Genetics, Tissue- and Databases

The creation of such biobanks and genetic databases can give rise to a range of problems, which are not generally covered by regulations on research and experimentation on humans or by data protection legislation. For example, in case of human biological specimens questions may arise as to the ownership of the material – however insignificant it may be – because of the potential economic importance (in the form of a patentable product or other research results) or repercussions of a personal nature (gametes used to help others procreate through assisted reproduction, or grafts and transplants of substances to be used in other people for therapeutic reasons).

The legal aspects probably of greatest interest at present concern the protection of information relating to the source individuals, particularly in view of the potentially predictive or pre-symptomatic capacity of the information. There is concern that such information can be abused, and that the right to have control over one’s own genetic information, the right to privacy and private life, and the prohibition of discriminatory treatment will not sufficiently be respected. Crucial to this concern is the fact, that the biological specimen is considered a medium carrying personal information and the genetic information should be granted at least the same protection in law as information relating to a person’s health.

Abstract:

Genetic research often requires the use of biological samples, taken from research subjects or from other persons unconnected with the experiments. Regardless of the source of the materials, the results of genetic and other tests can prove very useful for advances in research in certain areas (pharmacogenetics, genomics, for instance).

Recourse to samples which have been stored in human biological material banks (cells, tissues, surgical waste, umbilical cords, etc) for reasons other than for research is becoming increasingly appropriate and common. Similarly, the creation of biobanks for specific biological materials linked to certain pathologies whose characteristics or evolution is of research interest (for example, cancerous tumours) or which are linked to a given population or population group (Iceland, Estonia, United Kingdom) is becoming more and more common also.

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