The Korea Herald

지나쌤

S. Korean government launches central IRB to expedite clinical trials of COVID-19 vaccines, treatments

By Shim Woo-hyun

Published : July 30, 2021 - 16:57

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South Korea‘s first centralized institutional review board kicked off operations Friday, amid hopes it would expedite the review of drugs and treatments used to treat serious conditions, including COVID-19.

An institutional review board, or IRB, is a constituted group designated to review and monitor biomedical research involving human subjects. Many hospitals, universities and other medical institutions in South Korea have their own IRB, but there was no state-authorized central IRB.

“In multicenter trials, IRB reviews at different medical institutions can duplicate efforts, increase spending and delay clinical trials,” according to an official from the Ministry of Food and Drug Safety.

The newly established board will review studies involving multiple institutions on behalf of IRBs at the involved institutions.

The Drug Ministry said around 40 local hospitals have decided to join the state-authorized central IRB to date. The ministry added the review board will consist of IRB members from the participating hospitals.

The ministry also anticipated that the coalition of medical experts and their medical capabilities will help protect the rights, safety and welfare of study subjects in clinical research here.

According to the ministry, the central IRB will first conduct reviews on clinical studies of COVID-19 vaccines and treatments and later expand its reviews on studies involving other medications.

The ministry held an inauguration ceremony for the central IRB at Asan Medical Center in Seoul, Friday.