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  • We must broaden the scope of research ethics

Solomon Benatar argues that part of the moral responsibility of medical researchers is to ensure that their work is genuinely relevant to social need.

The author is professor of medicine and director of the Bioethics Centre at the University of Cape Town, South Africa.

Research is a crucial means of improving health and healthcare in developing countries. But it can only do so effectively if the health needs of developing countries are taken into account when research programmes are designed. Yet the fact that at present 90 per cent of the world’s spending on medical research goes on diseases that cause only 10 per cent of the global burden of disease indicates the way in which research priorities reflect the market interests of pharmaceutical companies and the needs of the rich.

Admittedly much research is conducted on diseases that affect people worldwide, such as pneumonia, asthma and hypertension (and therefore includes research participants from both developed and developing countries). But the relative lack of research on many diseases that primarily afflict hundreds of millions of people in developing countries (such as malaria, tuberculosis and river blindness) is a source of great concern.

Such injustice could be reduced by:
  • Only undertaking research in developing countries that is potentially of direct benefit to their citizens;
  • Linking research to the development of locally relevant health policy; and
  • Building the capacity of local healthcare professionals — in both research and clinical care.
Designing relevant research

Some research in developed and developing countries has exploited the participants involved. [1,2] A well-known historical example is the Tuskegee experiments in the United States where participants were not informed that they were enrolled in research, and were denied effective treatment for syphilis when this became available. A more recent example is research conducted in developing countries that has only benefited those in the developed world who can afford the treatment being tested — for example a hepatitis A vaccine trial in Thailand. [3]

Concern over such instances has led to greater emphasis by the World Health Organisation on the need to focus research on issues and diseases of direct relevance to developing countries. [4,5] It is increasingly accepted that the interests of research participants and their communities can best be served by undertaking research on diseases commonly afflicting them, and by ensuring that such research will benefit the community being researched.

To achieve these goals:
  • Countries in which the research is to be conducted (host countries) should be involved in the design and conduct of trials;
  • There should be consideration of how the research will be relevant to the health needs of the host country, and whether it is the only way to gain useful knowledge for the host country; and
  • The balance of benefits and burdens of the research should be carefully assessed and fairly distributed amongst those involved in the research and others who would benefit from the treatment being studied. [6]
In addition, prior evaluation by a local committee or governing body should consider the impact of the project. For example whether:
  • The study findings can and will be incorporated into the local healthcare system where appropriate;
  • The research will inappropriately deflect local human or material resources away from the host country's healthcare system towards the research project, thus more deeply entrenching existing disparities; and
  • The research will improve healthcare provision and assist in building the capacity of healthcare professionals in the host country.
Global influences on health and healthcare

To achieve these goals, those who participate in international research need some understanding of — and must be sensitive to — the social, economic and political context within which their research is taking place, and which greatly influences the health of research participants. This includes knowledge of the motivations behind the design and conduct of pharmaceutical research, and of the political relationships between the sponsoring and host countries.

Key areas include how the host country fits into the sponsoring country's foreign policy, what economic aid is provided, the nature of any debt relationships, the extent of arms trading between the two countries, and the human rights achievements of the sponsoring and host countries.

These requirements call for improved education of all those serving on research ethics committees, and for these bodies themselves to educate the relevant research communities. [2,7,8] An expansion of the concerns of research ethics along the above lines could empower researchers to influence their governments to improve relationships between the host and sponsoring countries, as part of the endeavour to improve health globally.


Inadequate understanding of global forces that affect health, from which research cannot be divorced, obscures the common ground that should be aimed for by those concerned about human health. We need advancement of knowledge for the benefit of individuals and society, in addition to adequate protection for research participants, and a fair distribution of benefits in research and healthcare.

The role of social conditions in shaping the world and the way that privileged people view the world and themselves mean that research cannot be considered in isolation. Medical research, healthcare, life-style patterns around the world and the requirements for leading productive lives may seem separate. But they are all interdependent. [9]

Taking these factors into account makes the task of improving international medical research more complex. Those in the healthcare profession and others involved in funding and conducting medical research need to acquire at least some ability to view their work from a broad perspective. This could engender some of the humility needed to make progress towards the greater justice required in healthcare and medical research, and to effectively deal with the challenge of growing disparities in health around the world.


[1] Spece RG, Shimm DS, Buchanan AE (1997). Conflicts of interest in clinical practice and research. Oxford University Press. New York.

[2] Benatar SR (2002). Some reflections and recommendations for research ethics in developing countries. Social Science and Medicine 54: 1131-1141.

[3] Vimolket T et al (1998). Immunogenicity and safety of a new inactivated hepatitis A vaccine in Thai young adults. Southern Asian Journal of Tropical Medicine Public Health 29: 779-85.

[4] Investing in Health Research and Development: Report of the ad hoc committee on health research relating to future intervention options (1996). WHO, Geneva.

[5] The 10/90 Report on Health Research (2000). Global Forum for Health Research, Geneva.

[6] Ethical considerations in HIV vaccine preventive research (2000). UNAIDS, Geneva.

[7] Benatar SR, Singer PA (2000). A new look at international research ethics. BMJ 321: 824-26.

[8] Benatar SR (2001). Justice and medical research: a global perspective. Bioethics 15(4).

[9] Benatar SR (1998). Global disparities in health and human rights: a critical commentary. Amer J Publ Health 88: 295-300.
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