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Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

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第一作者： Rebecca H,Li

第一单位： Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Boston, Massachusetts, USA.

作者： Rebecca H,Li ^[1] ; Mary C,Wacholtz ^[2] ; Mark,Barnes ^[3] ; Liam,Boggs ^[4] ; Susan,Callery-D'Amico ^[5] ; Amy,Davis ^[6] ; Alla,Digilova ^[7] ; David,Forster ^[8] ; Kate,Heffernan ^[9] ; Maeve,Luthin ^[9] ; Holly Fernandez,Lynch ^[10] ; Lindsay,McNair ^[6] ; Jennifer E,Miller ^[11] ; Jacquelyn,Murphy ^[12] ; Luann,Van Campen ^[13] ; Mark,Wilenzick ^[14] ; Delia,Wolf ^[15] ; Cris,Woolston ^[16] ; Carmen,Aldinger ^[1] ; Barbara E,Bierer ^[17]

作者单位： Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Boston, Massachusetts, USA. ^[1] Janssen R&D, Johnson & Johnson, Raritan, New Jersey, USA. ^[2] Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Boston, Massachusetts, USA Ropes & Gray LLP, Boston, Massachusetts, USA. ^[3] The Global Health Network/Oxford University, Oxford, UK. ^[4] Quality Assurance, AbbVie, Chicago, Illinois, USA. ^[5] WCG (WIRB- Copernicus Group), Olympia, Washington, USA. ^[6] Morgan Lewis, New York, NY, USA. ^[7] Health Care Group, Verrill Dana LLP, Boston, Massachusetts, USA. ^[8] Public Responsibility in Medicine and Research, Boston, Massachusetts, USA. ^[9] Petrie-Flom Center, Harvard Law School, Cambridge, Massachusetts, USA. ^[10] NYU Langone Medical Center, New York, New York, USA. ^[11] Colorado School of Public Health Anschutz Medical Campus Aurora, CO. ^[12] Eli Lilly and Company, Indianapolis, Indiana, USA. ^[13] International AIDS Vaccine Initiative, New York, New York, USA. ^[14] Harvard School of Public Health, Boston, Massachusetts, USA. ^[15] Sanofi, New York, New York, USA. ^[16] Multi-Regional Clinical Trials Center, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. ^[17]

关键词 Clinical Ethics Clinical trials Ethics Ethics Committees/Consultation