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The National Human Genome Research Institute in December formed a new branch the Social and Behavioral Research Branch (SBRB) within its Division of Intramural Research.
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It is difficult for those receiving federal dollars for research to avoid continuing interest by the Office of the Inspector General (OIG) in compliance efforts. In the last few months, two federal reports have included discussions of human subject protections.
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While IRBs often pay close attention to a protocols potential risks and may hold discussions on the risks vs. benefits ratio, the benefits side of the equation often is poorly explained and less well examined, experts say.
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Among the many changes experienced by IRBs and the research industry in recent years is the trend of more clinical studies being conducted in the community and in small clinics, a subtle shift away from major research centers.
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With the changes that have occurred for IRBs and the research industry in recent years, its a safe bet that the trend will continue in 2004.
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Hastings Center issues report on reprogenetics
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New federal laws aimed at encouraging drug companies to study how well their products work in children have had the unintended consequence of weakening already vague protections that prevent child research subjects from being exploited, a leading human subjects research advocate claims.
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In the emergency department (ED) at Palmetto Health-Richland, a 649-bed regional community teaching hospital in Columbia, SC, two waiting rooms have been converted into functional, secure units for patients with behavioral health problems who are waiting for transfer to a mental health treatment facility.
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The Alliance for Human Research Protection (AHRP), a nonprofit research advocacy organization based in New York City, offers the following recommendations for the safety of children involved in clinical research: