Compliance
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AMA Prepares for COVID-19 Vaccine with Coding Updates
The American Medical Association recently revealed updates to the Current Procedural Terminology, helping the U.S. healthcare industry lay the administrative groundwork for an eventual COVID-19 vaccine.
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Tips for Conducting a Good Mock Survey
To make a mock survey successful, plan ahead and execute carefully. Leaders can use this brief list to set goals.
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Mock Surveys Can Augment Compliance Efforts
Pretend surveys may reassure the organization that compliance is good and it is ready for a real survey — or it can unearth deficiencies that should be corrected before they result in real penalties. In most cases, it is a mixture of both.
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IRB Websites Can Offer a Wealth of Useful Tools
An important and useful function of an IRB’s website is its ability to give researchers — as well as the public — access to a wide variety of forms, guidance, and tools. When created well, an IRB’s website can be easy to navigate. It also should be updated with new and revised information regularly. Like crowdsourcing websites and with permission, an IRB’s website also can adopt and adapt tools that researchers and other IRBs have found useful.
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Investigators Benefit from Using Online Self-Auditing Tools
One method to improve regulatory compliance while maintaining IRB efficiency lies in teaching investigators how to conduct self-audits of their protocols and studies.
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Self-Assessing IRB Operations Can Help HRPPs Stay Compliant, on Track
If an IRB sets a goal of greater efficiency, then giving researchers self-assessment tools and using self-auditing tools on IRB operations is a method that can work. These tools can help study coordinators and investigators turn their study protocol submissions from a hot mess into a submission that is mostly compliant and easier to pre-review.
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Government Accountability Office to Study For-Profit IRBs at Senators’ Request
The Government Accountability Office agreed to “investigate the operations” of commercial IRBs at the request of U.S. Sens. Elizabeth Warren, D-MA, Sherrod Brown, D-OH, and Bernie Sanders, I-VT.
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Research Professionals Question Structure, Effectiveness of IRBs
Finding ways to evaluate IRB ethical quality and effectiveness has been an elusive ideal. Two research professionals are advocating for directly measuring quality of board oversight, rather than relying on the structure of the IRB. An upcoming U.S. Government Accountability Office evaluation of commercial IRBs also may promote the conversation.
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Court Vacates $911,000 Malpractice Verdict on Expert Testimony Rule
This case provides another example of how trial strategy and preparation is essential to the positive outcome of a case, with particular focus on the selection and retention of expert witnesses. Expert witnesses often can make or break a case, and that is true for either party in a medical malpractice action.
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Online Ratings Pose Risk of Defamation, May Need Response
The risk of defamation increases with the proliferation of online rating services in the medical industry, experts say.