1 History And Ethics Flashcards
Imhotep
First physician to rise out of antiquity circa 3000 BC
Likely the first person to describe cancer - breast cancer
Diet Protocol in Old Testament
Book of Daniel
Servants were given vegetables and water for 10 days compared to youths given the kings rich diet and wine.
Father of Modern Medicine
Hippocrates 460-370BC
Maintained meticulous clinical records
Stressed cleanliness in wound management by boiling water for irrigation and washing hands
Claudias Galen
Physician to Marcus Aurelius
One of the first to use animals in studies to understand human disease
Described transaction of spinal cords at different levels
Believed health and disease reflected the balance of the four humors
Four humors of bullshit
Blood
Phlegm
Black bile
Yellow bile
The Canon of Medicine
7 conditions
Describes the 7 conditions for drug use and strength
- Ensure drug is pure
- Test drug for only one disease
- Use control groups
- Use dose escalation
- Need for long term surveillance
- Need reproducible results
- Need human over animal testing
Antony van Leeuwenhoek
Invented the microscope in late 1600s
First described striated voluntary muscle, crystalline structure of the lens, red blood cells, and sperm
First modern clinical trial
1747 Navy surgeon compared 3 therapies for the treatment of scurvy in sailors
12 sailors
6 groups
Controlled diets with supplement vinegar, sulfuric acid, cider, seawater, spice mixture, and oranges/lemons
First massive immunization of a military
George Washington 1777
Used variolation against smallpox to inoculate the continental army
First blinded clinical study
Commission lead by Benjamin Franklin to assess whether a new healing method was due to real force or an illness of the mind. Blindfolded participants were told they were receiving magnetism when some weren’t Nd vice versa. Only people who were told they were receiving magnetism reported the felt it - pointed out importance of placebo effect
John Snow
Father of modern epidemiology
Determined how cholera was spread in contaminated water by use of statistical mapping
Knows nothing
Semmelweis
Worked in obstetrics ward
Insisted on scrubbing hands with disinfectant prior to entering maternity ward leading to drop in maternal mortality
Data rejected by his peers originally
Pasteur
Discovered germ basis of fermentation which turned into germ theory of disease
Emil von Behring
Demonstrated inoculation with diphtheria toxins in animals could produce antitoxin and be transferred to another
This discovered antibodies
Received first Nobel prize in 1901
Wilhelm Rontgen
Produced and detected electromagnetic radiation and took first X-ray of his wife’s hand
Won the first Nobel prize in physics 1901
Marie Curie
Won multiple Nobel prizes with husband and daughter
- Spontaneous radiation
- Separation of radium and it’s therapeutic properties
Helped synthesize new radioactive elements
Sir Alex Fleming
Discovered penicillin in 1928
Nuremberg Code
Resulted from nazi human experimentation
Designed to protect humans subjects by ensuring voluntary consent and asserting that the anticipated result of research must justify its performance
Prioritizes the rights and welfare of the subject
Guiding Principles in Medical Research Involving Humans
Issued by the NIH in 1953
Required prior review by a medical committee of all human research to be conducted at the new NIH Clinical Center
Kefauver-Harris amendment
Amendment to the US Federal Food drugs and cosmetics Act
Subjects must be told whether a drug is being used for investigational purposes and subject consent must be required
Declaration of Helsinki
Cornerstone set of ethical principles for human experimentation developed by WMA
Not legally binding under international law
Basic principles: respect for the individual, their right for self determination and informed decisions, subjects welfare must always take precedence over science and society, and ethical considerations take precedence over laws and regulations
Operational principles: research must be based on scientific knowledge, weigh risks vs benefits, have reasonable likelihood of benefit to the population, investigators must be well trained, subject to independent ethical review and oversight by committee
1974 National Research Act
Result of the public outcry from Tuskegee experiments
Established the National Commission for the Protection oh Human subjects of biomedical and Behavioral Research who identified the basic principles of research conduct
Regulations were passed studies conducted by the Dept of Health, Education and Welfare
- have voluntary informed consent of all participants
- be reviewed by Institutional Review Boards
US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
First National body to shape bioethics policy in the US
Penned the Belmont Report
Result of the National Research Act of 74’
The Belmont Report
1978
Summarizes ethical principles and guidelines for human research
Core principles
Respect for persons
Beneficence
Justice
Principles of the Belmont Report
Respect for persons: protect the autonomy of people and treat them with respect, allow informed consent
Beneficence: do no harm, maximize benefits for the research project and minimize risks for subjects
Justice: ensure reasonable, nonexploitive procedures. Fair distribution of costs and benefits to potential participants
Title 45, USCFR, Part 46
The Common Rule
Title 21, USCFR, Part 50
Protection of Human Subjects
Title 21, USCFR, Part 56
Institutional Review Boards
ICH GCP
US, EU, and Japan
Guidance promoting widely accepted ethical conduct of research and reporting of accurate and reliable data
