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The protocol review discussion will benefit greatly from the questions and input of IRB community members. But this resource too often is underdeveloped as the scientific experts on a board dominate discussions.
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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.
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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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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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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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When a family is adrift on the unfamiliar waters of pediatric research, it helps to have a guide and translator.
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FDA is reviewing safety of TZDs; SSRI use with tamoxifen; Metformin smells like fish; FDA Actions.