Contextualizing the Vulnerability Standard

Shivas, Tricha

doi:10.1080/15265160490497137

Cited by 16 publications

(14 citation statements)

References 5 publications

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“…First, the study supports prior recommendations to look at vulnerability as situational, rather then group-based, as is typically used by IRBs in the United States and internationally [3, 4]. At a practical level, we hope that AACTG, PACTG, and HPTN researchers could use the conceptual framework as a guide to identify areas of vulnerability within their respective clinical trial populations, and implement appropriate protections to their informed consent process and/or recruitment procedures.…”

Section: Discussionsupporting

confidence: 64%

“…Using a group-based approach—in which individuals are considered vulnerable if they belong to specified groups—has been criticized to be both too narrow and too broad in scope; too narrow because it does not take into account other factors that lead to vulnerability, or persons or populations with multiple vulnerabilities [3, 4], and too broad because some individuals who belong to these categories are not vulnerable in certain types of research [3, 5]. Another criticism with the group-based approach to identifying vulnerable populations is that the federal regulations do not provide adequate guidance about what additional safeguards should be taken with each of the groups identified [3].…”

Section: Introductionmentioning

confidence: 99%

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How Researchers Define Vulnerable Populations in HIV/AIDS Clinical Trials

Sengupta

Strauss

et al. 2010

AIDS Behav

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In this study, we interviewed researchers, asking them to define vulnerable populations in HIV/AIDS clinical trials, and provide feedback on the federal regulations for three vulnerable populations. Interview data informed a conceptual framework, and were content analyzed to identify acceptability or disagreement with the regulations. Beginning with several characteristics of vulnerable enrollees identified by researchers, the conceptual framework illustrates possible scenarios of how enrollees could be considered vulnerable in clinical research. Content analysis identified barriers affecting HIV/AIDS researchers' ability to conduct clinical trials with pregnant women, prisoners, and children, for which the regulations specify additional protections. This study challenges current thinking about federal regulations' group-based approach to defining vulnerable populations.

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Section: Discussionsupporting

confidence: 64%

Section: Introductionmentioning

confidence: 99%

How Researchers Define Vulnerable Populations in HIV/AIDS Clinical Trials

Sengupta

Strauss

et al. 2010

AIDS Behav

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“…This debate hinges in part on whether defining subgroups as vulnerable is more likely to ensure just treatment of members of that group, or to lead to their unjust stigmatization or exclusion (Hurst 2008;Kipnis 2004;Silvers 2004). The second key question considers the degree to which vulnerability should be conceptualized as arising from situations, contexts or relationships (Finder 2004;Henderson et al 2004;Hurst 2008;Jecker 2004;Levine et al 2004;O'Neill 1996;Shivas 2004) rather than as merely a characteristic of individuals: this question resonates with debates over the degree to which autonomy should be conceptualized relationally.…”

Section: Discussionmentioning

confidence: 99%

Beyond Rhetoric in Debates About the Ethics of Marketing Prescription Medicines to Consumers: The Importance of Vulnerability in People, Situations, and Relationships

Carter

Samuel

Kerridge

et al. 2010

AJOB Primary Research

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“…Second, Kipnis has been criticised by Tricha Shivas for focusing on individuals and the process of informed consent and failing to consider how vulnerabilities impact justice or the fair selection of participants 39. We disagree: many of the vulnerabilities can be applied to entire groups.…”

Section: Vulnerability Critiquesmentioning

confidence: 99%

Developing an ethics framework for living donor transplantation

Ross

Thistlethwaite

2018

J Med Ethics

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Both living donor transplantation and human subjects research expose one set of individuals to clinical risks for the clinical benefits of others. In the the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research (National Commission) articulated three principles to serve as the basis for a research ethics framework: respect for persons, beneficence and justice. In contrast, living donor transplantation lacks a framework. In this manuscript, we adapt the three principles articulated in the to serve as the foundation for an ethics framework for living donor transplantation which we supplement with the principles of vulnerability and responsibility. The National Commission supported additional protections for vulnerable groups of potential research participants. In 2001, Kenneth Kipnis effectively argued that the concept of vulnerable groups failed to explore in what ways particular groups of people were vulnerable, thereby risking unnecessary protections for some and inadequate protections for others. He proposed a taxonomy that explored different types of vulnerabilities that all research participants may experience to provide a more robust framework for human subjects protections, which we adapt to living donors. Robert Goodin claims that health professionals, who stand in special relationship with patients, are responsible for promoting and protecting their well-being. In living donor transplantation, the donor transplant team is responsible for empowering prospective donors to address their vulnerabilities and/or for protecting those who cannot by disqualifying them from donation.

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Contextualizing the Vulnerability Standard

Cited by 16 publications

References 5 publications

How Researchers Define Vulnerable Populations in HIV/AIDS Clinical Trials

How Researchers Define Vulnerable Populations in HIV/AIDS Clinical Trials

Beyond Rhetoric in Debates About the Ethics of Marketing Prescription Medicines to Consumers: The Importance of Vulnerability in People, Situations, and Relationships

Developing an ethics framework for living donor transplantation

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