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1.
  • Munthe, Christian, 1962- (författare)
  • Precaution and Ethics: Handling risks, uncertainties and knowledge gaps in the regulation of new biotechnologies
  • 2017
  • Bok (övrigt vetenskapligt)abstract
    • This volume outlines and analyses ethical issues actualized by applying a precautionary approach to the regulation of new biotechnologies. It presents a novel way of categorizing and comparing biotechnologies from a precautionary standpoint. Based on this, it addresses underlying philosophical problems regarding the ethical assessment of decision-making under uncertainty and ignorance, and discusses how risks and possible benefits of such technologies should be balanced from an ethical standpoint. It argues on conceptual and ethical grounds for a technology neutral regulation as well as for a regulation that not only checks new technologies but also requires old, inferior ones to be phased out. It demonstrates how difficult ethical issues regarding the extent and ambition of precautionary policies need to be handled by such a regulation, and presents an overarching framework for doing so.
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  • Cutas, Daniela, 1978-, et al. (författare)
  • Legal imperialism in the regulation of stem cell research and therapy: the problem of extraterritorial jurisdiction
  • 2010
  • Ingår i: Capps BJ & Campbell AV (eds.). CONTESTED CELLS: Global Perspectives on the Stem Cell Debate. - London : Imperial College Press. - 978-1-84816-437-6 ; s. 95-119
  • Bokkapitel (övrigt vetenskapligt)abstract
    • Countries worldwide have very different national regulations on human embryonic stem (ES) cell research, informed by a range of ethical values. Some countries find reason to extend the applicability of their regulations on such research to its citizens when they visit other countries. Extraterritorial jurisdiction has recently been identified as a potential challenge towards global regulation of ES cell research. This chapter explores the implications and impact of extraterritorial jurisdiction and global regulation of ES cell research on researchers, clinicians and national health systems, and how this may affect patients. The authors argue that it would make ethical sense for ES cell restrictive countries to extend its regulations on ES cell research beyond its borders, because, if these countries really consider embryo destruction to be objectionable on the basis on the status of the embryo, then they ought to count it morally on par with murder (and thus have a moral imperative to protect embryos from the actions of its own citizens). However, doing so could lead to a legal situation that would result in substantial harm to central values in areas besides research, such as health care, the job market, basic freedom of movement, and strategic international finance and politics. Thus, it seems that restrictive extraterritorial jurisdiction in respect to ES cell research would be deeply problematic, given that the ethical permissibility of ES cell research is characterised by deep and wide disagreement.
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6.
  • Friberg-Fernros, Henrik, 1972- (författare)
  • Hit but not down. The substance view in light of the criticism of Lovering and Simkulet
  • 2018
  • Ingår i: Bioethics. - 0269-9702. ; 32:6, s. 388-394
  • Tidskriftsartikel (refereegranskat)abstract
    • In his article The substance view: A critique', Rob Lovering argues that the substance view -according to which a human person comes into existence at the moment of conception - leads to such implausible implications that this view should be abandoned. I responded to his reductio arguments in A critique of Rob Lovering's criticism of the substance view' and concluded that his arguments did not justify a rejection of the substance view. Now Lowering and William Simkulet have both responded to my criticism, claiming that my criticism of Lovering's article did not refute his original arguments. In this article I respond to their criticism and conclude that, while the substance view has some less plausible implications, none of them justify a complete refutation of this view.
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7.
  • JOHNSSON, LINUS, 1978-, et al. (författare)
  • Making researchers moral : Why institutionalised distrust might not work
  • ????
  • Annan publikation (övrigt vetenskapligt)abstract
    • <p>Research ethics, once a platform for declaring intent, discussing moral issues and providing advice and guidance to researchers, has developed over time into an extra-legal regulatory system, complete with steering documents, overseeing bodies, and formal procedures. The process of institutionalising distrust is usually motivated by reference to past atrocities committed in the name of research and the need to secure public trust. This paper examines some limitations of this approach. First, past atrocities cannot provide the necessary justification unless institutionalised distrust is a necessary or efficient means to prevent future ones; and there are several reasons to doubt that this is the case. Second, the efficacy of ethics review in safeguarding morally acceptable research depends on the moral competence and integrity of individual researchers—the kinds of qualities that institutionalised distrust calls into question. Third, ethics guidelines cannot, as it is sometimes assumed, educate or guide researchers to moral behaviour unless they already have considerable capacity for moral judgment. Fourth, institutionalised distrust is a potential threat to the moral competence and integrity of researchers by encouraging a blinkered view of ethical issues, inducing moral heteronomy through incentives, and alienating them to research ethics as a pursuable activity. We conclude that the moral problem posed by inappropriate short-term behaviour on behalf of researchers is dwarfed by the potential long-term consequences of allowing their moral competence to deteriorate. Measures must therefore be taken to ensure that researchers are equipped to take their individual responsibility and not obstructed from doing so.</p>
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8.
  • Johnsson, Linus, 1978- (författare)
  • Trust in Biobank Research Meaning and Moral Significance
  • 2013
  • Doktorsavhandling (övrigt vetenskapligt)abstract
    • <p>What role should trust have in biobank research? Is it a scarce resource to be cultivated, or does its moral significance lie elsewhere? How does it relate to the researcher’s individual responsibility?</p><p>In this thesis I draw four general conclusions. First, trust is still very much present in at least some biobanking settings, notably in Sweden, but possibly also internationally. Second, a morally relevant conception of trust entails that to be trustworthy, researchers must consider the normative expectations that people have of them, and renegotiate expectations that are mistaken. Third, this conception differs from “public trust” assessed through surveys. The main use of the latter is to legitimate policy, not to identify moral duties. Fourth, in spite of ethics review, guidelines and informed consent procedures, ethical issues will always arise during the course of a research project. Researchers can therefore never avoid their individual moral responsibility. Ensuring that one is adequately trusted is one step towards conducting morally acceptable research.</p><p>Study I indicates that few Swedes refuse storage of samples in healthcare-associated biobanks and their use in research. Study II suggests that people are somewhat more willing to donate samples than surveys indicate, especially when approached face-to-face by health care personnel. Relationships of trust might thus be important in people’s decision-making. Study III investigates trust as a moral concept. The trustee is often in a unique position to determine what the other’s trust amounts to. When it is mistaken, the trustee has an obligation to counteract it, compensate for it, or renegotiate the expectations that cannot be met. In Study IV, I critique the feasibility of guaranteeing the trustworthiness of the research apparatus through formal measures such as ethics review and guidelines. Not only are there limitations of such measures to consider. They also risk blinding researchers to ethical issues that are not covered by the rules, fostering moral complacency, and alienating researchers to ethics.</p>
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9.
  • Klingstrom, Tomas, et al. (författare)
  • Supporting the Development of Biobanks in Low and Medium Income Countries
  • 2016
  • Ingår i: 2016 IST-AFRICA WEEK CONFERENCE. - 978-1-9058-2455-7
  • Konferensbidrag (refereegranskat)abstract
    • <p>Biobanks are an organized collection of biological material and associated data. They are a fundamental resource for life science research and contribute to the development of pharmaceutical drugs, diagnostic markers and to a deeper understanding of the genetics that regulate the development of all life on earth. Biobanks are well established in High Income Countries (HIC) and are rapidly emerging in Low and Middle Income Countries (LMIC). Surveys among biobanks operating in a LMIC setting indicate that limited resources and short term funding tied to specific projects threaten the sustainability of the biobanks. Fit-for-purpose biobanks targeting major societal challenges such as HIV and Malaria provide an excellent basis for integrating biobanks with the available research communities in LMIC regions. But to become sustainable for the future it is important that biobanks become an integrated part of local research communities. To achieve this, the cost of operating biobanks must be lowered, templates must be developed to support local ethics committees and researchers must be given the opportunity to build experience in successfully operating biobank based research projects. The B3Africa consortium is based on these conclusions and set up to support biobank based research by creating a cost efficient Laboratory Information Management System (LIMS) for developing biobanks and also contribute to the training and capacity building in the local research community. The technical platform called the eB3Kit is open source and consists of a LIMS and a bioinformatics module based on the eBiokit that allow researchers to take control over the analysis of their own data. Along with the technical platform the consortium will also contribute training and support for the associated infrastructures necessary to regulate the ethical and legal implications of biobank based research.</p>
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10.
  • Klingström, Tomas, et al. (författare)
  • Legal & ethical compliance when sharing biospecimen
  • 2018
  • Ingår i: Briefings in Functional Genomics. - Oxford University Press (OUP): Policy B - Oxford Open Option B. - 2041-2649 .- 2041-2657. ; 17, s. 1-7
  • 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 communication between involved researchers and experts in its mission to unite large prospective study sets in Europe. To facilitate efficient communication, it is useful for nonexperts to have an at least basic understanding of the regulatory system for managing 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 from their 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 proactively 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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