人體生物資料庫通知基因研究「偶然發現」(incidental findings)之倫理及法律問題──兼論臺灣生物資料庫面臨之挑戰與建議

Translated title of the contribution: Ethical and Legal Challenges to Returning Incidental Findings from Genomic Research, and Some Suggestions for Biobanks in Taiwan

Research output: Contribution to journalArticle

Abstract

Since the wide adoption of Next-Generation Sequencing (NGS) technology in genomic and genetic research, research projects and biobanks are expected to encounter incidental finding (IF) more frequently. The World Medical Association Declaration of Taipei (2016) and U.S.'s revision of the Common Rule both acknowledge and indicate the necessity of addressing this expectation. Nevertheless, law and practice in Taiwan have not planned on responding this issue in a systematic way, and individual research results are returned in very few, if any, situations. This essay first briefly illustrates the essence of IF and the obligation of returning such findings. This essay then discusses the difficulties, ethical challenges, and the corresponding measures when returning IFs is put into practice. Reflections upon Taiwanese current regulations and practice are also included to provide further analysis according to Taiwanese local context. A workable and ethical framework on the return of IFs needs to be built according to each research project and biobank's own features (e.g. size, research scope, resources and funding, etc.) Still, governmental (i.e. legislative and administrative) actions are needed for biobanks in order to lower the risks of breaching legal requirements and to make the best practice for biobanks governance when dealing with incidental findings according to ethical guidelines and obligations.
Original languageTraditional Chinese
Pages (from-to)145-191
Number of pages47
Journal政大法學評論
Issue number153
DOIs
Publication statusPublished - 2018

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Keywords

  • Bioethics
  • Biobanks
  • Incidental Finding
  • Individual Feedback
  • Re-Contact
  • Reidentification
  • Ethic Governance
  • ethics
  • Legal and Social Impact
  • the WMA Declaration of Taipei

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