Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research

Journal of Medicine and Philosophy 43 (1):83-114 (2018)

Abstract
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.
Keywords No keywords specified (fix it)
Categories No categories specified
(categorize this paper)
DOI 10.1093/jmp/jhx033
Options
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

Our Archive


Upload a copy of this paper     Check publisher's policy     Papers currently archived: 46,373
External links

Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
Through your library

References found in this work BETA

Exploitation.Michael Gorr - 1998 - Philosophical Review 107 (2):296.
Payment for Research Participation: A Coercive Offer?A. Wertheimer & F. G. Miller - 2008 - Journal of Medical Ethics 34 (5):389-392.
Theory Construction in Qualitative Research.Stefan Timmermans & Iddo Tavory - 2012 - Sociological Theory 30 (3):167-186.
Harm to Self.Joel Feinberg & Donald Vandeveer - 1988 - Ethics 98 (3):550-565.

View all 32 references / Add more references

Citations of this work BETA

Best to Exclude but Pay.Marion Danis, Sam Doernberg, Matthew Memoli & Joseph Millum - 2018 - American Journal of Bioethics 18 (4):87-88.
The Continued Complexities of Paying Research Participants.Christine Grady - 2019 - American Journal of Bioethics 19 (9):5-7.

View all 6 citations / Add more citations

Similar books and articles

Healthy Children as Subjects in Pharmaceutical Research.Gideon Koren - 2003 - Theoretical Medicine and Bioethics 24 (2):149-159.
Ethics at Phase 0: Clarifying the Issues.Jonathan Kimmelman - 2007 - Journal of Law, Medicine and Ethics 35 (4):727-733.
Payment for Research Participation: A Coercive Offer?A. Wertheimer & F. G. Miller - 2008 - Journal of Medical Ethics 34 (5):389-392.

Analytics

Added to PP index
2018-01-12

Total views
17 ( #534,060 of 2,286,140 )

Recent downloads (6 months)
9 ( #106,860 of 2,286,140 )

How can I increase my downloads?

Downloads

My notes

Sign in to use this feature