IRB Advisor
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Ethics tool could enhance protocols and subject protection
A multiple stakeholder group developed a protocol ethics tool kit to ensure there is no missing information regarding ethics considerations in protocols.
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Next stage for IRB collaborations: Better communication and connections
It’s complicated for research organizations to operationalize oversight of studies when relying on a single IRB for review of a multisite study, and the Notice of Proposed Rulemaking might even complicate things more.
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‘Optimistic bias’ may subvert informed consent in early-phase cancer trials
There is a gray area where optimism in a research patient in early phase cancer trials crosses over to a misperception of benefit and raises ethical questions about informed consent.
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Maryland Gets a New View of Conflicts of Interest
An investigative committee at the University of Maryland in College Park recommends mandatory education on conflicts of interest for research faculty.
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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.
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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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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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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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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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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.