Maybe We Should Pay Them More

Zink, Sheldon

doi:10.1162/152651601300169220

Cited by 9 publications

(5 citation statements)

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“…The latter are the focus of this paper. It is a widely, though not universally (Savulescu, 2001; Zink, 2001), held recommendation that low (Grady, 2001; Dickert and Grady, 1999), or no (McNeil, 1997; Reame, 2001) payments be offered to potential research participants to avoid unduly influencing them. The term “payments” refers to transfers of money or its equivalent (e.g., gift cards) not intended as reimbursement for actual expenses, for example, cab fare or parking.…”

Section: Introductionmentioning

confidence: 99%

Payments to Normal Healthy Volunteers in Phase 1 Trials: Avoiding Undue Influence While Distributing Fairly the Burdens of Research Participation

Iltis

2009

Journal of Medicine and Philosophy

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Clinical investigators must engage in just subject recruitment and selection and avoid unduly influencing research participation. There may be tension between the practice of keeping payments to participants low to avoid undue influence and the requirements of justice when recruiting normal healthy volunteers for phase 1 drug studies. By intentionally keeping payments low to avoid unduly influenced participation, investigators, on the recommendation or insistence of institutional review boards, may be targeting or systematically recruiting healthy adult members of lower socio-economic groups for participation in phase 1 studies. Investigators are at risk of routinely failing to fulfill the obligation of justice, which prohibits the systematic targeting and recruiting of subjects for reasons unrelated to the nature of the study. Insofar as we take seriously the obligation to engage in just subject recruitment and selection, I argue that we must acknowledge the implications low payments might have for subject recruitment and selection and examine the effect of low payments. If low payments de facto target the less well-off for phase 1 studies, we must defend the priority ranking of the obligation to avoid undue influence over the obligation of justice or adopt an alternative recruitment approach. This paper identifies a number of alternatives to the current system of low-value payments to research participants.

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Section: Introductionmentioning

confidence: 99%

Payments to Normal Healthy Volunteers in Phase 1 Trials: Avoiding Undue Influence While Distributing Fairly the Burdens of Research Participation

Iltis

2009

Journal of Medicine and Philosophy

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“…Similar semantic analyses have been done by Jan Marta (1996). 9 Sheldon Zink (2001) argues that researchers need to start paying more attention to who is participating in medical research and what their motivations are. She makes a compelling case that this type of understanding of participants will help guide discussions about informed consent and compensation for participation.…”

Section: Informed Consent In Context: Social Science Researchmentioning

confidence: 84%

Procedural Misconceptions and Informed Consent: Insights from Empirical Research on the Clinical Trials Industry

Fisher¹

2006

ken

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This paper provides a simultaneously reflexive and analytical framework to think about obstacles to truly informed consent in social science and biomedical research. To do so, it argues that informed consent often goes awry due to procedural misconceptions built into the research context. The concept of procedural misconception is introduced to describe how individuals respond to what is familiar in research settings and overlook what is different. In the context of biomedical research, procedural misconceptions can be seen to function as root causes of therapeutic misconceptions.Quite recently, I was struck by the realization that I did not get truly informed consent from subjects participating in my research project. This is not to say that I violated any federal or institutional regulations. Quite the contrary, I did everything by the book and so did my university institutional review board (IRB). 1 Moreover, the project itself is an empirical study of informed consent in the context of private-sector research within the clinical trials industry, so as I was developing the project, I was keenly aware of my responsibility to be ethically commendable in my own interactions with human subjects. What went wrong? And what generalizable implications does my experience have for thinking about human subjects research and informed consent?This article is based on 12 months of qualitative research examining the for-profit clinical trials industry in the southwestern United States. 2 The purpose of the study was to investigate the new relations, structures, and logics that have been produced within the research clinic through the privatization of pharmaceutical research. Using a mode of multi-sited, institutional ethnography, 3 my research was particularly attuned to the roles of the informants-i.e., physician investigators, coordinators, monitors, and even human subject volunteers-and the ethical conflicts, of various degrees of intensity, that they described and that were observed through their practices-e.g., recruitment of subjects, informed consent processes, and study retention and compliance. Studying approximately 20 for-profit research organizations in two major cities, I conducted 57 semi-structured interviews that were clustered to get the perspective of multiple employees at individual investigative sites-i.e., those conducting contract research-including 10 physicians, 18 research coordinators, 9 administrators, and 10 human subjects. Investigative sites represented a diverse sample of organizational forms, such as private practices, dedicated research sites, and large (nonacademic) hospitals. The sample also included interviews at two not-for-profit, nonhospital investigative sites. In addition, the research included attendance at industry conferences, the monitoring of publications produced by industry professional organizations, and participant observation in which I was screened for a Phase I, healthy volunteer clinical trial.

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“…Commentators on undue influence have argued that levels of financial compensation should not be held down when trial risks are no more than minimal (Dunn and Gordan, 2005;Phillips, 2011), and IRBs and bioethicists have long recognized that holding down payments is an anemic solution to the influences of precarious and divergent background financial need (see e.g. Macklin, 1981;Zink, 2001). Yet, some have also acutely felt the perversity of holding down payments only for some individuals who are worse off and so more likely to participate over their own objections (Macklin, 1981).…”

Section: From Undue Influence and Coercion To Structural Coercion Andmentioning

confidence: 99%

Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research

Walker

Cottingham

Fisher

2018

The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine

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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.

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Maybe We Should Pay Them More

Cited by 9 publications

References 0 publications

Payments to Normal Healthy Volunteers in Phase 1 Trials: Avoiding Undue Influence While Distributing Fairly the Burdens of Research Participation

Payments to Normal Healthy Volunteers in Phase 1 Trials: Avoiding Undue Influence While Distributing Fairly the Burdens of Research Participation

Procedural Misconceptions and Informed Consent: Insights from Empirical Research on the Clinical Trials Industry

Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research

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