IRB Advisor – November 1, 2016
November 1, 2016
View Issues
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New NIH/FDA Rules Will Bring Greater Transparency to Clinical Trials
The new rules published this fall by the NIH and FDA about reporting clinical trial results will expand transparency in research and give the world more knowledge about the effectiveness of investigational and new drugs and devices, FDA and NIH officials say.
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Highlights from Final Rule on Clinical Trial Results Submissions
The NIH published the final rule, “Clinical Trials Registration and Results Information Submission,” on Sept. 21, 2016, with an effective date of Jan. 18, 2017.
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Historical Exposé on Sugar Industry Funding Research has Relevant Lessons for Current IRBs
A recently published study linking secret funding by the sugar industry to bias in research studies published in the 1960s is less a historical curiosity than a clear warning to IRBs to remain vigilant about conflicts of interest.
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Big Sugar’s Smoking Gun
Though the influence of industry funding on research outcomes has long been a subject of concern for IRBs, it is unusual to find a “smoking gun” strongly linking an undisclosed funding source to biased research outcomes.
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BEAM Program Provides a Buddy Mentoring Approach
Many IRB leaders struggle with attracting young professionals to the human research protection field, but few would dream of heading to elementary schools to groom the next generation of IRB members or experts.
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Establishing Trust in Partnerships is Key to Centralized IRB Review
As IRBs begin to increase their reliance on central IRBs or form relationships as the IRB of record, the most important action they can take is to build close relationships and trust with research organizations and researchers, experts say.
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IRBs Should Ensure that Proposed Studies Include Whether Research is ‘Reproducible’
An emerging body of research reveals that past studies — some of which may form the basis of current policies and recommendations — cannot be replicated by investigators today.