IRB Advisor – August 1, 2017
August 1, 2017
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ICMJE Underlines Ethics on Importance of Data Sharing
The International Committee of Medical Journal Editors published an editorial in June 2017, saying there is an ethical obligation to share interventional clinical trial data. Beginning July 1, 2018, manuscripts with clinical trial results that are submitted to the committee's journals must contain a data-sharing statement.
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Assent Is Not Consent: Children in Clinical Trials Are Not Little Adults
The classic admonition in pediatric medicine is “children are not little adults,” implying in part that you cannot just scale down adult care and treatment. Does this phrase resonate as well in human research trials involving children, particularly around issues of consent for the former and assent for the latter?
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FDA’s Draft Guidance on eRecords Could Have Unintended Consequences
The FDA’s draft guidance on the use of electronic records and electronic signatures encourages systems to improve quality and efficiency, and expands the use of a risk-based approach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.
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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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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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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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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.