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Add up the number of citations of noncompliance related to IRB issues that the Office of Human Research Protections (OHRP) at the Department of Health and Human Services in Rockville, MD, handed out between October 1998 and June 2002 and the numbers are pretty staggering. Of the 1,120 citations given to 155 institutions, 1,014 of them say something about IRB noncompliance and deficiencies.
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Bernard Schwetz to head OHRP.
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While the mapping of the human genome provided scientists with a blueprint for understanding disease, Swedish researchers are trying to take the knowledge one step further, with the human proteome.
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Whether an IRBs protocol volume is small, medium, or large, its not easy to decide whether to have the entire board read every page in a protocol submission or have a primary and/or secondary reviewer system in which point people take on the bulk of the work.
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The IRB at Oakwood Healthcare System in Dearborn, MI, reviews protocols for four hospitals, including protocols written by masters level, doctoral level, nursing students, and the 150-plus residents.
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One of the challenges faced by clinicians and investigations in accumulating data that might be used for research, is to determine the rules that apply to ensure its availability if and when the research moves forward.
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Patients who participate in clinical trials not only have access to newer, experimental treatments, they also have access to more routine medical checkups and state-of-the-art technologies. For people with serious illnesses, and those without access to routine medical care, participation can make a significant difference in their care. Yet for many women, participation in medical research studies is still not an option.
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Genetic therapies are rapidly moving from the laboratory into the clinical setting, with more investigators testing experimental gene delivery systems and therapies designed to fundamentally alter our bodies to prevent or treat disease.
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Efforts to improve clinical trial participation among medically underserved populations often overlook one group in particular, say some cancer researchers in California.