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

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

3. Major Controversies l Informed Consent l Standard of Care

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

5. Informed Consent-- II l 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? l Key concept: “Exploitation” (Emanuel et al.) l It may be exploitive to do research in Third World which would not be allowed in West l It may be exploitive to hold Third World to Western standards

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

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

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

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

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

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

13. Standards of Care-- II l What is “state of art”? l Current care in West, even if unrealistic and unaffordable in host nation? l Current care in host nation, even if it is worthless and a sure cure exists in the West?

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

15. Western Standard-- II l 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 l Western “standard” care may not work in 3rd world due to differences in nutrition, chronic diseases, etc. l Placebo control is most informative in whether new treatment is better for host nation

17. Local Standard-- II l Placebo control may lead to quickest results l 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 l 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 l Research done in 3rd world should have demonstrable benefit to 3rd world, not to West l Rebuttable presumption in favor of using current Western standard of care in control group

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