Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional regulatory (...) protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research. (shrink)

Individuals with limited resources are often presumed to be vulnerable in research. Concerns include the possibility of impaired decision making, susceptibility to undue inducement, and risk of exploitation. Although each of these concerns should be considered by investigators and IRBs, none justifies categorical exclusion of individuals with limited resources.

Vulnerability in research is often understood as a diminished ability to protect one's own interests, manifested by a compromised capacity to give informed or voluntary consent. Certain groups of people are thought to be more vulnerable than others and therefore are at risk of being exploited or mistreated in research. Accordingly, the federal regulations call for additional safeguards to protect vulnerable groups.There remains some ambiguity and contradiction, however, regarding what groups are vulnerable in research and why,3 since the available codes (...) of research ethics and regulations describe many groups as vulnerable. When so many groups are considered vulnerable, but no specification is offered as to how they are vulnerable or what particular protections are appropriate, the possibility of meaningful safeguards is diminished. In addition, current concepts of vulnerability are usually applied to whole groups of people, without distinguishing between individuals in a group who might truly have a compromised capacity to protect their own interests from those who do not. (shrink)

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

The nursing community in the United States polarized in September 2020 between Dawn Wooten's whistleblowing about forced hysterectomies at an immigration center in Georgia and the American Nurses Association's refusal to endorse a presidential candidate despite the Trump administration's mounting failures to address the public health crisis posed by the COVID‐19 pandemic. This reveals a need for more attention to political aspects of health outcome inequities. As advocates for health equity, nurses can join in recent scholarship and activism concerning the (...) political determinants of health. In this paper, we examine recent work on the political determinants of health with an aim to add two things. First, we seek to build further on the notion of “political” determinants of health by distinguishing policy and governance structures from dynamics of politicization through appeal to critical disabilities studies. Second, we seek to apply this further nuanced approach to challenge rhetorical uses of “vulnerable populations,” where this phrase serves to misrecognize systemic institutionalized forces that actively exploit and marginalize people and groups. By refocusing attention to political systems organized around and perpetuating inequitable health outcomes, nurses and other health care professionals—as well as those whom they serve—can concentrate their effort and power to act on political determinants of health in bringing about more equitable health outcomes. (shrink)