Informed consent
Yann Joly, Bartha Maria Knoppers in Routledge Handbook of Medical Law and Ethics, 2014
One area where traditional approaches to informed consent are questioned is biobank-based research. Biobanks are research infrastructures (Kaye 2009) rather than one-dimensional research projects, which involve the long-term storage of biological samples, and constantly accumulate associated information, including clinical, familial, environmental, and social data. In the context of biobank research, many of the specific items that have traditionally been seen as essential elements of the duty to inform (e.g. nature of the research, risks and potential benefits, identity of the researcher) are not known at the time the samples and data are collected and stored. Many authors, including some in this book, have pointed out that traditional legal and ethical informed consent requirements are difficult if not impossible to respect in the context of biobanks (Kaye 2009; Deschênes et al. 2001; Caulfield and Knoppers 2010; Allen et al. 2013). Knoppers and Caulfield state that ‘the existing law and ethics policies were not developed with … the large-scale biobanking in mind’ (Knoppers and Caulfield 2010: 4). Many have therefore argued for different informed consent models for biobanking research. These models, several of which have overlapping elements, include the use of an option model, broad (or blanket) consent, and authorization.
Biobanking in sport: governance and ethics
Silvia Camporesi, Mike McNamee in Bioethics, Genetics and Sport, 2018
‘Big data’ is a phrase thrown around considerably in the media. But what does it actually mean? The first comprehensive and systematic meta-analysis of academic literature aimed at identifying the ethical issues of big data found that there is neither a commonly accepted definition of big data nor of biobanking shared across the literature, but that big data can refer both to the process and to the datasets themselves (Mittelstadt and Floridi 2016, 309). Biobanking by contrast has been with us for about 20 years. Biobanks are a generic name for a ‘wide variety of methods and repositories for the collection of biological material’ (Caulfield 2007, 211). The World Medical Association defines biobanking rather blandly as a ‘collection of biological material and associated data’.3 Essentially they are storage resource sites comprising large-scale data (including tissue and other human samples) that can be combined for powerful statistical analyses on large-scale populations. The use of biobanks to store tissue or genetic material is not new per se, but the potentially global scale and combination of genotypic with phenotypic data is a recent development. It is this aspect that has generated new epistemological and normative challenges for researchers, clinicians and participants alike.
The scope of consent
Andreas Müller, Peter Schaber in The Routledge Handbook of the Ethics of Consent, 2018
The fact that consent is directed at types of act feeds into a debate in medical research ethics that is often framed in terms of the normative scope of consent. Biobanks—mass research repositories of human biological samples, including genetic samples—are valuable research resources because samples and data can be endlessly re-used in an open-ended range of research projects. This creates an ethical problem because the consent for such uses is gained at the time of initial acquisition of the sample (Steinsbekk & Solberg 2011). Given that future research uses may be unknown at the time of consent, the question arises whether the subject can permit such unknown uses by her consent. If we simply consider consent, then the answer is unproblematic: of course she can. All consent is “broad” consent, and all consent involves ignorance of countless facts about the actions that are permitted by consent. If A consents to B’s use of her camera, she may have no idea what pictures A will take. If A consents to B’s use of her car, she may not know that at this junction she will turn left, at that, turn right, and there is no requirement at all for B to re-contact A every time she does something.
Uppsala Biobank—the development of a biobank organization in a local, regional, and national setting
Published in Upsala Journal of Medical Sciences, 2019
In 2003 Sweden got its first biobank act, Act (2002: 297) on biobanks in health care. According to that a biobank is defined as a collection of biological material stored for one or more purposes and information on this material. The legislation together with guidelines from the National Board of Health and Welfare (SOSFS 2002: 11 and SOSFS 2004: 2) regulate biobank operations in Sweden. Biobanks may consist of one or more sample collections. The collections of samples have different primary purposes, with collection for health care and diagnostics purposes being most common, followed by collection of samples for research. The Biobank Act applies to human material such as blood, saliva, urine, and different kinds of tissue samples. The donor must give an informed consent that biobank samples are stored and used for approved purposes. To be able to use samples collected within health care for research, an ethical approval and a written consent are needed.
Breast cancer glycan biomarkers: their link to tumour cell metabolism and their perspectives in clinical practice
Published in Expert Review of Proteomics, 2021
Tomas Bertok, Veronika Pinkova Gajdosova, Aniko Bertokova, Natalia Svecova, Peter Kasak, Jan Tkac
There is no doubt that a great potential lies in analysing these aberrant glycan structures in order to enhance the accuracy of cancer detection, as well as to provide an insight into early onset of the disease and for further diagnostic/prognostic applications. However, one important limitation in BCa glycan-based research is worth mentioning, i.e. having access to the samples necessary for these kinds of studies. Samples are usually obtained from specialised institutions known as biobanks. According to the OECD, a biobank is “a collection of biological material and the associated data and information stored in an organised system, for a population or a large subset of a population“ [53]. The biological material includes fixed or stabilised and properly stored specimens (paraffin-embedded specimens, frozen tissues or bodily fluids, for example). However, as proposed in a recent study by Krieger and Jahn, social data gaps in sample documentation should be taken into account and eliminated in order to address cancer inequities (socioeconomic, sociodemographic and geographic data) [54].
The impact of sample processing on inflammatory markers in serum: Lessons learned
Published in The World Journal of Biological Psychiatry, 2020
Alexander Y. Pan, Euijung Ryu, Jennifer R. Geske, Xinyang Y. Zhou, Susan L. McElroy, Mine S. Cicek, Mark A. Frye, Joanna M. Biernacka, Ana C. Andreazza
Psychiatric diseases are complex and heterogeneous, which undoubtedly contributes to variation in study results. However, there is also a possible contribution from analytical and preanalytical factors that may bias results; many biomarkers, and inflammatory cytokines in particular, are sensitive to sample handling conditions (Huang et al. 2001; Duvigneau et al. 2003; de Jager et al. 2009). This is particularly important when studies are conducted using existing biospecimens that have already been collected in biobanks. Biobanks are a useful tool in the study of complex diseases, because they allow biological data to be linked to clinical information from medical records or questionnaires. However, biobanks generally collect samples for future use with no specific study in mind at the time of collection (Ellervik and Vaught 2015). The utility of a study depends on the integrity of the specimens and appropriate control of preanalytical factors. This can be a key limitation for researchers if biospecimens are collected under a broad scope of research rather than for a specific study (De Souza and Greenspan 2013).
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