PCL102H1 Lecture Notes - Lecture 24: Institutional Review Board, Nuremberg Code, Serotonin
27 Apr 2016
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Pcl102 lec 24 ethics in clinical trials (phase i-iv) Nuremberg code (1947) part of judicial decision condemning atrocities of nazi physicians. Forced sterilizations, medical experiments and killing of individuals with mental illnesses. Fills in gaps of nuremberg code regarding independent review and risk-benefit. Examples of research that are not socially or scientifically valuable. Research that leads to results which can"t be generalized. Research in which intervention can"t be practically implemented. Methods must be feasible, appropriate, have clear scientific objective, be designed using accepted principles and practices, and have sufficient power. Researchers need to be uncertain about whether new treatment is superior or not. If there is consensus, then there is no real null hypothesis this makes research not scientifically valid: fair subject selection, favourable risk-benefit ratio, independent review. Making sure that researcher"s multiple interests do not affect study design. Reviewed by institutional review board (irb) and reb: informed consent, respect for potential and enrolled subjects.
