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FDA Moves to Shutter Stem Cell Clinics
The FDA recently filed complaints in federal court seeking “permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements.”
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Baby Blood: Suit Alleges Michigan Lacked Informed Consent
An attorney in Hemlock, MI, is suing the state for its practice of routinely taking blood samples from newborns for testing and medical research.
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Quality Assurance Project Designed to Improve Good Clinical Practice and Compliance
Using a quality assurance process and feedback loop, an IRB improved its good clinical practice, education, and overall research protection compliance.
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IRB’s New Online Learning System Teaches Student PIs About Submissions
The new Common Rule focuses on creating a more efficient and streamlined IRB review process. This means the time is ripe for better education on how to submit a protocol.
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With Common Rule Delay, IRBs Can Still Revamp Human Research Protection Programs
The new delay of the Common Rule implementation will give HRPPs an opportunity to revise and improve their program policies and procedures.
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All of Us: NIH Looks to the Future, Tries to Overcome the Past
Trying to address “big data” threats to privacy and step out of the long shadow of human research travesties, the National Institutes of Health recently launched its ambitious All of Us project.
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Hair Apparent: Surgeon Rebellion Succeeds on Head Covers
Previous recommendations for surgeons to fully cover their hair and ears to prevent infections have probably been observed more in the breach than the observance.
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Flu Mandates: Consider Accommodations and Avoid a Lawsuit
Legal challenges to vaccination mandates can be avoided if hospitals try to provide some alternative accommodation for those claiming religious exemption. -
Fauci: HIV Can Be Stopped, but Vaccine Remains Elusive
One of the great pandemics in human history has been fought to a near draw, with no vaccine in sight but treatments that dramatically extend life and block transmission to others. -
Consider Probiotics in Patients at High Risk of C. diff Infection
After the most exhaustive analysis to date on the efficacy of probiotics in preventing Clostridium difficile infection, a researcher recommends that high-risk patients consider taking the products.