Specific legislation on biobanks in Spain.

Spain has enacted specific legislation concerning biobanks. This legislation regulates how biobanks should be set up, how they should operate, and the requirements they need to comply with. The main objective of this legislation is to keep a good balance between scientific progress and respect for the rights and freedom of individuals participating in research. Therefore, this legislation lays down a series of basic principles, for instance, the principle to inform donors accurately i) on the deposit of samples in terms of the objectives and implications of their donation and on the need to obtain written consents; ii) on the obligation to establish consistent procedures to guarantee the confidentiality of personal data associated with and obtained from biological samples; iii) on the concept of free sample donation either by donors or by biobanks; iv) on the need for consistent procedures to deposit samples and data in biobanks; and v) for acts of donation and data for research projects to be performed correctly. Although this Spanish legislation fulfills its objectives, it has some drawbacks; mainly it overprotects research participants. This issue should be analyzed in future revisions of the legislation.