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In April, 2007, the Food and Drug Administration (FDA) issued its draft "Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting Improving Human Subject Protection."
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Now that IRBs have both the final guidance on unanticipated problems and adverse events from the Office for Human Research Protections (OHRP) of Rockville, MD, and the draft guidance from the Food and Drug Administration (FDA), their duties in handling these issues should be clear, right?
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Arecent study suggests that emergency medicine patients may not have a high level of acceptance of the practice of providing an exemption to informed consent for research involving emergency medical settings.
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The clinical research community has begun to accept the presence of clinical trial registries, despite lingering questions about intellectual property rights and other issues.
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As IRBs review research proposals that may include illegal immigrants or even recruit them outright those who work with this population say there are a number of issues boards should consider:
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Research compliance can be defined a variety of ways, and the trick is for institutions to define and understand the types of noncompliance that are reportable to federal agencies, a compliance expert says.
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Does the Office of Human Research Protections (OHRP) plan to release guidelines this year clarifying what is and isn't research requiring IRB review?
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As the national debate about illegal immigration heats up across the country, researchers continue to work to include such immigrants in their studies.
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When researchers are attempting to persuade subjects to answer questions about themselves, whether on the phone or by filling out a form, sometimes the altruism of participating in research isn't enough.
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Small IRB offices often do not have cross-trained or back-up staff in the event the IRB administrator is unexpectedly absent. So what happens when the people filling in cannot find the right forms or records or schedules?