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- Klingström, Tomas, et al.
(författare)
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Legal & ethical compliance when sharing biospecimen
- 2018
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Ingår i: Briefings in Functional Genomics & Proteomics. - Oxford : Oxford University Press. - 2041-2649 .- 2041-2657. ; 17:1, s. 1-7
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Forskningsöversikt (refereegranskat)abstract
- When obtaining samples from biobanks, resolving ethical and legal concerns is a time-consuming task where researchers need to balance the needs of privacy, trust and scientific progress. The Biobanking and Biomolecular Resources Research Infrastructure-large Prospective Cohorts project has resolved numerous such issues through intense ommunication between involved researchers and experts in its mission to unite large rospective study sets in Europe. To facilitate efficient communication, it is useful for onexperts to have an at least basic understanding of the regulatory systemformanaging biological samples. Laws regulating research oversight are based on national law and normally share core principles founded on international charters. In interview studies among donors, chief concerns are privacy, efficient sample utilization and access to information generated fromtheir samples. Despite a lack of clear evidence regarding which concern takes precedence, scientific as well as public discourse has largely focused on privacy concerns and the right of donors to control the usage of their samples. It is therefore important to roactively deal with ethical and legal issues to avoid complications that delay or prevent samples from being accessed. To help biobank professionals avoid making unnecessary mistakes, we have developed this basic primer covering the relationship between ethics and law, the concept of informed consent and considerations for returning findings to donors.
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| 2. |
- Reichel, Jane, 1971-
(författare)
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The Need for a Legitimate Regulatory Regime in Bioethics : A Global and European Perspective
- 2013
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Ingår i: Missouri law review. - School of Law University of Missouri. ; 78:1, s. 465-488
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Forskningsöversikt (övrigt vetenskapligt/konstnärligt)abstract
- Bioethics in global biobanking touches upon several internationally acceptedfundamental rights and values, namely the sample donor's right ofprivacy, the patient's right to health, and - at least implicitly - scientific freedom.From the perspective of fundamental rights, however, there are veryfew internationally applicable rules as to the enforcement of these rights atthe administrative level. Instead, the combination of the practical need forcommon rules and the lack of political will and/or legislative competencewithin the international community or the European Union (EU) seems tohave paved the way for soft law. Further, the role of courts in the area ofbioethics and biobanking, nationally as well as internationally, is limited.The implementation of administrative rules at the national or regional levelsis carried out by research committees and research funding institutions, usuallywith limited or no right to appeal to the general court system. Consequently,the traditional mechanisms of political and judicial control to a largeextent are unavailable. The question raised here is whether the theories connectedto global administrative law can be of any guidance in developing alegitimate regulatory regime for international biobanking. Can principles ofparticipation, transparency, and reasoned decisions be of relevance in this area of law?
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