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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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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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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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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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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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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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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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Expect a lot of interaction with unit staff but no control over where surveyors go or who they talk to. Thats what quality managers who participated in the pilot surveys for the Joint Commission
on Accreditation of Healthcare Organizations Shared Visions New Pathways process are saying.
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Perhaps the hardest thing to get used to about the Joint Commission on Accreditation of Healthcare Organizations new survey process is the lack of any set agenda, says Helena Feather, vice president of compliance and health information at Trident Health System in Charleston, SC.
