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For years, inmates of a Philadelphia city jail, known as Holmesburg Prison, participated in medical experiments. From the mid-1950s to 1974, when medical testing was banned, research, ranging from dermatological treatments to the effects of mind-altering drugs, was conducted at the jail.
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Monitoring student research isnt always a top priority for an IRB, and often the job may be partly handled by the students department and graduate advisor. However, in the cases where the student research involves human subjects who are children, the issue becomes far more complicated.
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Making changes under the Health Insurance Portability and Accountability Act (HIPAA) has not been easy for many research institutions and their IRBs.
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For many years, institutions involved in training the nations bioscience researchers have spent a great deal of time and money ensuring that their graduates function at the cutting edge of science and technology.
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The draft guidance on financial conflicts of interest and research published March 31, 2003, in the Federal Register offers more questions to be considered than specifics to be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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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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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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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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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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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.