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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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Juggling the work of an IRB of record and becoming a relying IRB can be challenging. But one underlying goal can keep an IRB on track with both roles: consistency.
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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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Virtual training for clinical trial teams may have existed for years, but it has gained significant attention during the COVID-19 pandemic. Experts expect the popularity of this kind of training to increase, even after COVID-19 restrictions are relaxed.
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As IRBs review participant incentives for studies, they assess whether the incentives are coercive or exploitive. New research provides a snapshot of the diversity of these incentive offerings, revealing monetary payments for biomedical studies tend to be 10 times higher than payments for sociobehavioral studies.
