1. Why do we need ethical guidelines for medical research
Why do we need ethical guidelines for medical research ? Dany Hilmanto health research ethical committee faculty of medicine University Padjajaran

2. Research activities↑ Competition in research field Desire of research environment Unfairness Dishonesty Requirement of ethical guidelines

3. Why is ethical guidelines needed for medical research?
Historical justification
Ethical justification

4. HISTORICAL JUSTIFICATION
1767 SLATER VS BAKER VS STAPLETON
2 PHYSICIANS (SURGEONS) DISUNITED THE CALLOUS WITHOUT CONSENT
Patient felt unhappy
Shake to the court
Expert witness physicians did unstandard procedure

5. 1897 Giuseppe Sanarelly
Injected yellow fever to subjects patients died
According to Walter Reed (1901)
Research ethics need:
Trial to the researcher
Informed consent
Limited to adult subjects

6.
Nazi’s doctors trial in Nuremberg
Dr Josepf Mengele (angel of death)
horryfying experiments
Risks
No beneficence
Under compulsion
Unfair selection
Limited scientifically
Nuremberg code

7. Nuremberg code:
Informed consent is absolutely essential
Qualified researchers
Favorable risk-benefit ratio
Participants free to stop at any time

8. 1964 Declaration of Helsinski
by world medical association (WMA)
22 recommendations for human subjects research

9. 1932-1972 Tuskegee experiments
Pathogenesis of syphilis
Black man in Tuskegee, Alabama
to see natural pathogenesis of syphilis
without treatment
1947: Penicilline as DOC

10. 1976 Belmort report
Defining 3 ethical principle for research:
Respect for person
Beneficence
Justice
led to formation of Institutional Review Boards (IRB)

11. Respect for persons
2 important elements:
Autonomy
Self determination
Beneficence
Maximize benefits
Minimize risks
Avoid harm
Justice
Risk and benefit equally distributed\equitable recruitment of research participant
Protection of vulnerable sebjects

12. Element of informed consent
Capacity to make autonomous decisions
Disclosure of relevant information
Understanding of this information
Voluntariness of decisions
Indication of agreement, e.g signature

13. Thank You