KELOMPOK TUTOR B3 Ahmed Reza 1301 1010 0029 Sheila Sumargo 1301 1010 0156 Sheila Aziza. Egie rahmalaelani 1301 1010 000662 Helmy Aries Stiawan 1301 1010 00091 Dwi Bandang Saskia 1301 1010 0045 Fatimah Lidya A 1301 1010 0092 015 Adlina Asfara 1301 1010 0053 Hafdzi Maulana 1301 1010 0096 Achamad Samjunanju 1301 1010 0067 Adi Yusup 1301 1010 0030

Overview Case nuremberg The doctors’ trial was held between 9 December 1946 and 19 July 1947. It prosecuted Nazi doctors for their roles in human experiments conducted on prison camp inmates. Josef Mengele was one of the most notorious Nazi doctors, although he was not tried because he avoided capture.

Overview Case Para tahanan dipaksa untuk berpartisipasi, secara tidak sukarela dan tidak pernah ada informed consent. Biasanya, percobaan mengakibatkan kematian, cacat atau cacat permanen

Ethical issues (Pro) Semua penelitian medis memiliki tujuan dan akhirnya dirancang untuk membantu upaya militer Jerman, seperti mengembangkan senjata baru, pengujian obat-obatan dan membantu dalam pengobatan medis personil militer yang terluka

Ethical issues (Cons) Tiap manusia memiliki hak yang sama seperti yang lain. Sehingga sangat tidak layak apa bila terjadi eksploitasi untuk penelitian yang membahayakan si subjek penelitian. Dokter memiliki kewajiban untuk melindungi pasien/partisipan, dan konsekuensi atau efek dari tindakan medis dokter atau pun peneliti harus dijelaskan lewat inform consent Jadi jelas percobaan tanpa informed consent seperti yang ada di kasusu ini menyalahi etik dokter itu sendiri

Ethical issues (Cons) Para dokter di Jerman mengambil Sumpah Hipokrates, namun mereka sengaja melanggar prinsip Hippocrates "tidak membahayakan".

History Nuremberg Code 19th and 20th centuries conducted experiments on patients without their consent and with little if any concern for the patients’ well-being Following World War Two, some of these physicians were tried and convicted by a special tribunal at Nuremberg, Germany.

History Nuremberg Code As a direct result of the trial, the Nuremberg Code was established in 1948, stating that "The voluntary consent of the human participant is absolutely essential," making it clear that participants should give consent and that the benefits of research must outweigh the risks.

The voluntary consent of the human subject is absolutely essential The voluntary consent of the human subject is absolutely essential. This means that the person inThe experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. No experiment should be conducted where there is a prior reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

PROFESSIONAL VALUE THAT HAVE BEEN VIOLATED… Respect Honesty Responsibility

LESSON CAN BE LEARNED… maupun peneliti harus menjunjung tinggi nilai respect terhadap pasien atau subject penelitian kita karena mereka memiliki hak Hal yang perlu ditekankan pula, sebagai dokter atau peneliti, kita harus selalu jujur, profesional dan bertanggung jawab terhadap apa yang telah kita lakukan. Jangan sampai kita merugikan pasien.

TUSKEGEE SYPHILIS STUDY

OVERVIEW CASE The Tuskegee syphilis experiment was an infamous clinical study conducted between 1932 and 1972 in Tuskegee, Alabama by the U.S. Public Health Service to study the natural progression of untreated syphilis in poor, rural black men who thought they were receiving free health care from the U.S. government

ETHICAL PROBLEM Informed consent, communication of diagnosis, and accurate reporting of test results. Respect for person Beneficent Non maleficent Justice Professional Value Honesty Respect

Develop ethical guideline Revelation of study failures led to major changes in U.S. law and regulation on the protection of participants in clinical studies. The Tuskegee Syphilis Study, cited as "arguably the most infamous biomedical research study in U.S. history," led to the 1979 Belmont Report and the establishment of the Office for Human Research Protections (OHRP). It also led to federal laws and regulations requiring Institutional Review Boards for the protection of human subjects in studies involving human subjects. The Office for Human Research Protections (OHRP) manages this responsibility within the US Department of Health and Human Services (HHS)

BELMONT REPORT : Respect for person Beneficence Justice

Respect Informed consent Lessons can be learned Respect Informed consent

References