Beyond Helsinki: a vision for global health ethicsBMJ 2001; 322 doi: http://dx.doi.org/10.1136/bmj.322.7289.747 (Published 31 March 2001) Cite this as: BMJ 2001;322:747
Improving ethical behaviour depends on strengthening capacity
- Peter A Singer, Sun Life chair and director (, )
- Solomon R Benatar, professor of medicine
- University of Toronto Joint Centre for Bioethics, Toronto ON, Canada M5G 1L4
- University of Cape Town, Observatory 7925, Cape, South Africa
The fifth revision of the 1964 Declaration of Helsinki, published in October 2000, sets out international standards for conducting medical research with human subjects.1 Revisions of this or any other research ethics code are unlikely to make research more ethical throughout the world, however, without some means of strengthening capacity to promote and implement such standards.
Strengthened capacity in research ethics is needed in both developed and developing countries, though the need is particularly acute in developing countries. A recent Washington Post investigation into research in developing countries revealed “a booming, poorly regulated testing system that is dominated by private interests and that far too often betrays its promises to patients and consumers.”2
Research in developing countries was a flash point of the fifth revision of Helsinki because the declaration retains the requirement that new treatments should be tested against the “best current” treatment. Critics argue that this standard does not allow the testing of low cost, sustainable treatments, such as aspirin for coronary artery disease, which might yield substantial health improvements in developing countries but are inferior to the best current treatment in developed countries. Bloom has argued convincingly that global health would be better served by adopting a standard of the “highest attainable,”3 and we have offered an expanded concept of the standard of care in research, advocating that visiting researchers need a deeper understanding of the social, economic, and political context of trials in developing countries.4
But even another revision of Helsinki that incorporated these recommendations would not, in isolation, improve the ethics of research in developing countries. Rather, people are the key—to apply international codes to local circumstances, develop and enforce national codes, staff research ethics boards, and implement research ethics processes.
The Fogarty International Center of the US National Institutes of Health is spearheading the movement to strengthen capacity in research ethics by committing $5.6m (£3.7m) over four years to train faculty from developing countries in bioethics. These North-South partnerships will be further strengthened by South-South regional networks (such as the Forum for Ethical Review Committees in Asia and the Western Pacific) and global networks, such as the Global Forum for Bioethics in Research, which brings together researchers in developing countries and organisations that support clinical research.5
The crucial step, yet to be taken, is to strengthen ethics centres and training programmes in developing countries. Direct support by international donors will be essential, at least initially. A model is the International Clinical Epidemiology Network (INCLEN), a programme initially supported by the Rockefeller Foundation that created a network of clinical epidemiology units around the world: we are proposing an INCLEN for ethics. With 30 training centres each producing 12 trainees a year, for example, 3600 people would be trained over 10 years to chair research ethics boards and teach research ethics to investigators, research ethics board members, students, and policy makers. The total cost would be about $100m.
Important questions remain about how to sustain this vision; the career paths of the trainees; selecting the centres; how communities, non-governmental organisations, and international organisations could be involved; and how to evaluate the effort. Moreover, how would this effort integrate with a broader vision of public health, and the process of strengthening national health—and health research—systems?
Any effort to strengthen capacity must recognise the current context of global health: 87% of the $2 trillion spent on health care globally is spent on 16% of the world's population6; 10% of the global burden of disease attracts 90% of global expenditure on health research.7 Over the past 20 years the structural adjustment programmes of the World Bank undermined health systems8 and public health.9 Recent attempts by the World Trade Organization to “outlaw the use of cross subsidisation, universal risk pooling, solidarity, and public accountability in the design, funding, and delivery of public services” may further undermine health care in many countries.10 As J K Galbraith warned many years ago, it is time for privileged people to move beyond self satisfied complacency.11
The creation of a global alliance for health ethics by the international donor community to pursue the vision outlined here could be tapped to influence the policies of international organisations. Its trainees would be opinion leaders to whom others turn for advice.12 They could form a global network of ethics opinion leaders which could help shape policy directions for the World Bank, World Trade Organization, and other international organisations, and thereby help to ameliorate the maldistribution of expenditure on health and health research.13
If this vision of capacity strengthening proved effective in research ethics the model could be extended to other issues in global health ethics such as genomics and biotechnology, priority setting in health systems, women's health, end of life care, and others, as well as to sectors other than health.
By 2010 strengthened ethics capacity would advance the cause of ethical research in the world far more than even another revision of the Helsinki Declaration. Ultimately, strengthening ethics capacity will facilitate health research and help redress one of the greatest ethical challenges in the world—the unconscionable inequities in global health.
PAS and SRB are recipients of Bioethics Research and Education Awards from the Fogarty International Center of NIH. PAS is supported by an investigator award from the Canadian Institutes of Health Research.