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.
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.
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.
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.
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.
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.
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.
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.
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.
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.