Project deliverable Open Access

Framework of modular contract clauses for HRICs

Adrian Thorogood

Regina Becker; Irene Schlünder; Christian Ohmann; Linda Ebermann

This deliverable provides a list of modular contractual clauses that can be integrated into data
sharing agreements that support the implementation of a Healthy Research and Innovation
Cloud (HRIC) in the EU. The document reviews common clauses found in the following
categories of data sharing agreements:
1. Data Access Agreements (between Data Providers/Data Hubs and Data Users,
where access to data is granted for research purposes),
2. Data Submission Agreements (between Data Providers and Data Hubs where
data are submitted to a Data Hub to be curated and stored to facilitate access by
prospective Data Users),
3. Data Hosting Agreements (between Data Providers and Data Hubs, outlining
conditions and processes of data access), and
4. Data Analysis Agreements (between Data Users and Data Hubs which provide
a Secure Processing Environment for the analysis of data).
The focus of this document is on addressing data protection requirements. This requires
assumptions to be made about the context in which these agreements are used, as well as the
resulting GDPR roles and relationships. The deliverable outlines the GDPR sub-components
of these agreements depending on the applicable relationships (e.g., GDPR data processing
agreements, joint controller agreements, data transfer agreements), and outlines the clauses
commonly needed in these agreements to satisfy GDPR compliance. For Data Access
Agreements specifically, a broader set of common clauses are described relating to
intellectual property rights (IPR), publication policies etc. .
The primary aim of this deliverable is to provide a checklist of clauses for data sharing
agreements in an HRIC. This will assist drafters with ensuring agreements cover essential
matters. Use of this deliverable can also support greater standardization of the content of such
agreements, which can improve the consistency of clauses, reduce time spent drafting and
negotiating agreements, as well as increase the connectability of resources. The clauses are
not intended, however, to be standard or harmonized agreement templates, as drafters retain
the flexibility to include (or not) certain clauses suitable to their context, or to select between
different options relating to a particular theme.

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