The Uneasy Ethical and Legal Underpinnings of Large-Scale Genomic Biobanks

Stanford University, Stanford, California 94305, USA.
Annual Review of Genomics and Human Genetics (Impact Factor: 9.13). 02/2007; 8:343-64. DOI: 10.1146/annurev.genom.7.080505.115721
Source: PubMed

ABSTRACT Abstract Large-scale genomic databases are becoming increasingly common. These databases, and the underlying biobanks, pose several substantial legal and ethical problems. Neither the usual methods for protecting subject confidentiality, nor even anonymity, are likely to protect subjects' identities in richly detailed databases. Indeed, in these settings, anonymity is itself ethically suspect. New methods of consent will need to be created to replace the blanket consent common to such endeavors, with a consent procedure that gives subjects some real control over what they might consider inappropriate use of their information and biological material. Through their use, these biobanks are also likely to yield information that will be of some clinical significance to the subjects, information that they should have access to. Failure to adjust to these new challenges is not only legally and ethically inappropriate, but puts at risk the political support on which biomedical research depends.

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    • "personalized medicine. For example, many diseases are associated with single-nucleotide polymorphisms, and performing genome-wide association studies using large collections of samples which represent tens or hundreds of thousands of individuals can help to identify disease biomarkers as stated by Greely (2007). Hewitt (2011) and many other researchers have identified biobanking as a key area for infrastructure development in order to promote drug discovery and drug development. "
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    ABSTRACT: This article describes the software architecture designed to cope with the computing demand of research usage of complex data from the Imaging Biobank of the Regional Ministry of Health in the Valencia Region (CS). It proposes the use of self-configured virtual clusters on top of on-premise and public cloud infrastructures. It uses a model based on recipes and autoconfiguration to deploy virtual elastic clusters that adjust themselves to the actual workload of the study, therefore reducing operating costs and preventing the need of up-front investments both at the level of the Imaging Biobank or the final user. All the software used is released under open-source licenses.
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    • "On the one hand, investigators are concerned about their potential liability for failure to return results. In fact, Hank Greely suggests that not offering to return results may be illegal, at least in extreme circumstances where the results ''pose a very high risk of a serious disease'' (Greely 2007). On the other hand, investigators worry that they could be sued for adverse outcomes resulting from premature disclosure, the disclosure of inaccurate findings, or medical mismanagement resulting from disclosure. "
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    ABSTRACT: Genomic researchers are increasingly faced with difficult decisions about whether, under what circumstances, and how to return research results and significant incidental findings to study participants. Many have argued that there is an ethical, maybe even a legal obligation to disclose significant findings under some circumstances. At the international level, over the last decade there has begun to emerge a clear legal obligation to return significant findings discovered during the course of research. However, there is no explicit legal duty to disclose in the United States. This creates legal uncertainty that may lead to unmanaged variation in practice and poor quality care. This paper discusses liability risks associated with the disclosure of significant research findings for investigators in the United States.
    Genome Research 03/2014; 24. DOI:10.1101/gr.170514.113 · 13.85 Impact Factor
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    • "By the late 1990s, scientists realized that some diseases originated from a single defective gene, but most genetic diseases are caused by multiple genetic factors on multiple genes [4]. For an understanding of whole-genome information of humans, the Human Genome Project (HGP) was begun in 1990, and the human genome was completely released in 2003. "
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    ABSTRACT: Many biobanks were established as biorepositories for biomedical research, and a number of biobanks were founded in the 1990s. The main aim of the biobank is to store and to maintain biomaterials for studying chronic disease, identifying risk factors of specific diseases, and applying personalized drug therapies. This report provides a review of biobanks, including Korean biobanks and an analysis of sample volumes, regulations, policies, and ethical issues of the biobank. Until now, the top 6 countries according to the number of large-scale biobanks are the United Kingdom, United States, Sweden, France, the Netherlands, and Italy, and there is one major National Biobank of Korea (NBK) and 17 regional biobanks in Korea. Many countries have regulations and guidelines for the biobanks, and the importance of good management of biobanks is increasing. Meanwhile, according to a first survey of 456 biobank managers in the United States, biobankers are concerned with the underuse of the samples in their repositories, which need to be advertised for researchers. Korea Biobank Network (KBN) project phase II (2013-2015) was also planned for the promotion to use biospecimens in the KBN. The KBN is continuously introducing for researchers to use biospecimens in the biobank. An accreditation process can also be introduced for biobanks to harmonize collections and encourage use of biospecimens in the biobanks. KBN is preparing an on-line application system for the distribution of biospecimens and a biobank accreditation program and is trying to harmonize the biobanks.
    12/2013; 11(4):211-217. DOI:10.5808/GI.2013.11.4.211
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