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MIMM 387 (17)

Jan 23 2012- murgita.docx

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Microbiology and Immun (Sci)
MIMM 387
Robert Murgita

rdMonday January 23 2012 Like last lecture not responsible for the immunology details Important the approach being used in terms of clinical trials for new agents The principles are most important Biomedical research Essentially any study meant to generate new insights relevant to at the end of the day human disease Clinical research is a subset of biomedical research and it involves studies involving human subject participation at any level It is not just studying people before and after taking a drug in a clinical trial it is also gathering information about people Examples of Clinical Research List of different clinical research there is beyond clinical trials Clinical Research and Therapeutics History I Events that have shaped our approach to clinical research research that has anything to do with humans Medicine shows were conducted on the streets by salesmen this is how medicinesthings called medicines were distributedThe Jungle gave a description of the meat processing in Chicago This triggered the concern that some of the things that we take in were processed in unsafe ways for humans Based on this the Food and Drug Act required at least labelling But there was no requirement for safety testing Because of Strep Elixir which was sold widely but turned out to be harmful it became imperative to do testing History II Experimentation that the Nazis did were only divulged at the end of the war Experiments done by physicians were unethical see slide So while some of these were done in a systematic way that would enable questions to be asked and answers to be generated the problems boiled down to the 4 points on the slide This led to the Nuremberg Trials where the experiments were public and physicians were tried for war crimes Excuses that they were just doing what they were told were not deemed to be sufficient History III The code resulted from these trials Just signing consent is not enough you need informed consent This means that the person must understand and you need to get across language barriers etc The subject needs to be able to stop without explaining themselves to the investigator
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