A Material Transfer Agreement (MTA) is a contractual agreement that allows for the transfer of materials from or to Brigham and Women’s Hospital (BWH). These transfers may be with academic, non-profit or industry collaborators. Materials may include cell lines, animals, compounds, human tissue specimens, etc. An MTA is required to ensure compliance with Mass General Brigham (MGB), industry, government and non-profit policies; protect intellectual property; and limit risk exposure to the hospital. An MTA also ensures publication rights are preserved for the parties involved.
Any transfer of materials in or out of an MGB hospital must be done in accordance with MGB policy and applicable law. MGB policy strictly prohibits the personal transport of materials. Please refer to Transporting Biological/ Other Research Materials and Policy on Transferring and Sharing of Biological Materials for further guidance.
There are two types of MTAs:
- MTA-Out: This agreement is used when a laboratory or Principal Investigator wishes to send materials to a third party from BWH.
- MTA-In: This agreement is used when a laboratory or Principal Investigator at BWH wishes to receive materials from a third party that are not purchased.*
*Some purchases of materials come with Conditions of Use. In that case, please contact the Transactional Affairs Group (TAG) for guidance on the need for an MTA.
If the material is to be used in a project that is being funded fully or partially by the party providing the material in the form of a subcontract or a sponsored research agreement, institutional service agreement, material purchase or gift, then it is best to contact your TAG associate to determine whether an MTA is appropriate before submitting a proposal for an MTA.
Requesting an MTA
Please work with your Department of Surgery Grants Administrator to set up an MTA record in Insight. MBG has instituted an automated process to request MTAs via the Insight 4.0 system. This system will guide you through the necessary background information needed by your assigned TAG associate to review, draft, negotiate and execute your requested MTA.
If you have further questions, please contact the TAG via email firstname.lastname@example.org
A Data Use Agreement (DUA) is a contractual document that allows Brigham and Women’s Hospital (BWH) investigators to access, obtain or transmit patient/human subject data or images from/to an outside party for use in research. The data or images may be full Protected Health Information (PHI), a Limited Data Set or de-identified within the meaning of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule.
The outside party may be a non-profit or for-profit institution or entity, government agency, or other public entity. A DUA is required for human subject/patient data exchange of any type aside from de-identified data in aggregate form. Aggregated data does not require a DUA although an Investigator may wish to protect such data by means of another type of agreement.
Human subjects data may be shared as part of (1) an ongoing collaboration between the Hospital and the outside party or for (2) independent research by the outside party. Where an ongoing collaboration is planned, data terms are incorporated into the collaboration agreement/subaward and no separate DUA is needed.
|DUA Type||Process||Responsible Office|
|Low Risk: Sending BWH data out to a non-profit domestic entity consistent with BWH templates||PI obtains IRB approval first, then drafts on appropriate template per the Low Risk Process||PI and BWH Department of Surgery Research Management|
|High Risk: Data coming in to BWH and/or data going out that does not fit the Low Risk Criteria||PI/BWH Department of Surgery Research Management create an Insight record under the appropriate contracting office. The contracting office drafts or negotiates and signs the finalized DUA||
For more information on DUAs, or for help getting started on setting one up, please contact your Grants Administrator.
A Sponsored Research Agreement (SRA) is a contract between Brigham and Women’s Hospital (BWH) and a sponsor for the purposes of funding and conducting research at BWH. SRAs may be supported by for-profit (e.g., private industry) or non-profit (e.g., state or federal government, foundations, etc.) sponsors.
Mass General Brigham (MGB) is authorized to review, negotiate, and execute SRAs on behalf of BWH. Several departments across MGB are responsible for drafting, reviewing, negotiating and executing research-related contracts. These departments perform multiple functions. To learn more about the departments and each of their functions and responsibilities, refer to Research Navigator, or contact your Grants Administrator.
SRAs generally include terms governing areas such as:
- Scope of work to be conducted, including reporting and other deliverables
- Period of performance
- Budget for the research
- Frequency of invoicing or payment obligations
- Publication of the research results
- Care of data and confidential information exchanged during the research
- Compliance with export control and other laws and regulations
- Requirements for prior approvals for particular expenditures, etc.
- Taxes, indemnification, choice of law, and other items necessary for contracts
- Rights and procedures to terminate the project
Confidentiality agreements, also known as non-disclosure agreements (NDAs), are usually signed in preparation for a future collaboration. The goal of confidentiality agreements is to protect the exchange of proprietary material, knowledge or information that parties want to share. Parties may include industry and non-profit organizations and may involve clinical or non-clinical information. The other party to the agreement determines which MGB office reviews a confidentiality agreement.
Consulting agreements are between an individual consultant and an entity. These are reviewed by the Office of Interactions with Industry (OII) before the consultant/employee can sign the agreement. If you have a consulting agreement that needs to be reviewed, please email PHSOII@partners.org with a copy of the agreement. You will then be sent a questionnaire to complete before the review can start.
Please note that consulting agreements are not routed through Insight for review.