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Unfunded research agreements are legally binding agreements that are related to Texas A&M University (TAMU) research but do not provide funding.

The most common types are:

  • Nondisclosure agreements / Confidentiality agreements (NDAs)
  • Material transfer agreements (MTAs)
  • Data use/data transfer agreements (DTUAs)
  • Collaboration Agreements

 

Texas A&M Research Administration (TAMRA) is responsible for managing all unfunded research agreements for Texas A&M University, the Texas A&M Health Science Center (TAMHSC), Texas A&M at Galveston (TAMUG) and Texas A&M at Qatar (TAMUQ). TAMRA will screen all unfunded research agreements to ensure that the institution is not prohibited from working with the outside party.

Where referenced below, Texas A&M includes TAMHSC, TAMUG and TAMUQ.

Nondisclosure Agreements, Confidentiality Agreements (NDAs)

NDAs are commonly requested when two or more parties wish to enter into initial discussions about specific processes, methods or technology for the purpose of determining the potential for a future relationship.  An NDA is a legal agreement which defines information that the parties wish to protect from dissemination and outlines restrictions on its use.   These agreements cover terms associated with protection of exchanged information and are not meant to function as sponsored agreements that address other contractual terms and conditions. NDAs are valuable to protect the ability to patent an invention, something that can be compromised if a disclosure of the invention becomes public knowledge.  If a Texas A&M employee is sharing new processes, unpublished data or other confidential information, the employee should protect his/her rights and Texas A&M’s rights by having an NDA in place.

Texas A&M prefers to use its own standard NDA templates. These terms and conditions have been vetted by the Texas A&M University System’s legal counsel and have been proven effective at protecting the needs and interests of both parties.  If a company is willing to accept Texas A&M’s standard NDA template with minimal or no changes, the process is expedited and signatures can be obtained within a few days. However, if a company requires the use of its own terms and conditions, this will require a thorough review and negotiation period to ensure that Texas A&M’s legal obligations and interests are not unduly compromised.  This review and negotiation period will likely cause a delay in processing. Ample time should be allowed for the review, negotiation and signature of the NDA.

 

TAMU NDA Templates

TAMU Mutual NDA template

TAMU as Receiving Party NDA template

TAMU as Disclosing Party NDA template

 

HSC NDA Templates

HSC Mutual NDA template

HSC as Receiving Party NDA template

HSC as Disclosing Party NDA template

 

Questions and comments may be directed to negotiations@tamu.edu.

Material transfer agreements (MTAs)

An MTA is a legal contract to document the transfer of physical material between Texas A&M and academic, non-profit, or industrial organizations. MTAs are used to document the transfer of biological materials (plasmids, cell lines, mouse strains, etc.), as well as a variety of non-biological materials. Investigators must ensure that an MTA is in place prior to receiving or sending any material.

MTAs are important because they define the parameters under which materials may be used. MTAs include terms related to permitted purpose and length of time either party may retain the material, confidentiality of material, publication of results, ownership of intellectual property, and warranty and liability. MTAs protect both the researcher’s and Texas A&M’s interests and the ability to conduct future research related to the material. It is important to ensure that the provider does not include terms that may restrict the researcher’s academic freedom, assert undue rights of ownership of discoveries, or use indemnification language that may put the Texas A&M at risk. Acceptable terms are negotiated by TAMRA and the provider.

For simple transfers not involving intellectual property, the NIH recommends a simple letter agreement. For materials that may be patented or for which more protection is desired, the Uniform Biological Material Transfer Agreement (UBMTA) may be used. Many U.S. and some international educational institutions have signed the UBMTA Master Agreement. AUTM (previously the Association of University Technology Managers) serves as the repository for the original UBMTA Master Agreements and maintains the list of the signatories. Signatories to the UBMTA only have to sign an Implementing Letter with the details of the particular transfer since they have already agreed to all the terms of the Master Agreement. The use of these documents dramatically expedites MTA processing.

NOTES: MTAs are not valid unless signed by an authorized representative at TAMRA. An executed MTA does not exempt the acceptance of the material from any compliance reviews including Institutional Animal Care and Use Committee (IACUC), Institutional Review Board (IRB,) Institutional Biosafety Committee (IBC) or export control.

Questions and comments may be directed to negotiations@tamu.edu.

Data use/Data transfer agreements (DTUAs)

A DTUA is a contractual document used for the transfer of data that has been developed by an institution, nonprofit organization, government, or private industry, where the data is nonpublic or is otherwise subject to some restrictions on its use.  Examples include records from governmental agencies, institutions, or corporations, student records information, and existing human research subjects’ data. Often, this data is a necessary component of a research project and it may or may not be human subject data from a clinical trial or a Limited Data Set as defined by HIPAA.  DTUA terms should protect confidentiality when necessary, but permit appropriate publication and sharing of research results in accordance with Texas A&M policies, applicable laws and regulations, and federal requirements.  DTUAs are similar to confidentiality agreements in that they restrict the use and disclosure of the data set.

 

Requirements for DTUAs

  • TAMRA serves as the campus signatory for DTUAs. Researchers are not authorized to sign (including electronic signatures through online systems) DTUAs on behalf of Texas A&M.
  • It is important for researchers to read the terms of a DTUA before forwarding to TAMRA for review. It is the researcher’s responsibility to understand and follow the terms of the agreement and to only use data for the purposes specified. TAMRA assumes that a researcher who transmits a DTUA has read and agrees to conform to those terms, whether or not the researcher’s signature is required on the DTUA itself.

For Human Subject Data, a DTUA is typically required when:

  • Disclosure of data is for research purposes, and
  • Individual authorization for disclosure to this recipient is not/has not been obtained (i.e. through use of a subject-signed informed consent authorization), and
  • When no other form of contract concerning the data use/transfer exists between the provider and the recipient (i.e. sub-award agreement or a contracted services agreement)

For Human Subject Data, a DTUA is NOT typically required:

  • When data is publically available
  • When data is exchanged that is not subject to a legal or other restriction on its use
  • If a research subject signs a consent authorization form that authorizes data sharing with the recipient
  • When another agreement, such as a sub-award agreement or a contracted services agreement which includes provisions for the data is in place

 

Data transfer as part of such a collaborative research project is often addressed in the study protocol or in the funding agreement terms and conditions (i.e. grant, contract, sub-award, contracted services agreement, etc.). In these cases, a separate DTUA is generally not necessary.

If a DTUA is necessary, using the Federal Demonstration Partnership’s Data Transfer and Use Agreement template will greatly expedite the review and approval processing time.

NOTES: DTUAs are not valid unless signed by an authorized representative from TAMRA. An executed DTUA does not exempt the transfer of data from IRB or privacy review, as applicable.

Questions and comments may be directed to negotiations@tamu.edu.

Collaboration Agreements

Research Collaboration Agreements are not required by the Texas A&M Division of Research, but for many unfunded collaborations, they can be beneficial. Researchers often collaborate on research or share research data and/or intellectual property with other scientists or institutions without an exchange of financial resources. Collaboration Agreements set out expectations, terms, and requirements that protect the interests of the investigators and the participating organizations.  These agreements likely involve the provision or exchange of something of value, and the relevant department should determine whether what TAMU provides under the agreement is commensurate in value with what it is receiving. Collaboration Agreements afford protection not only for the institution but also for the researcher. These formal agreements are especially useful when the collaborator’s contribution is essential to the success of the project.

Collaboration Agreements can:

  • Ensure a mutual understanding of the scope of the project and each party’s role;
  • Identify schedules and deliverables;
  • Safeguard intellectual property rights;
  • Preserve the right to publish the results of the project;
  • Identify and address potential export control compliance issues;
  • Require the identification of confidential information and/or export controlled information prior to disclosure;
  • Require compliance with human subject, animal subject, rDNA, or biohazard requirements;
  • Require compliance with data restrictions or data privacy requirements, including data security obligations;
  • Provide liability protection for the research partner’s misuse of research results or materials;
  • Establish rights and procedures associated with early termination of the collaboration;
  • Document a research relationship with a foreign entity;
  • Protect against third-party claims resulting from the research partner’s gross negligence or willful misconduct; and
  • Require compliance with campus policies and federal and state laws and regulations.

 

NOTE: Collaboration Agreements are legal contracts that faculty members, department heads, and deans do not have the authority to sign on behalf of the University.

TAMRA can assist with the preparation of collaboration agreements.

Questions and comments may be directed to negotiations@tamu.edu.