| ●巻頭言 | 栗原 雅直 | 6-7 | Full text | |
| ●生命倫理と研究倫理の過去・現在・未来（第2回） | ||||
| ・臨床研究の信頼性と公正性 | ||||
| 原著：臨床試験の信頼性確保のために －ICH-GCP（R2）と日本における臨床研究法案をめぐる考察－ | 河野 健一 | 9-20 | Abstract | |
| 資料：第190回国会（常会）に提出された臨床研究法案第3条に規定する 「臨床研究実施基準」等に関する提言について | （一財）医薬品医療機器 レギュラトリーサイエンス財団 | 21-4 | Abstract | |
| 論説：粉飾された臨床試験の判別法：臨床試験のすべての関係者へ | 奥村 泰之 | 25-34 | Full text | |
| ・フランス第Ⅰ相被験者死亡事故：「レンヌ事件」について | ||||
| 総説：レンヌ事件の教訓 | 熊谷 雄治，門間 毅 | 35-44 | Abstract | |
| 原著：「レンヌ事件」について－フランスにおける第Ⅰ相試験死亡事故の教訓 | 栗原千絵子，齊尾 武郎， 橳島 次郎 | 45-65 | Abstract | |
| ・研究対象者保護プログラムの最新動向 | ||||
| インタビュー：米国AAHRPP（研究対象者保護プログラム認証協会） Dr. Elyse I. Summers（会長・CEO），Dr. Sarah H. Kiskaddon（Director・Public Affairs） インタビュー：米国と世界の被験者保護システムの最近の動向 | Elyse I. Summers， Sarah H. Kiskaddon （インタビュー・訳 栗原千絵子） | 67-79 | Abstract | |
| 解説：韓国における「臨床試験と対象者保護プログラム（HRPP）運営ガイドライン」について | 栗原千絵子，李 侖珍 | 81-5 | Abstract | |
| 翻訳：臨床試験と対象者保護プログラム（HRPP）運営ガイドライン | 韓国食品医薬品安全省 医薬品安全局 臨床制度課 （訳 李 侖珍，栗原千絵子） | 87-90 | ||
| ●2nd Taiwan-Japan Academic Research Organization Workshop －Cancer translational research and cancer registry studies－ Sponsored and organized by：National Research Program for Biopharmaceuticals(NRPB), Taiwan; Academic Research Organization Council, Japan |
91-194 | Abstract | ||
| ・Supportive platform/infrastructure；Opening remarks | ||||
| Welcome and opening remarks; Infrastructure and activity of biotechnology development in Taiwan |
Pan-Chyr Yang | 95-8 | ||
| ARO's strategy and actions in translational research | Yoichi Nakanishi | 99-100 | ||
| Welcoming remarks | Andrew H.-J. Wang | 101 | ||
| ・Session I：Mental diseases | ||||
| Novel therapeutics for mental disorders and Alzheimer's disease: Consortium for Mental Disorders (CMD) |
Hsien-Yuan Lane | 102-5 | ||
| Elucidate the etiopathology of mental disorders: To overcome the psychopharmacology in crisis | Norio Ozaki | 106-9 | ||
| ・Session II：Oncology 1 | ||||
| Oncology Phase I Consortium and international collaboration | Josh Chia-Chi Lin | 110 | ||
| Early clinical development in EPOC (NCC & NCCE) | Toshihiko Doi | 111-4 | ||
| Clinical and translation research for lung cancer in Taiwan | James Chih-Hsin Yang | 115-8 | ||
| A nationwide genomic screening project in Japan (LC-SCRUM-Japan) | Koichi Goto | 119-23 | ||
| ・Session III：Oncology 2 & cancer registry | ||||
| GI Disease Consortium & designing reliable therapy for mass eradication of H. pylori to prevent gastric cancer in Taiwan |
Ming-Shiang Wu | 124-7 | ||
| Precision epigenetic risk diagnosis after mass eradication of H. pylori | Toshikazu Ushijima | 128-9 | ||
| Investigator-Initiated Trials and Translational Research in NICR/TCOG －Focusing on non-CRC GI Cancers |
Li-Tzong Chen | 130-4 | ||
| Continuous regional arterial infusion (CRAI) versus venous infusion of nafamostat mesylate for severe acute pancreatitis: Background and study protocol for a multicenter randomized controlled trial by a Japanese study group |
Morihisa Hirota | 135-8 | ||
| Registry and biobank for rare cancer in Japan: Gastrointestinal stromal tumor, sarcoma and neuroendocrine tumor |
Toshirou Nishida | 139-42 | ||
| ・Session IV：Oncology 3 | ||||
| Early cancer drug discovery and development in academic setting clinical development in EPOC (NCC & NCCE) |
Yun Yen | 143-6 | ||
| New strategy for cancer immunotherapy | Yasufumi Kaneda | 147-50 | ||
| Nano-Oncology: From nano scale molecular structure and dynamic analysis to new therapeutics and theranostics engineering |
Dar-Bin Shieh | 151-3 | ||
| Immune-escape polymeric micelles carrying radionuclides as theranostic agent for breast cancer | Shunsaku Kimura | 154-8 | ||
| Developing novel cancer imaging in Taiwan | Yeun-Chung Chang | 159-63 | ||
| PET screening study for early detection of cancer and its long-term follow-up | Shinsuke Kojima | 164-6 | ||
| Current status for the surgery of colorectal cancer in Taiwan | Jin-Tung Liang | 167-70 | ||
| Standardization of colon cancer surgery | Kenichi Sugihara | 171-4 | ||
| ・Session V：Oncology 4 & biobanking | ||||
| Drug development for hepatocellular carcinoma in Taiwan: A decade of evolution | Ann-Lii Cheng | 175 | ||
| The present and future of Taiwanese Gynecologic Oncology Group (TGOG) | Kung-Liahng Wang | 176-9 | ||
| JGOG's activities | Aikou Okamoto | 180-3 | ||
| Taiwan Biobank for the health of the next generations | Chen-Yang Shen | 184-8 | ||
| Biobank and informatics for cancer projects and clinical sequencing at Kyoto University Cancer Center |
Manabu Muto | 189-93 | ||
| General discussion organization | Fu-Tong Liu | 194 | ||
| ●ASIA ARO Network Workshop －The 4th Annual Japan ARO Council Meeting:Global ARO network building－ Organized by：Academic Research Organization Council Chairman：Akira Myoui，Tsutomu Nishimura |
195-240 | Abstract | ||
| ・1. Opening remarks | ||||
| Opening remarks | Akira Myoui | 197 | ||
| ・2. ARO structure, functions and activities in Korea | ||||
| Structure, functions, and activities of Medical Research Collaborating Center | Han-Suk Kim，Joongyub Lee | 198-201 | ||
| ARO at Asan Medical Center－Collaboration with local AROs | Sung-Ho Beck | 202-4 | ||
| KoNECT and KoNECT Collaboration Center: Fostering global clinical development in Korea | Deborah Chee | 205-7 | ||
| Mutual use of e-IRB system for Korea - Japan Research Cooperation | Hyunin Cho，Younjin Rhee | 208-12 | ||
| ・3. ARO structure, functions and activities in Taiwan | ||||
| Structure, functions and actives of NRPB in Taiwan | Ming-Shiang Wu | 213-5 | ||
| Taiwan Biobank and Biosignature Consortia | Fu-Tong Liu | 216-8 | ||
| ・4. ARO structure, functions and activities in Singapore | ||||
| Singapore ARO structure and research operational strategy | Damien Hong Yew Hui | 219-23 | ||
| ・5. Japan ARO network: Activity and achievements | ||||
| Overview of Japanese ARO Network | Yoichi Nakanishi | 224-7 | ||
| Supporting system for translational research and medical innovation in Osaka University Hospital | Kiyoshi Okada | 228-31 | ||
| New oncology agents development in NCC | Atsushi Ohtsu | 232-5 | ||
| ARO activity and achievements of Tohoku University Hospital | Tadao Takano | 236-8 | ||
| ・6. Discussion and closing remarks | ||||
| Closing remarks | Masanori Fukushima | 239-40 | ||
| ●訃報 | ||||
| 清水直容先生を悼む | 栗原 雅直 | 241-2 | ||
| ●投稿規定（和文・英文） | 243-51 | Full text | ||
| ●編集後記 研究倫理年表の最初になにを記すべきか？ | 津谷喜一郎 | 253 | Full text | |
| ［電子版のみ］ | ||||
| ●Interview | ||||
| Interview with Dr. Elyse I. Summers, President & CEO, and Dr. Sarah H. Kiskaddon, Director of Global Development & Public Affairs, Association for the Accreditation of Human Research Protection Program (AAHRPP) －Recent trend of human subject protection system in the U.S. and in the world－ |
Elyse I. Summers， Sarah H. Kiskaddon （Interview by Chieko Kurihara） |
255-67 W1-W13 | Full text | |