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An associate professor at Columbia Law School in New York City wrote about the handling of research grievances from research studies. The processes for resolving research participants’ concerns are a “curiously unregulated space." While the United States court system might recognize claims about physical injuries during a trial or a negligent study design, it usually is left to the IRB to resolve disputes between trial participants and research staff.
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Like many of its counterparts, the IRB at New York State Psychiatric Institute (NYSPI) evaluates any complaint from a research participant on an individual, case-by-case basis. IRB Advisor spoke with Corinne Rogers, MS, CIP, NYSPI IRB director, to find out more about her research-related dispute procedures.
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Data safety monitoring boards (DSMBs) have played a big role in delivering vaccines and treatments to the public faster in the past 18 months. DSMBs reviewed results and safety data of the various studies involving treatments and vaccines for COVID-19. IRB Advisor asked two scientists about how DSMB work has helped improve research protections during the pandemic.
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An IRB process improvement project reduced the protocol modification time by half. The change required the IRB chairs to give up some of their responsibilities and put these new responsibilities on the IRB coordinators.
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The results of a recent study indicate potential research participants are open to alternative vaccine trial designs, including challenge trials in which participants are exposed to COVID-19.
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As of Jan. 1, 2022, accredited facilities must educate, train, monitor, and assess more often.
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This case illustrates the standard of causation used in wrongful death and other actions alleging a patient’s injuries were caused by a doctor’s or hospital’s negligence. In this case, the expert essentially testified to several actions by the hospital and attending physician that increased the risk of injury to the patient, but did not specifically conclude any one or more of those allegedly negligent actions actually caused the patient’s death.
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This case shows the importance of jury instructions in medical negligence cases and defines how a court properly places the issues before the jury after evidence has been presented.
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The results of an analysis of closed nursing claims indicate costs have recently risen, and the increase is worse in some specialties. The average total incurred for each professional liability claim involving nurses has increased from similar analyses in 2011 and 2015. Costs increased to more than $210,000 per claim, a 4% increase since 2015.
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New research is shedding light on alarm fatigue and how to combat it. False alarms may be more problematic than the overall noise level in a unit.