Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 36, No. 3, March, 2021

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Excerpt from pg. 3 … IRBs, COVID, and Research On Convalescent Plasma

“IRBs and researchers working on the COVID-19 pandemic have yet another version of an oft-revised FDA guidance to heed. Titled “Investigational COVID-19 Convalescent Plasma,” the latest version was published in February.

Although it does not contain any section specifically titled for IRBs or human subject protections, the guidance nevertheless contains useful tips for certain IRBs and researchers.

As a FEDERAL REGISTER notice explained for an earlier version of the same guidance:

The guidance includes a discussion to facilitate the availability of investigational convalescent plasma when blood establishments, hospitals, and healthcare providers collect plasma that does not meet the Conditions of Authorization of the Emergency Use Authorization (EUA).

The guidance also provides recommendations for healthcare providers who wish to administer and study convalescent plasma under an investigational new drug (IND) application (85 Fed. Reg. 59319, September 21, 2020).”