Skip to main content

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,...

To Report or Not to Report: Exploring Healthy Volunteers’ Rationales for Disclosing Adverse Events in Phase I Drug Trials

May 31, 2018
Background: Phase I trials test the safety and tolerability of investigational drugs and often use healthy volunteers as research participants. Adverse events (AEs) are collected in part through participants’ self-reports of any symptoms they experience during the trial. In some cases, experiencing AEs can result in trial participation being terminated....

Captive to the Clinic: Phase I Clinical Trials as Temporal Total Institutions

May 9, 2018
This article develops the concept of temporal total institutions to describe how and why individuals voluntarily submit to highly controlled and often dehumanizing environments. We focus empirically on Phase I clinical trials, which offer compensation to healthy people in exchange for testing investigational pharmaceuticals. Analyzing the experiences of 67 U.S....

Exceptional Risk: Healthy Volunteers’ Perceptions of HIV/AIDS Clinical Trials

April 13, 2018
As with all early-stage testing of investigational drugs, clinical trials targeting HIV/AIDS can pose unknown risks to research subjects. Unlike sick participants seeking a therapeutic benefit, the motivations and barriers for healthy volunteers are more complex and understudied. Drawing on interviews and clinical trial data from 178 healthy volunteers, we examine how they perceive...

Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research

January 12, 2018
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...

Ethics of Treatment Interruption Trials in HIV Cure Research

November 10, 2017
Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption (ATI), involve uncertain and potentially high risk, with minimal chance of clinical...

From Fantasy to Reality

October 26, 2017
In this article, we explore the role that fictional media (film and television) play in evoking and managing collective and individual anxieties towards biomedical research. We draw on two data sets: fictional media depictions of human research subjects and interviews with Phase I clinical trial participants conducted in the USA...

Risk and Emotion Among Healthy Volunteers in Clinical Trials

December 20, 2016
Theorized as objective or constructed, risk is recognized as unequally distributed across social hierarchies. Yet the process by which social forces shape risk and risk emotions remains unknown. The pharmaceutical industry depends on healthy individuals to voluntarily test early-stage, investigational drugs in exchange for financial compensation. Emblematic of risk in...

Stem Cell Initiatives as a New Window Into Health Disparities

December 20, 2016
SAGE Publications

This Isn’t Going to End Well

December 20, 2016
Fictional television shows and films convey cultural assumptions about scientists and the research enterprise. But how do these forms of entertainment portray medical research participants? We sampled 65 television shows and films released between 2004 and 2014 to determine the ways in which medical research and human participants are represented...