Re: Revising the Declaration of Helsinki
As pointed in the BMJ Editorial, the public consultation of the World Medical Association provided researchers with a unique opportunity to influence research governance, based on real-life experience. As a group of clinical ad social sciences researchers active in North-South collaborative research, we would like to draw the attention to the concept of “vulnerability” in medical research, on how it is currently defined in the Declaration, and on how it could be refined.
“Vulnerability” is explicitly addressed in the Article 19 and Article 20 of the Draft Version for Public Consultation of the Declaration. In the Article 19, it is described as being unable to give or refuse consent, or as being at risk of coercion or undue influence, and is defined in terms of age, mental capacity or autonomy. For instance, young children and the mentally incapacitated are not in the position to consent for themselves; and prisoners and other persons living in highly hierarchized environments are potentially subject to some form of coercion or undue influence. Thus, these categories of people should always be considered as [potentially] vulnerable in the context of medical research: they have “an increased likelihood of incurring additional and greater harm”, and they need “specifically considered protection”. The concepts of coercion or undue influence, and of inability to consent, are retaken in the Articles 27 and 28, which require appropriate measures for consent if “the potential subject is in a dependent relationship with the physician or may consent under duress”, and if the potential research subject is incompetent.
But nowadays, we face situations where identifying vulnerable individuals or communities in medical research is less straightforward than Article 19 seems to portray. In fact, the substantial increase in the number of commercial and non-commercial clinical studies conducted in limited-resources settings has brought new opportunities as well as new challenges (1). In particular, research participants are more and more frequently recruited from [severely] socio-economically disadvantaged populations, whose status could be described in terms of poverty (i.e. the lack of physical necessities, assets and income) (2) and/or social exclusion. Social exclusion consists of dynamic, multi-dimensional processes driven by unequal power relationships interacting across an economic, political, social and cultural dimension and operating at different levels, including individual, household, group, community, country and global levels. It results in a continuum of inclusion/exclusion characterized by unequal access to resources, capabilities and rights, which leads to health inequalities (3). Patients recruited in these settings may have diminished autonomy and be vulnerable to exploitation (4) due to more subtle reasons than those traditionally considered (5), something which may directly impair their freedom to consent and expose them to exploitation. The lack of/limited access to quality health care, for example, may push these populations towards participation in research, simply because it is a way to get free access to quality health care. Noteworthy, the proposed Article 20 of the Declaration refers to “disadvantaged or vulnerable population or community”, but does not give defining criteria for them.
We acknowledge the WMA workgroup’s statement that specific vulnerable groups should not be mentioned explicitly in the Declaration and that a general regulation on vulnerability is more appropriate, to avoid misinterpretation. Nonetheless, in order to avoid such misinterpretation and ambiguity when defining vulnerable study populations, we propose that the general regulation should include at least a clear definition/defining criteria of the categories of people that constitute vulnerable groups (i.e. age, autonomy, poverty). In fact, the causes and features of vulnerability may vary, and the ways and tools to ensure protection of different vulnerable persons/communities will vary accordingly (i.e. assuring ethical research conduct for socially excluded/stigmatized persons will require different protective measures then for those who are poor but fully participating members of society). In light of the above, we suggest that both poverty and social exclusion are explicitly acknowledged in the Declaration of Helsinki as criteria to define vulnerable groups.
Noteworthy, vulnerability due to poverty and/or social exclusion should never in itself lead to exclusion from medical research, as research in socio-economically vulnerable populations is most often badly needed to address the specific health problems of these communities. Excluding them from pertinent medical research would result in a breach of the ethical principles of fairness and justice. And fortunately, in recent years there has been an increase in medical research on e.g. neglected tropical diseases addressing health needs of the most neglected patients (6,7). These additional criteria in the Declaration should be seen as a reason for taking special care to avoid both exploitation and neglect. We hope that this would contribute to achieve the best protection of research subjects and their communities, irrespectively of their socio-economic status, and in a timeless manner.
1. Halidou Tinto, Ramadhani A. Noor, Charles L. Wanga, Innocent Valea, Maimouna Ndour Mbaye, Umberto D'Alessandro, and Raffaella M. Ravinetto. Good Clinical Practice in Resource-Limited Settings: Translating Theory into Practice. Am J Trop Med Hyg 2013;88 608-613
2. Chambers R. Poverty and livelihoods: whose reality counts? Environ Urban 1995; 7:173-204. SAGE Publications. Available online at http://eau.sagepub.com/content/7/1/173
3. Popay J, Escorel S, Hernández M, Johnston H, Mathieson J, Rispel L. Understanding and tackling social exclusion. Final report to the WHO Commission on Social Determinants of Health. From the Social Exclusion Knowledge Network WHO, 2008. Available at: www.who.int/social_determinants/knowledge_networks/final_reports/sekn_fi...
4. Editorial: Strengthening clinical research in India. The Lancet 2007; 369 (9569): 1233
5. Kipnis K. Vulnerability in research subjects: a bioethical taxonomy. In: National Bioethics Advisory Commission. Ethical and policy issues in research involving human participants. Vol. II. Washington, DC: US Government Printing Office, 2001.
6. Boelaert M, Meheus F, Robays J, Lutumba P. Socio-economic aspects of neglected diseases: sleeping sickness and visceral leishmaniasis. Ann Trop Med Parasitol. 2010 Oct;104(7):535-42. doi: 10.1179/136485910X12786389891641. Review. PubMed PMID: 21092391.
7. Picado A, Rijal S, Sundar S, Boelaert M. Visceral leishmaniasis treatment in the Indian subcontinent: how to reach the most vulnerable. Expert Rev Anti Infect Ther. 2012 Aug;10(8):839-41. doi: 10.1586/eri.12.71. PubMed PMID: 23030320.
Competing interests: No competing interests