Abstract
Biobanking has a long tradition with records of the acquisition of biological samples stemming from ancient Greece and Egypt. Rudolf Virchow is regarded as the pioneer of modern biobanking at the beginning of the 20th century. Both ancient and Virchow’s approaches viewed the collection of patient samples as a ‘side effect’ of clinical work. Modern biosampling was further established by the Austrian ‘Ecole de Medecine de l’Universite de Graz’ (>3 Mio. specimens), the hospital ‘Pitie Salpetriere’ in Paris (∼10,000 brains post-mortem over 150 years) and the ‘Instituut Bunge’ in Antwerpen (∼3000 specimens since 1935). However, ethical questions and medico-legal aspects related to biobanking have only recently been considered in a comprehensive manner [1,2]. While experimentation involving humans was addressed by international regulations, the collection and use of biospecimens were not specifically mentioned. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established in 1974 to identify the basic ethical principles that should govern biomedical and behavioral research involving human subjects. The fundamental principles announced in the Belmont Report (1979) – namely, autonomy, beneficence and justice – have influenced the thinking of bioethicists across a wide range of issues. Later, nonmaleficence, human dignity and the sanctity of life were added to this list of cardinal values. In recent years, new technologies, such as high-throughput methods, new materials, new targets of investigation, preventive and predictive research, and quality requirements of samples and isolates, have resulted in intensive international efforts to establish high-quality biobanks worldwide [3]. In parallel, ethical and legal issues have been increasingly included in the developmental process [4,5]. However, the involvement of physicians and their potential conflicts related to biobanking are only partially taken into account with regard to ethical [6] and medico-legal issues yet [7]. All ethical questions are strongly related to cultural perception and societal values. In this regard, examination of the physician–patient relationship and potential conflicts of clinical scientists are no exception [8,9]. This fact must be kept in mind for the critical reflection of the following discussion. Biobanking is used in various backgrounds and takes many forms ethical and medicolegal implications vary widely depending on the type and purpose of sample acquisition: Specimens where storage is legally required (e.g., for clinicopathological investigation), sampling for crime investigations and nonhuman samples (animals, bacteria, viruses) are not subject to the same ethical requirements. Thus, we define biobanking in the context of this review as follows:
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