Focus for researchers
-Research goals
-Benefits of the research outcomes for society
-To achieve that they need the compliance of research participants
Research project, important to consider participants
-Wellbeing
-Individual rights
-Autonomy
2 - History of Research Ethics
2.1 - Cases of Ethical Violations in Medical Studies
Medical experiments under the Nazi regime in Germany during World War II
-Without any form of consent
-Tribunal in Nuremberg (1946): physicians were indicted for their participation in experiments
-Nuremberg Code: First international ethics code for research involving human subjects
Key Principle: voluntary informed consent
Willowbrook Study
-Institute for mentally disabled children, were deliberately infected with the hepatitis virus
-The legal caregivers of the children did give consent: information was misleadingly positive
-The social injustice of this study (and inhumane living conditions) led to a public outcry, resulted in
the end of medical experiments on mentally disabled children
Syphilis Study
-Study the natural process of untreated syphilis among African American males. Although the men
were not informed that they were infected with syphilis; nor did they get full info about the study
-The violation of the rights and welfare of human subjects in this study resulted into the publication
of the Belmont Report in 1979
Belmont Report
-Ethical principles and guidelines for the protection of human participants were described
-Research organisations are required to have an Institutional Review Board (IRB)
-Principles:
1. Respect for persons
The autonomy of all people involved in a study should be protected, that participants
should be treated with courtesy and respect and the should be fully informed about the
aims/procedure of the study by means of an informed consent procedure
2. Beneficence
"Do no harm". While researchers want to maximise the benefits of their research they
should also minimise the risks to the research subjects.
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