Ariella Binik, Ethox Centre, University of Oxford
Vulnerability has long been recognized as a central concept in research ethics. It aims to identify populations in need of special protections and to clarify the protections that should be provided. Despite a long history in research ethics guidelines and considerable attention in bioethics scholarship, offering a clear and persuasive account of what it means to be vulnerable, who is vulnerable, and why they are vulnerable remains controversial.
Debates over the concept of vulnerability have led to two different kinds of responses. (1) Some argue that problems with a notion of vulnerability are insurmountable and recommend abandoning the concept (Levine et al 2004; Wrigley 2005; Schroeder and Gefenas 2009). (2) Others argue that vulnerability is under-theorized, and propose new accounts (Kottow 2013; Goodin 1993; Macklin 2003; Luna 2009; Luna 2013; Hurst 2008; Rogers et al 2012; Kipnis 2003).
The second approach, and the new accounts of vulnerability to which it has given rise, has led to the widespread view that vulnerability should be far more context sensitive. That is, the concept of vulnerability should be responsive to local situations and should focus on individual—rather than group—characteristics that warrant special protections. This new approach is reflected in the most recent revisions to prominent ethics guidelines (CIOMS 2016; Helsinki 2008).
Proponents of this approach agree that a successful account of vulnerability should focus on context and on local characteristics as central elements in a successful account of vulnerability, but not enough has been said about what data is needed about local experiences or how to gather this data. More specifically, more needs to be said about what kinds of harms are likely to occur in particular kinds of health research, the situations in which these harms are likely, about the protections required to address these harms (Wendler 2017), and about how these harms are experienced by the populations involved. To put it another way, operationalizing new and context sensitive approaches to vulnerability and developing ethics guidance concerning health research with vulnerable populations depends on a better understanding of the challenges faced by a diverse range of populations.
REACH—an interdisciplinary, mixed-methods study—aims to address this gap by focusing on the challenges associated with research participation for women and children living in low resource contexts. REACH brings together experts in in bioethics and maternal-child health, paediatrics, infectious disease, anthropology, health systems research, and social science research across three international sites in the Wellcome Trust Major Overseas Programmes: Kenya, South Africa and Thailand. The objective is to gather data about the challenges associated with research participation for women and children living in low-resource contexts in order to inform an evidence-based, context-sensitive approach to these vulnerabilities.
By examining local challenges experienced by participants in health research, REACH aims to provide much needed data about the contextual features of women and children living in low-resource settings that may be used to inform context sensitive accounts of vulnerability for health research.
More information about the collaboration, case studies and research team can be found at: http://www.ethox.ox.ac.uk/reach. The REACH team are gathering in Oxford in early May 2018 for an international research ethics meeting where the early results of the case studies will be presented.
Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). 2016. International Ethical Guidelines for Health-Related Research involving Humans. Geneva, Switzerland. Available for download at: http://www.cioms.ch/
Goodin, Robert E. Protecting the vulnerable: A re-analysis of our social responsibilities. University of Chicago Press, 1985.
Declaration of Helsinki, 2013. World Medical Association. Ethical Principles for Medical Research Involving Human Subjects. http://www.wma.net/en/30publications/10policies/b3/
Hurst, Samia A. “Vulnerability in research and health care; describing the elephant in the room?” Bioethics 22, no. 4 (2008): 191-202.
Kipnis, K. “Seven Vulnerabilities in the Pediatric Research Subject.” Theoretical Medicine and Bioethics 24, no.2 (2003): 107-120.
Kottow, Michael H. “The vulnerable and the susceptible.” Bioethics 17, no. 5-6 (2003): 460- 471.
Levine, C, Ruth F, Christine G, Hammerschmidt D, Eckenwiler L, and Sugarman J. “The limitations of “vulnerability” as a protection for human research participants.” The American Journal of Bioethics 4, no. 3 (2004): 44-49.
Luna F. Elucidating the Concept of Vulnerability: Layers not Labels. International Journal of Feminist Approaches to Bioethics 2, no.1 (2009):121-139.
Luna, F, Vanderpoel, S. “Not the Usual Suspects: Addressing Layers of Vulnerability” Bioethics 27, no.6 (2013): 325-332.
Rogers, W., Mackenzie, C., Dodds, S. “Why Bioethics Needs A Concept of Vulnerability.” International Journal of Feminist Approaches to Bioethics 5, no.2 (2012): 11-38.
Schroeder, D., Genefas, E. “Vulnerability: Too Vague and Too Broad.” Cambridge Quarterly of Healthcare Ethics 18, no. 2 (2009):113-121.
Wender, David. “A Pragmatic analysis of vulnerability in Clinical Research.” Bioethics 2017, no.31: 515-525.
Wrigley, A. “An Eliminativist Approach to Vulnerability.” Bioethics 29, no.2 (2015):478-487.