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As the use of central IRBs grows nationally, these models are increasing consistency in IRB review, but they also are causing some confusion for institutional IRBs.
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Thanks to the rise in private equity ownership, the number of independent IRBs may be shrinking, but the number of services they offer is greatly expanding.
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Small IRBs often have a resource dilemma: How do you help the IRB improve consistency and quality of reviews when staffing is limited?
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The 21st century IRB office is run by professional-level staff more than in previous years. While 30 years ago an IRB could rely on a long-time employee who had experience without credentials, this model is becoming rare.
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Research institutions sometimes struggle with retaining experienced IRB members as the workload can be significant and there are so many competing duties and projects for these scientists, professors, bioethicists, and other professionals.
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The 2011 changes to the National Institutes of Health (NIH) Public Health Service (PHS) regulations for reporting investigator conflicts of interest may still be causing confusion for researchers and IRBs.
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Using the National Cancer Institute's Central IRB (CIRB) saved affiliated institutions money, staff time and time spent on review, according to a recent study of the costs and benefits associated with the CIRB.
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For more than 30 years, the National Surgical Adjuvant Breast and Bowel Project has collected copies of every consent form signed by the more than 130,000 patients enrolled in its clinical cooperative group trials.
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When an institution conducts IRB reviews of hundreds of protocols, it can be hard to maintain consistency on such details as language used in informed consent to describe potential risks and adverse events.
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Some of the thorniest questions that IRBs face are those for which there are no clear-cut answers opinions may vary, arguments on both sides may be compelling, regulatory guidance may be scanty.
