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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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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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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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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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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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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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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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In a typical informed consent process, the researcher assures subjects at the outset of a study that their information will be kept confidential and the issue may never come up again.
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Human subjects research has evolved and grown dramatically in recent decades, fueled by advances in medical technology, research globalization, and financial and professional incentives, a researcher and health science expert says.
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It's likely one of the first medical procedures most newborn babies undergo a simple heel stick, as blood samples are taken to screen for a variety of disorders that might not otherwise be apparent at birth.