author_facet Walker, Rebecca L
Cottingham, Marci D
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author Walker, Rebecca L
Cottingham, Marci D
Fisher, Jill A
spellingShingle Walker, Rebecca L
Cottingham, Marci D
Fisher, Jill A
The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine
Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research
Philosophy
General Medicine
Issues, ethics and legal aspects
author_sort walker, rebecca l
spelling Walker, Rebecca L Cottingham, Marci D Fisher, Jill A 0360-5310 1744-5019 Oxford University Press (OUP) Philosophy General Medicine Issues, ethics and legal aspects http://dx.doi.org/10.1093/jmp/jhx033 <jats:title>Abstract</jats:title> <jats:p>Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules.</jats:p> Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine
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title Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research
title_unstemmed Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research
title_full Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research
title_fullStr Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research
title_full_unstemmed Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research
title_short Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research
title_sort serial participation and the ethics of phase 1 healthy volunteer research
topic Philosophy
General Medicine
Issues, ethics and legal aspects
url http://dx.doi.org/10.1093/jmp/jhx033
publishDate 2018
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description <jats:title>Abstract</jats:title> <jats:p>Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules.</jats:p>
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author Walker, Rebecca L, Cottingham, Marci D, Fisher, Jill A
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spelling Walker, Rebecca L Cottingham, Marci D Fisher, Jill A 0360-5310 1744-5019 Oxford University Press (OUP) Philosophy General Medicine Issues, ethics and legal aspects http://dx.doi.org/10.1093/jmp/jhx033 <jats:title>Abstract</jats:title> <jats:p>Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules.</jats:p> Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine
spellingShingle Walker, Rebecca L, Cottingham, Marci D, Fisher, Jill A, The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine, Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research, Philosophy, General Medicine, Issues, ethics and legal aspects
title Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research
title_full Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research
title_fullStr Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research
title_full_unstemmed Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research
title_short Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research
title_sort serial participation and the ethics of phase 1 healthy volunteer research
title_unstemmed Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research
topic Philosophy, General Medicine, Issues, ethics and legal aspects
url http://dx.doi.org/10.1093/jmp/jhx033