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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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Anxiety disorders are the most prevalent mental health problem worldwide. As practicing emergency physicians know, anxiety is common in emergency department patients.
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How would one interpret the ECG in the figure, obtained in the ED from a middle-aged man with new chest pain?
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The FDA has approved a new, but controversial, treatment for Alzheimer’s disease.
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By shortening the duration of antibiotic therapy, a procalcitonin-guided protocol decreased the rate of infection-associated adverse effects, decreased costs, and reduced mortality in patients with sepsis.
