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Crisis Management Requires Action Plan for Quick Deployment
Crisis management after a significant clinical event or other issue can thrust the risk manager into a sink-or-swim situation. A proper response can minimize the negative effect and a poor response can greatly magnify the fallout. Managing such an event requires preparation up front so an action plan can be activated when needed.
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Point Taken: CMS Revisions in Stewardship Regulation
In finalizing a regulation requiring antibiotic stewardship programs in hospitals, the Centers for Medicare and Medicaid Services made several revisions based on comments from the field.
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CMS Finalizes Drug Stewardship Regulation for Hospitals
In a long-anticipated action, the Centers for Medicare and Medicaid Services recently finalized its 2016 rule requiring antibiotic stewardship programs in hospitals.
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Methods to Improve the IRB/PI Relationship
There are natural conflicts between IRBs and principal investigators, but IRBs can take several steps to improve this crucial relationship. For instance, IRBs should treat everything on a case-by-case basis, depending on the situation, the principal investigator, and the IRB’s policies.
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Protecting Research Data in the Digital Age
The increasing array of devices and systems to access, store, and transfer research data calls for diligence and common sense to prevent breaches. How seriously is the research community taking this threat? The National Institutes of Health has essentially hired hackers to constantly probe and test its database for the All of Us genome research project.
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Is ‘Informed Consent’ an Oxymoron?
A study asking readers to consent to a short form containing only the key information about the research resulted in suboptimal comprehension, suggesting participants only skimmed through it or skipped it outright.
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OHRP Holds Workshop on ‘Pervasive’ Data
The unprecedented level of digital data available across an expanding electronic landscape poses complex challenges for IRBs as they attempt to provide ethical insight and ensure participant privacy. Some of these data are collected in clinical care, but the public also is generating data through health monitoring devices, GPS location systems, social media, and information collected and shared on mobile apps.
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Hospital Fined $74k in Flu Shot Religious Exemption Case
As more facilities go to mandatory vaccination policies, infection preventionists must clarify what exceptions are allowed and under what conditions.
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Focus on the Differences Between IRBs and HRPPs
As research institutions move toward a single IRB model and more studies are deemed exempt, there is a greater need for all stakeholders to understand the differences between an IRB and a human research protection program.
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Single IRB Common Rule Changes Arrive in January
Academic institutions are grappling with ensuring their IRBs are prepared for the January 2020 deadline to move multisite research to a single IRB. This deadline looms over all policy and procedural changes.