In general it should:
Ensure confidentiality in the treatment of data.
Ensure traceability of the samples.
The preservation of data over a long period of time to ensure external traceability provides that-according to Spanish law, article 8 of Law 14/2007, of 3 July, concerning biomedical research- such data must be kept for at least 30 years.
The above fact should be properly reconciled with donors to guarantee their right to withdraw consent to use their samples and, therefore, with the immediate destruction of the biological material donated.
And, in general, ensure compliance with laws and regulations governing the operation of a biobank.
More particularly, in relation to information security a biobank should maintain
confidentiality, ensuring that only authorized persons have access to information,
integrity, ensuring accuracy, consistency and completeness of the information and the correct way in which it is processed
availability, ensuring that authorized users have access to information and associated resources when required.
In relation to management control
The law requires individual and joint responsibilities, so it is necessary to record actions so that the responsibilities arising are well defined. Therefore, a biobank should
keep a record of what occurs, i.e. of all actions involving responsibilities,
ensure proper implementation of the procedures associated with the operation of the biobank.
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