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A few years back, the Office of the Inspector General (OIG) released a report that referred to the IRB process as A System in Jeopardy.
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As more research heads for underdeveloped countries, there are greater challenges and opportunities for research institutions and IRBs located in the United States that may be connected to the research done in these countries through sponsorship or multisite clinical trials.
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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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Inevitably, some investigators will not be compliant with the federal or state statutes and regulations, institutional rules, or IRB policies when conducting clinical research.
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Except on the television drama ER, it rarely occurs, even at medical universities and affiliated hospitals, but occasionally an IRB may encounter a case where an investigator desires to have informed consent waived in order to conduct emergency medical research.
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The Partnership for Human Research Protection (PHRP) in Oakbrook Terrace, IL, recently announced the approval of final standards for a new accreditation program to safeguard the interests of human subjects participating in research efforts.