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The continuing publicity surrounding both ever increasing public financial support for clinical research and claims of improper human research activities has led to calls for additional oversight of the clinical research enterprise.
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The proposal for the study, A Multicenter, Randomized Dose Response Study of the Safety, Clinical and Immune Responses of DryVax Vaccine Administered to Children 2 to 5 Years of Age, provides the following details.
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Recently updated guidelines for human subjects biomedical research highlight the international research communitys concerns that studies conducted in poor nations may give too little attention to the health and well-being of participants who have few options and fewer medical resources.
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In an interview with IRB Advisor, Greg Koski talks about the initiatives launched and the success realized during his time as director of the Office for Human Research Protections.
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The 10-page human subjects consent form proposed for the Dryvax vaccination study of children, ages 2 to 5, has a number of flaws, according to the IRBs and experts who have reviewed the study proposal and consent form.
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Once a final decision is made regarding some proposed research involving very young children and an older smallpox vaccine, there could be long-term repercussions for IRBs nationwide.
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An unprecedented federal investment in bioterrorism scientific research is leading to breakthroughs in vaccines, treatment, and diagnostics for a murders row of most-feared agents, one of the nations top bioterrorism researchers reported.
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IRBs working with community partners on non-medical studies need fresh tools, such as resourcefulness and imagination, when engaging in training and education.
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For some patients, enrolling in a clinical trial is not an option. They may meet exclusion criteria, or the nearest trial center may be geographically inaccessible, despite having a disease or condition that could benefit from investigational treatment. In such cases, the patients physician can request expanded individual patient access from the Food and Drug Administration. In dire situations, the physician can seek emergency use.
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Advancements in imaging technology mean a greater chance of detecting incidental findings in imaging research subjects. As IRBs turn their attentions to figuring out how to handle and manage IFs, some may not know where to begin or how to get their plans to the implementation stage.