In this deliverable, we report on the activities for Deliverable 4.1 - Report on trust model for partner sites, and between sites and controlled-access researchers. The Work Package 4 (WP4) goals concern the development of a set of tools that can facilitate federated analyses of new and diverse genetic and genomic datasets, based on specific use cases. The tools selected will be using the common federated infrastructure established in WP1 and WP2, and the datasets will be described with metadata standards identified in WP3.

In our report we considered trust as the extent to which one party is willing to depend on the other party in a given situation with a feeling of relative security, even though negative consequences are possible. This work has contributed towards establishing a description of the trust model and four different levels of data access concerning specific cohort’s data, identifying use cases for the development of federated analysis workflows and describing existing data access models to inspire subsequent WP4 deliverables related to the implementation of the federated analysis workflow. Active communication and engagement of several WP4 members in other CINECA work packages enabled the inclusion in this document of other aspects of the CINECA cohort data access model. Examples include the WP2 cohort survey, the Data Use Ontology framework that was adopted by WP3 and by WP1, and WP5 provided input on the harmonisation and formalisation of clinical use cases.

https://doi.org/10.5281/zenodo.3909521

Authors: Éloïse Gennet & Melanie Goisauf

Keywords: ELSI, data sharing, secondary data, FAIR, data processing, consent, international data sharing

The aim of this deliverable is to give an overview of all the different ethical, legal and societal issues that the CINECA project might be confronted with: public health ethics, personal data protection, ethics of data sharing, protection of consent and vulnerability as well as compliance issues between Canada, Africa and Europe in pursuit of the project goal to enable the exchange of population scale health data across international borders to allow and promote the reuse of data for health research. The rationale for sharing and reusing data in public health research is deeply rooted in the promotion of a fair distribution of research risks and benefits, and it has become an essential and powerful tool for public health research. D7.1 has been elaborated in a bottom up approach, starting from the practical legal and ethical issues encountered notably through Work Package 9 (EC Ethics Requirements). As a basis for the lawful and ethical guarantees for data sharing and reuse within CINECA, all cohorts and consortiums have provided for the copies of their own ethics approvals (Deliverable 9.4), and they are all independently responsible for ensuring researchers accessing data have their own research ethics approval. This deliverable will serve as a starting point for the future deliverable 7.2 which will be aimed at identifying and discussing the gaps in the different legislative or regulatory frameworks and corresponding literature.

As a consequence, this deliverable will be divided into two main parts, the first one focusing on the collective perspectives of international data sharing in public health research (I), the second one examining the opposite perspective of the protection of individual data subjects when their personal data is used for secondary processing (II). Afterwards, future developments will be briefly mentioned (III) before highlighting some of the difficulties encountered in Work Package 9 (IV) and finally listing the references (V).

The overarching purpose of CINECA is to achieve federated human data interoperability between 10 existing cohorts from Canada, Europe and Africa which represent >1.4 million individuals. This will enable population scale genomic and biomolecular data access across international borders, accelerating research and improving the health of individuals resident across continents. This project will not generate novel data from human data, rather it relies on integrating existing resources which hold or store data to deliver new knowledge and innovation. All data access is determined by the existing data access committees (DACs) and the respective data processes for each dataset. The informed consent and ethics approvals for CINECA cohorts were documented in D9.3 and D9.4, and will be respected by this data management plan, which will be an integral part of the consortium’s Governance Framework. Given the international nature of this project, the data management plan is a component of Work Package 7 - Ethical and legal governance framework for transnational data-sharing. We note that all partners in the project have relevant national and/or international experience in acquiring, storing, analysing and sharing high complexity datasets and in the implementation of the FAIR principles for these resources.

The Data Management Plan (DMP) was developed based on the core requirements for DMPs as described by The Science Europe Practical Guide to the International Alignment of Research Data Management (https://www.scienceeurope.org). The DMP is a living document, expected to be updated during the lifetime of the project.

https://doi.org/10.5281/zenodo.3909577