Leaders:

Eva Winkler (Heidelberg), Christoph Schickhardt (Heidelberg) Research Assistant: Isabell Haase-Saebel

Abstract:

The ethical subproject will address ethical challenges, which arise from the research use of health data from children. The challenges to be addressed concerne especially children’s’ and proxies’ rights to give informed consent, to privacy, information access and withdrawal and the question of returning incidental findings. Beyond, we concentrate on relevant questions regarding data sharing and how to share them in both national and international data platforms with academic partners and industry. 

Tasks:

• Ethical review of existing information and consent tools
  After analyzing the ways in which the planned data sharing platforms, the storage and transfer of patient data will affect patients` informal rights and their privacy, we will elaborate recommendations for consent and information materials that meet the special needs of the young patients and their proxies.
• Ethical recommendations on Data Use and Access Committees and Governance
  We will develop ethical criteria guidelines for data use and access, i.e. for warranting access to the data to researchers from academia and industry.  
• Ethical guidance for a policy for responsible handling of incidental findings
  We will develop a guidance on how to deal with incidental findings towards the patients and their proxies based on already existing policies and experience of our consortium regarding the benefits and the disadvantages of the return- of-individual findings.