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IRBs often struggle with determining risks of social and behavioral research studies. Its easy to be both too cautious and too complacent.
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There are no industry standards for handling incidental findings (IFs) in research.
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As technology in genetic and genomic research expands, most if not all IRBs will face the issue of incidental findings, including how to manage them, and whether researchers have a duty to report them to study participants, experts say.
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The Cincinnati Childrens Hospital Medical Center IRB and a special task force developed guidance and a template for improving and simplifying informed consent forms.
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The exponential increase in smartphones and social networking sites has led to concerns from some patients regarding the possible unlawful distribution of images outside the realms of their care.
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An IRB member and human research protection expert learned firsthand how complicated informed consent (IC) forms could be when her granddaughter was seriously ill.
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While the informational quality of internationally registered trials has increased, theres still room for improvement, according to a recent study.
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One chief hurdle in human research protection program (HRPP) accreditation is the mindset that its all about the IRB, an expert says.
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The IRB at Grand Valley State University in Allendale, MI, uses a matrix that clarifies how IRB members and staff might describe various potential harms at four levels, from no more than minimal risk to high risk.
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Technology advances have driven increased interest in molecular studies involving tissue analyses. As a result, biotech firms increasingly are asking scientists to sell human tissues for study by outside enterprises.