IRB Advisor – October 1, 2016
October 1, 2016
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EU Will Require More Clinical Trial Transparency — Will U.S. Be Next?
The European Union soon will require investigators to give people the kind of transparent, easy-to-access clinical trials information they’ve been conditioned to expect in the age of Google.
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EU’s Requirements for Returning Trial Results
The EU’s European Clinical Trial Regulation requires clinical trial sponsors to create layperson-friendly content for the summary of results.
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The How and Why of Returning Study Results
Returning a layperson summary of study results to research volunteers is the right thing to do that also could benefit the research community, several human research protection experts say.
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Olympic Athletes, Staff Enrolled in Zika Virus Study
In an ongoing study of 1,000 U.S. athletes, coaches, and staff that recently traveled to Brazil for the Olympic Games, researchers are performing antibody testing to see if any acquired Zika virus.
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IRB Coordinators Can Get a Lot Done in a 30-minute Sit-down
The IRB of Oregon State University has found that short, in-person meetings with researchers can result in greater communication, collaboration, and efficiency.
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IRB Manager Offers Tips on Improving Office Operations
The work pace is speeding up, and it’s not just IRBs — although IRB directors are noticing the effect of having more demands on existing staff. This is a challenge IRB managers can meet by improving their office workflow and operational efficiency.
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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.
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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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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.”