Why do we need ethical guidelines for medical research

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Presentation transcript:

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

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

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

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

1897 Giuseppe Sanarelly Injected yellow fever to subjects 3 patients died According to Walter Reed (1901) Research ethics need: Trial to the researcher Informed consent Limited to adult subjects

1946-1949 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

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

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

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

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

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

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

Thank You