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Consenting to Adverse Events

Consenting to Adverse Events

(p.179) 7 Consenting to Adverse Events
Adverse Events
Jill A. Fisher
NYU Press

Chapter 7 draws on secondary data about the safety of Phase I trials to discuss how research staff and healthy volunteers alike struggle to make sense of the omnipresent hypothetical risks of studies, outlined in informed consent forms, in the face of tangible evidence of the trials’ relative safety. Serial participation fundamentally shapes healthy volunteers’ view of trial risks. This is because repeated enrollment diminishes the importance of the formal consent process as healthy volunteers’ own experiences take priority. As long as participants are unharmed in the studies they complete, they become desensitized to the risks and place trust in the research process, believing that the clinics will keep them safe. At the same time, as model organisms, healthy volunteers are often regarded as being indifferent to risks. They are even stigmatized as desperate people too focused on the money that they will earn from a study to assess appropriately the harms that might occur. From this vantage point, study participation is viewed contradictorily as safe unless someone is not taking the consent process seriously.

Keywords:   Phase I trials, healthy volunteers, model organism, research staff, risk, informed consent, serial participation, stigma

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