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 theyd 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