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HHS Releases Latest Edition
of ‘Healthy People’Decade-long plan addresses critical public health concerns such as opioid addiction and youth e-cigarette use.
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IRBs, Research Organizations Adjust to New Norms in COVID-19 Era
The research world’s axis shifted in 2020 with the COVID-19 pandemic. Research organizations and IRBs should expect that shift to be the new normal. There will be no return to the way it was before.
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More Research Needed Into How IRBs Operate and Make Decisions
The revised Common Rule’s provision that a single IRB should review protocols for multisite studies raises questions about how these IRBs handle conflicts of interest, local knowledge, and other issues. When a group of researchers sought to answer these questions, they found a big obstacle: Some IRBs, including the largest ones, were unwilling to participate.
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Steps for IRBs to Better Safeguard Participants
Technology is moving far faster than federal human research protection laws and regulations. But there are a few things IRBs can do that will help protect study participants.
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Combining Large Data Sets Challenges IRBs, Researchers to Ensure Privacy
The problems with HIPAA and current methods of protecting the privacy of individuals in research are being challenged in ways that were not possible in previous decades due to the ease and use of big data. Data scientists and other savvy investigators can combine de-identified data in a way that makes cross-references and re-identification possible.
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Mobile Technology, Wearables Are Changing Research, Challenging IRBs
Mobile technology and wearable sensors are broadening the limits of research and changing how IRBs view privacy. The voluminous data can point to health strategies previously unimaginable.
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Big Data Are Changing How IRBs Think About Research
Researchers and sponsors are adapting quickly to virtual technologies and using big data in studies, forcing IRBs and research protection programs to adapt — particularly when it comes to privacy. When IRBs review studies that use big data, they need to be reviewed through the lens of ethical review.
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7 Steps to Better HIPAA Compliance at Home
Ensuring HIPAA compliance with employees working from home will require a systematic approach. A compliance expert offers seven steps for better compliance.
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HIPAA Compliance a Concern as Working from Home Becomes Norm
Working from home is the new normal and will be for many healthcare employees for a while, so adjustments are necessary to maintain compliance with HIPAA. Protected health information must be managed properly whether the employee is in the healthcare facility or at home.
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Appellate Court Vacates $1.1 Million Sinus Surgery Verdict for Lack of Evidence
This case demonstrates the importance of carefully preparing one’s argument and presenting the evidence to support necessary findings. Another interesting lesson from this case is on the basic elements of medical malpractice: Even in the face of an undisputed breach of the standard of care, medical malpractice liability is not guaranteed.