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Full-Text Articles in Arts and Humanities
Ethical Issues Associated With The Introduction Of New Surgical Devices, Or Just Because We Can, Doesn’T Mean We Should, Sue Ross, Magali Robert, Marie-Andrée Harvey, Scott Farrell, Jane Schulz, David Wilkie, Danny Lovatsis, Annette Epp, Bill Easton, Barry Mcmillan, Joyce Schachter, Chander Gupta, Charles Weijer
Ethical Issues Associated With The Introduction Of New Surgical Devices, Or Just Because We Can, Doesn’T Mean We Should, Sue Ross, Magali Robert, Marie-Andrée Harvey, Scott Farrell, Jane Schulz, David Wilkie, Danny Lovatsis, Annette Epp, Bill Easton, Barry Mcmillan, Joyce Schachter, Chander Gupta, Charles Weijer
Charles Weijer
Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Industry should comply with all Health Canada requirements to obtain licenses for new products. Until Health Canada requires effectiveness and safety data, industry should cooperate …
Ethics And Schizophrenia, A. Rudnick, Charles Weijer
Ethics And Schizophrenia, A. Rudnick, Charles Weijer
Charles Weijer
No abstract provided.
U.S. Federal Regulations For Emergency Research: A Practical Guide And Commentary, Andrew Mcrae, Charles Weijer
U.S. Federal Regulations For Emergency Research: A Practical Guide And Commentary, Andrew Mcrae, Charles Weijer
Charles Weijer
Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with the relevant federal research regulations to optimally protect vulnerable research subjects, and to facilitate the institutional review board (IRB) review process. IRB …