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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. The IRB evaluates your study design to ensure that it has the possibility of answering your research hypothesis. The IRB focuses on the risks and benefits of your research. The IRB wants to know that research subjects are recruited fairly and that the potential for benefit is distributed equitably. 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. [ABSTRACT FROM AUTHOR]

The federal has established guidelines ane regulations for the protection of vulnerable research subjects, especially children, pregnant women, cognitively impaired persons, and prisoners. In addition, students, residents, and employees are recognized as special research populations. Clinical investigators need to be aware of and use these federal guidelines appropriately. This article provides practical guidance for respiratory therapists who conduct research with these patient populations and solutions to the barriers investigators commonly encounter when studying these patient populations. [ABSTRACT FROM AUTHOR]

OBJECTIVE:: To test the reliability and validity of a modified moral distress tool, originally developed for the nursing profession, on respiratory care practitioners. To describe the relationship between moral distress, career dissatisfaction, and job turnover in respiratory care. DESIGN:: A 28-question survey was developed. Three categories of survey questions were predefined: 'individual responsibility,' 'not in the patient's best interest,' and 'deception.' Additional questions measured career dissatisfaction, job turnover, and demographic information. SETTING:: University Hospital at the University of Virginia Health System, a 552-bed tertiary care hospital. SUBJECTS:: Fifty-seven of 115 (49.6%) of respiratory care practitioners responded to the survey. INTERVENTIONS:: Exploratory factor analysis was used to investigate the underlying factor structure. After we extracted theoretically meaningful factors, reliability of each factor was estimated. Multiple regression analysis was conducted to test if the underlying factors predicted career dissatisfaction and job turnover. MEASUREMENTS AND MAIN RESULTS:: The factor analysis yielded a five-factor structure. Several questions in the 'not in patient's best interest' category scored the highest moral distress including disagreements with surrogate decision makers and providing futile care. Higher scores were also found with questions regarding the perception of unsafe staffing and passively or actively participating in deception. None of the demographic variables predicted career dissatisfaction or job turnover. However, the perception of unsafe staffing was found to be a significant factor in predicting career dissatisfaction and job turnover. CONCLUSIONS:: In this one-center pilot study, respiratory care practitioners reported experiencing moral distress in many areas of their practice. Distress related to the perception of unsafe staffing may be related to career dissatisfaction and job turnover. Further exploration of the factors that contribute to respiratory care practitioners' moral distress is needed, as well as implementing ways to ameliorate it. [ABSTRACT FROM AUTHOR]