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Unformatted text preview: 972 U.S. Public Health Service’s study
600 lowincome AfricanAmerican men, of whom 400 had syphilis
Subjects not told about the disease
Penicillin became available in 1950s, but participants denied treatment
Researchers intervened to prevent treatment when subjects were diagnosed by doctors outside the study
Belmont Report (1979) was in response Declaration of Helsinki, 1964
Declaration of Helsinki, 1964 World Health Organization established recommendations guiding medical doctors conducting biomedical research involving human subjects
Some issued it addressed: Research with humans should be based on animal experimentation
Independent committee must review research protocols
Informed consent must be obtained
Only qualified individuals should conduct research
Risks should not exceed benefits National Research Act, 1974 led to National Research Act, 1974 led to Belmont Report The Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
That Commission identified the basic ethical principles that should underlie human subjects research
The result of the Commission’s work was the Belmont Report of 1979 The Belmont Report: Principles and The Belmont Report: Principles and Applications Principle: Respect for Persons
Principle: Beneficence Principle: Justice Application: Informed Consent
Application: Assessment of risks and benefits
Selection of Subjects Current Regulations and the Current Regulations and the “Common Rule” Based on the Belmont Report, the Department of Health and Human Services and the Food and Drug Administration issued regulations in 1981
In 1991, more than a dozen other government departments and agencies adopted the core DHHS regulations
These regulations are known as the Common Rule BME 314: BME 314: Engineering Foundations of BME Final Review
Krish Roy, Ph.D.
Biomedical Engineering Two most important Course Two most important Course Objectives Apply knowledge of biological and physical sciences, mathematics, and engineering to solve problems at the interface of enginee...
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This note was uploaded on 03/17/2014 for the course BME 314 taught by Professor Frey during the Spring '08 term at University of Texas at Austin.
- Spring '08