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Droit médical --- Human experimentation in medicine

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Human experimentation in medicine --- Veterans. --- Safety measures.

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Les bénéfices comme les risques des essais cliniques sont nombreux, qu'ils soient d'ordre économique, juridique, éthique ou de santé publique. La loi Huriet-Sérusclat a posé en 1988 des principes en matière d'essais cliniques qui ont inspiré le législateur européen. De récentes évolutions législatives ont profondément modifié les règles de droit et les pratiques. C'est pourquoi l'Institut Droit et Santé a organisé, en juin 2006, dans le cadre des « Rencontres Droit et Santé » une journée d'analyse et de bilan de ces évolutions. Ces travaux ont en particulier permis de s'interroger sur le décloisonnement entre les recherches biomédicales sur les médicaments, celles portant sur les dispositifs médicaux et la recherche biomédicale institutionnelle. Par ailleurs, le rôle des nouveaux acteurs de l'évaluation méritait d'être analysé, tout comme les enjeux de la transparence en matière d'essais cliniques. Cette dernière constitue une exigence déontologique de l'expertise mais aussi un droit fondamental de l'usager du système de santé, qui est désormais un acteur et un partenaire à part entière de la recherche.

Human experimentation in medicine. --- Biotechnology --- Research --- Law and legislation.

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From 1951 until 1974, Holmesburg Prison in Philadelphia was the site of thousands of experiments on prisoners conducted by researchers under the direction of University of Pennsylvania dermatologist Albert M. Kligman. While most of the experiments were testing cosmetics, detergents, and deodorants, the trials also included scores of Phase I drug trials, inoculations of radioactive isotopes, and applications of dioxin in addition to mind-control experiments for the Army and CIA. These experiments often left the subject-prisoners, mostly African Americans, in excruciating pain and had long-term debilitating effects on their health. This is one among many episodes of the sordid history of medical experimentation on the black population of the United States.The story of the Holmesburg trials was documented by Allen Hornblum in his 1998 book Acres of Skin. The more general history of African Americans as human guinea pigs has most recently been told by Harriet Washington in her 2007 book Medical Apartheid. The subject is currently a topic of heated public debate in the wake of a 2006 report from an influential panel of medical experts recommending that the federal government loosen the regulations in place since the 1970s that have limited the testing of pharmaceuticals on prison inmates.Sentenced to Science retells the story of the Holmesburg experiments more dramatically through the eyes of one black man, Edward "Butch" Anthony, who suffered greatly from the experiments for which he "volunteered" during multiple terms at the prison. This is not only one black man's highly personal account of what it was like to be an imprisoned test subject, but also a sobering reminder that there were many African Americans caught in the viselike grip of a scientific research community willing to bend any code of ethics in order to accomplish its goals and a criminal justice system that sold prisoners to the highest bidder.

Human experimentation in medicine --- Prisoners --- Anthony, Edward, --- Holmesburg Prison.

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Biomedical research on humans is an important part of medical progress. But, when health and lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research-institutional review boards, or IRBs-is growing. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better understand the issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the human participants in research. For three major research areas- drugs, medical devices, and genetic information - Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. Containing helpful summaries and checklists throughout and based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process. Biomedical research on humans is an important part of medical progress. This is a guide for new and veteran members of IRBs that helps them better understand the issues involved and the tasks they will be required to perform. It gives IRB members the tools they need to protect human lives and facilitate the research process.

Human experimentation in medicine --- Medical ethics --- Medicine --- Moral and ethical aspects --- Research --- Moral and ethical aspects