4. In Apr Dr.Leo Alexander has submitted to the
counsel for war Crimes six point defining
legitimate medical research .
The trial verdict adopted these point &added
extra four point.
The ten point constituted &called Nuremberg
code.
The Declaration of Helsinki & Nuremberg code
are the basis for code of federal regulation .
This regulation issued by the United state
Department of health and human Services.
5. The voluntary consent of human subject
yield fruitful result for the good of society .
designed &based on the result of animal experimentation
&knowledge of natural history of the disease.
conducted as to avoid all unnecessary physical ,mental
suffering and injury.
No expt. should be done when prior reason to death.
Should give adequate facilities to protect the subject
Expt. Conducted by only scientific qualified person.
Subject should have liberty to bring the expt. at end when
he suffer physical or mental injury continuation of expt. is not
possible.
Scientist must prepared to terminate the expt. At any stage.
Degree of risk should never exceed that determined by
humanitarian value .
6.
7. It adopted in June 1964 in
helsinki, Finland and undergo
six revision.
It is the first significant effect of
the medical community to
regulate itself, form basis of
most subsequent document.
8. It Intended to be read as a whole each of its constituent paragraph.
To promote safeguard the health of the patient.
Primary purpose of medical research is to understand the cause,
development, effect of disease, and improve ,prevention ,diagnosis .
WMA encourages other participant involve in study.
The research is evaluated for effectiveness, efficiency, accessibility
and quality.
Physician should consider the ethical, legal and regulatory norms
and standard for research.
No national or international ethical legal or regulatory requirement
should reduce or eliminate any of the protection for research
subject.
9. Duty of physician is to protect the life,health,dignity,intigrity,privacy
and confidentiality.
The protocol should be clearly described .
The research must provide monitoring information committee.
Voluntaries should require supervision by qualified physician .
Not allowed to reduce or eliminate any of protection for research .
Scientific training &qualification require to individual.
Physician must immediately stop a study when risk are outweigh the
potential.
Every precaution must be taken to protect privacy of research
subject.
Authors ,editors &publisher all have ethical obligation with regard to
publication of result of research.
Project is clearly described in research protocol .
Research protocol must be submitted for consideration, comment
guidance & approval to research ethics committee before study
begin.
10.
11. o Syphilis is sexually transmitted disease causes infection
by spirochete bacterium & transmitted by mother to
fetus during pregnancy or birth
o THE Tuskegee Syphilis studied by Fred D. Gray examines
a medical study that occur in Tuskegee. He was the
lawyer in the lawsuit against the government.
o The main goal of this study was to seek out African
American males in second stage of syphilis.
o The test subject were told that they were receiving
medical treatment for syphilis but in reality they never
receive penicillin which was most effective treatment
for syphilis.
o After 40 years of race based experiment test subject
realize that they had been involved in the exp. ¬
treated with medicine
12. o Grey wrote a book to explain the event of injustice
performed on the individual test subject & this is a example
of immorality
o Final settlement went in favor of prosecution, and they
were awarded with $10 million to split among the living
syphilitics and control ,and the relative of the deceased.