IRB Advisor – April 1, 2016
April 1, 2016
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French study’s death recalls 2006 UK clinical trial disaster
It was an unsettling sense of deja vu for researchers and bioethicists when French authorities reported in January that one man died and five others were seriously injured after being administered an investigational drug in a Phase I clinical trial.
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FIRST study proves a point, but which one?
A controversial study that was branded as unethical by some critics because it altered surgical residents’ training hours without informed consent from patients has found that “flexible, less restrictive” duty hours did not increase patient mortality or serious complications.
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IRBs Train Staff to be Experts
Here's how one human research protection program developed a formal training program that empowered its staff.
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A sample of IRB’s comprehensive training manual
The human research protection office at Washington University in St. Louis has a 43-page training tool that covers general and specific research protection information and tasks for new IRB staff.
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Using eFeedback helps promote subject safety
Seattle Children’s Research Institute in Seattle found that an eFeedback tool helps the organization improve and ensure the safety of pediatric patients who are enrolled in clinical trials.
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Human germline gene editing holds great promise, dire possibilities
An international summit on human gene editing recently concluded with a consensus statement to continue basic research in the controversial area, but warned against any clinical trials or human experiments because “once introduced into the human population, genetic alterations would be difficult to remove and would not remain within any single community or country.”
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IRBs and germline editing research: The outer limits of oversight
Guest columnist J. Benjamin Hurlbut, PhD, discusses human germline editing research and the role IRBs could play in research ethics.