Compliance
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Appellate Court Affirms Newborn’s Blindness Not Caused by Physician Negligence
The most important lesson to be learned from this case is that choosing the right expert is crucial — and selecting the wrong expert can be fatal to a party’s case.
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Criminal Charges Can Creep Up on Clinicians, Administrators
Some activities are particularly prone to criminal prosecution if risk managers are unaware of exactly how they are being conducted in the organization.
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Federal Wage and Hour Labor Laws May Confuse Healthcare Employers
Healthcare employers are especially at risk of violating the Fair Labor Standards Act. Many practices common in the industry could violate the law.
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Ethics of Genetic Research on Alcohol Addiction
Genetic testing is not yet ready for use in the prediction of alcohol dependence, according to recent ethical guidance.
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Was There Really Support for Single IRB Approach?
To answer this question, researchers reviewed the public comments submitted on the proposal for single-IRB review. They reviewed hundreds of comments on the question when it was originally broached in 2011 and then again in the 2015 Notice of Proposed Rulemaking.
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OHRP Explains What to Do About Expedited Reviews
Irene Stith-Coleman, director of the division of policy and assurances at the Office for Human Research Protections, answers questions about recent guidance related to the revised Common Rule and the recent frequently asked questions.
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Overcoming Bots and Trolls in Research on Social Media
Social science research using Twitter to gather attitudinal and behavioral data must account for bots and trolls but can still render meaningful results.
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Is It Standard of Care, Research, or Something Else?
Researchers and IRBs sometimes have questions about studies and treatment that fall in the gray area between research and personalized medical care. Is it innovative care that is intended to benefit a specific patient — or an innovation that has the potential of being generalizable?
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Researchers' Advertising Can Fall Into Noncompliance
Investigators might begin to market their study to potential participants even before they have received IRB approval, or make changes to their advertising and recruitment materials after an original version and format were approved.
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Preventing Rogue Researchers Should Be on IRBs’ Priority List
Bioethicists and the human research protections industry have been shocked in recent years by reports of rogue researchers carrying out investigations that raise huge red flags and, in some instances, could be regulatory breaches.