Resp Care
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Comparative Study
Feasibility and potential cost/benefit of routine isoflurane sedation using an anesthetic-conserving device: a prospective observational study.
Inhaled sedation is efficient and easily controllable; in low concentrations it causes minimal changes in the patient and very little interference with hemodynamics. Awakening after inhaled sedation is quick and predictable. The major reason inhaled sedation has not become widely used in intensive care is that no commercially available administration device has been available. ⋯ Routine ICU isoflurane sedation with the AnaConDa is easily feasible, effective, safe, and has a relatively short awakening period. In some patients with sedation difficulties, this sedation method may significantly decrease sedation cost and enhance sedation efficacy.
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The federal government regulates human research with a local institutional review board (IRB) at your institution. Your IRB's main responsibility is to protect the rights and welfare of human subjects recruited to participate in research. The IRB is responsible for reviewing and approving all research protocols that involve human subjects. ⋯ They also want to know how you plan to protect research subjects from the risks of research and how you will manage the data, especially protected health information. Though the Code of Federal Regulations is extensive, this article provides information to help you navigate your research protocol through the layers of regulations, including the Privacy Rule of the Health Insurance Portability and Accountability Act of 1996. Whether conducting a simple chart review or participating in a multi-site randomized placebo-controlled trial, if you follow tried-and-true scientific methods and good clinical practice, you will be able to work effectively with your IRB.
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Review
Institutional review board consideration of chart reviews, case reports, and observational studies.
Though the need for human-subjects review is readily apparent to investigators when conducting a randomized clinical trial, that same requirement is often less obvious when considering activities such as chart reviews, observational studies, or even case reports. In some cases all that is needed is notification of the institutional review board, which might then exempt the research. ⋯ In all cases, including case reviews, quality-improvement projects, and chart reviews, the most cautious approach for the investigator is to discuss regulatory requirements with the institutional review board official to ensure compliance. I will review what constitutes human-subjects research and how investigators may access protected health information, and consider some examples of observational research.