Results of the Inquiry and Citation Review

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Bioethics issues in human studies


General considerations

Biological sample is any sample of biological material (for example blood, skin and bone cells or blood plasma) usually containing nucleic acids from which characteristic genetic make-up of an individual can be derived [14]. The state of science at a given point in time and is degree of originality of biological material depends on the availability of biological material and the quality of the associated data [23].

Biobanks consist of a collection of biological samples as well as additional information which is organized in a systematic and standardized manner for research purposes. From biological material such as blood, tissue, buccal cells, body fluids genetic material and related data can be derived. Genetic material, genetic information as well as other information derived from the biological material or collected from the individual is usually stored separately from the biological sample. The value of a collection of biological samples is proportional to the amount and the quality of additional information stored in databases that can be linked with the biological samples [24].

Analogue, a DNA bank is a facility that stores extracted DNA, transformed cell lines frozen blood or other tissue, or biological materials for future DNA analysis. A DNA data bank is a repository of genetic information obtained from the analysis of DNA [25]. Biobanks are differently accessible and available for use and sample exchange [16].

Sample storage is organized in four different degrees of identification [14, 24, 25, 26]:

The study design of research with material or data of a bio bank can be retrospective or prospective. Retrospective research studies utilize existing samples for a secondary use (which is usually different from the original purpose of sample collection), whereas in prospective studies the specimens' collection is part of the study [25].

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