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Biobanks pose a daunting challenge to the very idea of informed consent how can potential subjects to give consent for research done on their biological samples when there is no way to tell them all the potential studies that could result from their participation?
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While some industries are laying off large percentages of staff, forcing wage cuts, and making other sorts of draconian workforce changes unseen for generations, health care and research have been somewhat insulated from the worst of these measures.
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It took investigators years of research to create the new consent form template for phase I oncology trials, which provides several pages of simple, clear language in an informed consent outline.
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The checklist includes examples of words and graphics that could be used to simplify the IC document, as well as advice on how to discuss a study with potential participants and how to assess their understanding.
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IRBs mostly are familiar with research that enrolls individuals, and their attention is paid to the individual informed consent. But there are other types of human subjects research, including cluster-randomized trials, which require IRBs to focus on interventions at a wider level, an expert says.
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Qualitative research based on in-depth interviews has the potential to reveal rich details about the lives of participants. As a result, it also has the potential to identify those participants, even in the absence of protected health information such as name, address or birth date.
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Pediatric biobanks which include samples taken from children treated for specific diseases or collected in large population-based studies require consent from parents at the time of collection.
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On the positive side, IRB professionals appear to be better insulated from the country's current economic troubles than people in many other industries.
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More than 75% of parents surveyed in a nationwide study would be willing to allow their children's newborn screening samples to be used for future research if researchers first asked their permission.
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In an effort to address the wide variance in state laws and policies regarding the research use of newborn screening blood spots, a federal advisory committee is considering a proposal for a national policy.
