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A year after its public meeting on the Support study, the Office of Human Research Protections (OHRP) issued a draft guidance to clarify its thinking on the disclosure of reasonably foreseeable risks in standard of care research.
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For years now, IRB managers have been developing and using tools, including checklists and templates. The goal is to improve IRB review consistency and to expedite the approval turnaround process. While checklists and tools are useful, they can also be a problem.
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Human research protection programs (HRPPs) are poised for the next level of evolution as todays controversies push research ethics in new directions.
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IRB board member self-evaluations are crucial for determining how members view their IRB service and measuring the performance of the HRPP itself. But IRB administrators who are looking for self-evaluation tools may have a hard time deciding where to start, or which issues should be the focus.
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Enid Virago, PhD, CIP, CCRP, and Joanna Lyons, RN, DEd, developed the Evaluation of Research Protections Programs and Committee Membership Self-Evaluation to measure IRB member service satisfaction and performance of the HRPP.
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summer when debates raged over Facebooks social media study. Public rebukes of studies involving big data and social media are fairly rare, but these studies can raise all kinds of ethical challenges.
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The top 10% of the 445 participants in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP®) were recognized in October for hitting the mark on a variety of data points deemed important to surgical outcomes.
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Theres nothing new in The Joint Commissions first chapter of the 2015 Comprehensive Accreditation Manual Hospitals, and yet, everything about it is new. The chapter includes more than two dozen standards, all of which appear in other chapters, all having to do with patient safety systems, creating a learning organization, and fostering a culture of quality.
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If you are an accredited hospital, you already know what to do if Ebola comes to your door. At least thats the theory. But what we think we know how to do, and what actually happens may not always coincide.
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If you ask someone familiar with Lean management systems to name one of the things that makes those systems different from more traditional healthcare management, he or she may very well mention that leadership makes it a point to head to the front lines regularly.
