Ethics of healthcare research in developing countries Medical and scienti®c research is now cross-national and cross-cultural.Therelentlessprogressofglobalizationposes complexethicalquestionsforthosewishingtodohealthcare research in developing countries 1±4 . While some forms of researchsponsorshiparealtruistic,muchresearchisdriven by economic or academic interests that may or may not re¯ect the needs of the host country. There is also the delicatematterofdoublestandards.Doesinformedconsent havethesamemeaninginapoorilliteratepopulationasit doesin,say,Basingstoke?Whatisanacceptablestandardof clinical care in a resource-poor community? And there is the economic dilemma of whether and how to sustain an intervention, if the trial shows it to be effective, after the researchisover.Perhapsmostimportantofallistheissue ofhowtodevelopanethicalmodelforresearchandtraining partnershipsbetweendevelopedanddevelopingcountriesÐ an approach with long-term advantage for the latter 5 . Happily, the era of `safari research' is now gone, but the typical funding agency still pays scant attention to the audit of collaborative partnerships, especially with regard todevelopmentofthehostcountry'sresearchcapacity. A report from the Nuf®eld Council on Bioethics, The Ethics of Research Related to Healthcare in Developing Countries 6 , isatimelycontributiontothedebateandausefulresource forgovernments,policy-makersandresearchers.Itsethical frameworkisbasedonfoursoundprinciplesofdutyÐthe duty to alleviate suffering, to show respect for human beings, to be sensitive to cultural differences, and not to exploitthevulnerable.Intheapplicationoftheseprinciples, the social, cultural and economic context must be taken intoaccount.Thereportrecommendsthat: . Countries should set national priorities related to provisionofhealthcareandtoenhancetheircapacityto conductresearchrelevanttotheirneeds . Whenexternallysponsoredresearchisproposedwhich falls outside the national priorities, its relevance must bejusti®edtotheappropriateresearchethicscommittees . All countries should establish an effective system for the ethical review of research, which includes the establishmentandmaintenanceofresearchethicscom- mittees, independent of government and sponsors . National and international sponsors of research should ensurethatadequateprovisionismadefortraininginthe ethicsofresearchforprofessionalsinvolvedinresearch related to healthcare . Developmentoflocalexpertiseinprovisionofhealth- care research should be an integral component of any proposed research. Noneoftheseideasisdrasticallynew.Amongthemost widely used existing international guidelines on research ethics are the Declaration of Helsinki, the Council for InternationalOrganisationsofMedicalSciencesGuidelines, and the Guidance on Good Clinical Practice. However, researchersdonotalwaysfollowguidelines,and,iftheydo, their interpretations vary. Many developed countries have speci®c guidelines on research ethics, mainly tailored towardstheirownnationalresearch 4 .Forexample,guide- lines in the USA are legally binding and American invest- igators are supposed to follow them no matter where the researchisconducted.ThisposesadilemmaforAmerican investigators working in developing countries since the regulations may not ®t in with the host country's own regulations, standards of care, consent procedures and cultural expectations. Several developing countries, among them Uganda, Gambia, India, Nepal and Brazil, now have in place well established ethical review committees with experienced and well trained members. Others, such as MyanmarandLaos,havenofunctionalethicscommitteesat all. Even where there is commitment to ethical review, meagre resources and poor infrastructure will make researchprojectshardtomonitor.IntheUK,therunning costsofanethicscommitteeareabout £36000ayearand intheUSAtheycanbeashighas $500000.Manydevel- oping countries lack regulatory mechanisms and a legal framework for biomedical research; moreover, poverty, poor pay and ignorance breed corrupt practices. The Nuf®eld report recommends international initiatives to establishresearchethicscommittees,totraintheirmembers andtomonitortheirdevelopment.Morecontroversially,it also declares that `Funding should be provided for these purposes by those who sponsor research in developing countries'. The worry about this last recommendation is that ethics committee members might not be clearly impartialwhenassessingtheprosandconsofatrialproposed bytheirsponsor. EDITORIALS 275 JOURNAL OF THE ROYAL SOCIETY OF MEDICINE June 2002 Volume 95 Number 6 ISSN 0141-0768