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Legal and ethical issues in using stored human biological samples for cancer science

Research Project

Project/Area Number 24701040
Research Category

Grant-in-Aid for Young Scientists (B)

Allocation TypeMulti-year Fund
Research Field Cancer epidemiology and prevention
Research InstitutionThe University of Tokyo

Principal Investigator

INOUE Yusuke  東京大学, 医科学研究所, 助教 (30378658)

Project Period (FY) 2012-04-01 – 2015-03-31
Project Status Completed (Fiscal Year 2014)
Budget Amount *help
¥3,510,000 (Direct Cost: ¥2,700,000、Indirect Cost: ¥810,000)
Fiscal Year 2014: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2013: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2012: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Keywordsがん研究 / 人試料 / ヒト試料 / 研究倫理 / バイオバンク / 倫理 / カストディアン / 研究資源 / 医事法 / 既存試料 / 法制度
Outline of Final Research Achievements

Human biological samples and data in a biobank are common resource for cancer research, and at the same time, it is a big challenge to maintain and manage these resource. In this research, I examined legal and ethical framework in using stored human biological samples as a source of sustainable research infrastructure. My main work was focused on empirical and comparative legal study on the EU countries, mainly targeted on Nordic regulatory framework on the human bioresource handling. My research results showed that roles and responsibilities of a "custodian" became even more important, and that the notion and nature of "custodian ethics" warrant further study. Additionally, donor’s rights and duties on samples or data, such as withdrawal of consent or access to research results, would also be a matter of further discussion.

Report

(4 results)
  • 2014 Annual Research Report   Final Research Report ( PDF )
  • 2013 Research-status Report
  • 2012 Research-status Report
  • Research Products

    (14 results)

All 2014 2013 Other

All Journal Article (6 results) (of which Peer Reviewed: 2 results) Presentation (3 results) Book (2 results) Remarks (3 results)

  • [Journal Article] Organ retention and communication of research use following medico-legal autopsy: a pilot survey of university of forensic medicine departments in Japan. Journal of Medical Ethics2014

    • Author(s)
      Tujimura T, Inoue Y, Yoshida K.
    • Journal Title

      Journal of Medical Ethics

      Volume: 40 Pages: 603-608

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed
  • [Journal Article] 世界医師会のヘルシンキ宣言と2013年のフォルタレザ改訂2014

    • Author(s)
      井上悠輔
    • Journal Title

      医薬ジャーナル

      Volume: 50 Pages: 55-62

    • Related Report
      2014 Annual Research Report
  • [Journal Article] 臨床研究の不正と医師の「誠実さ」2014

    • Author(s)
      井上悠輔
    • Journal Title

      年報医事法学

      Volume: 29 Pages: 196-202

    • Related Report
      2014 Annual Research Report
  • [Journal Article] ヒトゲノム解析に関する倫理指針の改正2014

    • Author(s)
      井上悠輔
    • Journal Title

      Organ Biology

      Volume: 21 Pages: 24-32

    • NAID

      130003398822

    • Related Report
      2014 Annual Research Report 2013 Research-status Report
  • [Journal Article] ヒト試料の取扱いと研究倫理2013

    • Author(s)
      井上悠輔
    • Journal Title

      医学のあゆみ

      Volume: 246 Pages: 545-551

    • Related Report
      2013 Research-status Report
  • [Journal Article] Beware side effects of research ethics revision2013

    • Author(s)
      Forsberg J, Inoue Y.
    • Journal Title

      Science

      Volume: 341 Issue: 6152 Pages: 1341-1342

    • DOI

      10.1126/science.341.6152.1341-b

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Presentation] To share or not to share? -“Custodianship” in biobank laws2014

    • Author(s)
      Yusuke Inoue
    • Organizer
      41st IMSUT Founding Commemorative Symposium
    • Place of Presentation
      The Univ. of Tokyo
    • Year and Date
      2014-05-29
    • Related Report
      2014 Annual Research Report
  • [Presentation] 研究倫理の原則に反した論文の撤回に関する一考察

    • Author(s)
      井上悠輔
    • Organizer
      日本生命倫理学会
    • Place of Presentation
      立命館大学
    • Related Report
      2012 Research-status Report
  • [Presentation] 米国大統領委員会における被験者保護の議論の現状

    • Author(s)
      井上悠輔
    • Organizer
      日本生命倫理学会
    • Place of Presentation
      立命館大学
    • Related Report
      2012 Research-status Report
  • [Book] 『遺伝子・DNA利用の製品研究開発における規制・倫理対応と解析、操作技術のトラブル対策』2014

    • Author(s)
      井上悠輔
    • Total Pages
      12
    • Publisher
      技術情報協会
    • Related Report
      2014 Annual Research Report
  • [Book] 『岩波生物学辞典』(第5版)2013

    • Author(s)
      井上悠輔(項目担当)
    • Publisher
      岩波書店
    • Related Report
      2012 Research-status Report
  • [Remarks] 東京大学医科学研究所公共政策研究分野

    • URL

      http://www.pubpoli-imsut.jp/

    • Related Report
      2014 Annual Research Report
  • [Remarks] http://www.pubpoli-imsut.jp/index.cgi

    • Related Report
      2013 Research-status Report
  • [Remarks] 東大医科研公共政策研究分野

    • URL

      http://www.pubpoli-imsut.jp/index.cgi

    • Related Report
      2012 Research-status Report

URL: 

Published: 2013-05-31   Modified: 2019-07-29  

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