Elsevier

Social Science & Medicine

Volume 54, Issue 7, April 2002, Pages 1131-1141
Social Science & Medicine

Reflections and recommendations on research ethics in developing countries

https://doi.org/10.1016/S0277-9536(01)00327-6Get rights and content

Abstract

The debate on the ethics of international clinical research involving collaboration with developing countries has achieved a high profile in recent years. Informed consent and universal standards have been most intensively debated. Exploitation and lack of adequate attention to justice in the distribution of risks/harm and benefits to individuals and communities have to a lesser extent been addressed. The global context in which these debates are taking place, and some of the less obvious implications for research ethics and for health are discussed here to broaden understanding of the complexity of the debate. A wider role is proposed for research ethics committees, one that includes an educational component and some responsibility for audit. It is proposed that new ways of thinking are needed about the role of research ethics in promoting moral progress in the research endeavour and improving global health.

Introduction

Debates on the ethical requirements for conducting medical research in developing countries have achieved considerable prominence in recent years. To some extent this is the result of growth of interest in research in developing countries since the HIV/AIDS pandemic. It also reflects renewed and encouraging interest in, and concern about, the nature of the relationship between researchers and their subjects. While researchers are generally privileged people many research subjects are among the most vulnerable in our world, living under the worst conditions of deprivation and exploitation. Appreciation of concerns regarding research in developing countries requires some knowledge of the growing global disparities in wealth and health, and of the lifestyle and worldview of potential research subjects. Against such a background it is apparent that the ethical dilemmas faced in conducting collaborative international research can only be addressed satisfactorily if research ethics is seen as intimately linked to health care, to human health globally and to the promotion of social and economic processes that could begin reversing widening global disparities in health (Benatar, 2001a).

Section snippets

Disparities in wealth and health

At the beginning of the 20th century the wealthiest 20% of the world's population were 9 times richer than the poorest 20%. This ratio has grown progressively—to 30 times by 1960, 60 times by 1990 and to over 70 times by 1997. The extent of absolute poverty has also increased and today almost half the world's population lives on <US$2 per person per day. Tens of millions of people, many of them children, die each year of starvation and malnutrition—in a world with enough food to feed all (

Contextual considerations—an illustrative narrative

When those in privileged positions and in wealthier countries consider undertaking collaborative research with colleagues in developing countries it is necessary to understand both their own framework of thinking, and the implications of very different mind-sets and environments in which research projects may be carried out in developing countries. The mind set of researchers from industrialised countries, and in which the debates on research ethics are taking place, is characterised by a

Excellence in research

Many moral lessons have been learnt from the history of medical research. Regrettably, 50 years after the Nuremberg trials and the Nuremberg code, unethical medical research on humans continues, even in highly privileged countries (Katz, Capron, & Glass, 1972; President's Advisory Commission, 1998; Brody, 1998). Similarly, the extent to which human rights abuses continue 50 years after the Universal Declaration of Human Rights, even in wealthy industrialised countries, illustrates how difficult

Debates on recent studies

In recent debates about HIV transmission studies in Thailand, South Africa and elsewhere the use of placebos and the implications of the Helsinki Declaration for the standard of care required for research subjects have been fiercely debated (Angell 1997; Lurie & Wolf, 1997; Anonymous, 1997a; Aaby et al., 1997; Bulletin of Medical Ethics, 1999; Varmus and Satcher, 1997; Fairchild & Bayer, 1999; Harvard University CD Rom). The recommendation from the Council for the Organisation of Medical

Exploitation or compensation and partnership?

World history is filled with examples illustrating the pervasiveness of exploitation. Although exploitation today may be less crude and less overt than in the past, the extent of covert exploitation under sophisticated guises continues to devastate the lives of billions of people (Hobsbawm, 1994; Benatar, 1998a; Falk, 1999; Lee & Zwi, 1996). Against this background, with the widening disparities described, and with acknowledgement of the potential for research to be exploitative, it can be

Research ethics committees

The role of research committees is briefly reviewed here to illustrate that for moral progress to be made, the functions of such committees need to be broadened. Their first, now well developed and implemented task, is to evaluate research proposals with special attention to risk/benefit ratios, equity in distribution of benefits and burdens, potential conflicts of interest, the adequacy of information provided for subjects, and the protection of freedom: (i) within the consent process; (ii)

Towards more comprehensive guidelines for research ethics in developing countries

The categories of issues thus requiring special consideration in formulating new Guidelines for Biomedical Research on Human Subjects in “developing” countries include:

Making scientific and moral progress in the quest for human flourishing

Scientific and moral progress are dependent on: (i) the ability to be critical of the status of current knowledge, method and dogma; (ii) the willingness to raise critical questions on any issue; (iii) acquiring an understanding of one's own base within a specific cultural context; (iv) the sensitivity to recognise the limitations of one's own world view—that one's own insights are not necessarily correct or better than those of others and (v) the willingness to debate differences with an open

Conclusions

Reflection on a century that has been characterised by both amazing scientific progress and intense human suffering on a vast scale makes it clear that new ways of thinking are now required about illness, human suffering, health care, international relations and other forces that shape the world and profoundly affect health. These include a better understanding of why disparities in wealth and health are widening; a greater commitment to social justice within nations and between nations; a

Acknowledgements

I am grateful to Ruth Faden for critical comments and her encouragement to pursue this project.

References (61)

  • S.R. Benatar

    Prospects for global healthLessons from tuberculosis

    Thorax

    (1995)
  • S.R. Benatar

    Global disparities in health and human rightsA critical commentary

    American Journal of Public Health

    (1998)
  • S.R. Benatar

    Imperialism, research ethics and global health

    Journal Medical Ethics

    (1998)
  • S.R. Benatar

    Avoiding exploitation in clinical research

    Cambridge Quarterly in Healthcare Ethics

    (2000)
  • S.R. Benatar

    Global issues in HIV vaccine trials

    Journal of HIV Therapy

    (2000)
  • S.R. Benatar

    Justice and medical researchA global perspective

    Bioethics

    (2001)
  • S.R. Benatar

    South Africa's transition in a globalising worldHIV/AIDS as a window and a mirror

    International Affairs

    (2001)
  • S.R. Benatar et al.

    A new look at international research ethics

    British Medical Journal

    (2000)
  • Bulletin of Medical Ethics (1999). Revising the declaration of Helsinki: A fresh start. The 150th issue of the Bulletin...
  • B.A. Brody

    The ethics of biomedical researchAn international perspective.

    (1998)
  • A. Cassese

    Inhuman statesImprisonment, detention and torture in Europe today

    (1996)
  • Commission on Health Research for Development (1990). Health research: Essential link to equity in development. Oxford:...
  • Council for International Organisations of Medical Research (CIOMS) (1993). Ethics and research on human subjects:...
  • J. de Jesus Mari et al.

    Erasing the global divide in health research

    British Medical Journal

    (1997)
  • E.J. Emanuel et al.

    Institutional conflict of interest

    New England Journal of Medicine

    (1995)
  • G.B. Ellis

    Keeping research subjects out of harm's way

    JAMA

    (1999)
  • A.L. Fairchild et al.

    Uses and abuses of Tuskeege

    Science

    (1999)
  • R. Falk

    Predatory globalisationA critique

    (1999)
  • E. Hardy

    Factors often not considered before a multicenter trial is started

    Clinical Pharmacology and Therapeutics

    (1996)
  • Harvard University. The debate over clinical trials of AZT to prevent mother-to-infant transmission of HIV in...
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