Whether intended or not, conceptions of informed consent are often rooted in archetypal notions of the researcher and prospective study participant. The former is assumed problematically to be a disinterested yet humanitarian individual who is well trained to conduct robust science. The latter is often characterized as being motivated by some altruistic notions about the contribution to science and society they are making even as they seek some personal benefit from the research. Cast in a dyad, the researcher has the (...) responsibility to inform the participant thoroughly about the purpose of the research, the risks and benefits of participation, and any alternatives to research available, as well as the .. (shrink)

Several foundational documents of bioethics mention the special obligation researchers have to vulnerable research participants. However, the treatment of vulnerability offered by these documents often relies on enumeration of vulnerable groups rather than an analysis of the features that make such groups vulnerable. Recent attempts in the scholarly literature to lend philosophical weight to the concept of vulnerability are offered by Luna and Hurst. Luna suggests that vulnerability is irreducibly contextual and that Institutional Review Boards (Research Ethics Committees) can only (...) identify vulnerable participants by carefully examining the details of the proposed research. Hurst, in contrast, defines the vulnerable as those especially at risk of incurring the wrongs to which all research ethics participants are exposed. We offer a more substantive conception of vulnerability than Luna but one that gives rise to a different rubric of responsibilities from Hurst's. While we understand vulnerability to be an ontological condition of human existence, in the context of research ethics, we take the vulnerable to be research subjects who are especially prone to harm or exploitation. Our analysis rests on developing a typology of sources of vulnerability and showing how distinct sources generate distinct obligations on the part of the researcher. Our account emphasizes that the researcher's first obligation is not to make the research participant even more vulnerable than they already are. To illustrate our framework, we consider two cases: that of a vulnerable population involved in international research and that of a domestic population of people with diminished capacity. (shrink)

What makes individuals, groups, or even entire countries vulnerable? And why is vulnerability a concern in bioethics? A simple answer to both questions is that vulnerable individuals and groups are subject to exploitation, and exploitation is morally wrong. This analysis is limited to two areas. First is the context of multinational research, in which vulnerable people can be exploited even if they are not harmed, and harmed even if they are not exploited. Second is the situation of women, who are (...) made vulnerable in cultural settings or in entire countries in which they are oppressed and powerless. (edited). (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)

Risk and benefit assessment is one of the fundamental requirements in the ethical review of research involving human participants. As a result, researchers should evaluate and seek to minimize all foreseeable risks involved in their proposed research and members of research ethics committees should evaluate and balance the risks and potential benefits involved in each research proposal as a part of their ethical obligations regarding research protocols. However, current literature provides little detailed guidance on the specifics of how this balancing (...) process should occur. Consequently, this article provides some details of the process to balance risks and benefits in biomedical research and reminds members of research ethics committees of their responsibility to protect those who are vulnerable from exploitation in research projects. (shrink)

Beneficence is one of the four principles that form the basis of the Australian National Statement. The aim of this paper is to explore the philosophical development of this principle and to clarify the role that beneficence plays in contemporary discussions about human research ethics. By examining the way that guidance documents, particularly the National Statement, treats beneficence we offer guidance to researchers and human research ethics committee members on the practical application of what can be a conceptually difficult principle.

In this article I examine several criticisms of the concept of vulnerability. Rather than rejecting the concept, however, I argue that a sufficiently rich understanding of vulnerability is essential to bioethics. The challenges of international research in developing countries require an understanding of how new vulnerabilities arise from conditions of economic, social and political exclusion. A serious shortcoming of current conceptions of vulnerability in research ethics is the tendency to treat vulnerability as a label fixed on a particular subpopulation. My (...) paper examines the role of this “label” metaphor in current statements of research ethics. In contrast to this prevailing “label” metaphor, my own positive account of vulnerability develops a dynamic way of understanding the structure of the concept of vulnerability based on the idea of “layers of vulnerability.” I examine several cases involving women, as they are sometimes labeled as a vulnerable population and sometimes not. My analysis demonstrates the essential role of this revised concept of vulnerability in bioethics and research ethics. (shrink)

Research involving migrant youth involves navigating and negotiating complex challenges in order to uphold their rights and dignity, but also all while maintaining scientific rigour. COVID-19 has changed the global landscape within many domains and has increasingly highlighted inequities that exist. With restrictions focusing on maintaining physical distancing set in place to curb the spread of the virus, conducting in-person research becomes complicated. This article reflects on the ethical and methodological challenges encountered when conducting qualitative research during the pandemic with (...) Syrian migrant youth who are resettled in Canada. The three areas discussed from the study are recruitment, informed consent and managing the interviews. Special attention to culture as being part of the study’s methodology as an active reflexive process is also highlighted. The goal of this article is to contribute to the growing understanding of complexities of conducting research during COVID-19 with populations which have layered vulnerabilities, such as migrant youth. This article hopes that the reflections may help future researchers in conducting their research during this pandemic by being cognizant of both the ethical and methodological challenges discussed. (shrink)

Concern for human vulnerability seems to be at the heart of bioethical inquiry, but the concept of vulnerability is under-theorized in the bioethical literature. The aim of this article is to show why bioethics needs an adequately theorized and nuanced conception of vulnerability. We first review approaches to vulnerability in research ethics and public health ethics, and show that the bioethical literature associates vulnerability with risk of harm and exploitation, and limited capacity for autonomy. We identify some of the challenges (...) emerging from this literature: in particular, how to reconcile universal human vulnerability with a context-sensitive analysis of specific kinds and sources of vulnerability; and how to reconcile obligations to protect vulnerable persons with obligations to respect autonomy. We then briefly survey some of the theoretical resources available within the philosophical literature to address these challenges, and to assist in understanding the conceptual connections between vulnerability and related concepts such as harm, exploitation, needs, and autonomy. We also sketch out a taxonomy of sources and kinds of vulnerability. Finally, we consider the implications for policy evaluation of making vulnerability an explicit and central focus of bioethics. Our investigation is in the form of a broad survey motivating a research agenda rather than a detailed analysis. (shrink)

Vulnerabilities often characterize the availability of immigrant populations of interest in social behavioral science, public health, and medical research. Refugees, asylum seekers, and undocumented immigrants present unique vulnerabilities relevant to protocol development as well as ethics review procedures and criteria. This paper describes vulnerable populations in relation to the Belmont Report and US federal regulations for the protection of human subjects, both of which are commonly used in international research contexts. It argues for safeguards for immigrants comparable to protections for (...) such populations as pregnant women, prisoners, and children. The paper further presents a two-part model for the review of protocols that involve immigrants. The model is intended to help identify the risks to immigrants associated with participation in research, and to suggest how researchers can responsibly frame studies and access to research participant immigrants through community-based, and/or non-governmental organizations that serve immigrants and immigrant communities. (shrink)

Despite broad agreement that the vulnerable have a claim to special protection, defining vulnerable persons or populations has proved more difficult than we would like. This is a theoretical as well as a practical problem, as it hinders both convincing justifications for this claim and the practical application of required protections. In this paper, I review consent-based, harm-based, and comprehensive definitions of vulnerability in healthcare and research with human subjects. Although current definitions are subject to critique, their underlying assumptions may (...) be complementary. I propose that we should define vulnerability in research and healthcare as an identifiably increased likelihood of incurring additional or greater wrong. In order to identify the vulnerable, as well as the type of protection that they need, this definition requires that we start from the sorts of wrongs likely to occur and from identifiable increments in the likelihood, or to the likely degree, that these wrongs will occur. It is limited but appropriately so, as it only applies to special protection, not to any protection to which we have a valid claim. Using this definition would clarify that the normative force of claims for special protection does not rest with vulnerability itself, but with pre-existing claims when these are more likely to be denied. Such a clarification could help those who carry responsibility for the protection of vulnerable populations, such as Institutional Review Boards, to define the sort of protection required in a more targeted and effective manner. (shrink)

The idea that research with human participants should benefit society has become firmly entrenched in various regulations, policies, and guidelines, but there has been little in-depth analysis of this ethical principle in the bioethics literature. In this paper, I distinguish between strong and weak versions and the social benefits principle and examine six arguments for it. I argue that while it is always ethically desirable for research with human subjects to offer important benefits to society, the reasonable expectation of substantial (...) public benefit should be a necessary condition for regarding research as ethical only when it imposes more than minimal risks on non-consenting subjects; or it is supported by public resources. (shrink)

The development of ethical guidelines and regulations regarding human subjects research has focused upon protection of vulnerable populations by relying on a limited typology of vulnerabilities. This results in several challenges: First, Institutional Review Boards struggle to interpret and apply the regulations because they are often vague and inconsistent. Second, applying the regulations to subjects who fit within multiple categories of vulnerability can lead to contradictions and the rejection of research that would be permissible if only one category were applicable. (...) Finally, some potential subjects have social and other context-based vulnerabilities that are not described in the federal regulations... (shrink)

The concept of vulnerability has been subject to numerous different interpretations but accounts are still beset with significant problems as to their adequacy, such as their contentious application or the lack of genuine explanatory role for the concept. The constant failure to provide a compelling conceptual analysis and satisfactory definition leaves the concept open to an eliminativist move whereby we can question whether we need the concept at all. I highlight problems with various kinds of approach and explain why a (...) satisfactory account of vulnerability is unlikely ever to be offered if we wish the concept to play a genuinely explanatory role in bioethical contexts. I outline why an eliminativist position should be taken with regard to this concept in light of these concerns but mitigate some of the severity of this position by arguing that we can still make sense of retaining our widespread use of the term by viewing it as nothing more than a useful pragmatic linguistic device that acts as a marker to draw attention to certain kinds of issue. These issues will be entirely governed by other, better understood ethical concepts and theories. (shrink)