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Compliance in research oversight has become a more prevalent concept in recent years, and this has led IRBs and research institutions to search for new ways to improve compliance communication and policies.
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On the surface, it seems that individuals who oversee biomedical research face challenges that are very different from those encountered by their peers in behavioral and social science research.
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Three weeks after a phase I clinical trial ended terribly wrong, four of the six London, England, volunteers remained hospitalized, and one patient remained in critical condition. No one could have predicted such an outcome for the first trial for a drug to treat cancer and autoimmune diseases.
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In the past, IRBs considering protocols that sought to survey or interview trauma victims had to essentially follow their gut when pondering the question: Would answering questions harm participants by causing them to relive their painful experiences?
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To keep IRBs informed on current FDA thinking, the agency has created the Good Guidance Practices (GGPs) program. This is a process whereby dated and obsolete guidance is replaced by new information sheets on a variety of topics, along with the opportunity to comment.
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Hospitals participating in the Maryland Patient Safety Centers (MPSC) Intensive Care Unit (ICU) Safety Culture Collaborative, a statewide effort to improve safety in intensive care units, are showing major improvements in the reduction of ventilator-associated pneumonias (VAPs) and catheter-related bloodstream infections (CR-BSIs).
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Robert Wood Johnson University Hospital Hamilton (RWJ Hamilton), a recipient of the 2004 Malcolm Baldrige National Quality Award, has just begun offering a new bariatric (weight loss) program; but long before it took its first case, it has been making preparations to ensure the highest possible quality of care.
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The Washington, DC-based National Quality Forum (NQF) has undertaken a project to seek consensus on a set of national performance measures for public reporting of health care-associated infections.
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The American Hospital Association (AHA) has created a performance improvement organization to serve as a resource specifically targeting process improvement in the hospital setting.
