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Work Package 8: Legal Issues, Ethics, and Governance

WP8 will provide a framework for all the legal, ethical, and governance aspects of the project. Its results will facilitate the sharing of information and experiences with all relevant parties. WP8’s work involves confirming the legal situation existing in participating countries in terms of data-sharing and protection, and in framing the secondary use of the medical data that has been gathered. WP8 will offer advice on whether compliance regulations are being observed and will provide appropriate legal and ethical support.

Objectives

Evaluating the relevant EU ethical and legal framework to offer advice on patient privacy, data protection, and governance;
Collaborating on a pilot study to test how data-sharing is working and whether it meets the required standards;
Drafting recommendations to address any specific cases that might arise (especially in cases where information about a single individual might provide a rich source of genetic data, thus enabling that person to be identified);
Ensuring that the concerns of patient-advocacy groups are taken into account;
Establishing a point-of-contact infrastructure;
Developing a template for consent that is legally defensible and appropriate (in English).

Work Package Partners

Amgen, Bayer, Celgene, EHA, GMV, HULAFE, IBSAL, Janssen, Leukanet, MediUni Wien, Menarini, Synapse, Ulm University, UNIBO.

Work Package Leadership

Public-private partnership for Big Data in Hematology

HARMONY and HARMONY PLUS are funded through the Innovative Medicines Initiative (IMI), Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. Funding is received from the IMI 2 Joint Undertaking and is listed under grant agreement for HARMONY No. 116026 and grant agreement for HARMONY PLUS No. 945406. This Joint Undertaking receives support from the European Union’s Horizon 2020 Research and Innovation Programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

HARMONY Coordination Office

Institute of Biomedical Research of
Salamanca (IBSAL)
Salamanca, Spain

harmonyoffice@ibsal.es

HARMONY Communications

European Hematology Association (EHA)
The Hague, The Netherlands

communications@harmony-alliance.eu

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