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Clinical trial investigators soon will need to follow more stringent data security and information protection standards, according to a notice of proposed rulemaking, published in the Federal Register, July 26, 2011.
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The first step was a mandate by the institution. The Mind Research Network (MRN) requires researchers to report incidental findings to subjects in a systematic way that protects confidentiality and is sensitive to the emotional impact of receiving the news.
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The vanguard of new technology includes multiple uses of mobile phones during the clinical research process. These devices have a penetration that laptops and land lines will never have, and so they are becoming an important tool for use in recruiting and monitoring subjects, an expert says.
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Regardless of hospital trauma level designation, every emergency department (ED) manages patients with traumatic injury and needs to address the pain and discomfort that accompanies it.
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Thirty seconds is all it might take to prevent a weeks-long regulatory hassle. That's what Eunice Newbert, MPH, tells clinical trial staff at Children's Hospital Boston (MA), where she is the manager of education and the quality improvement program.
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As the past year's devastating tornadoes, unexpected flooding, and other disasters have shown, it is impossible to predict when and where a natural disaster might interrupt a city's business as usual.
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Clinical research sites impacted by hurricanes, flooding, or other disasters a decade ago faced daunting challenges in retrieving files and irreplaceable study data because they either relied on paper or were early in the transition to electronic files.
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National research organizations and individual researchers have weighed in on the government's proposed changes to the Common Rule, saying regulators should reconsider their plans for requiring informed consent for all biospecimens.
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One of the more controversial proposed changes to the research Common Rule involves strengthening informed consent protections related to research involving biospecimens. Some researchers predict these changes could shut down much of their work and result in major collateral damage to the research enterprise.