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IRBs located in universities might find themselves inundated with low-risk protocols if they reviewed every single study proposed by college students working on their graduate papers. On the other hand, it would be poor policy and possibly provide risk to human subjects if these studies were routinely ignored.
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One of the challenges in clinical trial operations is to recruit patients to participate. The Food and Drug Administration notes that recruitment methods and material also should be reviewed as a part of the IRB oversight function.
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Nonaffiliated and nonscientist members of IRBs the so-called lay or community members say they need more introductory education and ongoing training to better meet the challenges of their roles.
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College student populations may offer a plentiful and accessible source for human subjects research, but IRB and university research officials say that a variety of issues arise when students are used.
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It started out a simple premise: protect patients privacy by securing their health information. But the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) is raising some concerns, not just among primary caregivers and treatment facilities.
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The draft guidance on financial conflicts of interest and research published March 31, 2003, in the Federal Register offers more questions to be considered than specifics to be followed.
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The Stanford (CA) University protocol application form includes a section that examines potential conflict of interest through seven questions.
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Before INTEGRIS Rural Health (IRH) implemented its physician-aligned model of case management, the process was piecemeal throughout the eight-hospital system.
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When Carol Reeder, RN, BSN, MSA, first goes into a hospital to consult on setting up a physician-aligned case management model, she encourages case managers to try to understand what physicians have to deal with in their daily practice.
