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Problem
An APRN writes a proposal to do a 12-week educational class for patients between 30 and 40 years of age with metabolic syndrome. The educational class includes content on diet, exercise, and medication. The APRN plans to offer the educational program to every third patient with this diagnosis at the local Happy Heart Clinic. The findings (patient satisfaction, weight, lipid and glucose profiles) at the end of the 12-week period of performance will be compared to those patients not included in the study but who meet inclusion criteria. This study has previously been done in 50-60 year old patients, with significantly improved outcomes.
Question A. What are the ethical concerns when replicating this study in a new population?
Question B. How can they be addressed prior to submitting the proposal to the IRB?
Question C. Explain how you would proceed with getting informed consent if you are concerned that your participants may not all follow through for the full 12 weeks of the study.
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