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Comparative Study of Legal and Ethical Governance of Medical Research

Research Project

Project/Area Number 15K03242
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field New fields of law
Research InstitutionKobe University

Principal Investigator

Maruyama Eiji  神戸大学, 法学研究科, 名誉教授 (10030636)

Project Period (FY) 2015-04-01 – 2018-03-31
Project Status Completed (Fiscal Year 2017)
Budget Amount *help
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2017: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2016: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2015: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
Keywordsインフォームド・コンセント / 個人情報保護 / 倫理審査委員会 / 人を対象とする医学系研究に関する倫理指針 / コモン・ルール / 臨床研究 / 個人情報保護法 / broad consent / 要配慮個人情報 / 個人識別符号 / 個人情報
Outline of Final Research Achievements

This research studied the ethical and legal ramifications of medical research involving human subjects focusing on informed consent, personal data protection, and ethics committee. The revision of the US Common Rule, the EU Clinical Trials Directive and Regulation, and the UK and French research governance systems were explored. Domestically, critical evaluation was made of the revision of Ethical Guidelines of Medical Research Involving Human Subjects during 2016 to 2017 after the 2015 amendment of Personal Information Protection Act. Logical inconsistencies were pointed out in the revised guidelines by means of public comments, journal articles and lectures. Investigation was also made about the drafting of administrative regulations to implement the Clinical Research Act that was enacted in 2017 and came into effect in April 2018.

Report

(4 results)
  • 2017 Annual Research Report   Final Research Report ( PDF )
  • 2016 Research-status Report
  • 2015 Research-status Report
  • Research Products

    (11 results)

All 2018 2017 2016 Other

All Journal Article (2 results) Presentation (6 results) (of which Invited: 1 results) Remarks (3 results)

  • [Journal Article] 米国コモン・ルールの改正2018

    • Author(s)
      丸山 英二
    • Journal Title

      年報医事法学

      Volume: 33

    • Related Report
      2017 Annual Research Report
  • [Journal Article] 個人情報保護法等改正と医学研究倫理指針2017

    • Author(s)
      丸山 英二
    • Journal Title

      法律時報

      Volume: 89(5) Pages: 1-3

    • Related Report
      2016 Research-status Report
  • [Presentation] これからの日本の臨床研究倫理委員会を考えよう:欧州・米国・日本の規制の違い2018

    • Author(s)
      丸山 英二
    • Organizer
      第56回医学系大学倫理委員会連絡会議
    • Related Report
      2017 Annual Research Report
  • [Presentation] 人を対象とする医学系研究に関する倫理指針と臨床研究法2018

    • Author(s)
      丸山 英二
    • Organizer
      臨床研究リスク管理研究会
    • Related Report
      2017 Annual Research Report
  • [Presentation] 倫理審査委員会の責務と裁量2017

    • Author(s)
      丸山 英二
    • Organizer
      第25回日本消化器関連学会週間
    • Related Report
      2017 Annual Research Report
  • [Presentation] 臨床研究と個人情報保護2017

    • Author(s)
      丸山 英二
    • Organizer
      愛媛大学病院連携病院長会議
    • Place of Presentation
      松山全日空ホテル(愛媛県・松山市)
    • Related Report
      2016 Research-status Report
    • Invited
  • [Presentation] 人を対象とする医学系研究に関する倫理指針の見直し2017

    • Author(s)
      丸山 英二
    • Organizer
      シスメックス株式会社研究倫理審査委員会倫理研修
    • Place of Presentation
      シスメックス株式会社(兵庫県・神戸市)
    • Related Report
      2016 Research-status Report
  • [Presentation] 人を対象とする医学系研究に関する倫理指針の策定について2016

    • Author(s)
      丸山英二
    • Organizer
      第52回医学系大学倫理委員会連絡会議学術会議
    • Place of Presentation
      京都国際会館(京都府・京都市)
    • Year and Date
      2016-01-09
    • Related Report
      2015 Research-status Report
  • [Remarks] 医と法のホームページ /医のページ /報告・講演記録

    • URL

      http://www2.kobe-u.ac.jp/~emaruyam/medical/Lecture/lecture.html

    • Related Report
      2017 Annual Research Report
  • [Remarks] 医と法のホームページ 医のページ 報告・講演記録

    • URL

      http://www2.kobe-u.ac.jp/~emaruyam/medical/Lecture/lecture.html

    • Related Report
      2016 Research-status Report
  • [Remarks] 報告・講演記録

    • URL

      http://www2.kobe-u.ac.jp/~emaruyam/medical/Lecture/lecture.html

    • Related Report
      2015 Research-status Report

URL: 

Published: 2015-04-16   Modified: 2019-03-29  

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