IRB Advisor – April 1, 2018
April 1, 2018
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Respect Tribal Sovereignty in Indigenous Research
In what may help overcome a history of well-earned distrust by indigenous people, a research collaborative has developed a curriculum to teach IRB members and others the distinct cultural issues that arise in studying Native Americans.
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Code of Ethics for IRBs Working With Indigenous Tribes
IRBs and researchers must recognize that “the truth comes from many places” if they want to work in good faith with Native American tribes.
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Try These Strategies for Improving Review Consistency
One IRB office created simple rules and a process to improve workflow efficiency. Using Toyota lean methodology, the office standardized interpretation of regulations and institutional policies.
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Smart Checklists Keep IRB on Track With Study Reviews
As an IRB office prepared for accreditation, staff looked for methods to increase compliance. An answer quickly formed: use the IRB’s electronic system to develop smart checklists.
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Preparation, Communication Key to Establishing IRB of Record
The first time the Vanderbilt University and Medical Center IRB served as an IRB of record was 15 years ago — a decade before the concept began to catch on with multisite clinical trials and large IRBs.
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The Search for Justice in the Human Genome
With sequencing of the human genome completed at the turn of this century, there was the heady expectation that the summit to great cures was about to be climbed like the iconic spiral staircase of DNA.
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Five Years in the Making, FDA Issues Final Rule on Data and Devices
The FDA issued a final rule, effective Feb. 21, 2019, to revise regulations about accepting data from clinical studies involving medical devices.
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Into the Gray: Local IRBs Must Define Research
It’s only fitting, with the revised Common Rule in limbo, that there should remain some uncertainty about what constitutes human research — and what doesn’t.