New technologies are set to change the face of biobanking in the years ahead.
This raises many ethical, legal and social issues that need to be resolved in dialogue with scientists, patients, data protection authorities and the public.
Fields of action
GBN/GBA examine unclear and unresolved issues in existing patient consent documents and develop proposals for solutions in collaboration with the Permanent Working Party of the German Medical Ehtics Committees (AK EK), the Medical Informatics Initiative Germany (Working Groups “Consent” and “Data Sharing”) as well as experts in the field of data protection (TMF, data protection authorities).
Data protection issues for medical research and biobanks are also being addressed considering the EU General Data Protection Regulation and new technological developments.
Important preliminary work has already been conducted in recent years on the national and European level, e.g., by the TMF, the Working Group “Biobanking” of the Permanent Working Party of the German Medical Ehtics Committees and by BBMRI-ERIC's Common Service ELSI. Their findings serve as a basis for GBN’s further activities.
The following ethical-legal questions are currently being discussed:
- Who is required to seek and countersign a consent (sample and data donation)?
- May German biobanks ask about and record ethnicity (e.g. following the model of UK Biobank)?
- How should data and sample be handled of those not deemed competent to consent?
- How to deal with incidental findings while respecting the basic “right not to know”?
- How can privacy be ensured in the age of genetic high-throughput technologies and social media?
- Should it be considered ethically acceptable to collect biospecimen from small children/adolescents using a “Broad Consent” – even if parents agree? What is to be done with the data/samples once the donor reaches the age of majority?
- May additional samples also be collected based on a “Broad Consent” as part of clinical AMG studies by the pharmaceutical industry?
- What issues have to be considered in the bidirectional exchange of samples/data between public institutions and private companies (e.g. pharmaceutical industry)?
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