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Human Experimentation in Medical Science

  • Important role of human beings in understanding disease mechanisms and transmission.

  • Clinical trials are critical for medical advancements.

  • Historical use of human subjects for testing drugs and treatments.

  • Presence of unethical practices in human experimentation.

Institutional Review Boards (IRBs) and Ethical Guidelines

  • Establishment of IRBs to protect human subjects.

  • World Medical Association's Declaration of Helsinki provides ethical guidelines for medical research involving humans.

  • Application of ethical guidelines varies by country.

  • Topics to discuss: unethical conduct in human experimentation (focus on U.S. history) and vulnerable individuals in clinical trials.

Historical Context of Disease Research

Robert Koch and Bacteriological Research

  • Discovery of tuberculosis bacillus prompted research on bacteria and infections.

  • Model organisms not available; physicians experimented on patients and sometimes themselves.

  • Initial experimentation focused on syphilis and gonorrhea; monkeys later identified as suitable study subjects.

Examples of Experimental Practices

  • Henry Heiman (1895): Reported gonorrheal infections in boys and a terminally ill man.

  • Mary Rafferty (1874): Human subject suffering from a cancerous ulcer subjected to painful electrode experiments causing suffering.

Informed Consent and Medical Ethics

  • Bartholow's experiments on Mary Rafferty deemed unethical; consent was questionable given her mental state.

  • Informed consent was ambiguous and variably applied by doctors.

  • Charles Francis Withington (1886): Highlighted conflict of interests between medical science and patient rights.

Case Study: The Tuskegee Syphilis Study

  • Conducted by Public Health Service (PHS) from 1932-1972, focusing on African American men with untreated syphilis.

  • Participants received incentives like transportation and food but lacked informed consent about their disease.

  • Treatment knowledge (e.g., penicillin) was withheld from participants despite its discovery.

Malaria Therapy and Neurosyphilis

  • Experiments aimed at treating syphilis with malaria therapy led to adverse effects on subjects.

  • Mark Boyd's Research: Focused on using malaria to treat neurosyphilis; ethical lapses present as patient welfare was compromised.

Human Radiation Experiments

  • Early understanding of radiation's effects led to human experimentation.

  • Example: Plutonium injections in patients without their knowledge (1945-1947) for research on radioactive exposure impacts.

  • Concerns about ethical violations and lack of informed consent in experiments.

Use of Vulnerable Populations

  • Historical context includes experiments on children, prisoners, and mentally ill individuals.

    • Henry J. Berkley (1897): Thyroid extract study observed harmful effects on mentally ill patients, using subjects incapable of giving consent.

    • Experiments on children from orphanages: Painful tuberculosis tests executed on children unable to consent.

    • Use of prisoners: Coerced participation in experiments lacking comprehension of health risks.

Conclusion: Ethical Evolution in Medical Research

  • Historical abuses in human experimentation highlight the need for ethical guidelines.

  • Regulations are now in place to ensure informed consent and subject protection.

  • Continuous oversight by review boards is crucial for ethical medical research practices.

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