**Possible reasons**

• Low level of awareness and transparancy (e.g. by a lack of public events and

• More time for personnel training and informed consent procedure with donors

• Creation of visual informed consent information if possible in various

• Implementation of a marketing concept for specific positioning on the

publications)

languages

biobanking market

**Possible consequences**

approval is in place)

**Possible coping strategies**

with new regulation/law in advance

experience about implementation

**84**

**Possible reasons**

*4.1.6 Changes of legal and ethical aspects*

**Possible consequences**

*Risk Management and Assessment*

• Reduced number of donors

**Possible coping strategies**

• Increased number of withdrawals

• Easy understandable informed consent

• Cooperation with media representatives

• New national/European/international regulation

• Further development of the field in the society

• New constitution of an ethical committee/IRB

• Test cases that force the legislative organs to sharpen the law

• Termination of biobank (if it is not allowed at all by law)

prepared, having an influence from the beginning)

• Loss of ethical approval and stop of operation (in best case until the new

• Cooperation with legislative organs on new regulation (being informed and

• Preparation of own approvals, applications, and governance in accordance

• Dialog with other biobank sand interest groups to be informed and exchange of

• Completely new development and/or sharpening of own governance

