Compliance and Legal Agreements

Data Use Agreements (DUA)

Data Use Agreements (DUAs) are contractual documents used for the transfer of nonpublic data that is subject to some restriction on its use. The data provider typically originates DUAs. Contact Fred Hutch Business Development & Strategy to initiate a DUA or review a received DUA, using this questionnaire. DUAs serve to outline the terms and conditions of the transfer. Specifically, DUAs address important issues such as limitations on use of the data, obligations to safeguard the data, liability for harm arising from the use of the data, publication, data destruction or return and privacy rights that are associated with transfers of confidential or protected data.

• DUAs serve to outline the terms and conditions of the transfer.

• DUA are used most commonly for sharing data within research and/or collaboration. DUAs are most often used when transferring data between Fred Hutch and an external entity (outside of the UW/Cancer Consortium) and may be used for transferring sensitive information between Fred Hutch and its consortium partners.

• DUAs typically originate with the sender. DUAs may be specific, such as those incorporated into the context of a Clinical Trial Agreement or a sponsored research agreement, or they can be general.

• If a Fred Hutch clinical trial is part of a multi-site trial, DUAs may be required to conduct the trial.

• Most data sharing involves de-identified data. Less common is sharing research data with identifiable individual health information for which patient informed consent and HIPAA authorization has been signed. Both types of data are required by Fred Hutch to have a DUA when sharing data.

• The Privacy Rule permits sharing of a Limited Data Set, which includes some identifiers. A LDS may be disclosed for research activities if the disclosing entity and the LDS recipient enter into a data use agreement. Limited Data Sets may be used or disclosed only for purposes of research, public health, or health care operation.

• A sample Fred Hutch MTA can be found here. Contact Fred Hutch BD&S for more information on Fred Hutch DUAs.

Material Transfer Agreement (MTA)

A Material Transfer Agreement (MTA) is a contract used to govern the exchange of research data or materials between organizations. Examples include:

Cell lines, cultures, bacteria, nucleotides, proteins, transgenic animals, pharmaceuticals, and chemicals, or data cell lines, cultures, bacteria, nucleotides, proteins, transgenic animals, pharmaceuticals, and chemicals, or data software, models, robots tangible research material or raw datasets (but not databases, which are protected by copyright)

The Fred Hutch Business Development & Strategy (BD&S) is responsible for negotiating and signing all MTAs with outside organizations. Fred Hutch BD&S is responsible for

• transferring materials from Fred Hutch (as Provider) to another academic or non-profit organization as Recipient), or

• receiving materials from another organization or company.

BD&S reviews MTAs to ensure contractual obligations are consistent with Fred Hutch policy and/or federal law.

Whether for inbound or outbound materials, MTAs are critical documents that require signatures from the Provider(s) and Recipient institution(s) to ensure that each party will comply with the terms of the agreement. Fred Hutch investigators cannot sign MTAs on behalf of the Fred Hutch. If the MTA is embedded in a Sponsored Research Agreement, is linked to a clinical trial, or is for clinical use or clinical studies in humans, the investigator should contact Business Development & Strategy.

Uniform Biological Material Transfer Agreement (UBMTA)

Fred Hutch is a signatory to the Uniform Biological Material Transfer Agreement (UBMTA) Master Agreement, a contracting mechanism published by NIH on behalf of the U.S. Public Health Service (PHS) to facilitate the transfer of biological materials between academic institutions. For institutions which have agreed to the terms of the UBMTA Master Agreement, it is not necessary to negotiate individualized terms for each transfer of a biological material. Instead, an Implementing Letter is executed, which denotes the biological material as well as the providing institution and receiving institution. The Fred Hutch scientist/investigator and a Fred Hutch institutional representative both sign the UBMTA.