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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.
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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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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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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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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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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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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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Language Creep and Informed Consent: When Did ‘Human Experiments’ Become ‘Clinical Trials?’
There was a time when research involving human subjects was not couched in the relatively innocuous terms like “clinical trials” or “research,” but labeled baldly as an “experiment.”
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Federal Marijuana Decision a Buzzkill for Researchers
In what was widely viewed as a blow to expanding marijuana research for such conditions as post-traumatic stress disorder, the U.S. Drug Enforcement Administration recently rejected a petition to reclassify cannabis from its current status as a Schedule I drug.
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Longstanding Sex Bias in Clinical Research Still a Problem
Echoing historical trends, researchers have found that a significant level of sex bias exists in human surgical studies.