IRB Advisor – May 1, 2019
May 1, 2019
View Issues
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WHO Calls for International Registry, Oversight of Gene Editing Research
Plans call for the committee to gather information from a wide range of sources with the goal of developing recommendations for “a comprehensive governance framework that is scalable, sustainable, and appropriate for use at the international, regional, national, and local levels."
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Preventing Rogue Researchers Should Be on IRBs’ Priority List
Bioethicists and the human research protections industry have been shocked in recent years by reports of rogue researchers carrying out investigations that raise huge red flags and, in some instances, could be regulatory breaches.
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Researchers' Advertising Can Fall Into Noncompliance
Investigators might begin to market their study to potential participants even before they have received IRB approval, or make changes to their advertising and recruitment materials after an original version and format were approved.
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Is It Standard of Care, Research, or Something Else?
Researchers and IRBs sometimes have questions about studies and treatment that fall in the gray area between research and personalized medical care. Is it innovative care that is intended to benefit a specific patient — or an innovation that has the potential of being generalizable?
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Overcoming Bots and Trolls in Research on Social Media
Social science research using Twitter to gather attitudinal and behavioral data must account for bots and trolls but can still render meaningful results.
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OHRP Explains What to Do About Expedited Reviews
Irene Stith-Coleman, director of the division of policy and assurances at the Office for Human Research Protections, answers questions about recent guidance related to the revised Common Rule and the recent frequently asked questions.
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Was There Really Support for Single IRB Approach?
To answer this question, researchers reviewed the public comments submitted on the proposal for single-IRB review. They reviewed hundreds of comments on the question when it was originally broached in 2011 and then again in the 2015 Notice of Proposed Rulemaking.
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Ethics of Genetic Research on Alcohol Addiction
Genetic testing is not yet ready for use in the prediction of alcohol dependence, according to recent ethical guidance.