Ethical issues posed by cluster randomized trials in health research

作     者：Weijer, Charles Grimshaw, Jeremy M. Taljaard, Monica Binik, Ariella Boruch, Robert Brehaut, Jamie C. Donner, Allan Eccles, Martin P. Gallo, Antonio McRae, Andrew D. Saginur, Raphael Zwarenstein, Merrick 

作者机构：Univ Western Ontario Dept Philosophy Rotman Inst Philosophy London ON N6A 5B8 Canada Univ Western Ontario Dept Med London ON N6A 5A5 Canada Univ Western Ontario Dept Epidemiol & Biostat London ON N6A 5C1 Canada Ottawa Hosp Res Inst Clin Epidemiol Program Ottawa ON K1Y 4E9 Canada Univ Ottawa Fac Med Dept Med Ottawa ON K1H 8L6 Canada Univ Ottawa Dept Epidemiol & Community Med Ottawa ON K1H 8M5 Canada Univ Penn Grad Sch Educ Philadelphia PA 19104 USA Univ Penn Dept Stat Wharton Sch Philadelphia PA 19104 USA John P Robarts Res Inst London ON N6A 5K8 Canada Newcastle Univ Inst Hlth & Soc Newcastle Upon Tyne NE2 4AX Tyne & Wear England Univ Western Ontario Schulich Sch Med & Dent London ON N6A 5C1 Canada Univ Calgary Foothills Med Ctr Div Emergency Med Calgary AB T2N 2T9 Canada Univ Ottawa Dept Med Ottawa ON K1Y 4E9 Canada Sunnybrook Hlth Sci Ctr Ctr Hlth Serv Sci Toronto ON M4N 3M5 Canada 

出 版 物：《TRIALS》 (心血管内科的电流控制试验)

年 卷 期：2011年第12卷第2011期

页      面：100-100页

核心收录：

学科分类：1002[医学-临床医学] 1001[医学-基础医学(可授医学、理学学位)] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

基　　金：Canadian Institutes of Health Research 

主　　题：Knowledge Translation Human Subject Research Data Monitoring Committee Clinical Equipoise Surrogate Decision Maker 

摘      要：The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4. How do we determine if the benefits outweigh the risks of CRTs? 5. How ought vulnerable groups be protected in CRTs? 6. Who are gatekeepers and what are their responsibilities? Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.