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  • Ormond, Kelly E., et al. (författare)
  • The clinical application of gene editing : ethical and social issues
  • 2019
  • Ingår i: Personalized Medicine. - : Future Medicine Ltd. - 1741-0541 .- 1744-828X. ; 16:4, s. 337-350
  • Tidskriftsartikel (refereegranskat)abstract
    • Gene-editing techniques have progressed rapidly in the past 5years. There are already ongoing human somatic gene-editing clinical trials for multiple diseases. And there has been one purported scenario of human germline gene editing in late 2018. In this paper, we will review the current state of the technology, discuss the ethical and social issues that surround the various forms of gene editing, as well as review emerging stakeholder data from professionals, the general public' and individuals and families dealing with genetic diseases potentially treatable by gene editing.
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3.
  • Scott, Anna Mae, et al. (författare)
  • Q-SEA – a tool for quality assessment of ethics analyses conducted as part of health technology assessments
  • 2017
  • Ingår i: GMS Health Technology Assessment. - 1861-8863. ; 13
  • Tidskriftsartikel (refereegranskat)abstract
    • Introduction: Assessment of ethics issues is an important part of health technology assessments (HTA). However, in terms of existence of quality assessment tools, ethics for HTA is methodologically under-developed in comparison to other areas of HTA, such as clinical or cost effectiveness.Objective: To methodologically advance ethics for HTA by: (1) proposing and elaborating Q-SEA, the first instrument for quality assessment of ethics analyses, and (2) applying Q-SEA to a sample systematic review of ethics for HTA, in order to illustrate and facilitate its use. Methods: To develop a list of items for the Q-SEA instrument, we sys-tematically reviewed the literature on methodology in ethics for HTA, reviewed HTA organizations’ websites, and solicited views from 32 ex-perts in the field of ethics for HTA at two 2-day workshops. We sub-sequently refined Q-SEA through its application to an ethics analysis conducted for HTA.Results: Q-SEA instrument consists of two domains – the process do-main and the output domain. The process domain consists of 5 ele-ments: research question, literature search, inclusion/exclusion criteria, perspective, and ethics framework. The output domain consists of 5 elements: completeness, bias, implications, conceptual clarification, and conflicting values.Conclusion: Q-SEA is the first instrument for quality assessment of ethics analyses in HTA. Further refinements to the instrument to enhance its usability continue.
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