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Your daughter calls you from a party and tells you that she is on her way home. Two hours later, she hasn't arrived and she does not answer her cell phone. You call the emergency department (ED) and ask if she is registered as a patient there.
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Was an abnormal lab result missed, such as a potassium level of 2.5? Was an incorrect medication prescribed? Or was a radiology study misinterpreted which revealed a pneumothorax? In every one of these scenarios, it is necessary for the ED physician to call the patient...
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When a family is adrift on the unfamiliar waters of pediatric research, it helps to have a guide and translator.
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The stress of dealing with a critically ill newborn did not prevent parents from making informed decisions about enrolling their child in research, according to a study conducted using a common competence assessment tool.
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Rather than blind, call it a "deaf spot." The adverse event reporting from clinical trials that helps inform conclusions about a drug's safety has a crucial hole in it the voices of actual patients taking the drug.
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One issue regarding IRB submission compliance that often is overlooked has to do with the complexity of IRB forms.
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Electronic IRB systems can be an efficient way to improve human subjects research compliance, but as one institution has found, these also can be a source of compliance problems.
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The quote above is a familiar truism of human subjects protection. Nevertheless, many institutions still spend a lot of time grappling with the documentation of informed consent and precious little looking at how well the process of informed consent actually informs and prepares subjects for making a decision about research participation.
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Electronic IRB systems can be an efficient way to improve human subjects research compliance, but as one institution has found, these also can be a source of compliance problems.
