Home > Work Package 8: Legal Issues, Ethics, and Governance

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. 


WP8 Partners

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

Achievements WP8

  • The HARMONY De-Facto Anonymization procedures were developed and adopted; Techniques (SOPs) ensuring the implementation of HARMONY’s anonymization process were created; Guidance on anonymization and pseudonymization were established to enable the execution of the Proof-of-Principle study.
  • Procedures for coordinating external legal support was secured and coordinated.
  • The informed consent template was developed.
  • A contribution to the Proof-of-Principle study was realized. Standard operating procedures describing data-intake processes in accordance with applicable legal and ethical frameworks were written.
  • Incidental Findings Guidelines were drafted; A comprehensive literature review was conducted; The contributions of key opinion leaders were included.
  • General guidelines on anonymization and pseudonymization were drafted; Previous research into the legal requirements was re-evaluated and compiled; Ethical requirements and concerns were considered; The external Ethics Advisory Board’s advice was included.

Achievements 2017:

  • Developed legally and ethically compliant approaches to the processing of clinical data for research;
  • Installed the Independent External Ethics Advisory Board (EAB);
  • Articulated the EAB’s Position on Public Interest, Informed Consent, and Tracking Data Records;
  • Developed the draft Participant Information and (Re) Consent Form;
  • Facilitated inter-WP dialogue and decision making.

Outlook 2019

  • A review on the implementation progress of the new EU General Data Protection Regulation (GDPR) in EU member states will be initiated.
  • An annual report for activities and achievements in 2018 will be written.

In 2017 WP8, together with data work packages and by consulting external expertise, has developed a solution to legally and ethically compliant processing of sensitive personal medical data for secondary use. 2018 will see the continuation of work regarding:

  • Developing informed consent documents further, in cooperation with BD4BO DO-IT;
  • Resolving final issues in the context of the proof-of-principle study;
  • Organising a stakeholder meeting to finalize the handbook on ethical considerations of fundamental rights in the field of data protection;
  • Providing the handbook on ethical considerations of fundamental rights in the field of data protection;
    Providing guidelines on anonymization and pseudonymization;
  • Providing a guidance document on incidental findings including a literature;
  • Intensifying collaboration with HARMONY’s ethics advisory board and external legal counseling.

In particular, a new legal framework for the protection of personal data within the EU, the General Data Protection Regulation, will be applicable from 25 May 2018. WP8 will continue to prepare for this transition which will accompany the project’s shift from the proof-of-principle study to the final implementation of the HARMONY framework.


Work Package Leadership