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BME 314 Lecture 23 2012

D associateprofessor biomedicalengineering

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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. Associate Professor 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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