Abstract
Experimentation is almost always strictly connected to the use of biological samples and to biobanks. Experimentation of drug on human beings generally imply the research on biological samples and their genetic materials. Biobanks are units that collect biological samples by individuals or groups, together with their personal information. The chapter analysis the different theories, in a pluralistic setting, focusing on the concept of ‘donation’ of samples (form individualism to communitarianism), underlining the implication on informed consent. A specific role of Ethics Committees or Institutional Review Boards is highlighted.
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Notes
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The Recommendation 2006/4 of the Council of Europe on research on biological materials of human origin and the Italian Data Protection Authority, General Authorization for the processing of genetic data (2007), both move in this direction.
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At the international level, the concept of benefit sharing is found in the Universal Declaration on the Human Genome and Human Rights of UNESCO (1997) which states that the main goal of studying the human genome (generally speaking, the applications in biology, genetics and medicine) is to improve the health of individuals and humankind as a whole (Art. 12) according to the principle of solidarity (Art. 17). UNESCO reiterates the importance of benefit sharing also in the International Declaration on Human Genetic Data (2003) which sets forth that benefits resulting from the use of human genetic data of biological samples collected for scientific research should be shared with society as a whole and the international community (Art. 19).
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A change is taking place in the regulation of committees for experimentation with the implementation of EU Regulation No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on the clinical trials of drugs for human use and which repeals directive 2001/20/EC. Cfr. Italian Committee for Bioethics (2015).
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The committees are made up of at least two clinicians, a general practitioner, a biostatistician, a pharmacologist, an expert in juridical-insurance matters or a medical examiner, a nursing representative, a volunteering representative, a chemist, the chief medical officer (the IRCCS scientific director) and an expert of ethics.
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Friesen et al. (2017).
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Palazzani, L. (2019). Biobanks and Ethics Committees. In: Innovation in Scientific Research and Emerging Technologies. Springer, Cham. https://doi.org/10.1007/978-3-030-16733-2_2
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DOI: https://doi.org/10.1007/978-3-030-16733-2_2
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