1 History And Ethics

Question 1

Imhotep

Answer 1

First physician to rise out of antiquity circa 3000 BC

Likely the first person to describe cancer - breast cancer

Question 2

Diet Protocol in Old Testament

Answer 2

Book of Daniel

Servants were given vegetables and water for 10 days compared to youths given the kings rich diet and wine.

Question 3

Father of Modern Medicine

Answer 3

Hippocrates 460-370BC

Maintained meticulous clinical records

Stressed cleanliness in wound management by boiling water for irrigation and washing hands

Question 4

Claudias Galen

Answer 4

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

Question 5

Four humors of bullshit

Answer 5

Blood

Phlegm

Black bile

Yellow bile

Question 6

The Canon of Medicine

7 conditions

Answer 6

Describes the 7 conditions for drug use and strength

1. Ensure drug is pure
2. Test drug for only one disease
3. Use control groups
4. Use dose escalation
5. Need for long term surveillance
6. Need reproducible results
7. Need human over animal testing

Question 7

Antony van Leeuwenhoek

Answer 7

Invented the microscope in late 1600s

First described striated voluntary muscle, crystalline structure of the lens, red blood cells, and sperm

Question 8

First modern clinical trial

Answer 8

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

Question 9

First massive immunization of a military

Answer 9

George Washington 1777

Used variolation against smallpox to inoculate the continental army

Question 10

First blinded clinical study

Answer 10

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

Question 11

John Snow

Answer 11

Father of modern epidemiology

Determined how cholera was spread in contaminated water by use of statistical mapping

Knows nothing

Question 12

Semmelweis

Answer 12

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

Question 13

Pasteur

Answer 13

Discovered germ basis of fermentation which turned into germ theory of disease

Question 14

Emil von Behring

Answer 14

Demonstrated inoculation with diphtheria toxins in animals could produce antitoxin and be transferred to another

This discovered antibodies

Received first Nobel prize in 1901

Question 15

Wilhelm Rontgen

Answer 15

Produced and detected electromagnetic radiation and took first X-ray of his wife’s hand

Won the first Nobel prize in physics 1901

Question 16

Marie Curie

Answer 16

Won multiple Nobel prizes with husband and daughter

1. Spontaneous radiation
2. Separation of radium and it’s therapeutic properties

Helped synthesize new radioactive elements

Question 17

Sir Alex Fleming

Answer 17

Discovered penicillin in 1928

Question 18

Nuremberg Code

Answer 18

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

Question 19

Guiding Principles in Medical Research Involving Humans

Answer 19

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

Question 20

Kefauver-Harris amendment

Answer 20

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

Question 21

Declaration of Helsinki

Answer 21

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

Question 22

1974 National Research Act

Answer 22

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

Question 23

US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Answer 23

First National body to shape bioethics policy in the US

Penned the Belmont Report

Result of the National Research Act of 74’

Question 24

The Belmont Report

Answer 24

1978

Summarizes ethical principles and guidelines for human research

Core principles
Respect for persons
Beneficence
Justice

Question 25

Principles of the Belmont Report

Answer 25

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

Question 26

Title 45, USCFR, Part 46

Answer 26

The Common Rule

Question 27

Title 21, USCFR, Part 50

Answer 27

Protection of Human Subjects

Question 28

Title 21, USCFR, Part 56

Answer 28

Institutional Review Boards

Question 29

ICH GCP

Answer 29

US, EU, and Japan

Guidance promoting widely accepted ethical conduct of research and reporting of accurate and reliable data