Ethical Problems with Research in Developing CountriesCase StudyMajor ControversiesInformed ConsentInformed Consent-- IIResearch Ethics?For Western ModelFor Local ModelNBAC Draft Report“Both-And”“Both-And”-- IIStandards of CareStandards of Care-- IIWestern StandardWestern Standard-- IILocal StandardLocal Standard-- IIQuestionSlide 19Presumption?Ethical Problems with Research in Developing CountriesInformed ConsentStandards of CareCase Study“076” trial of prevention of HIV transmission from pregnant woman to newbornWest Africa, ThailandFunded by US-CDCPlacebo control groupDescribe detailsMajor ControversiesInformed ConsentStandard of CareInformed ConsentUS requirement: Written individual consentStandards of disclosure higher than for therapeutic interventionsMust inform that it is research and what research it isInformed Consent-- IIThird World context•Illiteracy•Greater identity with family, clan, village, etc.•Custom of husband deciding for family, chief deciding for village•Major concepts may not translate (“gene”)Research Ethics?Key concept: “Exploitation” (Emanuel et al.)It may be exploitive to do research in Third World which would not be allowed in WestIt may be exploitive to hold Third World to Western standardsFor Western ModelOtherwise encourage 3rd world “research sweat shops” where multinational corporations carry out studies too risky to be done on Western subjects3rd World citizens run risks of research, benefit goes to wealthy WestFor Local Model“Cultural imperialism” to force 3rd world nation to conform to Western cultural practicesMay disrupt traditional social structures in the name of “science”Damage may last years after research is completedNBAC Draft ReportNational Bioethics Advisory Commission draft reportEthical and Policy Issues in International ResearchComments due 11/13/00See News section, course website“Both-And”Avoid “cultural imperialism” by insisting that research must include all local cultural practicesStill require that in addition, US-type individualized, explicit consent must occur“Both-And”-- IILogic: Quite all right for local scientists to do research in their own countries using local standards onlyBut US government and US firms should be held to US standardsStandards of CareMay use a placebo group so long as no subject is denied proven beneficial care for a significant illnessTherefore, in serious disease, control group must get “state of art” treatmentStandards of Care-- IIWhat is “state of art”?Current care in West, even if unrealistic and unaffordable in host nation?Current care in host nation, even if it is worthless and a sure cure exists in the West?Western StandardDiscriminatory and exploitive to deny any research subjects the standard they’d receive in USIf deny, taking unfair advantage of poor state of care in local nation (cf. Nazi experiments)Western Standard-- IIShould be doing research in 3rd world to improve status of health there, not to perpetuate existing inadequacies-- otherwise Western presence is inherently exploitiveLocal StandardWestern “standard” care may not work in 3rd world due to differences in nutrition, chronic diseases, etc.Placebo control is most informative in whether new treatment is better for host nationLocal Standard-- IIPlacebo control may lead to quickest resultsUnfair to saddle US agency or corp. with the task of single-handedly reforming a 3rd world health care system as a cost of doing researchQuestionShould the control group in the 076 trial have gotten the full dose AZT (Western standard) or a placebo (local standard)?NBAC Draft ReportResearch done in 3rd world should have demonstrable benefit to 3rd world, not to WestRebuttable presumption in favor of using current Western standard of care in control groupPresumption?Start by assuming that controls will get Western standardMay give reasons why it is beneficial, not exploitive for controls to get local standardBurden of proof on those who argue for local
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