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EDITORIAL

Ethical conduct of research in developing countries

Clinton, Michael RN PhD(East Anglia)

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International Journal of Evidence-Based Healthcare: June 2010 - Volume 8 - Issue 2 - p 43-44
doi: 10.1111/j.1479-6988.2010.00168.x
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The call to action on evidence-based healthcare in developing countries in this issue is a welcome expansion of the work of the Joanna Briggs Institute. Extending the work of the Institute through evidence review centres and groups in Africa and other countries is an important contribution to meeting the core evidence needs of first-line health professionals. No one can deny the need for better access to more and better information to guide the health interventions of our colleagues in developing countries and that the Institute is well positioned to respond to the overwhelming demand in the developing world for usable evidence-based information. The time has come for sustained efforts to make evidence-based health information available to groups and communities that lack the information technology resources available in developed countries. However, the challenge of providing the right information, to the right people, at the right time and in the right place involves not only a revolution in our thinking about how to make credible and up-to-date information available where it can result in more effective interventions, but it also involves careful thinking about the ethical realities of developed world research conducted in developed countries.

Not all health-related research in developing countries is conducted by researchers who belong to organisations in developed countries, but much of the research that takes place in sub-Saharan Africa either is sponsored by Western countries or is conducted by Western investigators, now more frequently with local collaborators, including national governments, health organisations and local communities. All well and good, but in recent years there has been an increasingly important debate about the ethics of research conducted in developing countries, especially that conducted by well-meaning Western investigators involved in allegedly unethical research studies.1 The accusation is that Western investigators are engaging in and defending research studies that would not receive institutional review board (ethical committee) approval in their own countries. Such accusations arise from concerns about the standard of care used in research in developing countries; the availability of useful and proven interventions during clinical trials; and the quality of informed consent procedures,2 including those that involve refugees.3 The first two concerns relate to a significant but vertically narrow part of the spectrum of health research, the third to an ethical issue that is relevant to all research involving human subjects/participants, especially to community studies. The fact that the first two concerns are relevant only to a narrow part of the research spectrum does not diminish their ethical importance.

Whereas each of the three concerns can be debated at length, let it be sufficient to point out that they converge on arguments and counter arguments about exploitation. The default position in developed countries is, or ought to be, the unequivocal requirement of research in developing countries to meet all the ethical and scientific standards of research in developed countries. The contrary view is that research ethics are essentially situational and that there are defensible ways of rationalising the application of less stringent research standards in developing countries. For example, oral consent rather than written consent can be taken in countries with low levels of literacy. Yet one is left to wonder whether low levels of literacy invalidate what it means to give informed consent, in that they may confound a genuine understanding of the risks and benefits that attend a research study.

The problem is that it is not easy to defend departures from the principles of the Belmont Report: respect for persons, beneficence and justice that guide the regulation of research conduct in the USA and other developed countries. The challenge is to decide whether there can be an ethical justification for departing from stringent ethical requirements when a study is sponsored by a US organisation, or other developed country entity, but conducted in a developing country. Koski and Nightingale argue that:

Our greatest challenge is to realize and fully accept that in all research involving human subjects, ethics and science are not separable – a given study must conform to ethical standards or it should not be performed, and it must be scientifically sound or it cannot be ethical. The use of a good research design and adherence to sound ethical principles should result in the conduct of research that is valid, reliable, and ethically acceptable in any country.4

By embracing this seemingly simple concept Koski and Nightingale conclude that we will be less likely to ‘conduct activities in the name of science that are disrespectful or harmful of others’.4 Well may we agree, but living up to this seemingly simple precept will remain a significant challenge for the foreseeable future. This is where the Institute can play an influential role by building relationships in developing countries that not only facilitate appropriate and evidence-based practice, but empower those at risk of exploitation to protect themselves from lower standards in the ethical conduct of research.

Michael Clinton RN PhD(East Anglia)

Professor in Nursing Science, Rafic Hariri School of Nursing, American University of Beirut, Beirut, Lebanon

References

1. Landes M. Can context justify an ethical double standard for clinical research in developing countries? Global Health 2005; 1: 1-11.
2. Emanual EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? J Infect Dis 2004; 189: 930-7.
3. Mackenzie C, McDowell C, Pittaway E. Beyond ‘do no harm’: the challenge of constructing ethical relationships in refugee research. J Refug Stud 2007; 20: 299-310.
4. Koski G, Nightingale SL. Research involving human subjects in developing countries. N Engl J Med 2001; 345: 138.
International Journal of Evidence-Based Healthcare © 2010 The Joanna Briggs Institute