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Whether institutions are the IRB of record or the relying IRB, setting up a seamless process involves many time-consuming processes — and it can take years. One of the obstacles to an efficient IRB reliance effort is handling the technological details.
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It is unlikely IRBs will see many studies with one enrolled participant (the N=1 study design), but they should be prepared for this type of protocol. The single-subject study design can be applied to chronic conditions like cystic fibrosis or to ultra-rare diseases.
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One hot topic during a recent webinar on diversity in clinical trials centered around whether researchers should use race in a clinical trial. Using race as a variable is never neutral and never scientific, one expert noted.
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Structural racism is a powerful construct that may influence participation in clinical research studies, panelists of a recent webinar noted.
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Diversity in clinical trials involves more than just including more minority participants, panelists said at a recent webinar. It is a commitment from leadership that addresses the diversity topic within every aspect of the clinical trial process.
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Emergency departments have a unique role in public health. They care for a disproportionate number of patients who lack access to care in other venues. Emergency departments also can play a role in decreasing vaccine hesitancy, providing information to patients on the vaccine, answering their questions, and correcting misinformation when it is present.
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Party Affiliation and Social Distancing; Ethnicity and Occupation as Risk Factors for COVID Infection
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Cytomegalovirus (CMV) viremia emerges in the majority of CMV seronegative recipients of liver transplants from CMV seropositive donors, most often within the first post-transplant month. The only independent risk factor identified was increasing donor age.
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A review of 24 cases of Nocardia brain abscess, two-fifths of which occurred in apparently non-immunocompromised hosts, had variable outcomes, but antibiotic therapy was effective in most.
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In addition to identifying several patient risk factors for contamination of blood culture specimens, the authors also highlighted various adverse clinical and financial adverse effects.