Tag: Jill A. Fisher

In phase I clinical trials, healthy volunteers are dosed with investigational drugs and subjected to blood draws and other bodily monitoring procedures while they are confined to clinic spaces. In exchange, they are paid. These participants are, in a direct sense, selling access to their bodies for pharmaceutical companies and...

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...

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...

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...

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...

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...

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...

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...

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...

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...