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Sacrificial Labor: Social Inequality, Identity Work, and the Damaging Pursuit of Elusive Futures.

January 23, 2020
This article explores the relationship between personal sacrifice and identity work within conditions of profound structural insecurity. We develop the concept of sacrificial labour to describe how individual self-sacrifice aligns workers’ identities to the needs of organizations while gradually foreclosing the actualization of individuals’ desired future selves. Drawing upon qualitative...

Picking and Choosing Among Phase I Trials: A Qualitative Examination of How Healthy Volunteers Understand Study Risks.

January 23, 2020
This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178...

Research Payment and Its Social Justice Concerns.

October 7, 2019
The field of bioethics has had a long preoccupation with payment for research participation. The end result of these debates has largely been consensus that there is nothing ethically wrong with paying people to participate in research and yet it does not feel quite right either. This discomfort is particularly...

Commentary on Zvonareva et al.: Exploring the Many Meanings of ‘Professional’ in Research Participation.

October 7, 2019
Within the field of bioethics and among many clinical trialists, the term “professional” has come to have a very specific meaning when referring to research participants. As highlighted by Roberto Abadie’s book The Professional Guinea Pig,2 the focus is largely on those participants, particularly healthy volunteers, who enroll in clinical...

Appraising Harm in Phase I Trials: Healthy Volunteers’ Accounts of Adverse Events

July 17, 2019
While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with...

Advancing Ethics and Policy for Healthy‐Volunteer Research through a Model‐Organism Framework

February 18, 2019
Nonhuman animal research and phase I healthy‐volunteer clinical trials are both critical components of testing the safety of investigational drugs as part of the development of new pharmaceuticals. In addition, these types of research share important structural features, as both take place in confinement and both use subjects that are...

Companion Animal Studies: Slipping Through a Research Oversight Gap

December 12, 2018
In human subject research ethics, we appeal to principles of respect for persons, beneficence, and justice. In laboratory animal studies, the three Rs (reduce, refine, replace) are key touchstones, along with an overarching principle of promoting animal welfare—when consistent with the needs of science and within the constraints introduced by...

Healthy volunteers’ perceptions of risk in US Phase I clinical trials: A mixed-methods study

November 26, 2018
There is limited research on healthy volunteers’ perceptions of the risks of Phase I clinical trials. In order to contribute empirically to long-standing ethical concerns about healthy volunteers’ involvement in drug development, it is crucial to assess how these participants understand trial risks. The objectives of this study were to...

Disadvantaged, Outnumbered, and Discouraged: Women’s Experiences as Healthy Volunteers in U.S. Phase I Trials

October 11, 2018
While enormous strides have been made in the representation of women in clinical trials, the percentage of women enrolling in Phase I trials still remains low, which both raises public health concerns about the safety of new drugs and social justice concerns regarding their inclusion in research. As part of...

Healthy Volunteers’ Perceptions of the Benefits of Their Participation in Phase I Clinical Trials

October 11, 2018
Other than the financial motivations for enrolling in Phase I trials, research on how healthy volunteers perceive the benefits of their trial participation is scant. Using qualitative interviews conducted with 178 U.S. healthy volunteers enrolled in Phase I trials, we investigated how participants described the benefits of their study involvement,...