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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an offer they can’t refuse: Agree to share your clinical trial data with subsequent researchers or your manuscript will not be published.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.
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IRB and IT collaboration can reap HRPP rewards
IRBs and researchers likely underestimate their vulnerability to data security breaches, which are a growing problem across the healthcare industry.
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IRB members in their own words
Robert L. Klitzman, MD, interviewed some 45 IRB members for his new book, The Ethics Police? The following are some of the published comments by both IRB chairs and members on how they came to be on an IRB and their challenges in weighing the risks and benefits of human research.
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The ethics police? New book issues challenge for change
Meet Robert L. Klitzman, MD, director of the Masters of Bioethics Program at Columbia University in New York City, and the author of The Ethics Police? The Struggle to Make Human Research Safe.
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Staffing remains a big issue for IRBs in 2016
The job market for experienced and credentialed IRB directors and staff remains high as 2016 begins, but IRB offices continue to cope with increasing workloads and understaffing.