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IRB Advisor

March 1, 2016

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Top medical journals propose mandating data sharing

The International Committee of Medical Journal Editors — which counts several prestigious periodicals among its members — is giving authors an offer they can’t refuse: Agree to share your clinical trial data with subsequent researchers or your manuscript will not be published.

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A clinical trial disaster in France results in injuries and death

One man died and five others were seriously injured in January 2016 after they participated in a Phase I clinical trial in France.

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Research communities work creatively to improve minority recruitment in clinical trials

In the three years since Congress passed the Food and Drug Administration Safety and Innovation Act of 2012 with its provision encouraging the inclusion of minorities in clinical trials, IRBs and research sites have continued to struggle with the need to diversify study participant pools.

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Strategies for improving study recruitment of minorities

Investigators and IRBs are finding a variety of ways to increase minority representation in studies and clinical trials, including policies mandating such recruitment.

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This IRB “party” gets the job done

There might be a simple solution to IRB workflow issues that stem from graduate student research cycles: A party.

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Should infection control research be IRB exempt?

The Association for Professionals in Infection Control and Epidemiology warns that proposed revisions to the Common Rule may have unintended consequences if infection prevention research is not excluded from approval by IRBs.

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