<b>研究者主導臨床研究における倫理・信頼性確保の試み(第一報) </b>:<b>―脳内タウイメージング用放射性薬剤[<sup>11</sup>C]PBB3 の多施設連携研究での経験から―</b>  [in Japanese] <b>Ethics and Quality Assurance in Investigator-Initiated Clinical Studies: The First Report</b>:<b>―Experience from a Multicenter Clinical Study of Tau PET Imaging with [<sup>11</sup>C]PBB3―</b>  [in Japanese]

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Author(s)

    • 栗原 千絵子 KURIHARA Chieko
    • 放射線医学総合研究所分子イメージング研究センター Molecular Imaging Center, National Institute of Radiological Sciences
    • 堀口 隆司 HORIGUCHI Takashi
    • 放射線医学総合研究所分子イメージング研究センター Molecular Imaging Center, National Institute of Radiological Sciences
    • 鈴木 和子 SUZUKI Kazuko
    • 放射線医学総合研究所分子イメージング研究センター Molecular Imaging Center, National Institute of Radiological Sciences
    • 須原 哲也 SUHARA Tetsuya
    • 放射線医学総合研究所分子イメージング研究センター Molecular Imaging Center, National Institute of Radiological Sciences

Abstract

Ethical Guidelines for Medical Research Involving Human Subjects have been enforced since April 2015 by the Ministry of Health, Labour and Welfare and the Ministry of Education, Science and Technology. According to the guidelines, a research project categorized as interventional or invasive clinical study that starts from October 2015 or later should implement monitoring and if necessary audit. Several study groups have issued guidelines on monitoring and audit, which seem to be appropriate for large-scale drug clinical trials, but a quality assurance system for other kinds of research is needed, especially for exploratory clinical research. We developed a scheme for exploratory clinical research, which we have been using even before monitoring and audit become mandatory. This scheme is composed of: (1) a questionnaire-based check sheet; (2) letter for site visit; (3) site visit protocol; and (4) site visit check sheet. We found that the scheme which we have implemented is useful for human subject protection and quality assurance of clinical research. This scheme can be applied flexibly according to the type and characteristics of other research projects.

Ethical Guidelines for Medical Research Involving Human Subjects have been enforced since April 2015 by the Ministry of Health, Labour and Welfare and the Ministry of Education, Science and Technology. According to the guidelines, a research project categorized as interventional or invasive clinical study that starts from October 2015 or later should implement monitoring and if necessary audit. Several study groups have issued guidelines on monitoring and audit, which seem to be appropriate for large-scale drug clinical trials, but a quality assurance system for other kinds of research is needed, especially for exploratory clinical research. We developed a scheme for exploratory clinical research, which we have been using even before monitoring and audit become mandatory. This scheme is composed of: (1) a questionnaire-based check sheet; (2) letter for site visit; (3) site visit protocol; and (4) site visit check sheet. We found that the scheme which we have implemented is useful for human subject protection and quality assurance of clinical research. This scheme can be applied flexibly according to the type and characteristics of other research projects.

Journal

  • Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics

    Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics 46(4), 211-224, 2015

    The Japanese Society of Clinical Pharmacology and Therapeutics

Codes

  • NII Article ID (NAID)
    130005093756
  • Text Lang
    JPN
  • ISSN
    0388-1601
  • Data Source
    J-STAGE 
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