Today’s blog is a summary from my notes and the reading list from a lecture given by Dr Silvia Camporesi. I was reminded of it this week by an email requesting subjects for a Stroke research project. Prior to Dr Camporesi’s lecture, I didn’t think enough about the difficulties around subject selection, and although I have much left to learn, I hope a summary of one aspect of subject selection is helpful to Physios who may be clinically orientated and not involved in research design. The concept of vulnerability in research bioethics emerged in the Belmont report in 1979, following the establishment of a National Commission which was itself a response to the infamous Tuskegee syphilis study, where syphilis was left untreated in a black male population to study the disease course until death, despite treatment being available.
The Belmont report sketched all research subjects as vulnerable and in need of protection, but required additional protections for those more at risk from exploitation including the removal of inducements, better risk-benefit ratios, or in cases of questionable abilities to consent, exclusion from research altogether.
The 7th revision of the Declaration of Helsinki (2013) outlines some groups and individuals as particularly vulnerable and inherently at risk of incurring harms. The declaration states this requires specific protection and is only justified if the research is responding to the health priorities of this group AND research cannot be carried out in a non-vulnerable group. Additionally, the subject group must benefit from the knowledge, practices or interventions that result from the research.
CIOMs (Council for International Organisations of Medical Sciences) defines vulnerable persons as: “Those who are relatively or (absolutely) incapable of protecting their own interests because they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests.” “Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are selected, the means of protecting their rights and welfare must be strictly applied.”
Themes in all 3 publications are similar, but does describing people as ‘vulnerable’ send us headlong into problems? Are all humans vulnerable to lesser or greater degrees, and where do we draw the line? The use of the term for adults without capacity, for example, does not reflect the vast range of ability within this group, and similarly grouping all children as vulnerable does not distinguish a 6-year-old from a 16-year-old. It is also unclear what action is required by ‘specific protection’ or ‘special justification’. Additionally, some vulnerabilities for an individual could be missed if they do not belong to a specific group outlined by the guidelines.
Academics have tried to answer these criticisms by advocating a layered relational concept of vulnerability, the starting point being to identify the harms that may occur, by focussing on personal, social, political, economic, environmental and context-specific sources of vulnerability:
“When the source of vulnerability is unpacked, we often find that it lies not in the inherent nature of [childhood], nor in innate aspects of research with children, but rather in the context of situation in which those [children] may be placed” (Wright K 2015; p.207)
This approach includes harms such as a sense of powerlessness, loss of agency and importantly, potential harms that might occur from NOT being included in research. This is highlighted beautifully in the case of pregnant women, where the evidence base for treatment is extremely weak because the research simply hasn’t been done. This makes pregnant women who need medical treatment or urgent care open to harms from dosage for example, because there is no data to rely on. Systemic exclusion from research can, it seems, be just as problematic as systemic inclusion. This returns us to the request for subjects with Stroke for a research project. Before Dr Camporesi’s lecture I might have taken a rather paternalistic view of my duty to protect a patient from harm, but I think I am now much more likely to ask a patient if they would like to be included in a study, provide them with as much information as I can, supporting their decision-making as an individual Stroke survivor rather than a member of a rather nebulously defined vulnerable group.
Hurst, Samia A. (2008) Vulnerability in research and health care; describing the elephant in the room? Bioethics 22, 4: 191-202.
Lange, M. M., Rogers, W., & Dodds, S. (2013) Vulnerability in research ethics: a way forward. Bioethics, 27, 6: 333-340.
Levine, Carol, et al (2004) The limitations of “vulnerability” as a protection for human research participants. The American Journal of Bioethics 4, 3: 44-4949.
Luna, F. (2009) Elucidating the concept of vulnerability: Layers not labels. IJFAB: International Journal of Feminist Approaches to Bioethics, 2, 1: 121-139.
Wright, Katharine (2015) Are children vulnerable in research? Asian Bioethics Review 7, 2: 201-213.