IRB Advisor
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Gene Expert: IRBs Should Prepare for Somatic Cell Trials
With somatic gene cell editing already underway in some trials, IRBs should prepare to deal with protocols involving noninheritable genetic changes.
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The Single IRB: One Board to Rule Them All
The National Institutes of Health recently delayed the effective date of its requirement to designate a single IRB in research involving multiple boards, but NIH officials have lost none of their enthusiasm for the idea.
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Community Research Training Helps Subjects Become Investigators
A new social-behavioral research model IRBs might encounter is one in which researchers include people who also could be participants, or their guardians, for the same studies.
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Finding the Best Role for Community Members: A Look at Two Strategies
IRB questions sometimes arise about the role and responsibility of community members/nonscientists on review boards. Should their — and other nonaffiliated members’ — contributions be limited? Do they have enough training to be primary or secondary reviewers?
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Newest Oncology Studies Raise Ethical, Other Questions for IRBs
Clinical research — especially involving oncology trials — is evolving with the introduction of new therapies and therapeutic mechanisms. These raise new and sometimes challenging questions for IRBs reviewing the study protocols.
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Paper Calls for More Transparency of Industry-sponsored Clinical Trials
A recent paper offers consensus recommendations and examples of best practices from the published clinical trial literature to help authors and trial sponsors communicate drug adverse events in a more informative and clinically meaningful manner.
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Very Strict Clinical Trial Criteria Can Pose Ethical Problem
Clinical trials routinely use overly strict enrollment criteria, found a recent study.
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Gray Zone Remains Between Clinical Research and Quality Improvement Efforts
The boundary between quality improvement projects and clinical research requiring IRB oversight remains nebulous with finalization of the Common Rule on Jan. 18, 2017. There was some attempt to address this situation in the proposed new rule, but ultimately the solutions were deemed problematic and the issue was left unresolved.
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Small IRB Revises Forms, Updates Policies and Procedures to Obtain FWA and Reach Next Level
A small university's human research protections program overhauled its processes to bring it up to the requirements of the Common Rule and Federalwide Assurance.
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FDA’s Draft Guidance on eRecords Could Have Unintended Consequences
The FDA’s draft guidance on the use of electronic records and electronic signatures encourages systems to improve quality and efficiency, and expands the use of a risk-based approach in validating and establishing audit trails for electronic systems. But it’s the validation part of the proposed guidance that could introduce a new problem.