Legal Agreement Templates

A unified contractual framework for data sharing in Swiss health research

Research projects sharing sensitive personal health data between institutions require a legal agreement. SPHN offers a nationally unified contractual framework with a series of templates for legal agreements that can be adapted to various collaboration setups. Refined through eight years of experience with complex, multi-institutional projects, the templates provide a strong foundation for collaborations. Based on insights from the SPHN Data Governance Working Group, the agreements define key principles of the collaboration (such as data use, ownership, publications, intellectual property and liability) and outline the rights, obligations and responsibilities of all parties involved (e.g. investigator, data provider, data recipient, processor, etc.). While tailored for Switzerland, they can also serve as a basis for setting up legal frameworks in international collaborations. All terms used in the templates are explained in the SPHN Glossary.

Introduction for researchers and legal professionals

The SPHN Legal Agreement Templates are accompanied by an introductory reference document. It helps users of various levels of legal expertise to navigate the SPHN contractual framework and supports all parties in making well-informed, project-specific adaptations to the templates that comply with current legislation. The paper is intended for a broad audience of research professionals, legal experts and other stakeholders involved in setting up multi-center health research projects.

Download reference document

Download Templates

Multi-center research projects typically require a Consortium Agreement integrating a Data Transfer and Use Agreement (DTUA) and Data Transfer and Processing Agreement (DTPA).  Further templates listed below offer options for specific configurations.

Consortium Agreement + DTUA + DTPA - new version

Specifies the parties’ collaboration, their rights and obligations according to project plan and funding decision
Describes governance structure between project leader, sponsor, investigators and defines executive and scientific board
Regulates financial conditions, confidentiality, intellectual property, publications, exit and further warranties
Reflects the agreement between the parties regarding the terms governing the processing, security and sharing of data under the Consortium Agreement
Describes terms and conditions for providing data by the provider, who is the controller of the data, to recipient, who wishes to conduct the research project. It specifies:
- - - Data processing
    - Liability and third party rights
    - Miscellaneous items, such as force majeure
    - Security requirements for recipient and external processor ensuring appropriate confidentiality, integrity, availability and resilience of the systems with regard to processing of the data.
  N.b. You may need to divide the document for signature purposes, if you do not want to share potentially confidential information with all parties (e.g. in the consortium agreement)
  
  Download template

Consortium Agreement (CA)

DTUA + DTPA

Describes terms and conditions for providing data by the provider, who is the controller of the data, to recipient, who wishes to conduct the research project. It specifies:

Data provision defined in the DTPA with a BioMedIT node
Data processing
Liability and third party rights
Miscellaneous items, such as force majeure
Security requirements for recipient and external processor ensuring appropriate confidentiality, integrity, availability and resilience of the systems with regard to processing of the data.

Download Template

DTPA

DTUA without an external processor