Ottawa statement on the ethical design and conduct of cluster randomized trials

Primarily intended for researchers and research ethics committees, the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials aims to provide detailed guidance on the ethical design and conduct of cluster randomised trials in health research. The consensus statement consists of fifteen recommendations covering: justification of the cluster design; REC review; identifying research participants; obtaining informed consent; gatekeepers; assessing benefits and harms; protecting vulnerable participants.

Reference

Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, Brehaut JC, Taljaard M; Ottawa Ethics of Cluster Randomized Trials Consensus Group. The Ottawa statement on the ethical design and conduct of cluster randomized trials. PLoS Med. 2012;9(11):e1001346. doi: 10.1371/journal.pmed.1001346.
PMID: 23185138