You need an MTA whenever you exchange proprietary or controlled tangible research materials (e.g., cell lines, antibodies, software, infectious agents) with an external collaborator, including other universities, companies, or government agencies.
Provide details about the materials being transferred, the purpose of the collaboration, and the intended use of the materials by the recipient. Any restrictions you wish to place on use should be specified.
MTAs may restrict commercial use of the materials, limit publication rights, or require confidentiality. Specific terms depend on the nature of the materials and the collaboration.
Sharing proprietary materials without an MTA can put the university's intellectual property (IP) at risk, as can resharing materials from a third party that are subject to prior agreements. Always consult OIPM before transferring any research materials that relate to an invention, are proprietary, or are subject to restrictions or other contractual agreements.
While OIPM leads negotiations, your input is crucial. Please provide us with your research plan, goals, and objectives. OIPM will attempt to negotiate term and conditions that align with your research goals and objectives and Tulane's interest.
A DUA will likely be required if all of the following are true:
When you are sending/receiving human data that consists of a limited data set for research or public health purposes;
There are no other contract/agreements with the other party already in place related to the data, i.e. this is a new request for data not controlled by an agreement like a clinical trial agreement; and
There is not a HIPAA authorization or HIPAA waiver that applies to and allows for the transfer
A DUA may also be needed to transfer data out of Tulane (either de-identified or a limited data set) if Tulane received the data from elsewhere under an agreement and is now redistributing it.
For more information on the differences between a de-identified data set and a limited data set, please click here.
When the data is de-identified, publicaly available and the data to be exchanged is not subject to legal (previously entered legal agreement) and/or government restrictions (federal statutes or policies).
When there is a HIPAA authorization or HIPAA waiver that applies to and allows for the transfer of the limited data set.
When your data set contains direct identifiers such as names, MRNs, etc. A HIPAA waiver, HIPAA authorization, Business Associate Agreement, or proof that all individuals in the data set are deceased will be necessary.
No, a DUA is not required prior to applying for an authorization or waiver with HRPO. If you have an executed DUA for a data transfer, you do not need to also obtain a HIPAA waiver or authorization with HRPO. Similarly, if you obtain a HIPAA waiver or authorization from HRPO for a transfer, a DUA is not necessary.
Name and contact information of the data receipient and provider; the type of data being sent or received; is the data de-identified or a limited data set (for human data); are there any current agreements/contracts with the recipient/provider related to the data; and are there any special terms or conditions which you would like included in the DUA.
You need an CDA when sharing confidential information with anyone outside the university, such as research collaborators, industry partners, or potential investors, before publicly disclosing the information.
OIPM handles MTA negotiations on your behalf. Unpublished research results, inventions, business plans, and any other unique or sensitive information not publicly known should be protected by an CDA.
You can initiate the CDA process by informing OIPM about the collaboration and requesting an CDA. OIPM will provide the appropriate CDA template and guide you through the process.
There are two main types: Unilateral CDAs protect only the disclosing party's information, while Mutual CDAs protect information shared by both parties. OIPM will choose the type that best suits your specific needs.
CDAs typically restrict the recipient from using or disclosing the confidential information except for the agreed-upon purpose of the collaboration. They may also specify publication rights and the duration of confidentiality.
CDAs should not prevent you from publishing your research findings once the confidential information has been publicly dislcosed or cleared for publication by the collaborating party.
Violating a CDA can lead to legal consequences, including injunctions, damages, and reputational harm. Always ensure the recipient understands and respects the terms.
OIPM is your primary resource for CDA guidance and support. The IP contract team can answer questions, provide templates, and assist with negotiations. Contact the IP contract staff directly at IPcontracts@tulane.edu.
OIPM leads negotiations to ensure consistency and protect the university's interests. However, your input is important, and OIPM can tailor the agreement to your specific needs within the legal parameters. All CDAs must be signed by an official with signature authority.
