Other Agreements for Review


 1. What is an MTA? When do I need one? Who reviews and/or drafts these documents for MCW?

A Material Transfer Agreement (MTA) is a written contract between two or more organizations that covers the transfer of tangible research materials.  It defines the terms and conditions under which one entity – the provider – is making the material available to the other – the recipient – for the recipient’s research purposes.  The purpose of the MTA is to identify and protect any intellectual and other property rights of the provider, while permitting use of the material for a limited and specified research purpose by the recipient.  These agreements generally identify the specifics of the material to be transferred, describe the terms and purpose of the exchange, publication rights, liability issues, confidentiality and any intellectual property rights to the material itself as well as any derivatives.

Outbound MTAs:  An MTA should be put in place when you will be providing any biological materials (e.g. reagents, cell lines, plasmids, vectors, animals), chemical compounds, equipment or other tangible material to another organization for their research purposes.  The MCW Office of Grants & Contracts (GCO) prepares these MTAs upon request of the MCW provider investigator and negotiates terms with the recipient organization.  Once the terms are agreed upon, the MCW provider investigator signs the agreement and it is forwarded to GCO to obtain MCW institutional signature.  The template MTA can be found here.

Inbound MTAs:  An MTA should be put in place when you will be receiving biological or other research materials from another organization.  The GCO reviews all inbound MTAs to ensure there are no conflicts with basic academic rights and that there are no unnecessary restrictions to investigators.  Potential issues are often found in the areas of confidentiality, publication, use of materials in sponsored research projects, and conflicts with existing agreements.   Inbound MTAs are reviewed and processed for MCW institutional signature by the GCO.  Investigators and research staff should not sign and return MTAs to material providers themselves.

Additional Resources*

Material Transfer in Academia – an informative booklet from the Council On Governmental Relations (COGR) about entering into Material Transfer Agreements. (PDF)

NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources – NIH portal for policy and guidance on resource sharing, including Biological Materials Policy.

 2. What is a Data Use Agreement (DUA) and when am I required to have one?

A DUA is a contractual agreement that covers the transfer of non-public, restricted, data.  MCW requires a DUA when we provide data that:

  • Is HIPAA-protected or constitutes a Limited Data Set (LDS);
  • Contains Protected Health Information (PHI);
  • Was collected under a sponsored research agreement that limits disclosure of data.

When MCW is the recipient of such data, we defer to the providing organization regarding whether a DUA is required.

 3. What is Protected Health Information (PHI)?

Protected Health Information (PHI) is any individually identifiable health information, whether oral, written, electronic, maintained or transmitted that identifies an individual or can reasonably be used to find out a person’s identity.  PHI identifiers include:

  • Names;
  • All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes;
  • All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death;
  • Telephone numbers;
  • Fax numbers;
  • Electronic mail addresses;
  • Social security numbers;
  • Medical record numbers;
  • Health plan beneficiary numbers;
  • Account numbers;
  • Certificate/license numbers;
  • Vehicle identifiers and serial numbers, including license plate numbers;
  • Device identifiers and serial numbers;
  • Web Universal Resource Locators (URLs);
  • Internet Protocol (IP) address numbers;
  • Biometric identifiers, including finger and voice prints;
  • Full face photographic images and any comparable images;
  • Any other unique identifying number, characteristic, or code.

Health information that excludes these identifiers is not considered PHI.

 4. What is a Limited Data Set (LDS)?

A Limited Data Set is Protected Health Information (PHI) that excludes all direct identifiers.  An LDS may be used for research purposes when the researchers and entity owning the information enter into a Data Use Agreement (DUA).

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