Identifying and evaluating layers of vulnerability -a way forward

Ochsner Journal

Background: The concept of vulnerability is a cornerstone of the theoretical basis and practical application of ethics in human subjects research. Risks to humans participating in research must be minimized; that is, subjects must be offered protection from risks. Vulnerable subjects require additional protections. Methods: This paper reviews the ethical and conceptual basis of vulnerability within the context of human subjects research and suggests a basic approach that institutional review boards (IRBs) can use when considering if the research includes adequate safeguards to protect the rights and welfare of subjects who are likely to be vulnerable. Results: Two distinct approaches to describing the features that make a person vulnerable are the categorical approach and the contextual approach. The categorical approach considers certain groups or populations as vulnerable. This approach is not optimal because it does not address persons with multiple vulnerabilities, does not account for variation in the degree of vulnerability within the group based on individual characteristics, and classifies certain persons as vulnerable rather than identifying situations in which individuals might be considered vulnerable. The alternate contextual approach allows for a more nuanced understanding of the nature of the vulnerability than the categorical approach and therefore a more focused approach to safeguards. The IRB is charged with ensuring that additional safeguards to protect the rights and welfare of subjects who are likely to be vulnerable are included in the study under review. To make this determination, the IRB might be advised to consider two questions: (1) is inclusion necessary? and (2) if so, are safeguards adequate? Conclusion: Although vulnerability is often presented as a yes/no consequence related to some characteristic of a group, a more accurate approach is to consider vulnerability as occurring along a spectrum of seriousness and as a consequence of situations and context. With this idea in mind, investigators and IRBs are advised to take a stepwise approach to determining if the study meets the regulatory and ethical admonition to ensure that safeguards protect the rights and welfare of vulnerable subjects.

Poiesis & Praxis, 2012

In connection with research on humans, the term ''vulnerability'' is only appropriate to identify the special need for protection of certain sections of the population and individuals, if this term refers to the additional risk of certain groups of subjects. Authors who focus on the additional risk suffering of a subject group when defining vulnerability succeed in considering the specific worthiness of protection in a context-sensitive way. The attempt to define the risk-benefit assessment for vulnerable subject groups on a binding basis faces considerable difficulties. This assessment depends both on the research situation and on the test subject. The normative aspect of this decision could be solved by referring to Rawl's decision model of an original position. In cases where there is no benefit for the subject, arguments in the discussion of the risks and benefits that are based on a ''group or overall benefit'' and an ''objective interest,'' cannot be fully sustained.

American Journal of Bioethics, 2004

The concept of vulnerability has held a central place in research ethics guidance since its introduction in the United States Belmont Report in 1979. It signals mindfulness for researchers and research ethics boards to the possibility that some participants may be at higher risk of harm or wrong. Despite its important intended purpose and widespread use, there is considerable disagreement in the scholarly literature about the meaning and delineation of vulnerability, stemming from a perceived lack of guidance within research ethics standards. The aim of this study was to assess the concept of vulnerability as it is employed in major national and international research ethics policies and guidelines.

American Journal of Bioethics, 2004

International Journal of Feminist Approaches to Bioethics, 2009

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.

Diametros, 2024

This paper examines the concept of vulnerability in the context of social research ethics. An ambiguity is noted in use of this term: it may refer to an incapacity to provide informed consent to participate in a research project, or it may imply heightened susceptibility to the risk of harm. It is pointed out that vulnerability is a matter of degree, and that there are different sources and types of harm, which must be taken into account in any judgment about whether additional precautions are required to protect particular categories of research participants. Furthermore, such judgments must be sensitive to the particular context in which research is taking place. This is one of several considerations that raise questions about the desirability of the sort of pre-emptive ethical regulation that has become institutionalized in many countries over the past few decades, a form that is more appropriate to medical rather than to social research. However, this is not to deny that a concern with the vulnerability of research participants is necessary on the part of social researchers. Furthermore, it must be recognized that researchers themselves may be vulnerable to harm in the research process. Finally, some discussion is provided of the way in which a concern with vulnerability can conflict with other considerations that researchers need to take into account in doing their work. The key point is that vulnerability is a complex and controversial concept, and it requires careful handling in thinking about social research ethics.

2015

Submitted in fulfilment of the degree of Doctor of Philosophy (PhD) in Bioethics and Health Law, Steve Biko Centre for Bioethics, University of the Witwatersrand. Johannesburg, November 2014

2021

Supplemental Material, sj-pdf-1-nej-10.1177_0969733020976180 for Vulnerability: An integrative bioethics review and a proposed taxonomy by Merve Mergen and Aslıhan Akpınar in Nursing Ethics

Introduction to a special issue of "The Ethics Forum / Les Ateliers d'Ethique"