Ethical Problems with Research in Developing Countries

1. Ethical Problems with Research in Developing Countries Informed Consent Standards of Care

2. Case Study • “076” trial of prevention of HIV transmission from pregnant woman to newborn • West Africa, Thailand • Funded by US-CDC • Placebo control group • Describe details

3. Major Controversies • Informed Consent • Standard of Care

4. Informed Consent • US requirement: Written individual consent • Standards of disclosure higher than for therapeutic interventions • Must inform that it is research and what research it is

5. Informed Consent-- II • Third 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”)

6. Research Ethics? • Key concept: “Exploitation” (Emanuel et al.) • It may be exploitive to do research in Third World which would not be allowed in West • It may be exploitive to hold Third World to Western standards

7. For Western Model • Otherwise encourage 3rd world “research sweat shops” where multinational corporations carry out studies too risky to be done on Western subjects • 3rd World citizens run risks of research, benefit goes to wealthy West

8. For Local Model • “Cultural imperialism” to force 3rd world nation to conform to Western cultural practices • May disrupt traditional social structures in the name of “science” • Damage may last years after research is completed

9. NBAC Draft Report • National Bioethics Advisory Commission draft report • Ethical and Policy Issues in International Research • Comments due 11/13/00 • See News section, course website

10. “Both-And” • Avoid “cultural imperialism” by insisting that research must include all local cultural practices • Still require that in addition, US-type individualized, explicit consent must occur

11. “Both-And”-- II • Logic: Quite all right for local scientists to do research in their own countries using local standards only • But US government and US firms should be held to US standards

12. Standards of Care • May use a placebo group so long as no subject is denied proven beneficial care for a significant illness • Therefore, in serious disease, control group must get “state of art” treatment

13. Standards of Care-- II • What 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?

14. Western Standard • Discriminatory and exploitive to deny any research subjects the standard they’d receive in US • If deny, taking unfair advantage of poor state of care in local nation (cf. Nazi experiments)

15. Western Standard-- II • Should be doing research in 3rd world to improve status of health there, not to perpetuate existing inadequacies-- otherwise Western presence is inherently exploitive

16. Local Standard • Western “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 nation

17. Local Standard-- II • Placebo control may lead to quickest results • Unfair to saddle US agency or corp. with the task of single-handedly reforming a 3rd world health care system as a cost of doing research

18. Question • Should the control group in the 076 trial have gotten the full dose AZT (Western standard) or a placebo (local standard)?

19. NBAC Draft Report • Research done in 3rd world should have demonstrable benefit to 3rd world, not to West • Rebuttable presumption in favor of using current Western standard of care in control group

20. Presumption? • Start by assuming that controls will get Western standard • May give reasons why it is beneficial, not exploitive for controls to get local standard • Burden of proof on those who argue for local standard