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  1. 1. TAMBOLI TAMANNA N.Department of pharmacologyM.PHARM First YearTatyasaheb Kore college ofPharmacy
  2. 2.  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.
  3. 3.  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 .
  4. 4.  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.
  5. 5.  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.
  6. 6.  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.
  7. 7. o Syphilis is sexually transmitted disease causes infection by spirochete bacterium & transmitted by mother to fetus during pregnancy or birtho 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
  8. 8. o Grey wrote a book to explain the event of injusticeperformed on the individual test subject & this is a exampleof immoralityo Final settlement went in favor of prosecution, and theywere awarded with $10 million to split among the livingsyphilitics and control ,and the relative of the deceased.