering ECU's Human Data

(ECU as Provider)



ORIC

n/a

ORIC

Assoc VC for Healthcare Regulatory Affairs

DUA Covering Provider's Human Data (ECU as Recipient)

Provider

ORIC

ORIC

ORIC Director

BAA Covering Provider's Human Data (ECU as Recipient)

Provider

ORIC

ORIC

Assoc VC for Healthcare Regulatory Affairs

MTA Covering ECU's Human Material (ECU as Provider)

ORIC

n/a

ORIC

Assoc VC for Healthcare Regulatory Affairs

MTA Covering Provider's Human Material (ECU as Recipient)

Provider

ORIC

ORIC

ORIC Director

DUA Covering Non-Human Data

(ECU as Provider)



OSP

n/a

OSP

OSP Director

DUA Covering Non-Human Data

(ECU as Recipient)



Provider

OSP

OSP

OSP Director

MTA Covering Non-Human Materials (ECU as Provider)

OTT

n/a

OTT

OTT Director

MTA Covering Non-Human Materials (ECU as Recipient)

Provider

OTT

OTT

OTT Director



IV. Responsibilities of the Researcher
A. When ECU is the Provider of Data or Material, the researcher must provide the following to the appropriate ECU office prior to execution of the DUA or MTA:
1. A copy of any confidentiality/non-disclosure agreement related to the Data or Material that was previously executed by ECU and the Provider;
2. If Human Data or Human Material are being provided:
a. A copy of the current ECU IRB approval or exemption covering sharing of the Data or Material, if applicable and
b. A copy of the Recipient's current IRB approval or exemption for use of the Data or Material;
3. A copy of any Data/Material security plan required by ECU; and
4. A disclosure of any ECU Data or Material that are or may be considered ECU intellectual property with potential commercial value.
B. When ECU is the Recipient of Data or Material, the researcher must provide the following to the appropriate ECU office prior to execution of the DUA or MTA:
1. A copy of any confidentiality/non-disclosure agreement related to the Data or Material that was previously executed by the Provider and ECU;
2. A copy of any Data/Material security plan required by the Provider;

3. If Human Data or Human Material, a copy of the current ECU IRB approval or exemption covering use of the Data or Material;

4. Copies of any other documents required by the Provider; and

5. A copy of any Conflict of Interest Management Plan previously developed that is related to use of the Data or Material.


The ECU researcher will be required to affirm his/her understanding of, and intended compliance with, the terms and conditions of any DUA or MTA by affixing his/her signature before the appropriate office adds the institutional signature.

V. Business Affiliate Agreements: Providers may request that ECU also enter into a Business Affiliate Agreement (BAA) when Human Data are provided to ECU. A BAA is only required and appropriate when ECU is acting as a service vendor/contractor rather than as a research collaborator. Requests for execution of a Business Affiliate Agreement should be referred to ORIC.

VI. Non-Research Related Information Exchange: ECU may provide data to, or receive data from, an external entity for non-research purposes. DUAs or MTAs covering non-research related exchange of information should be handled in accordance with University signatory policy, with the Office of University Counsel providing input in agreement negotiation as appropriate.


OSP v.04.18.2016 Page of


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