Legal Agreements for inter-institutional projects in Personalized Health (e.g. DTUA)
As a PHRT project PI, it is your duty to make sure that a legal agreement, e.g., a Data Transfer and Use agreement (DTUA), is in place between your institution and the institution providing the data. It is not only to ensure high quality of processes when doing research with patient data, it is also required by law. Need help? – The SPHN Data Coordination Center (DCC) has both a particular knowhow on the matter and a decent network, to support the elaboration of this kind of contracts: contact Julia Maurer (DCC). Please make sure you have all the information needed ready (e.g. proposal, collaboration partner (data provider, data recipient, service provider), application for ethical approval , data storage, archive, etc …). Further information and templates can be found on the SPHN webpage.
Why is it important?
No DTUA – no research: The contractual architecture for a collaborative use of health-related data depends on the project specifications and responsibilities of participating parties, and is part of the legal and regulatory framework. An agreement template establishes the contractual framework necessary to conduct, e.g., a multicenter research project involving the sharing of health-related data. Once put together, these agreements settle the important issues that need to be legally addressed (permitted use, ownership of data, publications, intellectual property and liability, etc.) and define the rights, obligations and responsibilities of all parties involved (investigator, data provider, data recipient, processor such as the BioMedIT nodes, etc.).
A legal agreement, thus, postulates a solid basis for a successful collaboration within an inter-institutional research project and needs to be submitted with the other project-specific documents when applying for an ethics approval.
Moreover, PHRT projects require these agreements signed before the start of funding.