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SUMMARY:Ethical issues posed by cluster randomized trials in health resear
 ch - Weijer\, C (Western Ontario)
DTSTART:20110815T161500Z
DTEND:20110815T165500Z
UID:TALK32349@talks.cam.ac.uk
CONTACT:Mustapha Amrani
DESCRIPTION:The cluster randomized trial (CRT) is used increasingly in kno
 wledge translation research\, quality improvement research\, community bas
 ed intervention studies\, public health research\, and research in develop
 ing countries. While there is a small but growing literature on the subjec
 t\, ethical issues raised by CRTs require further analysis. CRTs only part
 ly fit within the current paradigm of research ethics. They pose difficult
  ethical issues for two basic reasons related to their design. First\, CRT
 s involve the randomization of groups rather than individuals\, and our un
 derstanding of the moral status of groups in incomplete. As a result\, the
  answers to pivotal ethical questions\, such as who may speak in behalf of
  a particular group and on what authority they may do so\, are unclear. Se
 cond\, in CRTs the units of randomization\, experimentation\, and observat
 ion may differ\, meaning\, for instance\, that the group that receives the
  experimental intervention may not be the same as the group from which dat
 a are collected. The implications for the ethics of trials of experimental
  interventions with (solely) indirect effects on patients and others is no
 t currently well understood. Here I lay out some basic considerations on w
 ho is a research subject\, from whom one must obtain informed consent\, an
 d the use of gatekeepers in CRTs in health research (Trials 2011\; 12(1): 
 100).\n
LOCATION:Seminar Room 1\, Newton Institute
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