IRB Advisor – July 1, 2016
July 1, 2016
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Reanimation Study a Step Toward Brain-death Breakthrough?
A new reanimation study of brain death has many compelling and hopeful aspects to its principal investigator in India and biotech sponsor in the U.S.
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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.
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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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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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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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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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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.