Internal Review Boards
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Research noncompliance is a problem of system failure
Every IRB and research organization should view research noncompliance as systems failures that need to be dealt with professionally, consistently, and transparently, according to an IRB expert.
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Verbal consent and decision tree assist research community
As informed consent and IRB work evolve, new tools can help ease the transformation.
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ANPRM Update
The U.S. Department of Health and Human Services published a Notice of Proposed Rulemaking at press time in the Office of the Federal Register.
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AllTrials launches U.S. campaign, demands clinical trial data release
Originally founded in the UK, the AllTrials Campaign have brought their crusade for clinical trial transparency to the United States.
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Coping with unexpected risks in SBER studies
Social, behavioral, and educational research studies can sometimes reveal risks that are unanticipated and unimagined. Handling informed consent for these studies requires an IRB and research team to be flexible and able to adjust quickly as issues arise.
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Training research participants to become research assistants
One emerging trend in social-behavioral research studies involves the use of peer researchers to better engage a particular community or vulnerable population.
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Can IC be improved in Phase I cancer trials?
An interesting thing happened when researchers asked parents of children involved in Phase I oncology studies about their experiences with informed consent: Parents had a lot to say.
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IRBs have improved polices regarding COIs, but some problems remain
A new study examined the nature and consequences of relationships between industry and IRB members in the years between 2005 and 2014, finding both good news and not-so-great news.
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21st Century Cures Act Raises Subjects Protection Concerns
One short clause in a proposed health bill might unravel decades of efforts toward improving human research protection.
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Big data is at every IRB’s fingertips — but can you use it?
Research institutions increasingly are investing in electronic systems that have the capability of collecting and storing big data.