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The regulation of genetic testing - a case study in the difficulties of constructing and operating risk-based regulatory regimes

Stuart Hogarth
Research Associate, Department of Public Health and Primary Care, Institute of Public Health, Cambridge University
 

Date: 17 January 2006
Time: 1:00pm - 2:30pm
Venue: CARR Seminar Room, H615

Abstract
How risky are genetic tests and how should those risks be regulated? In recent years there has been both much optimism about the promise of personalized medicine based on a detailed understanding of our genetic predisposition to disease, and much concern about the possible harms which may arise from the widespread use of poorly evaluated genetic tests. Fears that new tests are evading proper regulatory processes have been balanced by concerns that over-regulation may hamper innovation; one proposed solution as been to focus regulatory scrutiny only on those tests which pose greatest risks to patients. But how does one decide how risky a genetic test is? This paper explores the factors which influence the development and operation of risk-based regulation by examining how regulatory regimes in the USA, Europe, Canada and Australia have dealt with this issue.

Biography
Stuart Hogarth is a Research Associate in the Epidemiology for Policy group at the Department of Public Health and Primary Care. He is working on a Wellcome Trust funded project examining policy issues in the evaluation of clinical genetic testing for common complex conditions.

Stuart trained as a historian of medicine and expects to complete his PhD early in 2006. He is interested in lay medical cosmologies, popular attitudes to public health, the cultural meaning of health and sickness and the doctor-patient relationship




 

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