Project 461789

The cluster randomized trial (CRT) is an important method to generate robust evidence about clinical, health policy, health systems, and public health interventions. Unlike trials that randomly assign individual participants to different interventions, CRTs randomize intact groups such as hospitals, schools, and communities. But CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of CRTs, published by our team in 2012, remains the only international guidance document specifically focused on CRTs. Its 15 recommendations have been broadly influential, helping many researchers plan their CRTs according to high ethical standards. However, since its publication, there have been various innovations in CRT methodology and new infrastructure for designing and conducting CRTs. These developments have raised new ethical challenges which need to be addressed. Our goal is to address these gaps, incorporate new recommendations into the Ottawa Statement and create two implementation guidance documents that demonstrate how the recommendations apply to settings in which CRTs are common, but their conduct is complicated (i.e., long-term care and low-resource settings). First, we will identify gaps in the Ottawa Statement. Second, we will develop methods for identifying and meaningfully engaging with patients and other key stakeholders in development of ethics guidelines. Third, we will assemble a multidisciplinary group of ethicists, clinical and public health experts, and methodologists to work with the stakeholders to update the Ottawa Statement. Fourth, we will assemble a panel of experts and stakeholders with lived experience in long-term care and low-resource settings to develop implementation guidance documents. Finally, we will develop a research agenda to enable researchers to work collectively on unresolved ethical issues raised by CRTs.