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
“The HARMONY consortium is committed to enabling the use of high-quality clinical and genomic data for the benefit of patients with Hematological Malignancies. Our consortium provides a solid and proven framework that meets the requirements of GDPR and national regulations for the secondary use of clinical data.”
John E. Butler- Ransohoff, VP, Global External Innovation, Bayer
WP8 Co-leader