IRB Advisor
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French study’s death recalls 2006 UK clinical trial disaster
It was an unsettling sense of deja vu for researchers and bioethicists when French authorities reported in January that one man died and five others were seriously injured after being administered an investigational drug in a Phase I clinical trial.
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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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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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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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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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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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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an offer they can’t refuse: Agree to share your clinical trial data with subsequent researchers or your manuscript will not be published.
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Patients using social media to lobby for access to investigational drugs
Social media campaigns have successfully pressured drug companies to approve some requests for investigational drugs for terminally ill patients under expanded access programs, but this raises significant ethical concerns, experts say.
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Improve evaluation of IRB’s QI/QA processes
IRB offices need a systematic approach to quality improvement processes. They also should have a way to evaluate performance, subjecting the office to internal scrutiny, an IRB expert says.
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IRB develops improved staff training for new hires
Leaders at one IRB decided to address concerns about new hire training through the development of a standardized training program for all new staff members.