Hulls IRB Talk - Vice President for Research amp; Economic ：船体内部信用评级的谈话-研发副总裁；经济.pptVIP

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Hulls IRB Talk - Vice President for Research amp; Economic ：船体内部信用评级的谈话-研发副总裁；经济.ppt

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HullsIRBTalk-VicePresidentforResearch

Research Protocol vs. Research Practice: Case Studies Richard T. Hull, Ph.D. Professor Emeritus Department of Philosophy A talk given at the Center for Tomorrow, April 26, 2001 at the Protection of Human Subjects Workshop Introduction Institutional Review Boards have as their chief, if not sole, role the protection of human subjects. Traditionally, this function has rested on overseeing the design of research, recruitment of subjects, informed consent, investigation of incidents, and issues of compensation. This presentation illustrates some of the more interesting ways in which research that is well designed and well vetted by IRBs can go awry. The aim is to draw some morals that may help sharpen IRBs’ review of research protocols and monitoring of research. Equipoise: A Key Concept A physician who recommends to a patient that the latter enroll in a research study should be in a state of equipoise: the belief that the result of being randomized to either arm of the study poses no greater risk to the patient than undergoing standard treatment. Otherwise, to recommend entry in a study when the physician believes another treatment is in the patient’s best interest would violate a primary duty to the patient: to recommend the best available treatment. Equipoise applies to subjects Similarly, a subject who is enrolled in a study should believe that the state of medical knowledge is such that the known risks and benefits of being assigned to the control or to the experimental arm of the study are balanced, so that no personal risk is greater given one assignment than the other. A First Study of AZT AZT (zidovudine, retrovir, AZido-deoxyThimidine)was the first drug to be developed to treat HIV+ individuals. The following study sought to evaluate AZT as a potential drug to decrease the concentration of virus particles in the blood of HIV+ individuals. It was a 2-armed, double-blind, multi-center study that used HIV+ patients as subjects. The following slides report event