• biobanks
• bioethics
• human rights
• human tissues
• scientific research

Norms on biomedicine can be found at the international level, the European level and the national level. The most of them are international and in particular they are conventional in nature. All main important treaties are negotiated in the framework of the Council of Europe, a regional International Organisation whose main aim is the protection of human rights in the Europe. They tend to find out general principles for a balance between the conflicting interests of scientific research and human rights. The Oviedo Convention on Human Rights and Biomedicine, of 4th April 1997 and its additional protocols are the main treaties in this regard. To search for a balance between the conflicting interests of research and scientific progress on the one hand and the protection of the human being on the other hand, the aforementioned treaties stated the primacy of the latter.
The scientific research is promoted and permitted insofar as it respects human dignity and is aimed to realise the welfare of the human beings. In the light of these declared aims, the treaties have to be interpreted.
At the European level, there is no specific legally binding document on the use of human tissues for research. Some principles can be inferred from other legal materials. For instance a directive not regulating in absolute terms the issue of the use of the human tissues and cells, regards a specific use of them, i.e. the donation aimed to transplantation. The Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. This directive, in the absence of other specific legal instruments on the topic, can be useful in order to infer general principles related to the use of human tissues and cells.
At the domestic level, the national legislations of the European States mostly conform to the principles stated in the mentioned European Directive.
The field of biomedicine often involves choices on ethics, in so far as it affects important human values. So the main bioethical guidelines issued by the national and international Authorities and related to the specific field of the use of human tissues for research are relevant too.
In the light of the aforementioned legal frameworks, issues such as those related to the legal nature of the human tissues, their use for research, the need for a consent by the interested person, their storage in biobanks are investigated.
First of all, the legal nature of the human tissues is examined. It is pointed out that, according to the existing legal framework, the human tissues and cells can be generally described as elements from the human body, as organs are. Anyway they cannot be considered simply as “goods”, i.e. like those “things” that, under civil law, can circulate in the market and be object of patrimonial rights. In fact they contain data, whose amount grows in step with the scientific progress and the capacity to individuate and extract them. They are sensitive data, as they concern the health of the individual or his/her genetic features. So they become something more complex and in principle the material dimension of the elements from the body and their informational dimension cannot be separated, apart from exception cases.
The human tissues can be used for several aims, such as for therapeutic, diagnostic or research purposes.
So, the following problem taken into account is whether one can dispose of them and, if so, who. Taking into consideration the described nature of the human tissues as goods incorporating sensitive data, it descends that the person from whose body they come from always keeps a relationship with them, so that is the natural titular of the power to dispose of them. Anyway their disposal is always subordinated to the deployment of a procedure, that requires preventive appropriate information and consent and one can never dispose of them for a financial gain.
As for the issue of consent, the Oviedo Convention at its Article 16 provides that Article 5, which states that “an intervention in the health field may only be carried out after the person concerned has given free and informed consent to it”, after being given all the related appropriate information, applies also to the case of research in the field of biology and medicine. Then the issue of consent is deeply analyzed, taking into account both the opting in and opting out systems.
The informational dimension of the human tissues is very relevant too as the related data protection issue. So the international treaties as well as the EU and municipal norms relating to it are object of analysis with special regard to the field of biomedicine. In fact there is the need to avoid that tissue donors are affected by a lack of safeguards for privacy and data protection, as regards as the data relating to health.
As far as the storage of human tissues for research is concerned, an appropriate regulation is lacking at both international and European level.
At the time being, a considerable amount of tissue specimens is stored in the Archives of the Units of Pathology. The Archives collect human tissues originally taken for diagnostic purposes, which can be useful to the patient for further diagnostic or therapeutic purposes.
The biobank is something more complex than an archive, as the tissues stored in it are not just stored but can also be used, under certain conditions, in order to get some added value from them. The biobanks contain tissues that the researchers can be allowed to use for the common good. So the difference between biobanks and other kinds of collections of biological materials, such as the archives of the pathological units, is analyzed and a proposal for a future regulation is suggested.
Finally the issue is examined taking into account the relevant related bioethical guidelines.