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A constitutional study on the ethical review regulation of clinical researches

Research Project

Project/Area Number 24530037
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Public law
Research InstitutionKyoto Sangyo University

Principal Investigator

NAKAYAMA Shigeki  京都産業大学, 法務研究科, 教授 (00320250)

Project Period (FY) 2012-04-01 – 2016-03-31
Project Status Completed (Fiscal Year 2015)
Budget Amount *help
¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000)
Fiscal Year 2015: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2014: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2013: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2012: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Keywords憲法 / 学問の自由 / 臨床研究 / 生命倫理 / 倫理審査 / 再生医療
Outline of Final Research Achievements

An ethical review of clinical research contains the risk-benefit assessment which includes the evaluations, not only of physical or tangible effects, but of scientific and social values of information the research will revea. An administrative agency should not be allowed to review research projects and stop them in the light of information to be gained. Constitutional academic freedom guarantees the autonomy of academic communities to evaluate the informational values of the scientific researches. The act on the safety of regenerative medicine is in constitutional doubt, because it would establish the administrative regulation power to stop the research in advance.

Report

(5 results)
  • 2015 Annual Research Report   Final Research Report ( PDF )
  • 2014 Research-status Report
  • 2013 Research-status Report
  • 2012 Research-status Report
  • Research Products

    (6 results)

All 2015 2014 Other

All Journal Article (3 results) (of which Acknowledgement Compliant: 2 results) Presentation (3 results)

  • [Journal Article] 患者の保護と医療を受ける権利・学問の自由2015

    • Author(s)
      中山茂樹
    • Journal Title

      年報医事法学

      Volume: (30) Pages: 126-135

    • Related Report
      2015 Annual Research Report
    • Acknowledgement Compliant
  • [Journal Article] 小児の臓器移植の法理論2015

    • Author(s)
      中山茂樹
    • Journal Title

      医事法講座第6巻 臓器移植と医事法

      Volume: - Pages: 207-237

    • Related Report
      2015 Annual Research Report
    • Acknowledgement Compliant
  • [Journal Article] 研究倫理審査と憲法―学問の自由の観点から2014

    • Author(s)
      中山茂樹
    • Journal Title

      町野朔先生古稀記念・刑事法の現代的課題

      Volume: 下

    • Related Report
      2013 Research-status Report
  • [Presentation] 患者の保護と医療を受ける権利・学問の自由2014

    • Author(s)
      中山茂樹
    • Organizer
      日本医事法学会
    • Place of Presentation
      中央大学駿河台記念館(東京都千代田区)
    • Year and Date
      2014-11-30
    • Related Report
      2014 Research-status Report
  • [Presentation] 学問の自由と法の支配2014

    • Author(s)
      中山茂樹
    • Organizer
      日本人類遺伝学会・日本遺伝子診療学会
    • Place of Presentation
      タワーホール船堀(東京都江戸川区)
    • Year and Date
      2014-11-21
    • Related Report
      2014 Research-status Report
  • [Presentation] ワークショップ「再生医療」における指定発言

    • Author(s)
      中山茂樹
    • Organizer
      日本医事法学会
    • Place of Presentation
      南山大学
    • Related Report
      2013 Research-status Report

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

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