A Comprehensive Research aiming at an Integration of Various Ethical Guidelines involving Medical Research -Protection of Study Participants and Public Welfare-

• Project/Area Number: 25500003
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Bioethics
• Research Institution: Kanazawa University (2014-2015); Kyoto University (2013)
• Principal Investigator: MURAYAMA TOSHINORI 金沢大学, 大学病院, 教授 (30378765)
• Co-Investigator(Kenkyū-buntansha): IHARA TOSHIKO 京都大学, 医学(系)研究科(研究院), 助教 (90425447)
• Co-Investigator(Renkei-kenkyūsha): NISHIMURA HIROMI 公益財団法人先端医療振興財団, その他部局等, 客員研究員 (10359440)
• Project Period (FY): 2013-04-01 – 2016-03-31
• Project Status: Completed (Fiscal Year 2015)
• Budget Amount: ¥5,070,000 (Direct Cost: ¥3,900,000、Indirect Cost: ¥1,170,000); Fiscal Year 2015: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000); Fiscal Year 2014: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000); Fiscal Year 2013: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
• Keywords: 研究者主導臨床研究 / 健康被害補償 / 倫理指針 / 被験者保護 / 利益相反 / 無過失補償 / 研究倫理

Outline of Final Research Achievements

Having been reviewed since December 2012, ‘Ethical Guidelines for Medical and Health Research Involving Human Subjects’ were at long last enacted in April 2015, partially reflected with our policy recommendation. On the other hand, we released ‘Points to Consider on Investigator-initiated Clinical Trials financially supported by Industry, Ver.1” by the Secondary Clinical Study Advancement Working Group in the Japan Society of Clinical Trials and Research in February 2015, and issued a booklet, ‘Project Management in the Notified Clinical Trials (Chiken) by Academia’, by the PM Liaison Committee of ARO Consortium in September 2015, as well. Furthermore, we launched to prepare ‘The Guidelines for Compensation of Bodily Health Damages in the Academia-initiated Clinical Trial Participants” in the Clinical Study Risk Management Forum, and have opened a public lecture enlightening clinical trials annually.

Research Products

• [Journal Article] Measuring motivation for medical treatment: confirming the factor structure of the Achievement Motivation Index for Medical Treatment (AMI-MeT) (2016)
  • Author(s): Taichi Hatta, Keiichi Narita, Kazuhiro Yanagihara, Hiroshi Ishiguro, Toshinori Murayama and Masayuki Yokode
  • Journal Title: BMC Medical Informatics and Decision Making Volume: 16 Issue: 1 Pages: 22-22
  • DOI: 10.1186/s12911-016-0260-0
  • NAID: 120005758425
  • Peer Reviewed / Open Access / Int'l Joint Research / Acknowledgement Compliant
• [Journal Article] Safety and efficacy of sustained release of basic fibroblast growth factor using gelatin hydrogel in patients with critical limb ischemia. (2015)
  • Author(s): Kumagai M, Marui A, Tabata Y, Takeda T, Yamamoto M, Yonezawa A, Tanaka S, Yanagi S, Ito-Ihara T, Ikeda T, Murayama T, Teramukai S, Katsura T, Matsubara K, Kawakami K, Yokode M, Shimizu A, Sakata R.
  • Journal Title: Heart and Vessels Volume: 30 Issue: 5 Pages: 713-721
  • DOI: 10.1007/s00380-015-0677-x
  • Peer Reviewed / Open Access
• [Journal Article] The Prostaglandin E2 Receptor EP4 Regulates Obesity-related Inflammation and Insulin Sensitivity. (2015)
  • Author(s): Yasui, M., Y. Tamura, M. Minami*, S. Higuchi, R. Fujikawa, T. Ikedo, M. Nagata, H. Arai, T. Murayama, and M. Yokode.
  • Journal Title: PLoS One Volume: 10 Issue: 8 Pages: e0136304-e0136304
  • DOI: 10.1371/journal.pone.0136304
  • NAID: 120005678204
  • Peer Reviewed / Open Access / Acknowledgement Compliant
• [Journal Article] Safety and Anti-tumor Activity of Anti–PD-1 Antibody (Nivolumab: ONO-4538/BMS-936558) in Patients with Platinum-resistant Ovarian Cancer. (2015)
  • Author(s): Hamanishi, J., M. Mandai, T. Ikeda, M. Minami, A. Kawaguchi, T. Murayama, M. Kanai, Y. Mori, S. Matsumoto, S. Chikuma, N. Matsumura, K. Abiko, T. Baba, K. Yamaguchi, A. Ueda, Y. Hosoe, S. Morita, M. Yokode, A. Shimizu, T. Honjo, I. Konishi.
  • Journal Title: J Clin Oncol Volume: 33 Issue: 34 Pages: 4015-22
  • DOI: 10.1200/jco.2015.62.3397
  • Peer Reviewed / Open Access
• [Journal Article] A pilot study of regenerative therapy using controlled release of recombinant human fibroblast growth factor for patients with pre-collapse osteonecrosis of the femoral head. (2015)
  • Author(s): Kuroda Y, Asada R, So K, Yonezawa A, Nankaku M, Mukai K, Ito-Ihara T, Tada H, Yamamoto M, Murayama T, Morita S, Tabata Y, Yokode M, Shimizu A, Matsuda S, Akiyama H
  • Journal Title: Int Orthop Volume: Dec 29 Issue: 8 Pages: 1747-1754
  • DOI: 10.1007/s00264-015-3083-1
  • NAID: 120005698292
  • Peer Reviewed / Open Access
• [Journal Article] エビデンスに基づく急速進行性腎炎症候群(RPGN)診療ガイドライン2014 (2015)
  • Author(s): 松尾清一, 木村健二郎, 有村義宏, 武曾惠理, 藤元昭一, 長谷川みどり, 要伸也, 臼井丈一, 猪原登志子, 小林正貴, 板橋美津世, 北川清樹, 平橋淳一, 天野宏一, 伊藤聡, 佐田憲映, 土橋浩章, 針谷正祥, 藤井隆夫, 山田秀裕, 和田隆志, 丸山彰一, 今井裕一, 横山仁, 吉田雅治, 山縣邦弘, 湯村和子, 川村哲也, 廣村桂樹
  • Journal Title: 日本腎臓学会誌 Volume: 57 Pages: 139-232
  • Peer Reviewed
• [Journal Article] Clinical effects of ghrelin on gastrointestinal involvement in patients with systemic sclerosis (2014)
  • Author(s): Ariyasu H, Iwakura H, Yukawa N, Murayama T, Yokode M, Tada H, Yoshimura K, Teramukai S, Ito T, Shimizu A, Yonezawa A, Kangawa K, Mimori T, Akamizu T
  • Journal Title: Endocrine Journal Volume: 61 Issue: 7 Pages: 735-742
  • DOI: 10.1507/endocrj.EJ14-0088
  • NAID: 130004443975
  • ISSN: 0918-8959, 1348-4540
  • Peer Reviewed / Open Access
• [Journal Article] Magnifying endoscopy with narrow band imaging to determine the extent of resection in transoral robotic surgery of oropharyngeal cancer. (2014)
  • Author(s): Tateya I, Ishikawa S, Morita S, Ito H, Sakamoto T, Murayama T, Kishimoto Y, Hayashi T, Funakoshi M, Hirano S, Kitamur M, Morita M, Muto M, Ito J.
  • Journal Title: Case Rep Otolaryngol Volume: 2014 Pages: 604737-604737
  • DOI: 10.1155/2014/604737
  • NAID: 120005615634
  • Peer Reviewed / Open Access
• [Journal Article] A randomized controlled clinical trial of topical insulin-like growth factor-1 therapy for sudden deafness refractory to systemic corticosteroid treatment. (2014)
  • Author(s): Nakagawa T., Kumakawa K., Usami S., Hato N., Tabuchi K., Takahashi M., Fujiwara K., Sasaki A., Komune S., Sakamoto T., Hiraumi H., Yamamoto N., Tanaka S., Tada H., Yamamoto M., Yonezawa A., Ito-Ihara T., Ikeda T., Shimizu A., Tabata Y., and Ito J.
  • Journal Title: BMC Med Volume: 12 Issue: 1 Pages: 219-219
  • DOI: 10.1186/s12916-014-0219-x
  • NAID: 120005517912
  • Peer Reviewed / Open Access
• [Journal Article] 腎臓内科医としてのキャリアと人生設計 臨床研究/臨床試験の支援 (2014)
  • Author(s): 猪原登志子
  • Journal Title: 日本腎臓学会誌 Volume: 56 Pages: 682-682
  • Peer Reviewed
• [Journal Article] An international survey of physicians regarding clinical trials: a comparison between Kyoto University Hospital and Seoul National University Hospital. (2013)
  • Author(s): Ito-Ihara T, Hong JH, Kim OJ, Sumi E, Kim SY, Tanaka S, Narita K, Hatta T, Choi EK, Choi KJ, Miyagawa T, Minami M, Murayama T, Yokode M.
  • Journal Title: BMC Med Res Methodol. Volume: 13 Issue: 1 Pages: 130-130
  • DOI: 10.1186/1471-2288-13-130
  • Peer Reviewed
• [Journal Article] Novel collagen/gelatin scaffold with sustained release of basic fibroblast growth factor: clinical trial for chronic skin ulcers. (2013)
  • Author(s): Morimoto, N., Yoshimura, K., Niimi, M., Ito, T., Aya, R., Fujitaka, J., Tada, H., Teramukai, S., Murayama, T., Toyooka, C., Miura, K., Takemoto, S., Kanda, N., Kawai, K., Yokode, M., Shimizu, A. and Suzuki, S.
  • Journal Title: Tissue Engineer. Part A Volume: 19 Issue: 17-18 Pages: 1931-1940
  • DOI: 10.1089/ten.tea.2012.0634
  • NAID: 120005312059
  • Peer Reviewed
• [Presentation] 信頼される臨床研究を計画・実施するために必要なこと ～日本臨床試験学会(JSCTR)との共同発表 (2015)
  • Author(s): 村山 敏典
  • Organizer: 第6回日本製薬医学会年次大会
  • Place of Presentation: 東京
  • Year and Date: 2015-07-25
  • Invited
• [Presentation] “Toward the advancement for investigator-initiated clinical trials -A challenge from Kanazawa/Hokuriku in Japan-” (2015)
  • Author(s): T. Murayama
  • Organizer: The DIA 27th Annual EuroMeeting
  • Place of Presentation: Ｐａｒｉｓ
  • Year and Date: 2015-04-13
  • Int'l Joint Research
• [Presentation] 研究者主導臨床研究の推進に向けて ～北陸・金沢の挑戦～ (2015)
  • Author(s): 村山 敏典
  • Organizer: 第6回日本臨床試験学会学術集会
  • Place of Presentation: 東京
  • Year and Date: 2015-02-20 – 2015-02-21
• [Presentation] 抗好中球細胞質抗体関連血管炎に対する血漿交換療法と国際共同臨床試験PEXIVAS (2014)
  • Author(s): 猪原登志子
  • Organizer: 第35回日本アフェレシス学会
  • Place of Presentation: 東京
  • Year and Date: 2014-09-26 – 2014-09-28
  • Invited
• [Presentation] 臨床研究における女性医師の活躍- 国際多施設共同臨床試験・調整事務局の経験から - (2014)
  • Author(s): 猪原登志子
  • Organizer: 第12回日本女性腎臓病医の会総会
  • Place of Presentation: 神戸市
  • Year and Date: 2014-06-14
• [Presentation] “Kyoto University Hospital Institute for Advancement of Clinical and Translational Science (iACT), aiming at a worldwide ARO” (2014)
  • Author(s): Murayama T.
  • Organizer: The DIA 26th Annual EuroMeeting
  • Place of Presentation: Vienna
• [Presentation] 京都大学医学部附属病院iACT ～世界に広がる臨床研究支援組織をめざして～ (2014)
  • Author(s): 村山 敏典
  • Organizer: 第5回日本臨床試験研究会学術集会
  • Place of Presentation: 東京
• [Presentation] “No-fault compensation to participants in un-notified clinical trials including stem cell study in Japan” (2013)
  • Author(s): Murayama T.
  • Organizer: The 34th Annual Meeting of the Society for Clinical Trials
  • Place of Presentation: Boston
• [Book] 内分泌代謝臨床研究マニュアル (2015)
  • Author(s): 村山 敏典
  • Total Pages: 206
  • Publisher: 診断と治療社
• [Remarks] 金沢大学附属病院 先端医療開発センター
  • URL: http://icrek.w3.kanazawa-u.ac.jp/
• [Remarks] 京都大学医学部附属病院 臨床研究総合センター 早期臨床試験部
  • URL: http://www.kuhp.kyoto-u.ac.jp/~iact/department/early_clinical/