Ethical issues posed by cluster randomized trials in health research
Seminar Room 1, Newton Institute
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. While there is a small but growing literature on the subject, ethical issues raised by CRTs require further analysis. CRTs only partly fit within the current paradigm of research ethics. They pose difficult ethical issues for two basic reasons related to their design. First, CRTs involve the randomization of groups rather than individuals, and our understanding 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. Second, in CRTs the units of randomization, experimentation, and observation may differ, meaning, for instance, that the group that receives the experimental intervention may not be the same as the group from which data are collected. The implications for the ethics of trials of experimental interventions with (solely) indirect effects on patients and others is not currently well understood. Here I lay out some basic considerations on who is a research subject, from whom one must obtain informed consent, and the use of gatekeepers in CRTs in health research (Trials 2011; 12(1): 100).