Arise when clinical trials

Ethical design clinical trials

  1. Cardiff Centre for Ethical and Social Aspects of Genomics and Epigenetics (Cesagene), Cardiff University, Cardiff, UK
  1. Adam Hedgecoe, Cardiff Centre for Ethical and Social Aspects of Genomics and Epigenetics (Cesagene), Cardiff University, 10 Museum Place, Cardiff CF10 3BG, UK. Email: hedgecoeam{at}


Focusing on the high-profile drug disaster at London’s Northwick Park Hospital in 2006, this article explores how such an event can be seen as an example of organizational deviance co-constructed between the company running the research and the research ethics committee which approved the trial. This deviance was the result of the normalization of a specific dosing practice in the broader regulatory field, allowing the researchers and regulators to take a risky dosing strategy for granted as best practice. Drawing on the work of Diane Vaughan, this article uses interview data with researchers and members of the research ethics committee concerned as well as documentary material, to show how work group cultures between regulators and those they are intended to oversee are maintained, and how the culturally embedded assumptions of such work groups can result in organizational and regulatory deviance.

Article Notes

  • Funding The data for this article were gathered as part of a Sixth Framework Programme grant (EXT 509551). This research was supported by the Economic and Social Research Council (ESRC).

BMC Medical Research Methodology at the 35th Annual Conference of the ..  — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.

Wiley-Interscience Bayesian Methods and Ethics in a Clinical Trial Design
Book (Wiley-Interscience)
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When Is IRB Review of Clinical Trial Websites Required?

When information posted on a clinical trial website goes beyond directory listings with basic descriptive information, such information is considered part of the informed consent process and therefore requires IRB review and approval. Basic descriptive information includes:

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