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_Lecture notes_ethics

_Lecture notes_ethics - Handout 2 The Biostatistician and...

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Handout 2: The Biostatistician and Ethical Issues in Clinical Trials A clinical trial is an experiment on human participants. All researchers involved in clinical trials, including biostatisticians, need to know the ethical principles for clinical trials and ensure that each trial is guided not only by good science, but also by the interests of the patients. History of biomedical ethics: Began with the Hippocratic Oath. (See Piantadosi.) Statement of core goal: do no harm, prescribe for the good of the patient. During WWII experimentation by physicians in concentration camps and on prisoners. Led to the Nuremberg Code. Key points: 1. Voluntary consent 2. No alternative way to get answers. 3. Based on biology and animal experiments. 4. Avoid unnecessary suffering and injury. 5. No expectation of death or disability as result of trial. 6. Degree of risk consistent with importance of study. 7. Subjects protected against even remote possibility of death or injury. 8. Study conducted by qualified scientists. 9. Subject can withdraw. 10. Investigator ends experiment if injury likely. Later developments: Helsinki Declaration (1964, 1975, 1983, 1989.) Some tension evident between health of patient as first priority and legitimacy of medical research. Adds documentation requirements to the Nuremberg Code (written protocol, written informed consent.) UN Code of Civil Rights WHO and Council of International Organizations of Medical Sciences (CIOMS) guidelines (1982, 1991), cover both clinical trials and epidemiologic studies.
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