IRB Advisor
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IRBs and IBCs: Critical Partners in Gene Research
In addition to IRB oversight, the National Institutes of Health requires that research using “recombinant or synthetic nucleic acid molecules” for gene transfer into human research subjects be approved by institutional biosafety committees.
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FDA Explains IRB Written Procedures Policy
New federal guidance on IRB written procedures leave “meaningful content” open to interpretation.
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Prepare Contingency Plans for Transferring Oversight
IRBs should create a contingency plan that would go into effect when a natural disaster or a major problem disrupts operations.
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Right to Try Law Raises Questions About FDA, IRB Oversight
The FDA “remains committed” to reviewing and approving investigational drugs through its expanded access program, which will continue in conjunction with the recently enacted federal Right to Try law.
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Correction
The March issue of IRB Advisor featured a story about plain language informed consent with an incorrect reference.
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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.