19 October 2005 is an important day for bioethics. On this date, the UN member states adopted a Universal Declaration on Bioethics and Human Rights (UNESCO, 2005). This declaration represents the first attempt to develop a global normative framework for bioethics. Article 8 of the declaration addresses the topics discussed here – "vulnerability" and "vulnerable groups". The article has a dual focus:

  • to proclaim "human vulnerability" as a basic principle of bioethics, and
  • to ensure that individuals and groups of "special vulnerability" receive adequate protection in the development and application of medical, scientific and technological knowledge.

The declaration does not contain a definition of the terms "vulnerability" or "human vulnerability", but it is stated elsewhere in the declaration that also families, groups and communities can be vulnerable. It also points out a number of circumstances that can make individuals and groups vulnerable, like:

  • disease
  • disability
  • other personal conditions
  • environmental conditions
  • limited resources

The declaration is of an anthropocentric nature, in the sense that its frame of reference is human vulnerability, not the frailties of other life forms.

Vulnerability – a complex and complicating principle of bioethics

Even though the principle of vulnerability has become increasingly prominent in national and international declarations and guidelines on research ethics, it is still a fact that this principle has been and remains the subject of fierce debate and criticism in the academic literature on professional ethics.

One type of criticism that has been directed towards this principle is that it is too vague to provide moral guidance (Ruof, 2004). A related criticism is that the principle is too wide-ranging, meaning that in practice it loses its moral force (Levine et al., 2004). The same critics also assert that the principle is too narrow, as it primarily focuses on group characteristics, and thus diverts the focus from aspects of current research or institutional, social and financial framework conditions that make research subjects vulnerable (Levine et al., 2004). Other critics point to the absence of clear and workable criteria in order to determine which individuals or groups are vulnerable, and in order to identify interventions that make individuals and groups more vulnerable (Macklin, 2003; Alwang et al., 2002). The risk of "stereotyping" is part of this problem; i.e. the undifferentiated labelling of entire groups of individuals as vulnerable, simply because they are classified within a specific group for reasons other than vulnerability (Levine et al., 2004; Luna, 2009).

More basic criticism against declaring vulnerability as a fundamental principle of bioethics is that one becomes guilty of taking an invalid naturalistic step from is to ought: one cannot automatically derive a morally binding principle of vulnerability from a descriptive (or metaphysical) determination of vulnerability as a universal aspect of humanity. The best that can be done is to apply this empirical or metaphysical understanding as inspiration for the development of a bioethical principle of protection (Kottow, 2004).
Below is a list of examples of individuals, groups, societies and populations classified as particularly vulnerable in research ethics guidelines and declarations.

The Belmont Report (1979)

  • Ethnic minorities
  • Economically disadvantaged
  • Terminally ill
  • Persons confined to institutions

The Declaration of Helsinki (2009)

  • Subjects unable to give informed consent
  • Subjects receptive to coercion or undue influence
  • Populations or societies that will not benefit directly from participation in research
  • Patients who participate in medical research in combination with medical treatment and care

CIOMS (2002)

  • Persons unable to give informed consent
  • Children
  • Junior or subordinate members of a hierarchical group (e.g. medical students, nursing students, subordinate health and laboratory personnel at hospitals, employees of pharmaceutical companies, military personnel and the police)
  • The elderly
  • Residents of retirement and nursing homes
  • People receiving welfare benefits or social assistance
  • Poor persons
  • The unemployed
  • Patients in emergency rooms
  • Some ethnic minorities
  • The homeless
  • Nomads
  • Refugees and asylum-seekers
  • Prisoners
  • Patients with incurable disease
  • Politically powerless individuals
  • Members of communities unfamiliar with modern medical concepts

Practical aspects of vulnerability

"The proof of the pudding is in the eating". This old saying may serve as a gateway to the question of the practical implications of applying different understandings of vulnerability in research ethics. This brings us right back to Article 8 of the UNESCO Universal Declaration on Bioethics and Human Rights. What is characteristic of this article is that it combines two different approaches to vulnerability. First, a tradition inspired by European philosophy, particularly continental philosophy. In the mid-1990s, an attempt was made by several European experts on bioethics to develop this tradition further (Solbakk, 1994; Botbol-Baum, 2000; Rendtorff , 2002). Vulnerability was declared to be an unalterable aspect of being human. At the same time, Article 8 expresses an understanding of vulnerability that is found in many national and international research ethics guidelines and policy documents and in Anglo-American literature on bioethics, namely an understanding that implies classification of certain individuals and groups that require extra forms of protection (Patrão Neves, 2008). From this perspective, Article 8 can be seen as an attempt to bring together two competing views of vulnerability, and thus also two different "moral regimes" of protection (Patrão Neves, 2008): on the one hand a human rights-based regime aimed at protecting humans' persistent vulnerability; on the other hand a regime of protection directed towards what can be called "fallen vulnerability"; i.e. forms of vulnerability that fall outside the scope of a human rights-oriented protection regime.

What are the practical consequences of operating with such a broad, almost all-encompassing understanding of vulnerability when comparisons are made with the many minimalistic interpretations of vulnerability that exist in the literature? In general it is possible to divide them into three sub-groups, with emphasis on absence of the ability or competence to consent, risk of harm and lack of understanding, respectively (Hurst, 2008: 192). An initial answer to this question is that all of these interpretations may be applied to specific situations in order to answer the following questions:

  • Who may potentially be exposed to additional forms of harm and wrongness?
  • What forms of susceptibility and layers of vulnerability need to be taken into particular consideration?
  • What contextual variables require special attention?
  • What kind of additional forms of harm and wrongness may potentially be at play?
  • What additional measures of protection – of affirmative action – need to be installed?
  • Whose obligation it is to install such additional measures in situations of “fallen” vulnerability?

Another answer is that none of the minimalistic interpretations of vulnerability apply a distinction between unalterable – i.e. persistent – and alterable forms of vulnerability. This weakness is not visible as long as one operates in contexts in which basic human rights – and thus humans' unalterable vulnerability – are protected. Responsibility for this lies with states, and not individuals or institutions. However, if one instead looks at areas in the world in which this baseline form of protection of vulnerability does not exist, application of a minimalistic understanding of vulnerability may easily lead to a blend of alterable and unalterable – i.e. persistent – forms of vulnerability. If this does happen, i.e. that alterable forms of vulnerability are perceived as inalterable – as being part of the realm of persistent vulnerability which falls under the protective power and responsibility of states, a conflation of protective responsibilities may be the result. This is an issue that has been widely discussed in international health research (Attaran, 1999; Angell 2000; Kottow, 2000 and 2003, Solbakk, 2004; Garrafa and Lorenzo, 2008). The background for this is suspicion that researchers from wealthy, democratic countries involved in clinical research in low-income countries characterised by political instability consciously abuse the principle of vulnerability in order to legitimise double standards in research ethics:

"The undiscriminating talk about vulnerable populations has triggered the kind of reactions that smuggle the susceptible under the category of the vulnerable and forgets to give them special consideration, based on the assumption that vulnerability is a human given that elicits no individual responsibilities or obligations beyond the state's protection." (Kottow, 2003: 466, 467).

According to the critics, those who defend double standards in research ethics consider research subjects in low-income countries to be vulnerable, i.e. to be persons who live and suffer under terrible, unchanging conditions, and towards whom outsiders have no obligation. If the same defenders had viewed these persons as they are, instead – i.e. susceptible, victims of "fallen vulnerability" who can be helped – these researchers and their sponsors would no longer be able to turn a blind eye and assert that this misery is fully outside their sphere of responsibility (Kottow, 2003).

If nothing else, this criticism illustrates some of the flaws associated with minimalistic views of vulnerability, when used in parts of the world in which people do not benefit from the mechanisms of protection that exist in a state governed by the rule of law. At the same time, the potential for protection is also made clear through an understanding that combines vulnerability as an unalterable aspect of being human with alterable forms of vulnerability (susceptibility) where action can be taken to change the situation. Consequently it also appears to be possible to declare vulnerability as a universal principle, and thus also ensure that it is not misused in order to legitimise the use of double moral standards in research ethics.

Vulnerable groups often include children, ethnic groups/minorities, persons with a limited lifespan, persons suffering from dementia, persons with mental disorders, abusers of drugs and alcohol and persons with disabilities.

This article has been translated from Norwegian by Cristina Pulido Ulvang, Akasie språktjenester AS.