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Is there clear and convincing evidence that an individual has no pain that would justify a prescription analgesic and is, therefore, seeking medication solely because of an addictive disorder, recreational use, or with the intent of diverting it to others?
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In general, patients think of a screening test as a good thing, says Arthur L. Caplan, PhD, director of the Division of Medical Ethics at NYU Langone Medical Center in New York, NY. "Patients aapproach this thinking that it is better to test than not test, and doctors have to be aware of that bias," he says.
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Most IRB directors or chairs can recount stories about their tensions with investigators. All boards must balance the institution's need to protect subjects with investigators' concerns about unduly hampering their research.
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The human subjects protection field continues to search for ways to improve the informed consent (IC) process. IRB professionals often express concern that potential research participants do not understand their rights or the true risks and benefits of a study, although they might sign the IC forms and say they have no questions.
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Robert Klitzman's survey of IRB chairs, members and administrators revealed a number of ideas that can be adopted by other institutions that want to improve relations with their investigators.
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Despite evidence suggesting that tobacco use can hamper cancer treatments, patients with cancer who enter clinical trials are rarely asked about their use of tobacco, according to a recent study.
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Research institutions that plan to use the teach-back method as part of their informed consent process should make certain there is adequate training for clinical trial professionals. One research site has found that simulations work best for this purpose.
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It's important that IRB meetings are run efficiently, keeping discussions brisk and on the important human subjects protection issues. But it's also important that these discussions are well-documented in the IRB meeting minutes.
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Nearly every baby born in the United States undergoes a simple heel-stick in the first few days of life that has potentially profound health implications for his or her life.
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It began as an infection control nightmare in New Hampshire, but it didnt stop there. A medical technician who worked in the cardiac catheterization lab in Exeter Hospital in Nashua was charged with diverting drugs and reusing the syringes on patients.
