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Phase I Trial Compensation: How Much Do Healthy Volunteers Actually Earn from Clinical Trial Enrollment?

August 26, 2021
Background/aims Financial compensation for research participation is a major focus of ethical concern regarding human subject recruitment. Phase I trials are sometimes considered to be a lucrative source of income for healthy volunteers, encouraging some people to become “professional guinea pigs.” Yet, little is known about how much these clinical...

Biomedical Researchers’ Perceptions of the NIH’s Sex as a Biological Variable Policy for Animal Research: Results from a U.S. National Survey

August 26, 2021
Background: In 2015, the National Institutes of Health (NIH) established a policy on sex as a biological variable (SABV) in an effort to address the overrepresentation of men and male animals in biomedical research and the lack of attention to sex-based responses to medical treatments. However, questions remain regarding how...

Ethical Dimensions of Peanut Allergy Immunotherapy Research

August 19, 2021
With funding from the National Institute of Allergy & Infectious Diseases (NIAID), Dr. Jill Fisher is conducting a research study on pediatric clinical trials for food allergies, focusing primarily on peanut allergy. Using ethnographic research methods, the project investigates the on-the-ground ethical challenges that emerge in these clinical trials. In...

Jill Fisher’s Book Wins the Robert K. Merton Book Award

August 12, 2021
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...

Speculating on Precarious Income: Finance Cultures and the Risky Strategies of Healthy Volunteers in Clinical Drug Trials

January 15, 2021
Speculation has become a normalized occupational strategy and quotidian economic rationality that extends throughout society. Although there are many contemporary articulations of speculation, this article focuses on contract labor as a domain of financialization. Seen through this lens, contract labor can be understood as a speculative investment strategy wherein individuals...

Evaluating the National Institutes of Health’s Sex as a Biological Variable Policy: Conflicting Accounts from the Front Lines of Animal Research

December 1, 2020
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...

Healthy Volunteers

November 1, 2020
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...

Gendered Logics of Biomedical Research: Women in U.S. Phase I Clinical Trials

October 11, 2020
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...

“My Body is One of the Best Commodities”: Exploring the Ethics of Commodification in Phase I Healthy Volunteer Clinical Trials

January 23, 2020
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...

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...