Chapter 10 Outline PDF

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Chapter 10 Outline...

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Tuesday, August 30, 2016

Chapter 10 Outline Medical Research on Vulnerable Human Subjects - Josef Mengele • German medical schools did not resist, but lead Nazi eugenics and the killing of undesirables - The Nuremberg Code • The judges at Nuremberg lacked a code of ethics for experimentation on captive populations, so they created 10 principles for ethical experimentation, known as the Nuremberg Code

• Its most important principle was that people should freely consent to participation in any experiment - Questionable American Research • Franklin Roosevelt established the Committee on Medical Research • The Department of Energy or its predecessors conducted at least 435 experiments in 21 states • The U.S. Public Health Service began to require informed consent of subjects, an important fact in judging the Tuskegee Study

- The Tuskegee Study • Nature and History of Syphilis - American reformers mounted the Syphilophobia Campaign - The Harm Reduction Movement (HRM) focuses on reducing the associated harms of these behaviors, not on moral censure or eliminating the behaviors

- Boeck’s and Bruusgaard’s studies had caused physicians to question the received views about the natural course and treatment of syphilis

• A Study in Nature Begins - Physiologist Calude Bernad in 1865 distinguished studies in nature from normal experiments - Vonderlehr had no sense that it might be wrong to use such vulnerable subjects in a life-long experiment • The Middle Phase: Poor Design - The study proved nothing • Spinal Taps and Deception - They told the black men that they had “bad blood” and that the spinal taps were treatment for their bad blood - Although penicillin was developed around 1941-1943 and was widely available by 1948, the subjects in the Tuskegee Study never received it

• Revelation of the Study to the World - In 1966, USPHS venereal disease investigator Peter Buxtun learned about the study - After Heller’s story appeared, the Secretary of Health, Education, and Welfare terminated her study - In 1972, as a direct relegation of the study, the federal government required all institutions to conduct human medical experimentation and receive federal funds to have Institutional Review Boards (IRBs)

• Informed Consent and Deception

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Tuesday, August 30, 2016 - Telling patients the truth was not legally required before 1966 • Media Coverage - Researchers did intend to withhold treatment - No reporters then or now have the medical background to understand such complicated stories and without that, cannot risk charging physicians with possible crimes

• Harm to Subjects - Kampmeier argued that withholding penicillin in 1946 did not harm subjects with latent syphilis - He argued next that proof of penicillin’s effectiveness did not come until 1948 and then only for primary syphilis

• Kant and Motives of Researchers - When physicians at CDC and USPHS debated the Tuskegee study in 1969, many assumed that if no harm could be proved, nothing unethical had been done

- We cannot use differing historical standards at differing times to excuse lack of informed consent, but not pay attention to what else researchers believed that that time

- The crucial fact is that when penicillin became available, most physicians believed it would help latent syphilitics

- For Kantian ethics, researchers deliberately willed harm on these subjects

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