sen

2. TAMBOLI TAMANNA N.
Department of pharmacology
M.PHARM First Year
Tatyasaheb Kore college of
Pharmacy

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 .

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.

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. &not
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.