In this classic work of feminist political thought, Iris Marion Young challenges the prevailing reduction of social justice to distributive justice.

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)

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)

Given that health systems research involves different aims, approaches, and methodologies as compared to more traditional clinical trials, the ethical issues present in HSR may be unique or particularly nuanced. This article outlines eight pertinent ethical issues that are particularly salient in HSR and argues that the ethical review process should be better tailored to ensure more efficient and appropriate oversight of HSR with adequate human protections, especially in low- and middle-income countries. The eight ethical areas we discuss include the (...) nature of intervention, types of research subjects, units of intervention and observation, informed consent, controls and comparisons, risk assessment, inclusion of vulnerable groups, and benefits of research. HSR involving human participants is necessary to ensure health systems strengthening and quality of care and to guide public policy intelligently. Health systems researchers must carefully define their intent and goals and openly clarify the values that may influence the premises and design of protocols. As new types of population-level research activities become more commonplace, it is critical that institutional review board and research ethics committee review processes evolve to evaluate these research protocols in ways that address the nuanced features of these studies. (shrink)