Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
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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. ⋯ This article is intended as a guide for emergency researchers and IRB members who review emergency research. It reviews the elements of Federal Regulations that apply to consent, subject selection, privacy protection, and the analysis of risks and benefits in all emergency research. It explores the challenges for IRB review listed above, and offers potential solutions to these problems.
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Review Comparative Study
Safety and clinical effectiveness of midazolam versus propofol for procedural sedation in the emergency department: a systematic review.
To synthesize the evidence comparing the adverse event (AE) profile and clinical effectiveness of midazolam and propofol for procedural sedation (PS) in adults in the emergency care setting. ⋯ The authors found no significant difference in the safety profile and the proportion of successful PS between midazolam and propofol for adults in the ED.