Internal Review Boards
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IRB turns pediatric assent into video game
A children’s hospital’s human research protection program developed a video game to obtain assent from pediatric patients.
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Sample items from an IRB authorization agreement
The University of Pennsylvania developed an IRB of record relying site division of responsibility form that outlines what each IRB involved in the collaboration and authorization agreement will do.
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Strategies for establishing collaborative IRB review
Some research institutions are not waiting for the changes to IRB review suggested by the Notice of Proposed Rulemaking and have already been developing models for collaborative review.
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Lean thinking can be well-suited for IRB office
The philosophy of Lean thinking and processes has branched from manufacturing and business into healthcare over the years, and now some IRB offices are finding that these types of continuous improvement processes work well when used to create greater efficiencies in the human research protection world.
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In their own words: Docs describe extended hours
How do physicians on the frontlines feel about the ongoing debate about their working hours? Here are some of the comments to a recent Washington Post article on the issue by people identifying themselves as physicians.
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Demands to Stop Controversial Work Trials
Refuting that it gave a green light to “highly unethical” research, the Accreditation Council for Graduate Medical Education won't rescind waivers of 2011 duty-hour requirements for physician training.
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Is it a study or not? Decision tree helps
When researchers told the Cornell University IRB in a survey how difficult it was to determine whether a study should be submitted for IRB review, the IRB office created a tool that would make it easier for researchers to make the correct choice.
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Small IRBs can demonstrate value to research institutions
Among the anticipated changes with the Common Rule’s recent Notice of Proposed Rulemaking (NPRM) is a shift from having IRBs make exempt determinations to researchers using an exempt status tool to make their own determination.
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Columbia researchers observing students in social situations to detect signs, clues to sexual violence
Students at Columbia University in New York City have expressed curiosity and concern about an ongoing ethnographic study wherein researchers observe their behavior in public settings that have included bars and parties in campus housing. One student termed it “pretty weird and uncomfortable,” while others said the researchers were friendly and forthcoming.
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Draft guidance for IRB meeting minutes calls for documenting a broad array of actions
When in doubt, document. That may be the best default position for IRBs based on draft federal guidelines created in part because some boards were being cited or warned about having inadequate meeting minutes.