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  1. An Ethical Justification for Expanding the Notion of Effectiveness in Vaccine Post-Market Monitoring: Insights from the HPV Vaccine in Canada.Ana Komparic, Maxwell J. Smith & Alison Thompson - 2016 - Public Health Ethics 9 (1):78-91.
    Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public’s health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across populations. We argue that post-market monitoring ought to (...)
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  • Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials.Jill A. Fisher - 2015 - Science, Technology, and Human Values 40 (2):199-226.
    Phase I clinical trials are the first stage of testing new pharmaceuticals in humans. The majority of these studies are conducted under controlled, inpatient conditions using healthy volunteers who are paid for their participation. This article draws on an ethnographic study of six phase I clinics in the United States, including 268 semistructured interviews with research staff and healthy volunteers. In it, I argue that an institutional banalization of risk structures the perceptions of research staff and healthy volunteers participating in (...)
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