Research ethics addresses the rights of people who participate in research studies and the related responsibilities of those who conduct the research
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Examples of Events that Support Need for Ethics Guidelines
Tuskegee Syphilis Study
Experimental measles vaccine
Alcohol use in Native Americans
Gelsinger case
Painted mice
Centenarian study
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Principles of Ethical Conduct in Research
Respect of person
Treat individuals as autonomous agents
Protect individuals with limited ability to make decisions for themselves
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Principles of Ethical Conduct in Research
Beneficence and nonmaleficence sets an obligation to do no harm and to maximize possible benefits
Justice is defined in relation to research as “fairness in distribution,” which is an opportunity to participate but to impose a burden of inequality
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Training
In most cases, there are both local and federal requirements for training in the ethical conduct of research
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Training
During basic training the following topics are covered for researchers:
Historical perspective
Principles of ethical research conduct
Compliance procedures
Informed consent procedures
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Training
During basic training the following topics are covered for researchers:
Risks associated with participation in research
Vulnerable populations
Special situations and populations
FDA regulations