Fondazione Zoé

Human biological material is increasingly important in scientific research.

From blood samples, isolated cells or parts of the human body we can extract essential information to improve diagnostics and treatments, above all in oncology. But, as well as being important, there is also an increasing risk that, through the analysis of these biological materials, we can acquire sensitive data (even if predictive in nature) on the person who the sample has been taken from and, in the case of genetic studies, their family as well. There is, therefore, a potential conflict between two constitutional rights: the right to research and, thus, the use of biological samples, and the right of person to ownership over parts of their own body and, above all, the connected right to the protection of any personal information found by researchers.

In Italy (where the situation is not very different from other EU countries and the USA) the principle of informed consent has also dominated this area. According to the “Provision by the Authority for the Protection of Personal Data” of 22 February 2007 and the “Decree by the Ministry for Health” on 21 December 2007, researchers can use biological samples only in ways and areas that the donor has defined specifically by consent. It becomes very problematic (if not impossible) to use a biological sample for research which is not given in the initial consent. Moreover, it is also complex using the many samples which have been collected over the years without the consent which is now necessary or leftover materials from diagnostic or treatment activities which are to be destroyed. Many therefore perceive the need for a better balance of rights so that we can remove obstacles to this research which do not help the care and well-being of people. In this context, in 2009 the “National Committee for Biosecurity, Biotechnologies and Life Sciences”, established by the Prime Minister’s Office, produced a detailed document dedicated to informed consent in collecting biological samples for research.
But I wish to also note that on 31 March last year, an interesting proposal called “From the biobank to the research biorepository” was presented and discussed at the Università Cattolica di Milano. The paper was the result of work in 2008 at the “Istituto Nazionale dei Tumori” involving a large number of doctors, lawyers, patient associations and other interested parties. As the title suggests, biodepositories do not have a commercial aim, given that “samples cannot be sold for money”. In biorepositories do not receive money (except for money covering their running costs), they do receive information on the results obtained using the samples: “to act as an instrument of accumulation, sharing and transmission of knowledge and technology transfer, the biodepository must rely on feedback from researchers who use the samples”.

But, it is on the (very delicate) point of consent that the proposal is most original. Indeed, it distinguishes consent for “procedure and limits” under which personal data can be used and consent for “scientific purposes and further research”. According to the proposal, it is only the first form of consent that should be protected by right to confidentiality, therefore meaning that it is possible to conduct further research that, although not initially foreseen are clear in the data handling, namely:

• possibilities and modalities of identification of data;
• flow of information (to whom, how);
• processing (comparisons, linkages);
• retention and subsequent availability of data.

The proposal is less courageous regarding left over samples stating the conditions for use where consent is lacking as “completely anonymous”.
The document also has many other ethical law recommendations which make up an essential and desirable legislative reform and point of reference for health professionals.



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