Speculating on Health

2020 ◽  
pp. 230-252
Author(s):  
Jill A. Fisher
Keyword(s):  
Clinical Trials ◽  
Health Behaviors ◽  
Phase I ◽  
Healthy Volunteers ◽  
Illicit Drugs ◽  
Model Organism ◽  
Healthy Weight ◽  
Economic Risk ◽  
Screening Process ◽  
Investigational Drugs

While healthy volunteers are concerned about the risks of studies, they are often much more vocal about the economic risk of not qualifying for studies. This chapter examines how being disqualified from studies through screen failures heightens their sense of risk as they attempt to earn income through clinical trials. It also considers how the screening process itself profoundly influences their health behaviors even outside of their study participation, including maintaining a healthy weight, eating nutritious food, consuming vitamins and supplements, and abstaining from deleterious substances, such as alcohol, tobacco, and illicit drugs. These actions on the part of healthy volunteers, which contribute to their model organism status, indicate that Phase I participation could counterintuitively improve their general health even as they expose themselves to the unknown risks of investigational drugs.

A Laboratory for Human Animals

2020 ◽  
pp. 129-150
Author(s):  
Jill A. Fisher
Keyword(s):  
Clinical Trials ◽  
Healthy Volunteer ◽  
Phase I ◽  
Healthy Volunteers ◽  
Model Organism ◽  
Phase I Trials ◽  
Strict Inclusion ◽  
And Control ◽  
Physiological Markers ◽  
Later Phase

The Phase I clinic can be seen as a type of laboratory for human animals. Chapter 5 further develops the concept of the healthy volunteer as a model organism, and it explores how standardization and control are imposed on healthy volunteers who are confined for studies. In Phase I clinics, what happens, and how often, to participants differs dramatically from later-phase clinical trials. Additionally, the strict inclusion-exclusion criteria for studies define “healthy” in terms of narrow physiological markers that volunteers must meet in order to participate. In the process, the healthy volunteer becomes a type of model organism that is maximally suited to Phase I research. The chapter also illustrates how research staff’s practices in selecting and managing healthy volunteers define who can enroll at their clinics and normalize those participants to the demands of Phase I trials.

Constructing Risk Knowledge

2020 ◽  
pp. 206-229
Author(s):  
Jill A. Fisher
Keyword(s):  
Phase I ◽  
Healthy Volunteers ◽  
Phase I Study ◽  
Model Organism ◽  
Clinical Procedures ◽  
Collective Risk ◽  
Investigational Drugs ◽  
Personal Experiences ◽  
Collective Experience ◽  
Risk Knowledge

Healthy volunteers’ construction of trials as safe is enabled by their categorization of some studies as riskier than others. Chapter 8 describes this process as a type of model organism epistemology and illustrates how this knowledge comes from personal experiences as well as stories and rumors healthy volunteers hear from other participants. This information accretes into what could be thought of as collective “risk filters” when the same types of investigational drugs or clinical procedures continuously emerge at the center of healthy volunteers’ stories. A risk filter acts as a preliminary basis for evaluating the risk of a specific Phase I study by comparing it to the collective experience of participants in similar clinical trials. Regardless of their claims about inherent risk, healthy volunteers mobilize this information in their decision-making about which Phase I trials to join and which to avoid.

scholarly journals Appraising Harm in Phase I Trials: Healthy Volunteers' Accounts of Adverse Events

2019 ◽  
Vol 47 (2) ◽  
pp. 323-333 ◽  
Author(s):  
Lisa McManus ◽  
Arlene Davis ◽  
Rebecca L. Forcier ◽  
Jill A. Fisher
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Events ◽  
Phase I ◽  
Healthy Volunteers ◽  
Trial Participation ◽  
Trial Participant ◽  
Phase I Trials ◽  
Investigational Drugs ◽  
Motivation To Participate

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 financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of the adverse events (AEs) they experience during clinical trials. Drawing upon qualitative research, we find that participants largely minimize, deny, or re-attribute the cause of these AEs. We illustrate how participants' interpretations of AEs may be shaped both by the clinical trial environment and their economic motivation to participate. While these narratives are emblematic of the larger ambiguity surrounding harm in the context of clinical trial participation, we argue that these interpretations also problematically maintain the narrative of the safety of clinical trials, the ethics of testing investigational drugs on healthy people, and the rigor of data collected in the specter of such ambiguity.

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

2018 ◽  
Vol 13 (5) ◽  
pp. 494-510 ◽  
Author(s):  
Jill A. Fisher ◽  
Lisa McManus ◽  
Megan M. Wood ◽  
Marci D. Cottingham ◽  
Julianne M. Kalbaugh ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
Employment Status ◽  
Qualitative Interviews ◽  
Trial Participation ◽  
Phase I Trials ◽  
Phase I Clinical Trials ◽  
Financial Compensation ◽  
Trial History

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, including, but not limited to, the financial compensation, and we analyzed how these perceptions varied based on participants’ sociodemographic characteristics and clinical trial history. We found that participants detailed economic, societal, and noneconomic personal benefits. We also found differences in participants’ perceived benefits based on gender, age, ethnicity, educational attainment, employment status, and number of clinical trials completed. Our study indicates that many healthy volunteers believe they gain more than just the financial compensation when they accept the risks of Phase I participation.

A Study on the Characteristics of Healthy Volunteers who Participate in Phase I Clinical Trials in Korea

2021 ◽  
pp. 155626462110342
Author(s):  
Ji-Hye Seo ◽  
Ock-Joo Kim ◽  
Sang-Ho Yoo ◽  
Eun Kyung Choi ◽  
Ji-Eun Park
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
Health Science ◽  
Trial Participation ◽  
Phase I Clinical Trials ◽  
Financial Reward ◽  
Therapeutic Purpose ◽  
The Republic

The phase I trial is the first step in administering a drug to humans, but it has no therapeutic purpose. Under the absence of therapeutic purpose, healthy volunteers demonstrated different motivations, unlike the actual patients participating in trials. There were many reported motivations, such as financial motivation, contributing to the health science, accessing ancillary health care benefits, scientific interest or interest in the goals of the study, meeting people, and general curiosity. The aim of this study was to identify the motivation and characteristics of healthy volunteers participating in phase I trials in the Republic of Korea. We gave surveys to 121 healthy volunteers to study their demographic characteristics and the reasons of participation. We identified whether the decision to participate in the research was influenced by demographic factors and whether the perception and attitudes toward the research were influenced by the characteristics of the healthy volunteers. After completion of the first survey, 12 healthy volunteers who had participated in a phase I clinical trial were selected to answer the second interview. According to our survey, most healthy volunteers were unmarried men and economically dependent. Most of them participated in the study because of financial reward. The most important factor to measure financial reward was the research period. Also, 43% of the volunteers were university students, 42% answered “university graduation” and 55% were residing in family-owned houses. Many healthy volunteers were found to be living in family homes and to have a student status or lack of economic independence. Results of the survey showed that 64% of respondents indicated having more than one clinical trial participation. In-depth interviews showed that healthy volunteers had diverse motivation to participate in research and that healthy volunteer perceive the clinical trial positively. The main motivation for healthy volunteers’ participation in research was “financial reward.” Healthy volunteers also considered research schedules, processes, and safety, and had a positive perception of clinical trials, but they thought that the public has a negative perception.

A Tale of Three Cultures

2020 ◽  
pp. 75-99
Author(s):  
Jill A. Fisher
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
West Coast ◽  
East Coast ◽  
Trial Participation ◽  
Phase I Trials ◽  
Hybrid Culture ◽  
Active Pursuit

Despite similar financial goals among healthy volunteers, there are regional differences in the culture of Phase I participation. Chapter 3 focuses on this theme to further unpack variations in how patterns of imbricated stigma influence healthy volunteers’ perceptions of Phase I trials, particularly with respect to the longevity of their study involvement. Specifically, East Coast participants tend to be well-networked as part of their long-term, active pursuit of clinical trials, but they often also express anti-capitalist critiques of the industry. In comparison, Midwesterners tend to be more passive about their trial participation, thinking of it as a short-term financial opportunity to counterbalance a temporary setback. West Coast participants occupy a hybrid culture between those of the East Coast and Midwest participants, actively seeking out new studies but expressing a distrust in the clinics and wanting to limit their study involvement. These regional cultures act as a prism for healthy volunteers’ perceptions of Phase I trials, shaping whether and how they adopt identities as research participants.

Comprehension and recall from the informed consent process by phase I healthy volunteers before dose administration

2019 ◽  
Vol 16 (3) ◽  
pp. 283-289 ◽  
Author(s):  
Rami Tadros ◽  
Gillian E Caughey ◽  
Sally Johns ◽  
Sepehr Shakib
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Phase I ◽  
Healthy Volunteers ◽  
Drug Administration ◽  
Study Drug ◽  
Informed Consent Process ◽  
Consent Process ◽  
Phase I Clinical Trials ◽  
Study Drug Administration

Aims/Background A fundamental part of all clinical trials is informed consent, reflecting the respect for the volunteer’s autonomy. Research participation is voluntary; therefore, certain aspects of the proposed study must be disclosed so that volunteers can make an informed decision. In this study, we aimed to examine the level of comprehension and recall of healthy volunteers from the informed consent process. Methods The study was carried out at a single phase I clinical trials unit. A questionnaire was administered to each volunteer to assess recall of important aspects of the study at the day-1 visit following the informed consent process. The questionnaire contained seven questions regarding study objectives, route, frequency and type of drug administration, adverse effects, number of subjects previously exposed and remuneration. One point was awarded for each correct answer. Results A total of 266 volunteers were administered the questionnaire. The mean total score (±standard deviation) for all volunteers was 4.5 ± 1.1 points out of 7, with a range of 0.8–6.7. For all 10 studies, 91% of volunteers responded correctly when answering about the route of administration, and 90% were able to accurately state the correct payment amount. Only 7% were able to repeat the aims of the study correctly. Conclusion The poor performance of our study volunteers raises concerns about recall of information prior to study drug administration. This has implications for the volunteer’s safety and ability to provide true informed consent. Interventions to improve recall prior to dosing should be undertaken.

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