taught that one had to study the living body in order to understand biological functions and malfunctions.
Aristotle
ancient doctors experimented with ______ (Latin vivus “living”, “alive” + section, -oni “cutting”) in order to advance medical science.
vivisection
Code which made for following the principles before conducting human experimentation
The Nuremberg Cod
Conduction of medical experiment in human being
Human Experimentation
Types of Human Experimentation
Therapeutic
Research
Innovative
Subject is ill
Condition is likely to improve
Therapeutic
Subject is healthy
Medicines +procedures well accepted
Research
Can be healthy/not
May have neg/positive
Innovative
335-280 BC
Greek physician
Vivisect prisoners from Ptolemaic kings teaching anatomy
Herophilus of chalcedon
(5) Ethics in medical research:
Nuremberg code (1947)
Declaration of Helsinki (1964)
ICMR guidelines on human research (2006)
Drugs and cosmetic rules (1945)
Autoexperimentation
-World war II (1939-1945)
-Nazi Physicians
-Held in NUREMBERG, GERMANY (~NUREMBERG TRIALS)
-Cruel experiments (eg: starvation, infection with bacteria -antibiotics)
Nuremberg code (1947)
developed a code Outlined the basic principles to be followed
if experimentation was to be conducted in future
US Judges in 1947
Basic-4 principles
BENEFICENCE
NONMALEFICENCE
JUSTICE
AUTONOMY
BENEFICENCE
DO GOOD
NONMALEFICENCE
DO NOT HARM
JUSTICE
EQUALITY
AUTONOMY
PERSONS RIGHT TO MAKE CHOICE
-18 th WMA general assembly
-Held at Helsinki, Finland
- In June 1964 (75,83,89,96,2000,02,04)
Declaration of Helsinki (1964)
Research protocol:
- ethical considerations
- principles
- funding, sponsors, incentives for subjects
3 main guidelines:
- PURPOSE → increase knowledge
- CONDUCT→dignity and well being of the subjects
3.EVALUATION→ at all stages
ICMR guidelines on human research 2006
