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There is a new kid on the block, helping to oversee human subject protections at some institutions and providing some assistance to overtaxed IRBs: the research subject advocate (RSA).
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Examples of Exculpatory Language
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Sometimes there are just too many acronyms, but its important for research professionals to learn the regulatory power wielded by the big three: OHRP (Office for Human Research Protections), FDA (Food and Drug Administration), and NIH (National Institutes of Health).
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In recent years, it has become a common practice for sponsors of clinical trials to collect extra blood and tissue samples from subjects for genetic analysis and possible later use in future research projects.
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Federal laws governing research on human beings prohibit research institutions and sponsors from requiring subjects to sign documents that waive or appear to waive any of their legal rights.
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The National Institutes of Health (NIH) in the early fall announced plans to transform the nations medical research enterprises and expedite turning research discoveries into practical improvements.
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Do you have an action plan for what to do when the next patient comes to your ED with respiratory symptoms consistent with severe acute respiratory syndrome (SARS)? ED nurses nationwide urgently are developing strategies to prepare for another outbreak.
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A child with a suspicious fracture. An elderly woman who says she hasnt been eating regularly. A drunk driver involved in a fatal motor vehicle accident. Do you know which of these cases you are required to report to agencies or law enforcement?
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When callers ask whether their family member or friend is in your ED, what do you tell them? If youre like most ED nurses, youre confused about exactly what information you can share to avoid violations of patient privacy regulations.
