IRB Advisor – June 1, 2018
June 1, 2018
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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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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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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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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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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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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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Correction
The March issue of IRB Advisor featured a story about plain language informed consent with an incorrect reference.