Professor Jill A. Fisher’s book, Adverse Events Race, Inequality, and the Testing of New Pharmaceuticals has been awarded the prestigious Robert K. Merton Book Award. The award, given by the Science, Knowledge, and Technology Section of the American Sociological Association. The Merton Award is given annually in recognition of an outstanding book on science, knowledge, … Read more

Background: Since the National Institutes of Health (NIH) Revitalization Act of 1993, focus on the equitable inclusion of women in clinical research has been ongoing. NIH’s 2015 sex as a biological variable (SABV) policy aims to transform research design, analysis, and reporting in the preclinical sphere by including male and female organisms in vertebrate animal … Read more

This chapter describes the involvement of healthy volunteers in biomedical research. Healthy individuals are valuable to research because they can offer data about biological processes or investigational products that are not distorted by illness or disease. In addition, healthy individuals are generally much easier to recruit to research than are ill patients. Recruitment of healthy … Read more

Despite the importance of including diverse populations in biomedical research, women remain underrepresented as healthy volunteers in the testing of investigational drugs in Phase I trials. Contributing significantly to this are restrictions that pharmaceutical companies place on the participation of women of so-called childbearing potential. These restrictions have far-reaching effects on biomedical science and public … Read more

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 their associates to run drugs … Read more

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 data from a longitudinal study … Read more

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 healthy volunteers enrolled in various … Read more

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 striking when it comes to … Read more

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 trials as though it were … Read more

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 investigational drugs, and participants are … Read more