Vulnerability and Health Research: The REACH Project

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.

References:

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.

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Vulnerability and Health Research: The REACH Project

In 2018, Let’s Root Out Genetic Racism For Good

Tobias Haeusermann is an affiliated researcher and student supervisor at the Department of Sociology at the University of Cambridge, where he received his PhD in 2016. At Cambridge he teaches and instructs undergraduate students for the HSPS Tripos “Introduction to Sociology: Modern Societies I” and the paper “Social Context of Health and Illness” within the Medical and Veterinary Sciences Tripos. He previously was a post-doctoral fellow at the Epidemiology, Biostatistics and Prevention Institute (EBPI) at the University of Zurich, Switzerland. He was also our Caroline Miles visiting scholar in February 2018.

In the wake of ever decreasing costs for analysing genetic information, companies such as 23andMe, FamilyTreeDNA, and Ancestry.com now provide customers easy and affordable access to their genetic data. In particular, tracing one’s ancestry is steadily gaining popularity, above all in nations with a rich history of immigration. When used to find lost family members and ties or to seek connection to other people and places, such tests can be of great value. Yet even then, one runs the risk of altering their self-perception, which, as a result, can lead to profound psychological distress for individuals and their families alike. We should therefore tread carefully when digging up family roots, as we may unearth some uncomfortable truths about the present.

Continue reading “In 2018, Let’s Root Out Genetic Racism For Good”

In 2018, Let’s Root Out Genetic Racism For Good

Oxford-Amsterdam Winter School – 5th edition!

Suzanne Metselaar, Dept. of Medical Humanities, VU University Medical Center, Amsterdam and Gerben Meynen, Humanities, Dept. of Philosophy, VU University, Amsterdam, and Ruth Horn and Michael Dunn from the Ethox Center, Wellcome Centre for Ethics and Humanities, University of Oxford

Making the transition from being a student to becoming part of an international community of bioethicists can be a challenge. What to expect when participating in conferences? How to critically engage in current bioethical debates? How to bring your point across as convincingly as possible, but to do this in a respectful way, acknowledging the work done by others?

In order to support students in making this transition, we have been organizing an annual Winter School for students of the MA-program Philosophy, Bioethics, and Health (PBH), a two-year MA-program of Philosophy and Medical Humanities, VU University (Medical Center) in Amsterdam. The Winterschool January 2018 was its 5th edition. Continue reading “Oxford-Amsterdam Winter School – 5th edition!”

Oxford-Amsterdam Winter School – 5th edition!

Do traditional bioethical solutions suffice in times of digital health?

Karin Jongsma is an assistant professor of medical ethics at the Julius Center of Utrecht University Medical Center, the Netherlands and a Post-doctoral fellow at the department of Medical Ethics and History of Medicine in Göttingen, Germany.  She was also our Caroline Miles visiting scholar in November 2017.

She works with Prof. Dr. Annelien Bredenoord (Utrecht) and Prof. Dr. Silke Schicktanz (Göttingen). Her research focuses on who should have a say in decision-making and representative practices, and she is particularly interested in digital health.

Apps and big data are increasingly used to track, analyse and predict health and health behaviour via smartphones, wearables and via online behaviour. Health care has a history of failed IT investments, and health research has a reputation of being expensive to innovate in, but commercial tech-companies such as Google, Facebook and Apple have succeeded in creating momentum towards a digital change. These companies have developed and implemented technologies that offer innovative ways for collecting, storing and analysing complex and rich health-related data. This data driven research and care may be referred to as digital health. The rising attention for big data and digital health has come with high expectations and is supposedly paradigm-changing. It is hoped that the possibilities of doing research and monitoring patients and not yet patients will create new ways of predicting, treating and preventing illnesses (eg Topol 2015), but digital health will simultaneously create new risks and harm and will shift the dynamics of health research and health care.

Continue reading “Do traditional bioethical solutions suffice in times of digital health?”

Do traditional bioethical solutions suffice in times of digital health?

Sacred Values and the Sanctity of Life

We had a great talk here at Ethox a few weeks ago by Dr Steve Clarke, on sacred values and the sanctity of life.  Steve is a Senior Research Associate in the Oxford Uehiro Centre for Practical Ethics and a Senior Research Fellow in the Centre for Applied Philosophy and Public Ethics, Charles Stuart University.

If you missed this talk, you can listen again here…

Listen to Dr Steve Clarke’s talk here

Continue reading “Sacred Values and the Sanctity of Life”

Sacred Values and the Sanctity of Life

The Ethics of AMR Carriership

Morten Fibieger Byskov is a postdoctoral researcher with the department of Communication, Philosophy, and Technology at Wageningen University & Research, the Netherlands, and our current Caroline Miles visiting scholar. 

Multi-drug resistant organisms (MDROs), or antimicrobial resistance (AMR), pose a dire threat to individual and public health. Not only is AMR a danger to vulnerable individuals who require antibiotic treatment, but the over- and misuse of antibiotics also threatens the effectiveness of antibiotics for future generations. As such, AMR presents a unique problem for public health ethics and healthcare ethics that should ideally address ethical issues at both the public and individual level.

Continue reading “The Ethics of AMR Carriership”

The Ethics of AMR Carriership

Tensions and challenges in a justice-oriented bioethics curriculum for medical students

Amy Caruso Brown, Assistant Professor of Pediatrics at SUNY Upstate Medical University, and our 2017 Andrew Markus visiting scholar

Two years ago, SUNY Upstate Medical University, an American medical school located in Upstate New York, underwent an intensive curricular reform. Previous required coursework in bioethics and in public health was reorganised and integrated into a new longitudinal course, spanning the first two years of the four-year curriculum. Within the course, students meet in small groups approximately once a week for three hours of discussion; each session includes two cases with a shared theme. For example, one such session focused on trauma and violence: the first case involved an adolescent who had attempted suicide, using a parent’s handgun, and the second involved a woman who survived sexual violence as a refugee and presented with chronic abdominal pain. Pairs of faculty with expertise in bioethics and public health guide students to consider not only what to do medically for the hypothetical patient but also how to navigate social, cultural, legal, and economic concerns. Working outward from the level of the interaction between the individual physician and patient, students are eventually asked to consider their obligations to advocate for individual patients, for their local communities, and for policies at regional, state, national and international levels, in order to promote human health.  Continue reading “Tensions and challenges in a justice-oriented bioethics curriculum for medical students”

Tensions and challenges in a justice-oriented bioethics curriculum for medical students