Should Research with Human Biobanks be Regulated?

Human biobanks are collections of samples of human bodily substances (e.g. DNA, blood, tissue) linked electronically to personal data of the donors. They are used for patient-based medical research and epidemiology, which in turn aim to improve medical diagnostics, prognostics, prevention and therapy. Because of the high sensitivity of the data involved, the ethical and legal framework of human biobanks is, however, the subject of controversial debate.

The event takes up the recommendation that a legal basis should be established for research with human biobanks, which was formulated in June 2010 in an Opinion of the German Ethics Council on human biobanks. The key recommendation is legally anchored biobank secrecy, which should protect donors from misuse of their data, but at the same time facilitate medical research with biobank samples by relaxing the principle of purpose limitation for the use of samples.

Together with the TMF, the German Ethics Council invites all those affected by research with human biobanks and the interested broader public to discuss possible consequences of implementing the recommendations. The focus is on the following questions:

• Which regulation needs exist for research with human biobanks?
• How transparent is current research with human biobanks?
• What potential for misuse can be identified?
• Can research standards simplify the need for regulation?
• Is there a danger of overregulation?
• Are different regulations needed for publicly funded human biobanks and commercial ones?

Scientists, lawyers, data protection experts and ethicists will explore various aspects of research with human biobanks and the consequences of regulatory measures for research practice. Representatives of politics and research then will discuss together with patient representatives and the interested public the perspectives of a biobank law.

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