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A study on informed assent of children participate in medical research

Research Project

Project/Area Number 25500012
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Bioethics
Research InstitutionTokoha University (2015-2016)
Teikyo Gakuen Junior College (2013-2014)

Principal Investigator

Ishiyama Izumi  常葉大学, 保育学部, 准教授 (70541704)

Co-Investigator(Kenkyū-buntansha) 山縣 然太朗  山梨大学, 総合研究部, 教授 (10210337)
Project Period (FY) 2013-04-01 – 2017-03-31
Project Status Completed (Fiscal Year 2016)
Budget Amount *help
¥5,200,000 (Direct Cost: ¥4,000,000、Indirect Cost: ¥1,200,000)
Fiscal Year 2016: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2015: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2014: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2013: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Keywordsインフォームド・アセント / 子ども / 医学研究 / 研究倫理 / 面接調査 / レジリエンス / インフォームド・コンセント / フォーカスグループインタビュー / 尺度 / 倫理指針 / 子どもの権利
Outline of Final Research Achievements

When a potential research subject is able to give assent to decisions about participation in research, the researcher must seek that assent in addition to the consent of the legally authorized representative. These were declared in Japanese Ethical Guidelines for Medical and Health Research in 2015.
We researched on informed assent of children by (1) literature research of official guidelines, (2) a nationwide survey touward peoples (age; 20-69) in Japan, (3) a focus group study toward experts, and (4) an empirical study toward children (age; 4-9). In the empirical study, we targeted healthy children and medical research with no invasion or intervention. At the first interview, a child received clear explanations about the second interview from a researcher using scenarios and figures. 5-year children signed with marks or first name and 6-year or over children; in elementary school children, signed with full name. It was suggested a 5-year child might have capacity for assent.

Report

(5 results)
  • 2016 Annual Research Report   Final Research Report ( PDF )
  • 2015 Research-status Report
  • 2014 Research-status Report
  • 2013 Research-status Report
  • Research Products

    (12 results)

All 2017 2016 2015 2014 2013

All Journal Article (3 results) (of which Acknowledgement Compliant: 2 results) Presentation (9 results) (of which Int'l Joint Research: 4 results)

  • [Journal Article] 医学研究に参加する子どものインフォームド・アセント:アセント可能年齢に関する一般市民の意識2016

    • Author(s)
      石山ゐづ美
    • Journal Title

      常葉大学保育学部紀要

      Volume: 3 Pages: 57-65

    • NAID

      120006400445

    • Related Report
      2015 Research-status Report
    • Acknowledgement Compliant
  • [Journal Article] Ethical guideline, law and people’s opinion toward informed consent/assent of minors participate in medical studies in Japan2015

    • Author(s)
      Izumi Ishiyama
    • Journal Title

      Bulletin of Teikyo-Gakuen Junior College

      Volume: 19 Pages: 99-107

    • NAID

      40020488595

    • Related Report
      2014 Research-status Report
    • Acknowledgement Compliant
  • [Journal Article] Informed assent of children in medical research: A comparison of official guidelines2013

    • Author(s)
      石山 ゐづ美
    • Journal Title

      Bulletin of Teikto-Gakuen Junior College

      Volume: 18 Pages: 21-39

    • NAID

      40020261130

    • Related Report
      2013 Research-status Report
  • [Presentation] Empirical research on capability of informed assent around 7 year old children: A pilot study2017

    • Author(s)
      Izumi Ishiyama, Kimiko Akama, Zentaro Yamagata
    • Organizer
      The 21st International Epidemiological Association, World Congress of Epidemiology
    • Place of Presentation
      Sonic City in Saitama, Japan
    • Year and Date
      2017-08-19
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research
  • [Presentation] 小学校就学前後の子どものインフォームド・アセントに関する研究2017

    • Author(s)
      石山ゐづ美, 赤間公子, 山縣然太朗
    • Organizer
      第27回 日本疫学会学術総会
    • Place of Presentation
      ベルクラシック甲府, 山梨県
    • Year and Date
      2017-01-25
    • Related Report
      2016 Annual Research Report
  • [Presentation] Expert's opinion on child's capacity of informed assent in genomic research: A focus group study2016

    • Author(s)
      Izumi Ishiyama, Zentaro Yamagata
    • Organizer
      The American Society of Human Genetics 66th Annual Meeting 2016
    • Place of Presentation
      Vancouver, Canada
    • Year and Date
      2016-10-18
    • Related Report
      2016 Annual Research Report
    • Int'l Joint Research
  • [Presentation] People's attitude toward genetic testing for children and informed consent/assent in Japan2015

    • Author(s)
      Izumi Ishiyama, Zentaro Yamagata, Jusaku Minari, Go Yoshizawa, Kazuto Kato
    • Organizer
      ASHG2015 (The American Society of Human Genetics)
    • Place of Presentation
      Baltimore, MD
    • Year and Date
      2015-10-06
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research
  • [Presentation] Attitudes toward genetic research on children in Japan2015

    • Author(s)
      Zentaro Yamagata, Kaori Muto
    • Organizer
      ESHG2015 (European Society of Human Genetics)
    • Place of Presentation
      Glasgow, Scotland
    • Year and Date
      2015-06-06
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research
  • [Presentation] 日本における子どもに対する遺伝子研究に関する意識とインフォームド・コンセント2015

    • Author(s)
      山縣然太朗
    • Organizer
      第118回日本小児科学会学術集会
    • Place of Presentation
      大阪国際会議場、リーガロイヤルホテル大阪
    • Year and Date
      2015-04-17
    • Related Report
      2015 Research-status Report
  • [Presentation] People's opinion toward informed consent/assent of children participating birth cohort study in Japan2014

    • Author(s)
      Izumi Ishiyama, Zentaro Yamagata, Jusaku Minari, Go Yoshizawa, Kaori Muto, Kazuto Kato
    • Organizer
      British Sociological Association Medical Sociology Group 46th Annual Conference 2014
    • Place of Presentation
      Birmingham, UK
    • Year and Date
      2014-09-10 – 2014-09-12
    • Related Report
      2014 Research-status Report
  • [Presentation] Attitudes toward genetic testing of children for common disease risk in Japan2014

    • Author(s)
      Zentaro Yamagata, Kaori Muto, Izumi Ishiyama
    • Organizer
      European Society of Human Genetics 2014
    • Place of Presentation
      Milan, Italy
    • Year and Date
      2014-05-31 – 2014-06-03
    • Related Report
      2014 Research-status Report
  • [Presentation] People's Opinion toward Informed Consent/Assent of Children Participating Birth Cohort Study in Japan2014

    • Author(s)
      石山ゐづ美、山縣然太朗、三成寿作、吉澤剛、武藤香織、加藤和人
    • Organizer
      British Sociological Association Medical Sociology Group Annual Conference 2014
    • Place of Presentation
      Aston University, Birmingham, UK
    • Related Report
      2013 Research-status Report

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Published: 2014-07-25   Modified: 2019-07-29  

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