Reflections and recommendations on research ethics in developing countriesIntroductionDisparities in wealth and healthContextual considerations-an illustrative narrativeExcellence in researchAchieving universal standardsInformed consent and conflict of obligationsProtecting research subjects-beyond informed consentDebates on recent studiesExploitation or compensation and partnership?Research ethics committeesTowards more comprehensive guidelines for research ethics in developing countriesConditions in developing countriesThe research agenda of the industrialised worldInformed consentJustice in the distribution of knowledge and resources flowing from researchMaking scientific and moral progress in the quest for human flourishingConclusionsAcknowledgementsReferencesSocial Science & Medicine 54 (2002) 1131–1141Reflections and recommendations on research ethics indeveloping countries$S.R. Benatar*,1Faculty of Health Sciences and Groote Schuur Hospital, University of Cape Town, Observatory 7925 Western Cape, South AfricaAbstractThe debate on the ethics of international clinical research involving collaboration with developing countries hasachieved 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 andcommunities have to a lesser extent been addressed. The global context in which these debates are taking place, andsome of the less obvious implications for research ethics and for health are discussed here to broaden understanding ofthe complexity of the debate. A wider role is proposed for research ethics committees, one that includes an educationalcomponent and some responsibility for audit. It is proposed that new ways of thinking are needed about the role ofresearch ethics in promoting moral progress in the research endeavour and improving global health. r 2002 ElsevierScience Ltd. All rights reserved. Keywords: Ethics research; Ethics committees; Developing countries; Global health; Informed consent; International collaboration;Justice; Standard of careIntroductionDebates on the ethical requirements for conductingmedical research in developing countries have achievedconsiderable prominence in recent years. To some extentthis is the result of growth of interest in research indeveloping countries since the HIV/AIDS pandemic. Italso reflects renewed and encouraging interest in, andconcern about, the nature of the relationship betweenresearchers and their subjects. While researchers aregenerally privileged people many research subjects areamong the most vulnerable in our world, living underthe worst conditions of deprivation and exploitation.Appreciation of concerns regarding research in devel-oping countries requires some knowledge of the growingglobal disparities in wealth and health, and of thelifestyle and worldview of potential research subjects.Against such a background it is apparent that the ethicaldilemmas faced in conducting collaborative interna-tional research can only be addressed satisfactorily ifresearch ethics is seen as intimately linked to health care,to human health globally and to the promotion of socialand economic processes that could begin reversingwidening global disparities in health (Benatar, 2001a).Disparities in wealth and healthAt the beginning of the 20th century the wealthiest20% of the world’s population were 9 times richer thanthe poorest 20%. This ratio has grown progressive-lyFto 30 times by 1960, 60 times by 1990 and to over 70times by 1997. The extent of absolute poverty has alsoincreased and today almost half the world’s populationlives on oUS$2 per person per day. Tens of millions ofpeople, many of them children, die each year of$Based on presentations at the 4th World Congress onBioethicsFTokyo, Japan in November 1998, and at a Seminaron Research Ethics sponsored by the Victor i GrifolsFoundation in Barcelona. Spain, May 1999. *Tel.: +27-21-406-6115; fax: +27-21-448-6815.E-mail address: [email protected] (S.R. Benatar).1Department of Public Health Sciences and Medicine, JointBioethics Centre, University of Toronto, 88 College Street,Toronto, Ontario, Canada M5G 1L4.0277-9536/02/$ - see front matter r 2002 Elsevier Science Ltd. All rights reserved. PII: S 0277-9536(01)00327-6starvation and malnutritionFin a world with enoughfood to feed all (Hobsbawm, 1994; World HealthOrganisation, 1997; Benatar, 1998a; Falk, 1999).At the beginning of the 21st century patterns ofdiseases and longevity also differ markedly across theworld. Of the approximately 52 million people who dieeach year 18 million die of infectious and parasiticdiseases (over 16 million of theseFmany in theiryouthFin the developing world), 10 million die ofdiseases of the circulatory system (4.5 million of these inthe developing world) and 6 million die of malignantdiseases (3.5 million in the developing world). Poorcountries bear over 80 percent of the global burden ofdisease in disability adjusted life years (DALYs). TheWHO estimated that in 1998, 11 million children andadults of working age died of six infectious diseases thatcould have been prevented at $20 per life saved (WHO,1997). Life expectancy at birth ranges from well over 70years in highly industrialised countries to below 50 yearsin many poor countries. Life expectancy is increasingworldwide. However, in 16 of the world’s poorestcountries it has fallen in recent years. In sub-SaharanAfrica gains in longevity achieved during the first half ofthe 20th century are rapidly being reversed by the HIV/AIDS pandemic.Poverty (defined as lack of economic resources, lackof education, lack of access to basic life resources suchas food water and sanitation, and lack of control overthe reproductive process) directly accounts for almostone-third of the global burden of disease. It is now wellestablished that there is a definite relationship betweenwealth/poverty and health/disease, although this rela-tionship is not linear (Wilkinson, 1996). For example,one of the wealthiest nations in the worldFtheUSAFhas worse health statistics (infant mortality andlongevity) than some other industrialised countries; anda particularly poor stateFKerala in IndiaFhasachieved lower infant mortality rates and greater long-evity than many wealthier nations. Despite having thelargest per capita health expenditure in the world the USis ranked 24th in overall