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DNP 825 Describe the purpose of the Institutional Review Board (IRB) and the types of determinations the board makes

Re: Topic 1 DQ 2

I hope you are doing well. In combining your questions from both topics one and two, I learned that IRBs had faced several challenges during the COVID-19 pandemic, the most important of which is the need to rapidly review an influx of applications in a way that will avoid unnecessary delays in promising science during a public health emergency while simultaneously making sure that Hsu appropriately protects the rights, welfare, and interests of research participants, (Hsu, N. S., et, al., (2021).   A snapshot of how a group of HRPPs approached the review of COVID-19-specific protocols at the start of the pandemic in the USA, as well as the number and types of studies reviewed during this time and IRB turnaround speed, was surprising to me because of the critical nature of the pandemic.  A review of COVID-19-specific protocols by Hsu N. S. et al. (2021)  determined that IRBs were identifying the same type of administrative, regulatory, and ethical concerns in these protocols as those typically placed in the general review of research.   Common institutional approaches included efforts to manage IRB workloads (and other institutional resources) through administrative review before board review and increasing IRB responsiveness by moving COVID-19-specific protocols to the front of the queue, holding additional meetings, or relying on COVID-19-specific review panels. Research shows that IRBs received a substantial number of new protocols but could take advantage of regulatory pathways intended to minimize the burden, including exemption and expedited review, for most of them. This likely enabled IRBs to focus on the smaller number of COVID-19-specific protocols in need of more significant oversight due to increased risk and complexity.

Hsu, N. S., Hendriks, S., Ramos, K. M., & Grady, C. (2021). Ethical considerations of COVID-19-related adjustments to clinical research. Nature medicine27(2), 191–193. https://doi.org/10.1038/s41591-020-01216-2


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