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Full-Text Articles in Medicine and Health Sciences
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 …