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1.
J Bioeth Inq ; 16(4): 535-549, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31713712

RESUMO

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 clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others' experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials.

4.
J Law Med Ethics ; 47(2): 323-333, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31298107

RESUMO

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.

5.
Ethics Hum Res ; 41(1): 4-14, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30744313

RESUMO

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 dissimilar to the target population. By mobilizing a model-organism framework for phase I trials, we employ concepts and mechanisms typical to animal research to query gaps in the human subjects ethics and policy framework. By bringing these two research worlds together, we aim to illustrate how the model-organism framework can enhance healthy volunteers' welfare during trials, improve research oversight, and more critically assess the science value of current phase I trials.


Assuntos
Experimentação Animal/ética , Ética em Pesquisa , Voluntários Saudáveis , Adulto , Animais , Drogas em Investigação/administração & dosagem , Humanos , Políticas
6.
Kennedy Inst Ethics J ; 29(4): 305-331, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31983696

RESUMO

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 through. However, commodification is rarely investigated as an ethical dimension of phase I trial participation. We address this gap in the literature by bringing the voices of phase I healthy volunteers into conversation with philosophical perspectives on body commodification. Querying the intersection of commodification and phase I clinical trials illuminates important features of healthy volunteers' experiences, disentangles commodification from a dominant narrative about exploitation, and brings focus to the question of what, if any, market norms will best protect the multiple ways in which healthy volunteers' welfare is impacted by clinical trial participation.

7.
Sociol Inq ; 88(4): 724-748, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30546162

RESUMO

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. healthy volunteers, we illustrate how comparisons between Phase I trials and prison are salient to participants as they reflect on their confinement in research facilities and their interactions with other participants and research staff. We argue that conditions of contemporary economic insecurity and/or poverty facilitate the existence of coercive temporal total institutions by undermining voluntariness. Phase I clinics take advantage of the steady supply of individuals who will submit to the organization's demands out of hope that the income gained will be transformative for their lives.

8.
PLoS Med ; 15(11): e1002698, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30457992

RESUMO

BACKGROUND: 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 investigate (1) participants' views of the overall risks of Phase I trials, (2) their views of the risk of personally being harmed in a trial, and (3) how risk perceptions vary across participants' clinical trial history and sociodemographic characteristics. METHODS AND FINDINGS: We qualitatively and quantitatively analyzed semi-structured interviews conducted with 178 healthy volunteers who had participated in a diverse range of Phase I trials in the United States. Participants had collective experience in a reported 1,948 Phase I trials (mean = 10.9; median = 5), and they were interviewed as part of a longitudinal study of healthy volunteers' risk perceptions, their trial enrollment decisions, and their routine health behaviors. Participants' qualitative responses were coded, analyzed, and subsequently quantified in order to assess correlations between their risk perceptions and demographics, such as their race/ethnicity, gender, age, educational attainment, employment status, and household income. We found that healthy volunteers often viewed the overall risks of Phase I trials differently than their own personal risk of harm. The majority of our participants thought that Phase I trials were medium, high, or extremely high risk (118 of 178), but most nonetheless felt that they were personally safe from harm (97 of 178). We also found that healthy volunteers in their first year of clinical trial participation, racial and ethnic minority participants, and Hispanic participants tended to view the overall trial risks as high (respectively, Jonckheere-Terpstra, -2.433, p = 0.015; Fisher exact test, p = 0.016; Fisher exact test, p = 0.008), but these groups did not differ in regard to their perceptions of personal risk of harm (respectively, chi-squared, 3.578, p = 0.059; chi-squared, 0.845, p = 0.358; chi-squared, 1.667, p = 0.197). The main limitation of our study comes from quantitatively aggregating data from in-depth interviews, which required the research team to interpret participants' nonstandardized risk narratives. CONCLUSIONS: Our study demonstrates that healthy volunteers are generally aware of and reflective about Phase I trial risks. The discrepancy in healthy volunteers' views of overall and personal risk sheds light on why healthy volunteers might continue to enroll in clinical trials, even when they view trials on the whole as risky.


Assuntos
Ensaios Clínicos Fase I como Assunto/métodos , Conhecimentos, Atitudes e Prática em Saúde , Voluntários Saudáveis/psicologia , Seleção de Pacientes , Percepção , Sujeitos da Pesquisa/psicologia , Adolescente , Adulto , Compreensão , Feminino , Humanos , Consentimento Livre e Esclarecido , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , Medição de Risco , Fatores de Risco , Estados Unidos , Adulto Jovem
10.
J Empir Res Hum Res Ethics ; 13(5): 494-510, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30296882

RESUMO

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.


Assuntos
Atitude , Pesquisa Biomédica , Voluntários Saudáveis , Motivação , Seleção de Pacientes , Adolescente , Adulto , Ensaios Clínicos Fase I como Assunto , Tomada de Decisões , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , Remuneração , Fatores Socioeconômicos , Estados Unidos , Adulto Jovem
11.
J Acquir Immune Defic Syndr ; 79 Suppl 1: S30-S36, 2018 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-30222703

RESUMO

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 HIV/AIDS studies in the early stages of testing. A subset of healthy volunteers see phase I HIV/AIDS studies as particularly risky for reasons ranging from fear of catching the disease or having long-lasting and uncomfortable side effects to inexplicable fears that they cannot even articulate. Some participants have had past negative experiences in such trials that inform these views, but others cite information from staff and other participants as influential. Healthy volunteers' general fears concerning AIDS also shape their views of participating in phase I HIV/AIDS clinical trials.


Assuntos
Fármacos Anti-HIV/administração & dosagem , Ensaios Clínicos como Assunto , Medo/fisiologia , Infecções por HIV/tratamento farmacológico , Voluntários Saudáveis/psicologia , Motivação/fisiologia , Adolescente , Adulto , Feminino , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Adulto Jovem
12.
AJOB Empir Bioeth ; 9(2): 82-90, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29693508

RESUMO

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. Because of the economic incentives underlying their motivation to participate, there is concern that healthy volunteers routinely fail to report AEs and thereby jeopardize the validity of the trial results. METHODS: We interviewed 131 U.S. healthy volunteers about their experiences with AEs, including their rationales for reporting or failing to report symptoms. RESULTS: We found that participants have three primary rationales for their AE reporting behavior: economic, health-oriented, and data integrity. Participants often make decisions about whether to report AEs on a case-by-case basis, evaluating what effects reporting or not reporting might have on the compensation they receive from the trial, the risk to their health, and the results of the particular clinical trial. Participants' interpretations of clinic policies, staff behaviors, and personal or vicarious experiences with reporting AEs also shape reporting decisions. CONCLUSIONS: Our findings demonstrate that participants' reporting behavior is more complex than previous portraits of healthy volunteers have suggested. Rather than finding participants who were so focused on the financial compensation that they were willing to subvert trial results, our study indicates that participants are willing in most cases to forgo their full compensation if they believe not reporting their symptoms jeopardizes their own safety or the validity of the research.


Assuntos
Compensação e Reparação/ética , Revelação/estatística & dados numéricos , Conhecimentos, Atitudes e Prática em Saúde , Voluntários Saudáveis/psicologia , Seleção de Pacientes/ética , Sujeitos da Pesquisa/psicologia , Adulto , Ensaios Clínicos Fase I como Assunto , Revelação/ética , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Motivação , Pesquisa Qualitativa , Autorrelato , Estados Unidos , Adulto Jovem
13.
J Med Philos ; 43(1): 83-114, 2018 01 12.
Artigo em Inglês | MEDLINE | ID: mdl-29342285

RESUMO

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 undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules.


Assuntos
Ensaios Clínicos Fase I como Assunto/ética , Ensaios Clínicos Fase I como Assunto/métodos , Coerção , Ética em Pesquisa , Voluntários Saudáveis/psicologia , Adulto , Feminino , Humanos , Consentimento Livre e Esclarecido/ética , Masculino , Princípios Morais , Medição de Risco , Populações Vulneráveis/psicologia
14.
Health Risk Soc ; 19(5-6): 284-300, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29249899

RESUMO

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 in 2013. We show how fictional media provide an outlet for collective uncertainties surrounding biomedical research through depictions that mock and dehumanise research participants, using such emotions of shock, disgust, pity, amusement and humour. We analyse how themes from fictional media are also used to manage actual clinical trial participants' own anxiety concerning the unknown risks of research participation. By contrasting the reality of their research experience with fantasy derived from entertainment media, clinical trial participants minimise the seriousness of the side effects they have or may experience in actual Phase I clinical trials. We conclude that fictional media serve an important role in the collective and individual management of risk emotion.

15.
Public Underst Sci ; 26(5): 564-578, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27048679

RESUMO

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 in popular media. We found that research participants are largely represented as White, male, and lower or working class and that 40% of the participants depicted in these fictional accounts were seeking financial compensation, 34% were hoping for a therapeutic benefit, and 15% were coerced into participation. Regardless of participant motivation, media representations tended to portray a negative outcome of medical research. Interpreting the themes in these media, we argue that these fictional portrayals might provide the public with valuable representations of medical research, especially in terms of risks to research participants, scientific failure, and researchers' conflicts of interest.


Assuntos
Pesquisa Biomédica , Filmes Cinematográficos , Percepção , Televisão , Motivação , Opinião Pública
16.
Soc Psychol Q ; 79(3): 222-242, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28867852

RESUMO

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 late modernity, Phase I testing is a rich site for examining how class and race shape configurations of emotion and risk. Using interview data from 178 healthy trial participants, this article examines emotion and risk as mutually constituting processes linked to biographical context and social structure. Biographical events like economic insecurity and incarceration influence how risk is felt by providing comparative experiences of felt risk and felt benefits. Such events, in turn, are structured by class-based and racial inequalities, linking class and race positions to primary emotional experiences of risk.

17.
J Contemp Ethnogr ; 44(6): 709-736, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26688613

RESUMO

Establishing contacts and gaining permission to conduct ethnographic or qualitative research can be time-consuming and stressful processes. Gaining access can be especially challenging when representatives of prospective research sites see their work as being sensitive and would prefer to avoid outside scrutiny altogether. One result of this dynamic is that many organizations that exert a profound influence in governing populations and regulating individuals' access to basic needs are relatively invisible to the public and shielded from meaningful public accountability. Therefore, it is vital to effectively study secretive or guarded organizations and fill out the empirical record, which in turn could create the conditions for greater public awareness and debate. To that end, this paper draws on our collective research experience and the scholarship of others to present nine strategies that we have found to be especially effective for securing access to secretive organizations.

18.
Sci Technol Human Values ; 40(2): 199-226, 2015 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-25914430

RESUMO

Phase I clinical trials are the first stage of testing new pharmaceuticals in humans. The majority of these studies are conducted under controlled, inpatient conditions using healthy volunteers who are paid for their participation. This article draws on an ethnographic study of six phase I clinics in the United States, including 268 semistructured interviews with research staff and healthy volunteers. In it, I argue that an institutional banalization of risk structures the perceptions of research staff and healthy volunteers participating in the studies. For research staff, there are three mechanisms by which risk becomes banal: a perceived homogeneity of studies, Fordist work regimes, and data-centric discourse. For healthy volunteers, repeat study participation contributes to the institutional banalization of risk both through the process of desensitization to risk and the formation of trust in the clinics. I argue that the institutional banalization of risk also renders invisible ethical concerns about exploitation of underprivileged groups in pharmaceutical research.

19.
J Empir Res Hum Res Ethics ; 10(1): 65-75, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25742668

RESUMO

Phase I testing of investigational drugs relies on healthy volunteers as research participants. Many U.S. healthy volunteers enroll repeatedly in clinical trials for the financial compensation. Serial participants are incentivized to ignore restrictions on their participation, and no centralized clinical trial registry prevents dual enrollment. Little is currently known about how healthy volunteers participate in studies over time, hampering the development of policies to protect this group. We detail a methodology developed as part of a longitudinal study to track in real-time healthy volunteers' Phase I participation. Illustrating these data through three case studies, we document how healthy volunteers use strategies, such as qualifying for studies at more than one clinic and traveling significant distances, to maximize their participation. Our findings suggest that "clinical trial diaries" can generate critical information about serial research participation and point to ethical issues unique to healthy volunteers' involvement in Phase I clinical trials.


Assuntos
Ensaios Clínicos Fase I como Assunto/ética , Voluntários Saudáveis , Seleção de Pacientes/ética , Adolescente , Adulto , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Registros , Estados Unidos , Adulto Jovem
20.
Sociol Health Illn ; 37(1): 127-42, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25601069

RESUMO

The first stage of testing new pharmaceuticals in humans is referred to as a phase I clinical trial. The purpose of these studies is to test the safety of the drugs and to establish appropriate doses that can later be given to patients. Most of these studies are conducted under controlled, in-patient conditions using healthy volunteers who are paid for their participation. To explore healthy volunteers' experiences in clinical trials, an ethnographic study was conducted at six in-patient phase I clinics in the USA. In addition to the observation of clinic activities (from informed consent procedures to dosing to blood draws), 268 semi-structured interviews were conducted, 33 with clinic staff and 235 with healthy volunteers. Drawing on this dataset, this article explores healthy volunteers' exchange of contemporary legends about phase I clinical trials. In addition to potentially scaring the listener and communicating distrust in the medical community, these incredible stories help participants cope with perceived stigma and establish a gradient of risk of trial participation, creating potential boundaries to their participation in medical research. The article argues that contemporary legends play a productive role in society, shaping how people view themselves and others and influencing their decisions about risky activities.


Assuntos
Ensaios Clínicos Fase I como Assunto , Drogas em Investigação , Voluntários Saudáveis/psicologia , Sujeitos da Pesquisa/psicologia , Feminino , Humanos , Entrevistas como Assunto , Masculino , Assunção de Riscos , Estados Unidos
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