Cookies on this website
We use cookies to ensure that we give you the best experience on our website. If you click 'Continue' we'll assume that you are happy to receive all cookies and you won't see this message again. Click 'Find out more' for information on how to change your cookie settings.
Skip to main content

The conduct of pragmatic randomized controlled trials is increasing due to their societal importance and their role within the Patient-Centered Outcomes Research Institute (PCORI) initiative “to improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policy makers make informed health decisions.” Cluster randomized trials (CRTs), in which groups rather than individuals are randomized to intervention and control conditions, naturally tend to be more pragmatic. CRTs may be categorized as “individual-cluster trials” where the intervention is delivered directly to individuals, or “cluster-cluster trials” where interventions are not divisible at the individual-level. The Ottawa Statement is the first comprehensive ethical guidance document specific to CRTs. Whereas the Ottawa Statement generally presumes that informed consent will be sought for individual-cluster trials, such trials—when used to evaluate usual care interventions—raise particular ethical issues that require further analysis and guidance. This paper has three objectives: to (1) describe current practices and reporting of ethical issues in published individual-cluster trials; (2) present an in-depth ethical analysis of an individual-cluster trial randomizing dialysis centers to two different usual care interventions; and (3) identify ethical issues that require further analysis and guidance.

Please note:

If you are not a member of the Ethox Team and are planning on coming, please email jane.beinart@ethox.ox.ac.uk.

Forthcoming events

Oxford-Peking University Joint Symposium on Precision Medicine

Thursday, 19 September 2019, 10am to 6pm @ Seminar rooms, BDI, Old Road Campus, OX3 7LF

CKB Workshop - Infections, immunity and cancer: aetiology and beyond

Friday, 20 September 2019, 1pm to 5pm @ Seminar rooms, BDI, Old Road Campus, OX3 7LF

NDPH Seminar - Changing the way medical research is funded: Some lessons from Australia

Thursday, 26 September 2019, 4pm to 5pm @ Seminar rooms, BDI, Old Road Campus, OX3 7LF

Ethox/WEH Seminar - Reclaiming a Sense of Common Humanity: A Confucian Ethical Vision

Wednesday, 02 October 2019, 11am to 12.30pm @ Level 1 Ax Meeting Room, BDI, Old Road Campus, OX3 7LF

UVBO Seminar - Can wearable sensors and machine learning enhance our understanding of lifestyle health behaviours?

Thursday, 17 October 2019, 1pm to 2pm @ L1 Meeting room, Richard Doll Building, Old Road Campus, OX3 7LF

UVBO Seminar - Nutrient timing and human health

Thursday, 24 October 2019, 1pm to 2pm @ School of Anthropology, 61 Banbury Road, OX2 6PE