IRB Advisor
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Smoothing the Path for an IRB of Record
As increasing numbers of IRBs are entering into central IRB agreements, there are steps they can take to better prepare, including building trust with other research organizations and IRBs, experts say.
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Will NIH Answer Concerns from IRBs, Others?
The National Institutes of Health's final policy requiring the use of a single IRB for NIH-funded, multisite research leaves IRBs and research organizations with many unanswered questions.
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NIH’s New IRB of Record Policy Guidance Coming Soon
The Final National Institute of Health Policy on the Use of a Single Institutional Review Board for Multi-Site Research acknowledges that additional guidance is needed and will be issued before May 25, 2017, when the policy becomes effective.
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IRBs Have Less Than a Year to Prepare for NIH Policy
Ready or not, IRBs across the United States have only 10 months remaining to change the way they handle reviews of multisite research that is funded by the National Institutes of Health.
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State Passes Bill Granting Oversight of UM Psychiatric Research
Legislators have passed a bill granting oversight of psychiatric drug research at the University of Minnesota in Minneapolis to an independent state ombudsman’s office.
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Education May Overcome Reticence to Join Trials
People in general, and cancer research subjects in particular, are reluctant to participate in clinical trials -- a trend that could undermine progress toward treatment, according to a new survey.
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NIH Explains its Draft CT Protocol Template
A draft clinical trial template tool might help investigators design and submit better protocols.
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FDA Discusses New Guidance on Using EHRs for Clinical Investigations
New FDA guidance advises sponsors and clinical investigators to adhere to best practices, including the planning and management of using electronic health records in research, modifying the data, providing audit trails, and maintaining privacy and securing data.
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Add Some Climbs and Hills to Typically Flat Career Path
It might require creativity, but there are ways to make the IRB office structure less flat.
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Adopt the ‘Not a Success Until You Find a Successor’ Philosophy
With a huge chunk of the nation’s IRB leadership about to retire, now is the time to do succession planning, long-time IRB leaders say.