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Haverford College of Haverford, PA, has spent more than a year dealing with a problem that IRBs do everything they can to avoid: a research noncompliance investigation requested by the Office for Human Research Protections (OHRP).
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Over the past decade, several large-scale disasters have tested emergency response teams and healthcare providers. They've also tested the research community's ability to quickly, efficiently and ethically dispatch investigators to do vital research that could help prevent and respond to future disasters.
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IRBs have an important role to play in improving community involvement in cancer clinical trials everything from increasing their own community membership to working with community advisory boards and pushing for more community-friendly informed consent.
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More meaningfully involving communities especially minorities and other ethnic groups in clinical research isn't just good ethics it could help address under-recruitment and failure of cancer clinical trials, says one of the authors of a new report on the subject.
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The activities of state public health departments including disease tracking, cancer registries and death statistics can be a rich source of data for research.
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Quality assurance programs for clinical trials do more than improve the data coming out of studies and the validity of the results.
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It's just about a given that informed consent documents making their way to the IRB for approval will need to be revised for comprehension and readability. Investigators and sponsors tend to include long sentences and paragraphs and technical jargon that leads the MEGO syndrome "my eyes glaze over," says Stewart A. Laidlaw, PhD, an associate vice president for compliance at the Los Angeles Biomedical Research Institute at the Harbor-UCLA Medical Center (LA BioMed) in Torrance, CA.
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The new IRB Advisor pilot program at Rutgers, The State University of New Jersey in New Brunswick, NJ, resulted in a reduction in protocol submissions that had to be returned to investigators, according to the IRB director.
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A recent study of an instrument for assessing decisional capacity in patients with Alzheimer's disease shows that it's a reliable tool for determining whether those patients are competent to give their own consent for research.
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Knowing that an investigator has a financial interest in a clinical trial doesn't substantially affect people's willingness to participate, according to a study that surveyed 470 people about their reaction to informed consent documents that detailed such interests.